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  • 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:

      • 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
  • A bilingual virtually-based intervention (PEDALL) for the prevention of weight gain in childhood ALL patients considering key genetic and sociodemographic risk factors - NCT05963971

    Primary Objective To prevent the development of overweight and obesity (OW/OB) during maintenance chemotherapy using a six-month virtually delivered dietary education intervention (PEDALL) in English and Spanish speaking families of children and adolescents undergoing treatment for ALL. Exploratory Objectives To assess the effect of intervention on BMI z-score trajectories over time (from time zero to one-year post-completion of treatment for ALL) and modification of this effect by genetic and sociodemographic factors. To examine the modifying effect of genetic predisposition to OW/OB, defined by a genome-wide polygenic score (GPS) for obesity optimized for Hispanic and Non-Hispanic application, on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL. To examine the modifying effect of multi-level sociodemographic factors on the efficacy of PEDALL for the prevention of OW/OB in children and adolescents undergoing treatment for ALL. To understand the effect of intervention on reported lifestyle behaviors as measured by World Cancer Research Foundation/American Institute for Cancer Research lifestyle guidelines. To understand contextual factors that shaped the recruitment and retainment of participants and to identify strategies that may hinder or support implementation within routine care at their site including resource, training and technological needs using a one-time, brief structured survey at the end of the study with study site designate. To understand individual factors and site-specific factors that shaped both experience with and response to the intervention using a one-time, brief open-ended questionnaire to patients and caregivers.

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    • Protocol Number:
      112307

    • Principal Investigator:
      Peter Cole M.D.

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Other

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Age: 5-21 years old at enrollment
    • Diagnosis and Treatment: Plan to receive or are receiving maintenance or continuation chemotherapy for B- or T-cell ALL, or mixed phenotype acute leukemia.
    • Timing: Patient is eligible for entry only if it is feasible to start the study intervention during the first month of the maintenance phase of ALL therapy.
    • Language: Fluency in English or Spanish
    • Weight Status: Healthy weight at baseline as determined by BMI z-score < 1.04 and >-1.04 for those under 5-18, and BMI between 19 and 25 for those >18.
    • Ethnicity: Hispanic or Non-Hispanic of any race.

    Exclusion Criteria:

    • Patients on nutrition support (enteral or parenteral nutrition)
    • Patients with a history of eating disorder

    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
  • A Digital Intervention to Improve Skin Self-Examination Among Melanoma Survivors. - NCT05373823

    Aim 1. To enhance MSS by collaborating with multi-level stakeholders. We will collaborate with stakeholders in enhancing MSS through qualitative interviews and usability testing of potential enhancements. Enhancements are based on empirically validated behavior change techniques (BCTs) and our prior study. We will utilize an iterative process that includes: (1) key informant interviews with survivors, providers, and professional organizations regarding proposed enhancements; (2) conversion to an enhanced mobile-based delivery platform; (3) usability testing, and; (4) iterative program refinements. Aim 2. To evaluate the effects of enhanced MSS on thorough SSE in an RCT and examine its impact on the diagnosis of new/recurrent melanomas (N= 300). We will conduct a RCT comparing MSS and a non-interactive educational webpage with 300 survivors to test its effects on SSE. We propose that MSS participants will be more likely to perform thorough SSE over the 18-month follow-up. We will explore the impact of MSS on new/recurrent melanomas. We propose that there will be more earlier stage melanomas diagnosed in MSS as compared with UC. Aim 3. To assess selected implementation outcomes and identify factors relevant to future scale-up for widespread dissemination and implementation. We will use mixed methods to assess implementation outcomes and explore perspectives from survivors, care providers, and professional organizations about how to best disseminate and implement MSS on a broad scale. The sub-aims are: 3a) To estimate program costs and assess cost-effectiveness of MSS relative to control. We hypothesize that MSS costs will be higher than UC. We expect that MSS will be a more cost-effective strategy, given its greater effectiveness to increase SSE and identify new or recurrent melanoma. If our findings support this as expected, exploratory cost-effectiveness analyses from the health care and societal perspectives will be conducted using simulation models of melanoma-related costs, disease progression, and survival over 5- and 10-year analysis horizons. 3b) To examine MSS reach, adoption, engagement, acceptability, appropriateness, feasibility, and maintenance. For reach, we predict that demographic variables will not differ from the general population of melanoma survivors. For adoption, we propose that the proportion of contacted/eligible survivors randomized to MSS who consent, complete the baseline, and log into MSS will be equal or greater than the efficacy trial. For engagement, we propose that 80% of MSS participants will log in. For acceptability, we predict MSS will be rated as highly acceptable. 3c) To identify and describe contextual factors from multilevel stakeholders as key to scale-up and widespread implementation of MSS, including consideration of potential delivery settings, timing of delivery, and needed resources to promote its implementation and sustainability.

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    • Protocol Number:
      132202

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
    • Three months to five years post-surgery
    • No current evidence of cancer
    • Not adherent to thorough SSE (i.e., did not check entire body at least once during the past three months)
    • ≥ 18 years old
    • Internet access
    • Able to speak/read English
    • Able to provide informed consent

    Exclusion Criteria:

    • Children

    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
  • A Dose Finding Study of CycloSam? (153Sm-DOTMP) to Treat Solid Tumor(s) in the Bone or Metastatic to the Bone (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewings Sarcoma, and other solid tumor(s) to the bone all eligible). - NCT06008483

    The primary objective of this study is: To determine the MTD of CycloSam?, given as a tandemly administered pair of doses to subjects with one or more solid tumor(s) in the bone or metastatic solid tumors to the bone that are visible on bone scan. The secondary objectives of this study are: 1. To describe the toxicity and long-term effects of infusional CycloSam?; 2. To assess the clinical response of solid tumors to the bone or metastatic to the bone to therapy with infusional CylcoSam?; 3. To describe the distribution of absorbed doses delivered to each targeted lesion and the distribution of lesion equivalent uniform dose delivered to each subject; 4. To observe overall survival and time to progression in subjects treated with infusional CycloSam?, and model any relationship between total absorbed dose and progression; 5. To assess the extent of pain palliation using a visual analogue scale (VAS) in subjects treated with infusional CycloSam?.

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    • Protocol Number:
      052201

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Breast,Prostate,Lung,Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      CycloSam (153Sm-DOTMP)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Subjects will be between the ages of 15 and 75, inclusive. 2. Subjects must have a histologically confirmed diagnosis of a solid tumor metastatic to bone, or a histologically confirmed diagnosis of a solid tumor to the bone or metastatic to the bone. 3. Subjects must have measurable disease on anatomic imaging that is also avid for phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan. Not all lesions must be positive on bone scan. 4. Adequate organ function, including: i. Adequate renal function, defined as a measured creatinine clearance >70 mL/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR). ii. Adequate hematologic function, defined as a platelet count >100,000 cells/mm3 and an absolute neutrophil count (ANC) >1,000 cells/mm3. 5. Life expectancy of at least eight weeks. 6. Karnofsky performance status >50%. 7. Subjects must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to CTCAE v5.0 grade ≤1. Subjects with Grade 2 anemia per CTCAE v5.0 will be permitted as long as the subject has normal cardiac function. 8. Adequate cardiac function. Subjects with previously identified cardiac disease will be eligible, as 153Sm-DOTMP is not expected to cause cardiac dysfunction and is only expected to result in very transient hypocalcemia. 9. A stem cell product collected either by peripheral stem cell mobilization or bone marrow harvest prior to the infusion of CycloSam® must be available, prior to trial entry. A minimum of 2 x 106 CD34+ cells/kg ideal body weight are required. 10. Female subjects of child-bearing potential (defined as premenopausal and capable of becoming pregnant) must have a negative serum pregnancy test at the Screening visit. Females must be surgically sterile, postmenopausal for at least one year prior to Screening (no other medical cause involved) with a Follicle Stimulating Hormone (FSH) level of greater than 40 mIU/mL or must be using a highly effective method of birth control and agree to its use for at least 30 days following the last dose of 153Sm-DOTMP. Highly effective methods of contraceptive are defined as tubal ligation or an approved hormonal contraceptive such as oral contraceptives, patches, implants, injections, rings, or hormonally-impregnated intrauterine device. 11. Male subjects with partners of child-bearing potential must agree to use highly effective methods of contraception for at least 90 days after the last dose of 153Sm-DOTMP. 12. The subject and/or the subject's legally authorized guardian, if the subject is a minor, must acknowledge in writing that informed consent to become a study subject has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services. 13. Subjects must have previously received effective treatment for their underlying disease and have no potentially curative options available. 14. The concurrent use of hormonal therapies or bisphosphonates is acceptable, provided the latter do not render target lesions invisible on 99mTc bone scan. Subjects will have the option to re-screen up to once more after seven days if they do not initially meet all of the inclusion criteria

    Exclusion Criteria:

      1. Subject is pregnant or breastfeeding. 2. Subject is sexually active and does not agree to use accepted, effective forms of contraceptive. 3. Subject has received prior radiotherapy to all known areas of current active disease. 4. Subject has a body mass index (BMI) > 50 kg/m2.

    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
  • A Double-Blinded, Phase III Randomized Trial of T-DM1 Compared with T-DM1 and Tucatinib. - NCT04457596

    Primary Objective: To determine if the iDFS with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy. Secondary Objectives: 1. To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) improves the following: - overall survival (OS) - breast cancer free survival (BCFS) - distant recurrence-free survival (DRFS) - disease-free survival (DFS) - brain metastases-free survival (BMFS). 2. To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases.

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    • Protocol Number:
      042106

    • Principal Investigator:
      Coral Omene MD, PhD

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      ado-trastuzumab/T-DM1 Tucatinib/Placebo

      • Contacts:

      • Rutgers University Prinicipal Investigator: Coral Omene MD, PhD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) according to current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Central testing is not required * Known hormone receptor (HR) status as defined by ASCO/CAP guidelines (based on pretreatment biopsy material). Hormone receptor positive status can be determined by either known positive estrogen receptor (ER) or known positive progesterone receptor (PR) status; hormone receptor negative status must be determined by both known negative ER and known negative PR
    • Patients with clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible. (Note: Patients with T1a/bN0 tumors are not eligible at initial breast cancer diagnosis are not eligible)
    • Patients with residual HR-negative, HER2 positive (+) disease in the breast and/or lymph nodes per the surgical pathology report are eligible; however, patients with HR+ HER2+ cancers must have node-positive residual disease per the surgical pathology report in order to qualify for the study. The presence of residual invasive disease in the breast is not mandatory for these patients
    • Patients with weakly ER-positive (1-10%) breast cancer (based on the pretreatment core biopsy) are eligible even if they have node-negative disease per the surgical pathology report
    • The residual disease tissue (breast and/or lymph nodes) is not required to be HER2-positive, as eligibility for NCI-2020-03770 (A011801) is based on a positive HER2 status at the time of the initial breast cancer diagnosis * Note: The presence of micrometastases in lymph nodes after preoperative therapy counts as residual disease, whereas the presence of isolated tumor cells does not
    • Patients with synchronous bilateral invasive disease are eligible provided both lesions were confirmed to be HER2-positive, and at least one of the lesions meets the criteria outlined above. Multifocal disease is allowed, as long as the largest biopsied breast tumor was HER2-positive
    • Patients must have received neoadjuvant chemotherapy with one of the following regimens: docetaxel/trastuzumab/pertuzumab (THP), paclitaxel/methotrexate/cisplatin (TMP), doxorubicin/cyclophosphamide/paclitaxel/trastuzumab/pertuzumab (AC-TH(P)); docetaxel/carboplatin/trastuzumab/pertuzumab (TCH(P)); fluorouracil/doxorubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FAC-TH(P)), or fluorouracil/epirubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FEC-TH(P)). Note: apart from TCHP, where T is docetaxel, treatment with docetaxel or paclitaxel is acceptable
    • Prior receipt of T-DM1 in the neoadjuvant setting is not allowed.
    • Prior treatment must have consisted of >= 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of >= 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or Food and Drug Administration [FDA]-approved biosimilars). Patients who have received at least 9 weeks of preoperative taxane, pertuzumab and margetuximab are also eligible if they received >= 6 cycles of systemic therapy prior to enrollment. Note: Patients who complete at least nine of a planned twelve doses of weekly paclitaxel, or three of a planned four doses of docetaxel, but discontinue prematurely due to toxicity are eligible. Patients receiving dose-dense chemotherapy regimens are also eligible. Prior use of nab-paclitaxel (Abraxane) instead of paclitaxel or docetaxel is permitted. Prior use of subcutaneous trastuzumab (Hylecta) and subcutaneous trastuzumab and pertuzumab (Phesgo) is also allowed.
    • Patients who received neoadjuvant systemic therapy which included experimental HER2-targeted therapy/therapies are potentially eligible, as long as the investigational agent was not a HER2-targeted antibody-drug conjugate (e.g. T-DM1, DS-8201a [trastuzumab deruxtecan]) or a HER2 targeted tyrosine kinase inhibitor (TKI) (e.g. tucatinib, lapatinib, neratinib).
    • Patients may have received =< 1 cycles of T-DM1 in the adjuvant setting. Note: These patients will be randomized to receive a further 14 cycles of T-DM1 and tucatinib/placebo as tolerated. The most recent cycle of T-DM1 should have been administered =< 5 weeks prior to registration * Note: Both of the following two criteria need to be met for the patient to be eligible for this study
    • An interval of no more than 12 weeks between the completion date of the last definitive treatment (e.g. postoperative chemotherapy or radiation, or if neither given, breast surgical date) and the date of registration. Concurrent radiation therapy is permitted while receiving study treatment
    • Patients must be registered on study within =< 180 days of the date of the most recent definitive breast cancer surgery (not including reconstructive surgery)
    • All systemic chemotherapy should have been completed preoperatively unless participating in EA1181 (CompassHER2 pathologic complete response [pCR]) or the BIG DECRESCENDO Trial (which is very similar to CompassHER2 pCR in terms of study design, drugs, and eligibility). However, patients who received 4 cycles of neoadjuvant THP off study can receive a further 2-4 cycles of chemotherapy postoperatively to meet eligibility for A011801. Patients who participated in EA1181 or MA41 and proceeded to surgery immediately after the de-escalated trial regimen must receive postoperative chemotherapy to complete a total of >= 6 cycles of systemic treatment prior to enrollment on A011801, as outlined above (e.g. 4 cycles pre-operatively, and 2 cycles post-operatively). The postoperative chemotherapy regimen prescribed is at the discretion of the treating oncologist (i.e. 2-4 cycles AC or THP, other). Continuation of trastuzumab + pertuzumab (HP) pre- or post-operatively as maintenance therapy (while awaiting a surgical date or an official pathology report) is allowed for all study participants
    • Toxicities related to prior systemic treatment should have resolved or be at baseline, apart from alopecia and peripheral neuropathy =< grade 1
    • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
    • Breast surgery: total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision
    • For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection
    • Lymph node surgery ** The axilla needs to be evaluated with either sentinel node biopsy or axillary lymph node dissection. If patients have a sentinel lymph node biopsy and sentinel nodes are negative, no further axillary treatment is necessary. If patients have isolated tumor cells (ITCs) in the setting of residual breast disease, at least one of the following is required: axillary lymph node dissection (ALND) or planned nodal irradiation. If patients have micro- or macro-metastatic nodal disease, ALND and planned nodal irradiation are required. Of note, co-enrollment on Alliance A011202 is not allowed
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Absolute neutrophil count (ANC) >= 1,000/mm^3
    • Hemoglobin >= 8 g/dL (Note: packed red blood cells [PRBC] transfusion is not permitted to achieve eligibility)
    • Platelet count >= 100,000/mm^3
    • Creatinine =< 1.5 x upper limit of normal (ULN)
    • Total bilirubin =< 1.0 x upper limit of normal (ULN) or direct bilirubin within the institutional normal range for patients with Gilbert's syndrome
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
    • Screening left ventricular ejection fraction (LVEF) >= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute percentage points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >= 55% after completion of neoadjuvant chemotherapy. Note: LVEF assessment may be repeated once up to 3 weeks following the initial screening assessment to assess eligibility

    Exclusion Criteria:

    • No adjuvant treatment with any anti-cancer investigational drug within 28 days prior to registration
    • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum pregnancy test done =< 7 days prior to registration is required
    • Patients with known active and/or untreated hepatitis B or hepatitis C or chronic liver disease are ineligible. Patients with a diagnosis of hepatitis B or C that has been treated and cleared and normal liver function are eligible to participate in the study if the other eligibility parameters are met
    • Stage IV (metastatic) breast cancer
    • History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
    • Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
    • Evidence of recurrent disease following preoperative therapy and surgery
    • Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation)
    • History of exposure to the following cumulative doses of anthracyclines: doxorubicin > 240 mg/m^2; epirubicin or liposomal doxorubicin-hydrochloride (Myocet) > 480 mg/m^2. For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m^2
    • Cardiopulmonary dysfunction as defined by any of the following:
    • History of National Cancer Institute (NCI) CTCAE version (v) 5.0 grade >= 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria class >= II
    • Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease
    • High-risk uncontrolled arrhythmias: i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular block (AV)-block (second degree AV-block type 2 [Mobitz 2] or third degree AV-block)
    • Significant symptoms (grade >= 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy
    • History of a decrease in left ventricular ejection fraction (LVEF) to < 40% with prior trastuzumab treatment (e.g., during preoperative therapy)
    • Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
    • Current severe, uncontrolled systemic disease
    • Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to registration or anticipation of the need for major surgery during the course of study treatment
    • History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product
    • Peripheral neuropathy of any etiology that exceeds grade 1
    • Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol
    • Use of a strong CYP3A4 or CYP2C8 inhibitor within 2 weeks, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to registration is prohibited.
    • Please note that use of sensitive CYP3A substrates should be avoided two weeks before registration and during study treatment. Additionally, CYP3A4 or CYP2C8 inducers are prohibited as concomitant medications within 5 days following discontinuation of tucatinib treatment. Patients who require medications that are known to be sensitive substrates of CYP3A4 with a narrow therapeutic window should be excluded.

    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.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
  • A First-in-Human Study of Mutant-selective PI3K alpha; Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer - NCT05216432

    RLY-2608 Single Agent Arm Primary Objectives: To determine the MTD and/or RP2D of RLY-2608 as a single agent To determine the safety and tolerability of RLY-2608 as a single agent RLY-2608 + Fulvestrant Arm Primary Objectives: To determine the MTD and/or RP2D of RLY-2608 in combination with fulvestrant To determine the safety and tolerability of RLY-2608 in combination with fulvestrant Triple Combination Arms Primary Objectives: To determine the MTD and/or RP2D of RLY-2608 in combination with CDK4/6 inhibitor (palbociclib or ribociclib) and fulvestrant To determine the safety and tolerability of RLY-2608 in combination with CDK4/6 inhibitor (palbociclib, ribociclib) and fulvestrant

    View All Details
    • Protocol Number:
      042402

    • Principal Investigator:
      Mridula George

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      RLY-2608

      • Contacts:

      • Rutgers University Prinicipal Investigator: Mridula George

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria

      Patient has ECOG performance status of 0-1One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor perlocal assessment
    • Other potentially oncogenic PIK3CA mutations may be considered but must be approved by the Sponsor prior to enrollment.Part 1 - Ability to provide archived tumor tissue or be willing to undergo pretreatmenttumor biopsy to assess PIK3CA status retrospectively Part 2 - Submit tumor tissue priorto study drug initiation for determination of PIK3CA mutation retrospectively.Key Inclusion for RLY-2608 Single Agent Arm
    • [For Part 1]: Evaluable disease per RECIST v1.1
    • [For Part 2]: Measurable disease per RECIST v1.1
    • Disease that is refractory to standard therapy, intolerant to standard therapy, or has declined standard therapy.
    • Part 1- histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
    • Part 2 - Unresectable or metastatic solid tumor with PIK3CA mutation(s) and one of the following tumor types:Group 1: clear cell ovarian cancer Group 2: head and neck squamous cell carcinoma Group3: cervical cancer Group 4: other solid tumors, excluding colorectal, clear cell ovarian,head and neck squamous cell, and cervical cancers Group 5: unresectable or metastaticsolid tumors with PIK3CA double mutationsKey Inclusion for Combination Arms
    • [For Part 1 and Part 2]: Evaluable disease per RECIST v1.1
    • [For Part 1 and Part 2]: Male or female with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy. Females may be postmenopausal, premenopausal, or perimenopausal. Premenopausal or perimenopausal females must have a histologically or cytologically confirmed diagnosis of HR+ HER2- advanced or metastatic breast cancer that is not amenable to curative therapy and must have been previously treated with GnRH agonist at least 4 weeks prior to start of study drug
    • [For Part 1 and Part 2]: Had previous treatment for breast cancer with: 1. ≤1 line of chemotherapy in the metastatic setting 2. ≥1 cyclin-dependent kinases (CDK) 4/6 inhibitor, in either the adjuvant and/or metastatic setting 3. ≥1 antiestrogen therapy in either adjuvant and/or metastatic setting, including, but not limited to, selective estrogen-receptor degraders (eg, fulvestrant), selective estrogen receptor modulators (eg, tamoxifen), and aromatase inhibitors (AI) (letrozole, anastrozole, exemestane), and 4. ≥1 PARP inhibitor, if appropriate, if documented germline BRCA1/2 mutation Note: Systemic local, loco-regional, or adjuvant treatment with chemotherapy and PARP inhibitors is not to be included in enumeration or previous treatment[For RLY-2608 + fulvestrant arm; Part 2, Group 2]: Received prior treatment with a PI3Kαinhibitor and discontinued the inhibitor due to intolerance and not disease progression,where intolerance is defined as treatment discontinuation due to treatment related AE(eg. hyperglycemia, rash, diarrhea, stomatitis) other than severe hypersensitivityreaction and/or life-threatening reactions, such as anaphylaxis and Stevens-Johnsonsyndrome.

    Key Exclusion Criteria

      Prior treatment with PI3Kα, AKT, or mTOR inhibitors (except for RLY-2608 + fulvestrantarm, Part 2, Group 2).Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasmaglucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%.History of hypersensitivity to PI3K inhibitors. For combination arms only:hypersensitivity to fulvestrant, palbociclib, and/or ribociclib, as appropriate for thecombination.For triple combination arms only: history of pneumonitis or interstitial lung disease.For the single agent and combination arms other than with ribociclib: mean QT intervalcorrected using Fridericia's formula (QTcF) >480 msec. For the combination arms withribociclib: mean QTcF ≥450 msec.Patient has a history of prolonged QT syndrome or torsades de pointes. Patient has afamilial history of prolonged QT syndrome.Clinically significant, uncontrolled cardiovascular disease CNS metastases or primary CNStumor that is associated with progressive neurologic symptoms

    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
  • A First-in-Human, Open-Label, Phase 1/2 Dose-Escalation with Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor activity of GIM-122 as a Single Agent in Adult Subjects with Advanced Solid Malignancies - NCT06028074

    Primary Objective Part A and B To characterize the safety and tolerability of GIM-122 as a single agent in subjects with programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) refractory/resistant advanced solid tumor malignancies that have a Food and Drug Administration (FDA) approval for anti-PD-1/PD-L1 therapy at time of recruitment. Primary Objectives Dose Expansion (Part B) To identify a recommended dose for future studies (RP2D) To assess the anti-tumor activity of GIM-122 as a single agent in subjects with programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) refractory/resistant advanced solid tumor malignancies that have FDA approval for anti-PD-1/PD-L1 therapy at time of recruitment. Secondary Objectives To assess safety and tolerability (Part B only) To characterize the pharmacokinetic (PK) profile of GIM-122 (Part A and Part B) To assess the emergence and persistence of anti-drug antibodies (ADA) and the impact on GIM-122 exposure (Part A and Part B) To assess the change from baseline in tumor tissue markers as potential predictors of efficacy of GIM-122 (Part A and Part B) To evaluate the preliminary anti-tumor activity of GIM-122 (Part A only)

    View All Details
    • Protocol Number:
      052401

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      GIM-122

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      General
    • Written informed consent
    • ECOG performance status 0-1.
    • Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
    • Recommended Double methods of contraception 90-days post treatment Cancer Specific
    • Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor
    • Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant
    • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
    • Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
    • No other lines of therapy that are available

    Exclusion Criteria:

      General
    • Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
    • Women who are pregnant or breastfeeding
    • History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
    • Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
    • Current second malignancy at other sites
    • Leptomeningeal disease
    • Spinal cord compression
    • Symptomatic or new or enlarging central nervous system (CNS) metastases

    Treatment-specific Exclusion Criteria

    • Ongoing toxicity > Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
    • Has undergone a major surgery < 1 month prior to administration of GIM-122
    • Has received radiation therapy within 2 weeks prior to administration of GIM-122
    • Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
    • Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
    • Prior treatment with other immune modulating agents within < 4 weeks prior to the first dose of GIM-122.
    • Has a diagnosis of immunodeficiency, either primary or acquired
    • Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
    • Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
    • Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.
    • Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date > 30 days prior to administration of GIM-122).

    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
  • A Long-Term Study for Participants Previously Treated With Ciltacabtagene Autoleucel. - NCT05201781

    To collect long-term follow-up data on delayed adverse events after administration of cilta-cel, and to characterize and understand the long-term safety profile of cilta-cel.

    View All Details
    • Protocol Number:
      012204

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Matthew Matasar

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
    • Participants who have provided informed consent for this 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
  • 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.

    View All Details
    • Protocol Number:
      132005

    • Principal Investigator:
      Carolyn Heckman Ph.D.

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

      • Contacts:

      • Rutgers University Prinicipal Investigator: Carolyn Heckman Ph.D.
    • Rutgers Cancer Institute
  • 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. - NCT05239728

    Primary Objective: 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 Objectives: - 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).

    View All Details
    • Protocol Number:
      082106

    • Principal Investigator:
      Biren Saraiya M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Kidney

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Belzutifan (MK-6482)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Biren Saraiya 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
  • 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:
      Eugenia Girda Assistant

    • Phase:
      Phase III

    • Scope:
      National

    • 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:

    • Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
    • Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.Additional eligibility criteria for participants who enter Second Course Phase once theyare 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.
    • 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.Additional eligibility criteria for participants who enter dosing with Lenvatinib:
    • Adequately controlled blood pressure (BP) to <150/90 mmHg, with or without antihypertensive medications.
    • For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.
    • Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.

    Exclusion Criteria:

    • There are no exclusion criteria to participate in MK-3475-587.Participants are excluded from entering Second Course trial treatment once they areenrolled 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. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
    • 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).Additional exclusion criteria for participants who enter dosing with Lenvatinib:
    • Has had major surgery within 3 weeks prior to first dose of study intervention(s).
    • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
    • Has urine protein ≥1 g/24 hours.
    • Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
    • Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.
    • Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to >480 ms.
    • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
    • Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
    • Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
    • Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.

    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
  • A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) with Pembrolizumab (MK-3475) in Selected Solid Tumors. - NCT06036836

    Primary: Cohort A: To evaluate pathological complete response (pCR) rate of MK- 4280A or pembrolizumab as assessed by blinded central pathology review Cohort B: To evaluate lenvatinib in combination with MK-4280A or pembrolizumab with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator

    View All Details
    • Protocol Number:
      102310

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Favezelimab (MK4280A) Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

      Cohort A only
    • Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
    • Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 8
    • Is systemic treatment naïve
    • Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided
    • Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consentCohort B only
    • Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local test report
    • Documented evidence of stage IVB (per 2009 International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation
    • Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting
    • Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention)
    • Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
    • Has adequately controlled blood pressure without antihypertensive medicationAll Cohorts
    • Agrees to follow contraception guidelines if a participant of childbearing potential
    • Has a life expectancy >3 years per investigator assessment
    • Has adequate organ function
    • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and undetectable viral load prior to randomization
    • If positive for hepatitis C, has undetectable viral load at screening
    • If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy

    Exclusion Criteria:

      All Cohorts
    • Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb)
    • History of allogeneic tissue/solid organ transplantCohort A only
    • Received prior radiotherapy to the index lesion (in-field lesion)
    • Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligibleCohort B
    • Has had major surgery within 3 weeks prior to first dose of study interventions
    • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
    • Has urine protein ≥1 g/24 hours
    • Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multi-gated acquisition (MUGA) or echocardiogram (ECHO)
    • Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
    • Has clinically significant cardiovascular disease within 12 months from first dose 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.

    • Monmouth Medical Center
    • Community Medical Center
    • Monmouth Medical Center Outpatient Infusion Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
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