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SCCA Clinical Studies: Phase 1 Program

MK-3475 + PegIFN-2b and MK-3475 + Ipilimumab
A Phase I/II Clinical Trial to Study the Safety and Tolerability of MK-3475 + Pegylated Interferon Alfa-2b (PEG-IFN) and MK-3475 + Ipilimumab (IPI) in Subjects With Advanced Melanoma (MEL) and Renal Cell Carcinoma (RCC)
Status Conditions Phase Study ID
Recruiting Renal Cell Carcinoma
Melanoma
Phase I/II NCT02089685
Summary

This study is being done to analyze the safety, tolerability, and efficacy of treatment for advanced melanoma (MEL) and renal cell carcinoma (RCC) using combination regimens of MK-3475 + pegylated interferon alfa-2b (PegIFN-2b) and MK-3475 + ipilimumab (IPI). The primary hypothesis is that these combinations will be sufficiently well-tolerated to permit continued clinical investigation.


Investigator
John Thompson, MD
Location    
SCCA Phase 1 Program Office 206-288-7551 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
  • Histologically- or cytologically-confirmed diagnosis of advanced/unresectable or metastatic MEL or RCC (Part 1 only) with predominantly clear cell elements
  • MEL subjects may be treatment naïve or may have received prior lines of therapy for metastatic disease
  • RCC subjects must have received >=1 prior line of therapy for metastatic disease
  • Measurable disease as defined by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate organ function
  • Resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 and/or recovered from major surgery or radiation therapy
  • Female participants of childbearing potential must be willing to use adequate contraception during the course of the study through 120 days after the last dose of study drug
  • Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study drug
Exclusions (conditions that would prevent participation in this study)
  • Uveal or ocular MEL
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
  • Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137 antibody, anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) or other immune checkpoint inhibitor agents
  • Monoclonal antibody for direct antineoplastic treatment, prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or has not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
  • Active, non-infectious pneumonitis
  • Active infection requiring systemic therapy
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial from screening through 120 days after the last dose of study drug
  • Prior therapy with interferon alfa for treatment of metastatic disease
  • Uncontrolled thyroid dysfunction
  • Uncontrolled diabetes mellitus.
  • Known history of human immunodeficiency virus (HIV)
  • Known active Hepatitis B or Hepatitis C
  • Received a live vaccine within 30 days prior to first dose of study drug
Last Updated
June 23, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.