10 results
  • A Phase 1 Study of Talimogene Laherparepvec and Panitumumab in Patients with Locally Advanced Squamous Cell Carcinoma of the Skin (SCCS). - NCT04163952

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

    • Protocol Number:
      091804

    • Principal Investigator:
      Adam Berger

    • Phase:
      Phase I

    • Scope:
      Local

    • Applicable Disease Sites:
      Other Skin

    • Therapies Involved:
      Chemotherapy multiple agents systemic Surgery

    • Drugs Involved:
      PANITUMUMAB Talimogene laherparepvec

      • Contacts:

      • Rutgers University Prinicipal Investigator: Adam Berger

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Selinexor in Combination with Pembrolizumab Recurrent Advanced Melanoma. - NCT04768881

    Primary Objective: To evaluate overall response rate (ORR) per RECIST v1.1 response criteria. Secondary Objectives: 1. To evaluate PFS per RECIST v1.1 response criteria. PFS defined as time from date of first treatment to the date of firstconfirmed progressive disease (PD), or death due to any cause,whichever occurs first. 2. To evaluate overall survival (OS). 3. To evaluate rates of CR. 4. To evaluate duration of response (DOR): DOR defined as the duration of time from first occurrence of response ≥PR until the first date of PD or death due to any cause, whichever occurs first. 5. To evaluate disease control rate (DCR) 6. To evaluate the safety and tolerability of pembrolizumab and selinexorcombination regimen: Safety and tolerability of study treatment will be evaluated based on AE reports, vital signs, clinical laboratory results, electrocardiogram (ECG) and physical examination findings, by the occurrence, nature, and severity of AEs as categorized by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. View All Details

    • Protocol Number:
      092101

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Selinexor Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Sarah Weiss MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Age greater than or equal to (≥) 18 years at the time of informed consent.
    • Participant must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy. 1. Participants must have confirmed PD per Response Evaluation Criteria in Solid Tumors (RECIST) on or within 12 weeks of the last dose of anti-PD-1/L1 monotherapy or combination therapy (including relatlimab or other anti-LAG-3 mAb) per Society for Immunotherapy in Cancer Guidelines (Kluger,2020). 2. Arm A (primary resistance): participant has disease progression after receiving at least 6 weeks of prior anti-PD-1/L1 mAb with the best response as PD, or stable disease (SD) less than (<) 6 month (participants with a partial response [PR] or complete response [CR] who have disease progression within 6 months will be considered to have primary resistance in this study). 3. Arm B (secondary/acquired resistance): participant has disease progression after receiving at least 6 months of prior anti-PD-1/L1 mAb with the best response as CR, PR, or SD greater than (>) 6 months (participants who have disease progression after neoadjuvant or adjuvant therapy, will be considered to have secondary resistance in this study). 4. Participants who progress on or within 12 weeks after elective discontinuation of anti-PD-1/L1 mono or combination treatment in the absence of PD or treatment limiting toxicity must have confirmed PD per RECIST.
    • Participants should have at least 1 prior line of CPI therapy but no more than 2.
    • Measurable disease according to RECIST v1.1.
    • Participants with stable previously treated brain metastases are permitted in this study.
    • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (≤) 1.
    • Adequate bone marrow function at screening, defined as: 1. Absolute neutrophil count (ANC) ≥1.5 * 10^9 per liter (L). 2. Hemoglobin ≥10 gram per deciliter (gm/dL) (≥6.2 millimoles per liter [mmol/L]). 3. Platelet count ≥100 * 10^9/L.
    • Serum direct bilirubin ≤1.5 * upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 * ULN (with confirmed liver metastases: AST and ALT ≤5 * ULN).
    • Calculated creatinine clearance (CrCl) ≥15 milliliters per minute (mL/min) based on the Cockcroft and Gault formula.
    • Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for at least four months following the last dose of study treatment. Childbearing potential excludes: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy.
    • Male participants who are sexually active must use highly effective methods of contraception throughout the study and for at least four months following the last dose of study treatment. Male participants must agree not to donate sperm during the study treatment period.
    • Written informed consent signed in accordance with federal, local, and institutional guidelines.

    Exclusion Criteria:

    • Metastatic uveal or ocular melanoma.
    • Active central nervous system (CNS) metastases or other CNS (e.g., meningeal) involvement.
    • Participants must have resolution or improvement of immune-mediated treatment related adverse reactions related to prior treatment(s) to Grade ≤1 without steroid maintenance therapy or his or her previous baseline prior to the corresponding CPI therapy a. History of immune-mediated treatment related adverse reactions leading to discontinuation of prior anti-programmed death protein 1 (PD-1), anti-programmed death protein ligand 1 (PD-L1), or anti programmed death protein ligand 2 (PD-L2) monoclonal antibodies (mAbs) or severe hypersensitivity reaction to any mAb or any excipients which in the opinion of the Investigator precludes future use of anti-PD-1/PDL1 therapy.
    • Concurrent systemic steroid therapy higher than physiologic dose (>10 milligrams per day [mg/day] of prednisone or equivalent).
    • Previous treatment with selinexor or other exportin 1 (XPO1) inhibitors.
    • Insufficient time since or not recovered from procedures or anti-cancer therapy, defined as: 1. Not recovered from major surgery ≤28 days prior to Day 1 dosing. Minor procedures, such as biopsies, dental work, or placement of a port or intravenous (IV) line for infusion are permitted. 2. Have ongoing clinically significant anti-cancer therapy-related toxicities Common Terminology Criteria for Adverse Events (CTCAE) Grade >1. In specific cases, participants whose toxicity has stabilized or with Grade 2 non-hematologic toxicities can be allowed following documented approval by the Sponsor's Medical Monitor 3. Had last dose of previous anti-cancer therapy ≤14 days prior to Day 1 dosing 4. Palliative radiotherapy >14 days prior to the study is allowed 5. Received investigational drugs in other clinical trials within 28 days, or 5 half-lives of the investigational drug (whichever is shorter), prior to Cycle 1 Day 1 (C1D1).
    • Live-attenuated vaccine (e.g., nasal spray influenza vaccine) ≤14 days prior to the intended C1D1.
    • Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (e.g., vomiting, or diarrhea that is CTCAE version 5.0 grade >1).
    • Life expectancy less than (<) 4 months based on the opinion of the Investigator
    • Active pneumonitis requiring steroid therapy.
    • Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).
    • Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, prevent the participant from giving informed consent, or being compliant with the study procedures.
    • Female participants who are pregnant or lactating.
    • Active hepatitis B virus treated with antiviral therapy for hepatitis B within 8 weeks with a viral load >100 international units per milliliter (IU/mL).
    • Untreated hepatitis C virus positive without documentation of negative viral load per institutional standard.
    • Human immunodeficiency virus positive with CD4+T-cells ≤350 cells per microliter, positive viral load per institutional standard, and a history of acquired immunodeficiency syndrome defining opportunist infections in the last year.

    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 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma (PIVOT IO 001). - NCT03635983

    Primary Objectives: 1. To compare ORR using RECIST 1.1 for NKTR-214 combined with nivolumab and that of nivolumab monotherapy in participants with previously untreated unresectable or metastatic melanoma. 2. To compare PFS using RECIST 1.1 of NKTR-214 combined with nivolumab and that of nivolumab monotherapy in participants with previously untreated unresectable or metastatic melanoma. 3. To compare OS of NKTR-214 combined with nivolumab and that of nivolumab monotherapy in participants with previously untreated unresectable or metastatic melanoma. Secondary Objectives: 1. To evaluate efficacy of NKTR-214 combined with nivolumab and that of nivolumab monotherapy. 2. To evaluate the association between PD-L1 tumor expression on tumor cells and efficacy measures including PFS and ORR by BICR and OS. 3. To evaluate the safety and tolerability of NKTR-214 combined with nivolumab and that of nivolumab monotherapy. View All Details

    • Protocol Number:
      092003

    • Principal Investigator:
      Adam Berger

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

    • Therapies Involved:
      Chemotherapy single agent systemic Chemotherapy multiple agents systemic

    • Drugs Involved:
      NKTR-214 Opdivo (Nivolumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Adam Berger

    Read Inclusion & Exclusion Criteria

    For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:

    • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
    • Histologically confirmed stage III (unresectable) or stage IV melanoma
    • Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents

    Exclusion Criteria:

    • Active brain metastases or leptomeningeal metastases
    • Uveal melanoma
    • Participants with an active, known or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply

    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 Pilot and Feasibility Study of the Sun Safe Family Facebook Intervention:

    The goal of this pilot study is to develop and pilot test a social media-delivered family sun safety intervention to improve sun safety among children between the ages of 2 and 17 years of age by intervening with their parents. We will conduct a pilot trial of 300 parents of children between 2 and 17 years of age recruited from Facebook ads and an internet panel. Due to a difference in parenting role, we will conduct separate Facebook groups for parents of children aged 2-9 years of age, children aged 10-13 years of age, and teenagers 14 -17 years of age. Aim 1: To evaluate the acceptability and feasibility of a social-media delivered sun-safety intervention, Sun Safe Families, for parents of children between 2 and 17 years of age. We will evaluate feasibility by three metrics: a) study acceptance rates; b) engagement in the Facebook groups, 3) treatment evaluations of the Facebook groups using quantitative and qualitative feedback, and;4) completion rates for post-intervention surveys. Aim 2: To provide preliminary data on Sun Safe Families. We will evaluate the impact of the intervention on parent-reported child sun protection and exposure, as well as on parent knowledge, parent attitudes, norms, agency about child sun protection, and communication with the child about sun protection and exposure. View All Details

    • Protocol Number:
      132021

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Other Skin

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD
    • Rutgers Cancer Institute of New Jersey
  • An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage IIIB/C Melanoma Patients. - NCT03567889

    Primary Objective: Efficacy of Daromun neoadjuvant treatment followed by surgery to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery alone). Secondary Objective(s): (1) The key secondary objective of the study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery improves in a statistically significant manner the overall survival (OS) of patients with resectable Stage IIIB or C melanoma patients with respect to the standard of care (surgery alone). (2) Other secondary objectives include improvement of RFS as determined by the local investigator, local recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) as well as demonstration of safety and tolerability of the Daromun treatment. Exploratory Objective(s): Investigate efficacy of the neoadjuvant Daromun treatment by (1) Biomarker studies (both Arms): immunophenotypic characterization of PBMCs for changes in absolute counts and relative percentages of lymphocytic subpopulations (e.g., Tregs, MDSCs etc.) over time (only for patients recruited in German centers). Study of blood biomarkers. (2) For Patients included in Arm 1 only, Pathological Complete Responses (pCR) and Overall Response (OR partial or complete response by RECIST) after the treatment with Daromun assessed at time of surgical resection. View All Details

    • Protocol Number:
      091907

    • Principal Investigator:
      Adam Berger

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

    • Therapies Involved:
      Chemotherapy multiple agents systemic Surgery

    • Drugs Involved:
      L19IL2 L19TNF

      • Contacts:

      • Rutgers University Prinicipal Investigator: Adam Berger

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Diagnosis of clinical stage IIIB and IIIC (AJCC v7) metastatic melanoma, eligible for complete surgical resection of all metastases (surgically resectable). 2. Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm. 3. Males or females, age ≥ 18 years 4. ECOG Performance Status/WHO Performance Status ≤ 1 5. Life expectancy of > 24 months 6. Absolute neutrophil count > 1.5 x 109/L 7. Hemoglobin > 9.0 g/dL 8. Platelets > 100 x 109/L 9. Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/dl) 10. ALT and AST ≤ 2.5 x the upper limit of normal (ULN) 11. Serum creatinine < 1.5 x ULN 12. LDH serum level ≤ 1.5 x ULN 13. Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is also required. 14. All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade ≤ 1 unless otherwise specified above 15. All women of childbearing potential (WOCBP) must have negative pregnancy test results at the screening. WOCBP must be using, from the screening to three months following the last study drug administration, highly effective contraception methods. WOCBP and effective contraception methods are defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Pregnancy test will be repeated at the safety visit (only WOCBP and only for patients in Arm 1). 16. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration. 17. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 18. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

    Exclusion Criteria:

      1. Uveal melanoma or mucosal melanoma 2. Evidence of distant metastases at screening 3. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1), second primary melanoma in situ or any cancer curatively treated ≥ 5 years prior to study entry 4. Concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. 5. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris. 6. Inadequately controlled cardiac arrhythmias including atrial fibrillation 7. Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria) 8. LVEF ≤ 50% and/or abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator. 9. Uncontrolled hypertension 10. Ischemic peripheral vascular disease (Grade IIb-IV) 11. Severe diabetic retinopathy 12. Active autoimmune disease 13. History of organ allograft or stem cell transplantation 14. Recovery from major trauma including surgery within 4 weeks prior to enrollment. 15. Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies or any other constituent of the product. 16. Breast feeding female 17. Anti-tumor therapy (except small surgery) within 4 weeks before enrollment 18. Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before enrollment 19. Planned administration of growth factors or immunomodulatory agents within 7 days before enrollment 20. Patient requires or is taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion. 21. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol 22. Previous enrolment and randomization in the same 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
  • Cancer treatment and survivorship experiences among Southern New Jersey residents.

    The primary objective of this project is to conduct a survey of cancer survivors to understand cancer burden, treatment outcomes, care needs, cancer prevention practices, health care access, and health information seeking behaviors of persons living in Southern New Jersey (Atlantic, Burlington, Camden, Cape May, Cumberland, Gloucester, Mercer, Ocean, and Salem counties). To date, health needs of cancer survivors who are residents of these Southern New Jersey counties remain largely unexplored. Specific Aim 1: To determine the feasibility of conducting research on the access and needs of patients diagnosed with cancers who reside in the New Jersey counties outlined. Specific Aim 2: To characterize the cancer burden, quality of life characteristics, care needs, cancer prevention practices, health care access, survivorship care experiences, cancer surveillance, and health information seeking behaviors of patients diagnosed with cancers who reside in the New Jersey counties outlined. View All Details

    • Protocol Number:
      131803

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Colon,Breast - Female,Melanoma, Skin,Ovary,Lung,Rectum,Cervix,Other Female Genital,Thyroid,Prostate,Urinary Bladder

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD
    • Rutgers Cancer Institute of New Jersey
  • EA6174: A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma - NCT03712605

    Primary Objective: To compare Overall Survival (OS) and Recurrence Free Survival (RFS) as co-primary endpoints across the two arms. Secondary Objective(s): (1) To evaluate adverse events. (2) To evaluate Distant Metastasis Free Survival (DMFS). (3) To evaluate the impact of radiation on clinical outcomes (OS, RFS, DMFS). View All Details

    • Protocol Number:
      091909

    • Principal Investigator:
      Adam Berger

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Skin

    • Therapies Involved:
      Chemotherapy (NOS)

    • Drugs Involved:
      MK-3475 (Pembrolizumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Adam Berger

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patient must be >= 18 years of age
    • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1, or 2 (However, those patients with a performance state of 3 because they are wheel chair bound due to congenital or traumatic events more than one year before the diagnosis of Merkel cell carcinoma are eligible).
    • Patient must not be pregnant or breast-feeding due to the unknown effects of the study drug in this setting. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy. A patient of childbearing potential is anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
    • Patients of childbearing potential, and sexually active males, on Arm A MK-3475 (pembrolizumab must not conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment. For patients on Arm B only receiving radiation therapy, contraception use should be per institutional standard.
    • Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (American Joint Committee on Cancer [AJCC] version 8) I-IIIb.
    • Stage I patients with negative sentinel lymph node biopsy are ineligible. Patients who have a positive biopsy or for whom no biopsy was done are eligible.
    • Patients with distant metastatic disease (stage IV) are ineligible.
    • The primary tumor must have grossly negative margins. (Microscopically positive margins are allowed).
    • Cancers of unknown primary that have regional disease only are eligible.
    • Complete nodal dissection is not required for eligibility.
    • Patients with all macroscopic Merkel cell carcinoma (either identified by physical exam or imaging) have been completely resected by surgery within 16 weeks before randomization.
    • All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 8 weeks prior to randomization.
    • Patient may not have a history of distant metastatic disease.
    • NOTE: Loco-regional recurrent disease is acceptable, as long as this is not metastatic (prior surgery with or without radiation therapy is acceptable).
    • For patients with initial presentation of Merkel cell carcinoma, patient must have no previous systemic therapy or radiation therapy prior to surgery for Merkel cell carcinoma and cannot have completed adjuvant radiation therapy for Merkel cell carcinoma more than 6 weeks prior to randomization. Patients actively undergoing radiation therapy or having completed adjuvant radiation therapy within 6 weeks of randomization are eligible, as long as resection date is within 16 weeks of randomization. Patients with prior radiation at a non-Radiation Oncology Core (IROC) provider are eligible for the trial. If the patient has not received radiation, and treatment at a Radiation Oncology Core (IROC) provider is not possible, the patient can start and complete radiation prior to randomization, with recommendations to follow radiation protocol guidelines with submission of treatment records.
    • White blood count >= 2000/uL (within 4 weeks prior to randomization).
    • Absolute neutrophil count (ANC) >= 1000/uL (within 4 weeks prior to randomization).
    • Platelets >= 75 x 10^3/uL (within 4 weeks prior to randomization).
    • Hemoglobin >= 8 g/dL (>= 80 g/L; may be transfused) (within 4 weeks prior to randomization).
    • Creatinine =< 2.0 x institutional upper limit of normal (ULN) (within 4 weeks prior to randomization).
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN (within 4 weeks prior to randomization).
    • Total bilirubin =< 2.0 x institutional ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL) (within 4 weeks prior to randomization).
    • Patients who are human immunodeficiency virus (HIV)+ with undetectable HIV viral load are eligible provided they meet all other protocol criteria for participation.
    • Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are eligible provided viral loads are undetectable. Patients on suppressive therapy are eligible.
    • Patients must not be on active immunosuppression, have a history of life threatening virus, have had other (beside non-melanoma skin cancers, or recent indolent cancers e.g.: resected low grade prostate cancer) invasive cancer diagnoses in the last two years, or have had immunotherapy of any kind within the last 2 years prior to randomization.
    • Patients must not have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    • Operative notes from patient's surgical resection must be accessible.

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

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

    • Saint Barnabas Medical Center
    • Rutgers Cancer Institute of New Jersey
  • Facebook Intervention for Young Onset Melanoma Patients and Families - NCT03677739

    The study has one primary and two secondary aims. 1)The primary aim (FDRs) is to examine the efficacy of the Young Melanoma Family Facebook intervention versus the Healthy Lifestyle Facebook intervention on total cutaneous exam (primary outcome), skin self-exam frequency and comprehensiveness, and sun protection practices (secondary outcomes) of FDRs of young melanoma survivors. 2)A secondary aim (survivors) is to examine the efficacy of the Young Melanoma Family Facebook intervention on patients skin self-exam frequency and comprehensiveness and sun protection habits. 3)Another secondary aim is to examine the mechanisms of intervention efficacy. View All Details

    • Protocol Number:
      131812

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • PATIENT: Diagnosed with stage 0-3 melanoma in the last 5 years
    • PATIENT: Age at diagnosis 18-39 years
    • PATIENT: Completed treatment at least 3 months previously
    • PATIENT: Recruited from New Jersey or California State Cancer Registry or MD Anderson Cancer Center
    • PATIENT: Does not have a concurrent cancer diagnosis
    • PATIENT: Able to speak and read English
    • PATIENT: Access to computer, internet, and has a Facebook account
    • PATIENT: At least one family member consents
    • FDR: Current age 18-80 years
    • FDR: Does not have a personal history of melanoma
    • FDR: Able to speak and read English
    • FDR: Access to computer, internet, and has a Facebook account
    • FDR: Has only one FDR with melanoma (patient)
    • FDR: Has not had a total cutaneous examination (TCE) in the past 3 years, has done skin self-exam (SSE) fewer than three times in the past year, OR has a sun protection habits average score less than or equal to 4 (?often?)
    • FDR: Patient consents

    Exclusion Criteria:

    • Physical Activity Readiness Questionnaire (Thomas, et. al., 1992): This 7-item scale will be used to screen out individuals who will need to consult a physician for medical clearance before engaging in physical activity. If a participant checks off any of the items, the investigators will ask for a physician clearance before consenting to 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
  • Melanoma Margins Trial-II - A Phase III, Multi-centre Randomised Controlled Trial Investigating 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (ANZMTG 02.18 MelMarT-II) - NCT03860883

    Primary Objective: The primary objective of the trial is to assess whether there is no difference in disease-free survival for patients treated with a 1cm excision margin when compared to a 2cm margin for stage II primary melanomas (AJCC 8th edition; pT2b-pT4b). Secondary objectives: We hope to show that we can reduce the risk of long-term pain. If the study shows no difference in the risk of tumour recurrence then we will also be able to determine how much of an impact the narrower excision makes to patients in terms of improving QOL and reducing side effects. We will also have enough to data to determine the economic impact of narrower excision margins on the health services and society in general. View All Details

    • Protocol Number:
      091908

    • Principal Investigator:
      Adam Berger

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

    • Therapies Involved:
      Surgery

      • Contacts:

      • Rutgers University Prinicipal Investigator: Adam Berger

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Patients must have a stage II primary invasive cutaneous melanoma with Breslow thickness > 2mm without ulceration, or >1mm (with ulceration only) (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis. 2. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, or sole). 3. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma. 4. Staging sentinel node biopsy must be completed within three months (92 days) of the original diagnosis. 5. Patients must be 18 years or older at time of consent. 6. Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan. 7. Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI. 8. Patients must have an ECOG performance score between 0 and 1. 9. A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:
    • The patient has undergone potentially curative therapy for all prior malignancies,
    • There has been no evidence of recurrence of any prior malignancies for at least FIVE years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrence), and
    • The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.

    Exclusion Criteria:

      1. Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'. 2. Patient has already undergone wide local excision at the site of the primary index lesion. 3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion. 4. Desmoplastic or neurotropic melanoma. 5. Microsatellitosis as per AJCC 8th edition definition 6. Subungual melanoma 7. Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible. 8. History of previous or concurrent (i.e., second primary) invasive melanoma. 9. Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, genitalia, perineum or anus, mucous membranes or internal viscera. 10. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma. 11. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including sentinel lymph node biopsy, of the index melanoma. 12. Any additional solid tumour or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer. 13. Melanoma-related operative procedures not corresponding to criteria described in the protocol. 14. Planned adjuvant radiotherapy to the primary melanoma site after Wide Local Excision is not permitted as part of the protocol and any patients given this treatment would be excluded from the study. 15. History of organ transplantation. 16. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at enrolment or within 6 months prior to enrolment. Pregnancy is not a specific exclusion criterion for this trial, though it may not be clinically appropriate to perform a wide excision and sentinel node biopsy until the pregnancy has been completed, which is likely to exclude the patient due to violation of inclusion criterion 4. We would advise careful counselling of the patient prior to enrolling the patient, which would include a discussion at the treating centre's multidisciplinary team meeting or tumour board. We would strongly advise contacting the central trial office to discuss the case prior to enrolling on 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
  • PROPHETIC Predicting responsiveness in oncology patients based on host response evaluation during anti cancer treatments - NCT04056247

    To create a proteomic profile (Host Response) using plasma from patients before and after anti-cancer therapy, and to associate the changes in the levels of plasma proteins with response to treatment (ORR) as defined by RECIST 1.1 /other validated clinical scale to asses response. View All Details

    • Protocol Number:
      002042

    • Principal Investigator:
      Adam Berger

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

      • Contacts:

      • Rutgers University Prinicipal Investigator: Adam Berger

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Cancer patients with stage IV NSCLC or stage IV malignant melanoma
    • Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response
    • ECOG PS - 0/1-2
    • Normal hematologic, renal and liver function: 1. Absolute neutrophil count higher than 1500/mm3 2. Platelets count higher than 100,000/mm3 3. haemoglobin higher than 9 g/dL 4. Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min 5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit.

    Exclusion Criteria:

    • Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug
    • Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in 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