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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).

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    • 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.

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    • 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

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    • 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

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    • 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.

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    • Protocol Number:
      052006

    • Principal Investigator:
      Ryan Stephenson

    • 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: Ryan Stephenson

    Read Inclusion & Exclusion Criteria

    Abbreviated Inclusion Criteria:

      1. Subject with histological 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 an 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 Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer (ECLIPSE)

    Primary Objective: To prospectively assess the efficacy of 177Lu-PSMA-I&T on the improvement of radiographic progression-free survival (rPFS) as determined by PCWG3-modified RECIST 1.1 in men with metastatic Castration-Resistant Prostate Cancer (mCRPC) compared to standard of care hormone therapy. Secondary Objectives: To assess if 177Lu-PSMA-I&T improves overall survival (OS) in patients with mCRPC compared to those treated with standard of care hormone therapy. Other Secondary Objectives: 1. To assess the time to the second radiographic progression event in participants who crossover from standard of care hormone therapy to treatment with 177Lu-PSMA-I&T (rPFS2). 2. To assess the time to progression as determined by the investigator in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy. 3. To assess the time to progression 2 as determined by the investigator in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy. 4. To evaluate the change in baseline PSA50 response rate following 177Lu-PSMA-I&T radioligand therapy compared to standard of care hormone therapy. 5. To assess the time to first symptomatic skeletal event (SSE) following treatment with 177Lu-PSMA-I&T radioligand therapy compared to standard of care hormone therapy. 6. To evaluate the time to radiographic soft tissue progression in participants treated with 177Lu-PSMA-I&T compared to those treated with standard of care hormone therapy. 7. To evaluate the time to chemotherapy in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy. 8. To assess any improvement in the quality of life measurements in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy.

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    • Protocol Number:
      082107

    • Principal Investigator:
      Tina Mayer M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Prostate

      • Contacts:

      • Rutgers University Prinicipal Investigator: Tina Mayer M.D
    • Rutgers Cancer Institute of New Jersey
  • A Multi-Level Investigation of US Indoor Tanning Policy Enactment, Implementation, Compliance, Impact, and Economics

    1. Identify factors contributing to adoption or rejection of indoor tanning legislation through document analysis of indoor tanning bills and key informant interviews. 2. Assess indoor tanning law implementation. 3. Investigate important economic factors relevant to Indoor tanning law maintenance.

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    • Protocol Number:
      132005

    • Principal Investigator:
      Carolyn Heckman Ph.D.

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Other

      • Contacts:

      • Rutgers University Prinicipal Investigator: Carolyn Heckman Ph.D.
    • Rutgers Cancer Institute of New Jersey
  • 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

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    • Protocol Number:
      041807

    • Principal Investigator:
      Maria Kowzun

    • Phase:
      Phase II

    • Scope:
      National

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

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      WOKVAC DC1VAC

      • Contacts:

      • Rutgers University Prinicipal Investigator: Maria Kowzun

    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 (excluding ado-trastuzumab emtansine [T-DM1]) 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 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:
    • Absolute neutrophil count (ANC) ≥ 1,000/ 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 extended use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. A brief course of corticosteroids for prophylaxis (eg., for contrast dye allergy) or for treatment of non-autoimmune conditions (eg., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.
    • Potential participant is currently on active treatment 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, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022) - NCT05239728

    Primary To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. Hypothesis (1): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS. Secondary To compare overall survival (OS) for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. Hypothesis (2): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to OS. To compare the safety and tolerability profiles for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. To compare measures of disease recurrence-specific survival (DRSS) as assessed by the investigator, in participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. To evaluate change from baseline in health-related quality of life (HRQoL) and symptoms using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life 30 Questionnaire (QLQ-C30) and the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-related Symptoms (FKSI-DRS)

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    • Protocol Number:
      082106

    • Principal Investigator:
      Eric Singer M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Kidney

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eric Singer M.D

    Read Inclusion & Exclusion Criteria

    The main inclusion and exclusion criteria include but are not limited to the following:

    Inclusion Criteria:

    • Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
    • Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: 1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0 2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0 3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous)
    • Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
    • Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
    • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization.
    • Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
    • Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last
    • Has adequate organ function

    Exclusion Criteria:

    • Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
    • Has a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
    • Has clinically significant cardiovascular disease within 6 months from first dose of study intervention
    • Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis
    • Has preexisting brain or bone metastatic lesions
    • Has received prior systemic therapy for RCC
    • Has received prior radiotherapy for RCC
    • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
    • Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
    • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed
    • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
    • Has an active infection, requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection
    • Has had an allogenic tissue/solid organ transplant

    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.

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    • 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 Open-Label, Multicenter, Phase1a Study of AN2025 and AN0025 in Double Combination with Atezolizumab and in Triple Combination with Atezolizumab in Patients with Advanced Solid Tumors. - NCT04975958

    Primary Objective: To determine the safety and tolerability of the double combinations AN2025 + Atezolizumab (Dose Limiting Toxicity [DLT] Observation I), AN0025 + Atezolizumab (DLT Observation II) and the triple combination AN2025 + AN0025 + Atezolizumab (DLT Observation III) in patients with locally advanced or metastatic cancer that were previously treated with 1-3 lines of therapy. Secondary Objectives: 1. To evaluate the preliminary efficacy of AN2025 and AN0025 in double and triple combinations with Atezolizumab as assessed by: - Overall Response Rate (ORR) and Progression-Free Survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 2. Duration of Response (DOR) 3. Overall Survival (OS); Efficacy by Phosphatidylinositol-4,5-bisphosphate 3 Kinase Catalytic Subunit Alpha (PIK3CA) mutation in DLT Observations I and III. Exploratory Objectives: 1. To assess the preliminary anti-tumor activity by modified RECIST 1.1 for immune-based therapeutics (iRECIST). 2. To assess the immune cell populations in the tumor infiltrate and correlate with the anti-tumor activity of AN2025 and AN0025 in combination treatments with Atezolizumab. 3. To explore the pharmacodynamic effect of AN2025 and AN0025 on selected immune cell populations and selected biomarkers in blood and tumor biopsies. 4. To characterize the pharmacokinetics (PK) of AN2025 and AN0025 in combination treatments with Atezolizumab and explore the potential exposure/response relationship with selected pharmacodynamic biomarkers as appropriate. 5. Efficacy by programmed death receptor-ligand 1 (PD-L1) expression.

    View All Details
    • Protocol Number:
      052102

    • Principal Investigator:
      Kristen Spencer DO, MPH

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      AN2025 AN0025(E7046) Atezolizumab (MPDL3280A)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Kristen Spencer DO, MPH

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Age ≥18 years at the time of informed consent and have provided signed informed consent for the trial. 2. Willing and able to comply with all aspects of the protocol. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Life expectancy ≥3 months. 5. Diagnosed with histologically confirmed locally advanced and nonresectable, or metastatic disease. 6. Have received at least one line of prior systemic therapy or no alternative therapy to prolong survival exists. 7. Have received no more than 4 prior lines of systemic therapy for advanced disease. Prior therapy in an adjuvant or neoadjuvant setting is not considered as a prior line of systemic therapy. 8. Have measurable disease per RECIST 1.1 as assessed by the local site investigator and/or radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 9. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. If previously treated with anti-PD-1/PD-L1 therapy, tumor tissue sample obtained following the most recent anti-PD-1/PD-L1 therapy is required. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. 10. Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple gated acquisition (MUGA) scan. 11. Patient has organ function as shown by the following: 1. Absolute neutrophil count (ANC) ≥1.5 x 109/L. 2. Hemoglobin ≥9 g/dL (which may be reached by transfusion 2 weeks prior to the start of the study treatment). 3. Platelets ≥100 x 109/L (which may be reached by transfusion). 4. International normalized ratio (INR) ≤1.5. 5. Calcium (corrected for serum albumin) within normal limits (WNL) or ≤ grade 1 severity according to NCI-CTCAE version 5.0 if judged clinically not significant by the Investigator. Patients concomitantly taking bisphosphonates or denosumab for calcium correction are eligible. (only applicable to Observations I and III) 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x upper limit of normal (ULN) or <5.0 x ULN if liver metastases are present. 7. Total serum bilirubin ≤ ULN or ≤1.5 x ULN if liver metastases are present; or total bilirubin ≤3.0 x ULN with direct bilirubin below or within normal range in patients with well documented Gilbert's Syndrome. Gilbert's syndrome is defined as presence of episodes of unconjugated hyperbilirubinemia with normal results from cells blood count (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis. 8. Serum creatinine ≤1.5 x ULN or calculated or directly measured creatinine clearance (CrCL) >30 mL/min. 9. HbA1c ≤8%. (Only applicable to Observations I and III) 12. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior to Screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment, is she considered not of child-bearing potential. 2. Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 5 months after the last dose of Atezolizumab. Highly effective contraception is defined as either:
    • Total abstinence: When this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
    • Female sterilization: When the female study patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
    • Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female study patients, the vasectomized male partner should be the sole partner for that patient.
    • Using a combination of any two of the following:
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS), and
    • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
    • Hormonal contraception methods (e.g., oral, injected, implanted). 13. A male participant must agree to use contraception during the treatment period and for at least 5 months after the last dose of Atezolizumab.

    Exclusion Criteria:

      1. Have been discontinued treatment due to a Grade 3 or higher immune-related AE (irAE) from prior anti-PD-1or anti-PD-L1, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137). 2. Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter. Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or returned to baseline. Participants with ≤ Grade 2 neuropathy or alopecia may be eligible. 3. Have received prior palliative 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. 4. Severe, uncontrolled tumor-related pain. 5. Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Non live COVID vaccinations or boosters should not occur during Cycle 1 or within 30 days prior to the first dose of study drug. 6. Are currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks after the last dose of the previous investigational agent (see Number 2 above). 7. Have had an allogenic tissue/solid organ transplant. 8. Have 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 drug. 9. With a history of another primary malignancy within the past 2 years, with the exception of basal or squamous cell skin cancer, or carcinoma in situ of the cervix or breast that has undergone potentially curative therapy. 10. Have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 11. Have known severe hypersensitivity to study treatment components. 12. Have an 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) is not considered a form of systemic treatment and is allowed. Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis. 13. Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis. 14. Have an active infection requiring systemic therapy within 2 weeks prior to Day 1 of Cycle 1. 15. Participants with known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay. 16. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment (including oral anticoagulation). 17. Major surgery within 4 weeks before the first dose of study drug. Note: If participant received major surgery, they must have recovered adequately from surgery and the toxicity and/or complications requiring the intervention prior to starting study treatment. 18. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the oral bioavailability of the investigational drugs. 19. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. 20. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study, e.g. history of or active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, or history of suicidal attempt or ideation, homicidal ideation (e.g., risk of doing harm to self or others), or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders [DSM V]) are not eligible. Note: For patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous six weeks prior to start of study drug. 21. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 5 months after the last dose of Atezolizumab. 22. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures >/=1 time per month. 23. Leptomeningeal disease. 24. Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for >/=2 weeks prior to Day 1 of Cycle 1. 25. Oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1 for an active infection (prophylactic antibiotic dosing that is deemed to be essential by the investigator is allowed). 26. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 27. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation. 28. Active tuberculosis. 29. Patient has received previous treatment with any protein kinase B (PKB/AKT), mammalian target of rapamycin (mTOR) inhibitors, or phosphatidylinositol 3 kinase (PI3K) pathway inhibitors (only applicable to Observations I and III). 30. Patient has grade ≥2 neuropathy, colitis, pneumonitis, elevated HbA1C, and uncontrolled endocrinopathies (e.g., hypothyroidism) from previous treatment (only applicable to Observations I and III). 31. Have clinically manifest diabetes mellitus (DM) (treated and/or with clinical signs) that is not well controlled (only applicable to Observations I and III). 32. Patient is currently receiving warfarin or other coumarin-derived anti-coagulant, or anti-Xa agents, for treatment, prophylaxis, or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), fondaparinux or novel oral anticoagulants (NOACs) is allowed. 33. Have diarrhea ≥2 CTCAE Grade 2 (only applicable to Observations I and III). 34. Patient is currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A4, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug (only applicable to Observations I and III). UGT inducers or inhibitors such as atazanavir, probenecid, valproic acid, mefenamic acid, quinidine (only applicable to Observation II). 35. Patient has a history of non-compliance to any medical regimen or inability to grant consent. 36. Patient that is currently receiving NSAIDs. 37. Patient that is currently receiving angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs): Patients on these hypertensives at study entry should be switched to other hypertensives prior to study drug dosing.

    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 Safety and Tolerability Study of DeTIL-0255 in Adults with Advanced Malignancies - NCT05107739

    Primary Objectives: - To evaluate the safety and tolerability of DeTIL-0255 in adult patients with advanced malignancies. - To evaluate the preliminary anti-tumor activity of DeTIL. Secondary Objectives: - To evaluate immune cell infiltration in the tumor following DeTIL-0255 infusion.

    View All Details
    • Protocol Number:
      052104

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      DeTIL-0255

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • One of the following malignancies: Recurrent or persistent platinum-resistant EOC, recurrent, metastatic or persistent carcinoma of the cervix with progression after treatment with taxane-containing regimen, or advance or recurrent endometrial cancer with disease progression after or during second line or greater therapy
    • Disease that is metastatic and measurable by RECIST v1.1 criteria
    • A resectable lesion for TIL generation
    • At least 2 prior lines of therapy
    • ≥ 18 years and ≤ 70 years of age
    • Life expectancy of at least 4 months
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Adequate organ and bone marrow function, in the absence of growth factors
    • Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol
    • A signed consent form indicating that the subjects understands the purpose and procedures required for the study

    Exclusion Criteria:

    • Known untreated brain metastases
    • Uncontrolled intercurrent illness
    • History of known seizure disorder
    • Unable to comply with study requirements
    • Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy
    • Pregnant, breastfeeding, or planning to become pregnant while enrolled on this study or within 6 months after DeTIL infusion
    • Live vaccine within 28 days of first dose of NMA chemotherapy or planned live vaccination within 6 months following DeTIL infusion
    • Active known second malignancy with the exception of any of the following: Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or adequately treated follicular or papillary thyroid cancer; or any other cancer from which the patient has been disease-free for ≥ 2 years
    • Systemic anti-cancer therapy, including investigational agents, or radiotherapy within 4 weeks of tumor resection
    • Major surgery within 4 weeks before tumor resection, or will not have fully recovered from surgery, or has surgery planned within 8 weeks after infusion
    • Use of systemic corticosteroids within 15 days (or other immunosuppressive drugs within 30 days) prior to tumor resection
    • Use of biotin or other supplements containing higher that the daily adequate intake of biotin
    • Clinically significant, uncontrolled cardiac, class III or IV heart failure, thromboembolic events, cardiovascular disease, or history of myocardial infarction within 6 months of planned start of study drug
    • History or current evidence of anything that might confound the results of the study

    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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