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  • 14690: Total Cancer Care Protocol: A Lifetime Partnership with Patients Who Have or May be at Risk of Having Cancer.

    1.1 To establish a longitudinal clinical and related data and tissue repository that will contain: X Initial demographics, medical history, family history, nutritional history, cancer predisposing risk factors, quality of life, and quality of care data from all participants via surveys, review of medical records and cancer registries. (Required participation element for Consortium Sites) X Lifetime follow-up information regarding medical treatment, pathology records, and response and recurrence history of all participants as long as the study remains in progress. (Required participation element for Consortium Sites). View All Details

    • Protocol Number:
      001502

    • Principal Investigator:
      Eric Singer M.D

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eric Singer M.D
    • Rutgers Cancer Institute of New Jersey
  • 16-001: Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents. - NCT03020030

    To test a novel risk group classification scheme with the goal of reducing rates of treatment-related toxicity without compromising complete remission rates and overall event-free survival. a. To test whether remission induction can be de-intensified in low-risk B-ALL patients without adversely impacting complete remission rates or proportion of patients classified as very high risk on the basis of high minimal residual disease (MRD levels). b. To determine rates of event-free survival, disease-free survival and overall survival associated with novel risk group classification scheme. View All Details

    • Protocol Number:
      111805

    • Principal Investigator:
      Peter Cole M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, not otherwise specified,Lymphoid Leukemia,Leukemia, other

      • Contacts:

      • Rutgers University Prinicipal Investigator: Peter Cole M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Confirmed diagnosis of acute lymphoblastic leukemia. Diagnosis should be made by bone marrow aspirate or biopsy demonstrating ≥ 25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-precursor or T-ALL phenotype.
    • - For patients with circulating blasts in the peripheral blood, flow cytometry confirmation of B-ALL or T-ALL phenotype is sufficient for registration onto the study. Bone marrow aspirate and/or biopsy should be performed as soon as feasible, preferably prior to the initiation of any therapy. 2. Prior Therapy: No prior therapy is allowed except for the following:
    • Corticosteroids: Short courses of corticosteroid (defined as ≤ 7 days of corticosteroids within the 4-weeks preceding registration) are allowed prior to registration.
    • -- Participants who have been on corticosteroids chronically (defined as more than 7 days of corticosteroids within the 4-weeks preceding registration or more than 28 days of corticosteroids over the preceding 6 months) are not eligible.
    • IT cytarabine: A single dose of intrathecal cytarabine (at the time of the diagnostic lumbar puncture) is allowed prior to registration. If patient has received IT cytarabine prior to registration, Day 1 IT cytarabine should not be administered.
    • Emergent Radiation Therapy: Emergent radiation to the mediastinum or other life-threatening masses is allowed prior to registration. 3. Age: 365 days to < 22 years 4. Direct bilirubin < 1.4 mg/dL (23.9 micromoles/L). 5. Ability of parent or guardian to understand and the willingness to sign a written informed consent document.

    Exclusion Criteria:

      1. Mature B-cell (Burkitt's) ALL (defined by the presence of surface immunoglobulin and/or the t(8;14)(q24;q32), t(8;22), or t(2;8) translocation and/or c-myc-gene rearrangement). 2. World Health Organization diagnostic criteria of mixed phenotype acute leukemia (MPAL) or leukemia of ambiguous lineage 3. Any chemotherapy or radiotherapy for previous malignancy are not eligible. 4. Treatment in past with any anti-neoplastic agent, including methotrexate, 6-mercaptopurine, 6-thioguanine, vincristine cyclophosphamide, cytarabine (except for IT cytarabine), or any anthracycline, for any reason (eg, rheumatologic or autoimmune condition). 5. Currently receiving any investigational agents. 6. Known HIV-positivity 7. Uncontrolled intercurrent illness including, but not limited to ongoing infection with vital sign instability (hypotension, respiratory insufficiency), life-threatening acute tumor lysis syndrome (eg, with renal failure), symptomatic congestive heart failure, cardiac arrhythmia, intracranial or other uncontrolled bleeding, or psychiatric illness/social situations that would limit compliance with study requirements. 8. Pregnant women are excluded from this study because many of the agents used on this protocol have potential for teratogenic and/or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with these chemotherapy agents, breastfeeding should be discontinued if the mother is enrolled. 9. History of a previous malignancy. Exception: Individuals with a previous malignancy treated with surgery only (no chemotherapy or radiotherapy) more than 5 years prior to registration may be enrolled.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma - NCT02954094

    Primary Aims 1. Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice Secondary Aims 1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function 2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires 3. Establish a Biorepository Specimen Bank (BSB) Exploratory Aims 1. Investigate optimal type, duration, and sequence/combination of treatment interventions for HCC used in usual clinical practice 2. Perform biomarker analyses to identify potential markers predictive of response patterns or side effect profiles 3. Generate hypotheses that may lead to further investigations regarding natural course and treatment of HCC View All Details

    • Protocol Number:
      001720

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

      • Contacts:

      • Rutgers Robert Wood Johnson Medical School Prinicipal Investigator: Vinod Rustgi MD, MBA

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male or female patients, age ≥18 years 2. Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)

    Exclusion Criteria:

      1. Inability to provide written informed consent

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Basket Trial of Pembrolizumab in Patients with Advanced Solid Tumors and Genomic Instability (multi-center) - NCT03428802

    To evaluate the response rate of pembrolizumab in patients with evidence of genomic instability classified as follows: 1) All solid tumors with POLE and POLD1 mutations 2) All solid tumors with BRCA1/2 mutations View All Details

    • Protocol Number:
      051709

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Be willing and able to provide written informed consent/assent for the trial
    • Have a diagnosis of a tumor with evidence of genomic instability on Clinical Laboratory Improvement Amendments (CLIA) certified genomic testing, inclusive of mutations in POLE, POLD1 for arm 1 and in BRCA1 and BRCA2 for arm 2; in arm 2, enrollment of breast and ovarian histologies will be limited to a total of 10 patients
    • Have advanced cancer (metastatic, recurrent or locally advanced) and measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    • Be willing to provide archived tumor tissue; tissue from the most obtained core or excisional biopsy of a tumor lesion is preferred; 20 unstained slides are preferred but a minimum of 15 slides will be acceptable; if adequate tissue is not present the patient may consent to a newly obtained biopsy
    • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
    • Absolute neutrophil count (ANC) >= 1,500 /mcL, performed within 10 days of treatment
    • Platelets >= 100,000 / mcL, performed within 10 days of treatment
    • Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment), performed within 10 days of treatment
    • Serum creatinine =< 1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]), performed within 10 days of treatment
    • Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases, performed within 10 days of treatment
    • Albumin >= 2.5 mg/dL, performed within 10 days of treatment
    • International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment
    • Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment
    • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
    • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
    • Male subjects should agree to abstinence or use of an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy

    Exclusion Criteria:

    • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
    • Has a diagnosis of immunodeficiency that requires receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment or has resulted in life threatening episodes previously regardless of current treatment
    • Has a known history of active TB (Bacillus tuberculosis)
    • Hypersensitivity to pembrolizumab or any of its excipients
    • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
    • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent
    • Note: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
    • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
    • Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, or malignancies that have been inactive for three years or exceptionally indolent; any current diagnosis of second malignancy requires approval from principal investigator and sponsor
    • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 30 days prior to trial treatment; patients who had oligometastatic disease treated with stereotactic radiation or gamma knife therapy may receive treatment 14 days after therapy as long as they are not requiring steroids; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
    • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
    • Has known history of, or any evidence of active, non-infectious pneumonitis
    • Has an active infection requiring systemic therapy
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
    • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
    • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
    • Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
    • Has received a live vaccine within 30 days of planned start of study therapy
    • Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
    • Tumors harboring non-hotspot POLE or POLD1 mutations that show clear evidence of microsatellite instability (MSI) will be excluded
    • Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A First-in-Human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects with Advanced Solid Tumors - NCT04485013

    Primary Objective: To assess safety and tolerability of increasing dose levels of TTX-080 in successive cohorts of subjects with advanced solid tumors to identify the maximum tolerated dose (MTD) or maximum administered dose and select the recommended Phase 2 dose (RP2D)/schedule. Secondary Objectives(s): (1) To characterize the single-dose and/or multiple-dose pharmacokinetics (PK) of TTX-080 following intravenous (IV) administration in subjects with advanced solid tumors. (2) To evaluate the immunogenicity of TTX-080 in subjects with advanced solid tumors. (3) To evaluate the preliminary antitumor activity of TTX-080 in subjects with advanced solid tumors. Exploratory Objective: To assess the effects of TTX-080 on pharmacodynamic biomarkers relating to mechanism of action and immune responses. View All Details

    • Protocol Number:
      052006

    • Principal Investigator:
      Nancy Chan M.D

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      TTX-080

      • Contacts:

      • Rutgers University Prinicipal Investigator: Nancy Chan M.D

    Read Inclusion & Exclusion Criteria

    Abbreviated Inclusion Criteria:

      1. Subject with histological or cytological diagnosis of advanced/metastatic cancer 2. Age 18 years or older, is willing and able to provide informed consent 3. Evidence of measurable disease 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

    Abbreviated Exclusion Criteria:

      1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody 2. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy 4. History of severe autoimmune disease 5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Global, Multicenter, Randomized, Placebo - Controlled Phase 3 Trial to Compare the Efficacy and Safety of Fruquintinib Plus Best Supportive Care to Placebo Plus Best Supportive Care in Patients with Refractory Metastatic Colon Cancer (FRESCO-2) - NCT04322539

    This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in subjects with refractory metastatic colorectal cancer (mCRC). View All Details

    • Protocol Number:
      072005

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Fruquintinib/Placebo

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Provide written informed consent;
    • Age ≥18 years;
    • Histologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines;
    • Subjects must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Subjects are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Subjects who have been treated with both TAS-102 and regorafenib are permitted. Subjects must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy;
    • Subjects with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the subject's country unless the patient is ineligible for treatment with a checkpoint inhibitor;
    • Subjects who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Subjects who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible;
    • Body weight ≥40kg;
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
    • Have measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions;
    • Expected survival >12 weeks.
    • For female subjects of childbearing potential and male subjects with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the subject. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male subjects involved in this clinical trial if they have a partner of childbirth potential, and male subjects must always use a condom.
    • Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the subject's home country unless the patient is ineligible for treatment with a BRAF inhibitor.

    Exclusion Criteria:

    • Absolute neutrophil count (ANC) <1.5×109/L, platelet count <100×109/L, or hemoglobin <9.0 g/dL. Blood transfusion within 1 week prior to enrollment for the purpose of increasing the likelihood of eligibility is not allowed;
    • Serum total bilirubin >1.5 × the upper limit of normal (ULN). Patients with Gilbert syndrome, bilirubin <2 X ULN, and normal AST/ALT are eligible;
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 × ULN in patients without hepatic metastases; ALT or AST >5 × ULN in patients with hepatic metastases;
    • Serum creatinine >1.5 × ULN or creatinine clearance <60 mL/min. Creatinine clearance can either be measured in a 24-hour urine collection or estimated by the Cockroft-Gault equation.
    • Urine dipstick protein ≥2+ or 24-hour urine protein ≥1.0 g/24-h. Subjects with greater than 2+ proteinuria by dipstick must undergo a 24-hour urine collection to assess urine protein level;
    • Uncontrolled hypertension, defined as: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg despite optimal medical management;
    • International Normalized Ratio (INR) >1.5 x ULN or activated partial thromboplastin time (aPTT) >1.5 × ULN, unless the patient is currently receiving or intended to receive anticoagulants for prophylactic purposes;
    • History of, or active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation or fistulas; or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation; within the 6 months prior to screening;
    • History or presence of hemorrhage from any other site (eg, hemoptysis or hematemesis) within 2 months prior to screening;
    • History of a thromboembolic event, including deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial embolism within 6 months prior to screening.
    • Stroke and/or transient ischemic attack within 12 months prior to screening;
    • Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction (LVEF) <50% by echocardiogram;
    • Mean corrected QT interval using the Fridericia method (QTcF) >480 msec or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in a first-degree relative.
    • Concomitant medications with a known risk of causing QT prolongation and/or Torsades de Pointes.
    • Systemic anti-neoplastic therapies (except for those described in Exclusion 18) or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
    • Systemic small molecule targeted therapies (eg, tyrosine kinase inhibitors) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug;
    • Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of study drug;
    • Brachytherapy (i.e., implantation of radioactive seeds) within 60 days prior to the first dose of study drug.
    • Use of strong inducers or inhibitors of CYP3A4 within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug;
    • Surgery or invasive procedure (i.e., a procedure that includes a biopsy; central venous catheter placement is allowed) within 60 days prior to the first dose of study drug or unhealed surgical incision;
    • Any unresolved toxicities from a previous antitumor treatment greater than CTCAE v5.0 Grade 1 (except for alopecia or neurotoxicity grade≤2);
    • Known human immunodeficiency virus (HIV) infection;
    • Known history of active viral hepatitis. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
    • Clinically uncontrolled active infection requiring IV antibiotics;
    • Tumor invasion of a large vascular structure, eg, pulmonary artery, superior or inferior vena cava;
    • Women who are pregnant or lactating;
    • Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease for 14 days or longer; patients requiring steroids within 4 weeks prior to start of study treatment are excluded;
    • Other malignancy, except for non-melanoma skin cancer, in situ cervical ca or bladder ca (Tis and T1) that have been adequately treated during the 5 years prior to screening;
    • Inability to take medication orally, dysphagia or an active gastric ulcer resulting from previous surgery (eg, gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product;
    • Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition (e.g., current alcohol or drug abuse) that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at undue risk of harm based on the investigator's assessment;
    • Known hypersensitivity to fruquintinib (or placebo) or any of its inactive ingredients including the azo dyes Tartrazine - FD&C Yellow 5 and Sunset yellow FCF - FD&C Yellow 6;
    • Subjects who have received prior fruquintinib;
    • Live vaccine <28days before the first dose of study drug(s). Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Saint Barnabas Medical Center
    • Monmouth Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Multi-Institutional Registry for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) - NCT02457117

    To evaluate the in-breast local failure (Ipsilateral breast events) and patterns of in-breast failure following CK-SAPBI. View All Details

    • Protocol Number:
      041902

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

      • Contacts:

      • RWJBarnabas Health - Community Medical Center Prinicipal Investigator: David D'Ambrosio

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Subjects are eligible to participate in the registry if they receive CK-SAPBI in 5 fractions within 12 weeks of surgery and sign an institution specific consent form. Additionally, subjects will be considered standard risk and optimal for CK-SAPBI if they meet the following criteria:
    • Newly diagnosed AJCC (seventh edition) Stage 0 or I breast cancer.
    • On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast
    • Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy
    • Age 50 years or greater
    • ER positive
    • PR positive
    • Her2 negative (IHC 0-1+; for IHC 2+, FISH must be non-amplified)
    • Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection.
    • Negative inked surgical margins of excision or re-excision, clear of invasive tumor and DCIS by at least 2 mm
    • Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications.
    • No involved axillary lymph nodes, N0(i+) allowed
    • Target lumpectomy cavity/whole breast reference volume must be <30% based on treatment planning CT

    Exclusion Criteria:

    • -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
    • Patients with tumors greater than 2 cm
    • Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation.
    • Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. Breast MRI will be required to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
    • Patients with involved axillary nodes.
    • Patients with collagen vascular diseases (active).
    • Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN, CDH1)
    • Patients with prior ipsilateral breast irradiation.
    • Patients with prior ipsilateral thoracic irradiation.
    • Patients with Paget's disease of the nipple.
    • Patients with diffuse suspicious microcalcifications.
    • Patients with suspicious microcalcifications remaining on the post-excision mammogram.
    • Patients receiving (neo)adjuvant systemic therapy other than hormonal therapy
    • Patients with oncoplastic reconstruction and absence of surgical clips

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Community Medical Center
  • A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients with HER-2 Positive Breast Cancer. - NCT03384914

    Primary Objectives - To evaluate safety and tolerability of each vaccine therapy - To determine disease free survival (DFS) of patients with HER2 positive breast cancer after treatment with each vaccine Secondary Objectives - To evaluate the immunogenicity following each vaccine therapy View All Details

    • Protocol Number:
      041807

    • Principal Investigator:
      Nancy Chan M.D

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Breast - Female,Breast - Male

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      WOKVAC DC1VAC

      • Contacts:

      • Rutgers University Prinicipal Investigator: Nancy Chan M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Clinical stage I-III HER2 positive breast cancer treated with neoadjuvant chemotherapy including HER-2 directed treatment for at least 12 weeks.
    • Residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant chemotherapy.
    • Completed last cycle of cytotoxic chemotherapy or radiation > 30 days with resolution of all acute toxic effects of prior therapy to grade ≤ 2 (except alopecia)
    • Currently on HER-2 targeted therapy (eg; trastuzumab +/- pertuzumab or adotrastuzumab emtansine (T-DM1) per standard of care) or has completed HER-2 targeted therapy less than 6 months ago
    • Age ≥ 18 years.
    • Eastern Cooperative Group (ECOG) performance status 0 or 1.
    • Must have normal organ and marrow function as defined below within 30 days of start of treatment:
    • Absolute neutrophil count (ANC) ≥ 1,500/ μL
    • Platelets ≥ 75,000/ μL
    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be <3.0 mg/dL
    • AST/ALT ≤ 3 x institutional upper limit of normal (ULN)
    • Creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
    • Hemoglobin A1C <6.5%
    • Left ventricular ejection fraction (LVEF) above institutional lower limit of normal (by echocardiogram or MUGA scan within 90 days of registration).
    • Females of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and males must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for three months following the last dose.
    • Ability to understand and willingness to sign a written informed consent document prior to initiation of any screening or study-specific procedures.

    Exclusion Criteria:

    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • Uncontrolled autoimmune disease requiring active systemic treatment.
    • Known hypersensitivity reaction to the Granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contraindication to GM-CSF.
    • Pregnant or breast feeding.
    • Known HIV-positive.
    • Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared.
    • Major surgery within 4 weeks of initiation of study drug.
    • Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30days prior to starting study drug will be excluded.
    • Potential participant is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Multicenter, Open Label, Phase III Extension Trial to Study the Long-Term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial. - NCT03486873

    Primary Objective: To estimate the OS. Secondary Objectives: - To estimate the DOR and DOCR per evaluation criteria used in the parent trial by investigator assessment for participants who have received or are receiving First Course Phase trial treatment with pembrolizumab or a pembrolizumabbased combination. - To evaluate the safety and tolerability of pembrolizumab or a pembrolizumab-based combination in participants who receive it as First or Second Course Phase trial treatment. View All Details

    • Protocol Number:
      051804

    • Principal Investigator:
      Kristen Spencer DO, MPH

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Kristen Spencer DO, MPH

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Advanced unresectable or metastatic tumor(s)
    • Currently enrolled in a Merck-sponsored pembrolizumab study and is receiving study treatment or in a Follow-up Phase at the time MK-3475-587 is open. The parent studies must have completed all regulatory requirements and submissions, if any, or have fully addressed their primary endpoint(s) before all their participants roll over into this MK-3475-587 extension study. Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
    • Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase
    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Demonstrates adequate organ function
    • Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
    • Male participant must agree to use contraception during the Second Course Phase study treatment period and for ≥120 days, corresponding to time needed to eliminate any study combination treatment(s), plus 75 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.
    • A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.

    Exclusion Criteria:

    • There are no exclusion criteria to participate in MK-3475-587. Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:
    • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
    • Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase
    • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
    • Has known active central nervous system metastases and/or carcinomatous meningitis
    • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
    • Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease
    • Has an active infection requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection.
    • Has a known history of or is positive for hepatitis B or hepatitis C
    • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
    • Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
    • Has hepatic decompensation (Child-Pugh score >6 [class B and C])
    • Has uncontrolled thyroid dysfunction
    • Has uncontrolled diabetes mellitus
    • Has had an allogeneic tissue/solid organ transplant
    • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Multicenter, Open-Label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors(LEAP-005) - NCT03797326

    Primary Objectives: (1) To evaluate objective response rate (ORR) of pembrolizumab in combination with lenvatinib per tumor cohort based on RECIST 1.1 by investigator assessments in initial cohorts and BICR in cohorts that expand combining the initial and expansion cohorts. (For participants with GBM, response will be assessed based on Response Assessment in Neuro-Oncology (RANO) criteria; all further references to RECIST 1.1 assessment apply to all cohorts except GBM). (2) To assess safety and tolerability of treatment with pembrolizumab in combination with lenvatinib per tumor cohort assessed by the proportion of AEs. Secondary Objectives: (1) To evaluate disease control rate (DCR), duration of response (DOR) and progression-free survival (PFS) of pembrolizumab in combination with lenvatinib per tumor cohort based on RECIST 1.1 by investigator assessments in initial cohorts and BICR in cohorts that expand combining the initial and expansion cohorts. (2) To evaluate overall survival (OS) of pembrolizumab in combination with lenvatinib per tumor cohort. (3) To characterize the population pharmacokinetics (PK) of lenvatinib when coadministered with pembrolizumab in participants per tumor cohort. View All Details

    • Protocol Number:
      051902

    • Principal Investigator:
      Nancy Chan M.D

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary,Other Digestive Organ,Brain and Nervous System,Breast,Stomach,Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Pembrolizumab (MK-3475) Lenvatinib (E7080/MK-7902)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Nancy Chan M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer
    • Must have progressed on or since the last treatment
    • Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR
    • Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
    • Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period
    • Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation
    • Has adequate organ function For Triple Negative Breast Cancer Participants:
    • Has received one or 2 prior lines of therapy
    • Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)
    • Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses For Ovarian Cancer Participants:
    • Has received 3 prior lines of therapy. Note: The initial 30 participants in this cohort included participants with primary ovarian cancer. The expanded cohort will include participants with primary ovarian cancer, fallopian tube, and peritoneal ovarian cancer. For Gastric Cancer Participants:
    • Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible For Colorectal Cancer Participants:
    • Has received 2 prior lines of therapy For GBM Participants:
    • Has failed initial systemic therapy for newly diagnosed GBM
    • Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines
    • Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable
    • Has histologically confirmed World Health Organization (WHO) Grade IV GBM
    • Has locally determined result for O^6-methylguanine-DNA methyltransferase (MGMT) analysis For Biliary Tract Cancer Participants:
    • Has received 1 prior line of therapy
    • Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6 For Pancreatic Cancer Participants:
    • Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment
    • Has received one or 2 prior lines of therapy
    • Has received prior therapy with at least 1 (platinum-containing regimen or gemcitabine-containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer

    Exclusion Criteria:

    • Has presence of gastrointestinal condition including malabsorption that might affect the absorption of lenvatinib
    • Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort)
    • Has radiographic evidence of major blood vessel invasion/infiltration. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are excluded
    • Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
    • Has significant cardiovascular impairment within 12 months of the first dose of study treatment: such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability
    • Has a history of arterial thromboembolism within 12 months of start of study treatment
    • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
    • Serious nonhealing wound, ulcer or bone fracture
    • Has had major surgery within 3 weeks prior to first dose of study interventions
    • Has biologic response modifiers (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry
    • Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula
    • Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
    • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start
    • If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
    • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
    • Has received a live vaccine within 30 days prior to the first dose of study treatment
    • Has known intolerance to lenvatinib (and/or any of the excipients)
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
    • Has known active CNS metastases and/or carcinomatous meningitis
    • Has tumors involving the brain stem
    • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
    • Has an active autoimmune disease that has required systemic treatment in past 2 years
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
    • Has an active infection requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection
    • Has a known history of hepatitis B or known active hepatitis C virus infection
    • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
    • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
    • Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection) For GBM Participants:
    • Has carcinomatous meningitis
    • Has recurrent tumor greater than 6 cm in maximum diameter
    • Has tumor primarily localized to the brainstem or spinal cord
    • Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease
    • Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans
    • Has received Optune® TTFields within 2 weeks of study intervention

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 1 Study of Talimogene Laherparepvec and Panitumumab in Patients with Locally Advanced Squamous Cell Carcinoma of the Skin (SCCS) - NCT04163952

    Primary Objectives: (1) To determine the safety of the combined treatment of talimogene laherparepvec and panitumumab. (2) To determine the preliminary efficacy of the combined treatment of talimogene laherparepvec and panitumumab, in comparison to single-agent panitumumab by historical control. Secondary Objectives: (1) To assess the clinical efficacy of panitumumab in combination with intratumoral talimogene laherparepvec in terms of immune-related progression-free survival (irPFS) at 12 months, PFS hazard ratio, overall response rate (ORR), 1-year survival, overall survival (OS) and time to resectability. (2) To measure the pathologic complete response rate to panitumumab combined with talimogene laherparepvec. (3) Assess the response of injected and non-injected tumor deposits after panitumumab and talimogene laherparepvec. (4) Assess the time to initial response. (5) Assess the durable response rate. (6) To analyze the following molecular correlates with response to therapy to confirm mechanism of action, and identify potential future targeted strategies and biomarkers of response: A) Mutation load in tumor tissue by next generation sequencing B) DNA mutation signature in tumor tissue pre- and post-therapy by next generation sequencing C) mRNA signature in tumor tissue pre-and post-therapy by Nanostring technology D) Immune cell populations and immune profile in pre- and post-therapy tumor tissue and peripheral blood by flow cytometry and IHC. View All Details

    • Protocol Number:
      091804

    • Principal Investigator:
      Adam Berger

    • Phase:
      Phase I

    • Scope:
      Local

    • Applicable Disease Sites:
      Other Skin

    • Therapies Involved:
      Chemotherapy multiple agents systemic Surgery

    • Drugs Involved:
      PANITUMUMAB Talimogene laherparepvec

      • Contacts:

      • Rutgers University Prinicipal Investigator: Adam Berger

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically confirmed squamous cell carcinoma of the skin (SCCS) that is a) locally advanced or metastatic for which curative surgery or radiation would be difficult or impossible, or b) recurrent after initial surgery, chemotherapy, or radiation therapy, or c) considered to have aggressive features including the following: tumors 2 cm or more, tumors invading deep tissues such as muscle, cartilage or bone; tumors showing perineural invasion, and/or tumors metastatic to loco-regional lymph nodes. Patients may have had prior surgical interventions or been treated with investigational agents with residual or recurrent disease
    • Tumor suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion, or aggregate of lesions, >= 10 mm in diameter
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
    • No prior treatment with panitumumab or talimogene laherparepvec for advanced disease
    • Prior surgery or radiation is allowed if there is documented progression in the radiated/resected area or elsewhere by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v) 1.1
    • Measurable disease by RECIST criteria v 1.1
    • Patients with a history of hematologic or solid organ transplant will be considered if they do not require high dose steroids or high dose immunosupressants for disease control or control of transplant rejection, and have adequate hematologic, renal, and hepatic function as specified below. Current medications must be reviewed with transplant pharmacy team to exclude potentially serious interactions and case discussed with the study principal investigator (PI)
    • Second primary malignancy only if treatment would interfere with the patient?s participation in this trial in the opinion of the treating physician. Clear exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g., in situ carcinoma of the cervix) and, 3) additional skin cancers that have been definitively treated by surgery and/or radiation. Patients with chronic lymphocytic leukemia will be allowed if their blood counts are within acceptable hematologic parameters and if they are not currently requiring cytotoxic or biologic anticancer treatment (supportive treatment such as intravenous immunoglobulin [IVIG] is permitted)
    • Patients with autoimmune disorders will be considered if they do not require high dose steroids or other immunosuppressants for disease control. Prednisone in daily doses up to 10 mg and inhaled steroids are acceptable
    • Absolute neutrophil count (ANC) >= 1500/uL
    • Platelet count >= 100,000/mm^2
    • Hemoglobin >= 9 g/dL
    • Total bilirubin < 1.5 x institutional upper limit of normal (ULN); if patient has conditions of congenital hyperbilirubinemia, then patient must have isolated hyperbilirubinemia (e.g., no other liver function test abnormalities) with maximum bilirubin < 2 x institutional ULN
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x institutional ULN in absence of liver metastases; =< 5 x ULN in presence of liver metastases
    • Alkaline phosphatase < 2.5 x institutional ULN
    • Creatinine < 1.5 x institutional ULN or calculated creatinine clearance >= 60 mL/min as estimated using the Cockcroft-Gault formula

    Exclusion Criteria:

    • Pregnant women. Women of childbearing age must be willing to undergo a pregnancy test prior to therapy and to use adequate contraception (e.g., hormonal or barrier method of contraception or abstinence) for the duration of the study and 6 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Menopausal status will be defined as one or more of successful hysterectomy, bilateral tubal ligation or bilateral oophorectomy, amenorrhea >= 12 consecutive months without another cause, or a documented serum follicle stimulating hormone (FSH) >= 35 mIU/mL
    • Tumor not suitable for direct or ultrasound-guided injection
    • Prior treatment with talimogene laherparepvec for advanced disease
    • Patients with active, uncontrolled infections including active herpetic infections or chronic herpetic infections requiring anti-viral therapy (e.g., acyclovir)
    • Patients without adequate organ function as documented above
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to panitumumab, talimogene laherparepvec or other agents used in the study
    • History of interstitial pneumonitis, pulmonary fibrosis, or evidence of interstitial pneumonitis

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 1 Study of TJ011133 Administered Alone or in Combination with Pembrolizumab or Rituximab in Subjects with Relapsed/Refractory Advanced Solid Tumors and Lymphoma - NCT03934814

    The primary objectives of the study are: to evaluate the tolerability and safety of TJ011133 administered alone in subjects with advanced, relapsed or refractory solid tumors or lymphoma; to evaluate the tolerability and safety of TJ011133 administered in combination with pembrolizumab or rituximab in subjects with advanced, relapsed or refractory solid tumors or lymphoma; to determine the maximum tolerated dose (MTD) of TJ011133 administered alone, administered in combination with pembrolizumab, and administered in combination with rituximab; to evaluate the recommended Phase 2 dose (RP2D) of TJ011133 administered alone, administered in combination with pembrolizumab, and administered in combination with rituximab. The secondary objectives of the study are: to characterize the pharmacokinetic (PK) and pharmacodynamic profiles of TJ011133 administered alone and in combination with pembrolizumab or rituximab; to assess the preliminary anti-tumor activity of TJ011133 alone or in combination with pembrolizumab or rituximab, as measured by best overall response (BOR), objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) (assessed based on Response Evaluation Criteria in Solid Tumors [RECIST 1.1] and immune RECIST [iRECIST] guidelines for response criteria for use in trials testing immunotherapeutics for solid tumors and Lugano criteria and lymphoma response to immunomodulatory therapy criteria [LYRIC] for lymphoma); to evaluate the immunogenicity of TJ011133 administered alone or in combination with pembrolizumab or rituximab; to evaluate the immunogenicity of pembrolizumab or rituximab when administered in combination with TJ011133. View All Details

    • Protocol Number:
      012008

    • Principal Investigator:
      Kevin David M.D

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma,Hodgkin's Lymphoma

      • Contacts:

      • Rutgers University Prinicipal Investigator: Kevin David M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Part 1: Subjects with advanced relapsed/refractory solid tumors and lymphoma.
    • Part 2 with Rituximab: Subjects with DLBCL or Indolent B-cell Lymphoma, with at least one measurable lesion by Lugano and available fresh metastatic biopsy sample prior to study entry.
    • Part 2 with Pembrolizumab: Subjects with locally advanced non-small-cell lung carcinoma (NSCLC) with disease progression or immune-oncology treatment naive Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with at least one measurable lesion defined by RECIST 1.1, and available fresh metastatic biopsy prior to study entry.
    • All Parts: Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 and adequate bone marrow, renal, and liver functions.

    Exclusion Criteria:

    • Subjects with known symptomatic central nervous system tumors or known central nervous system metastases or leptomeningeal disease requiring steroids. Subjects who document stable and central nervous system metastases and are off steroids for more than 4 weeks may be enrolled in the study
    • Subjects with Burkitt's lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma
    • Subjects with mantle cell lymphoma
    • Impaired cardiac function or clinically significant cardiac diseases
    • Prior treatment with CD47 or SIRPα inhibitors
    • Prior autologous stem cell transplant ≤3 months prior to starting study
    • Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning
    • Prior chimeric antigen receptor or chimeric antigen receptor T-cell therapy
    • History of autoimmune anemia or autoimmune thrombocytopenia
    • Positive Direct Antiglobulin Test
    • Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
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