Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

Completed · Phase 1/Phase 2

Conditions studied: Microsatellite-instability (MSI) High Colorectal Cancer (CRC), Endometrial Cancer, Head and Neck Cancer, Hepatocellular Carcinoma (HCC), Gastric Cancer, Lung Cancer, Lymphoma, Renal Cell Carcinoma (RCC), Ovarian Cancer, Solid Tumors, UC (Urothelial Cancer), Melanoma, Bladder Cancer, Triple Negative Breast Cancer (TNBC)

In brief

The purpose of this study was to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in participants with certain cancers. This study was conducted in 2 phases, Phase 1 and Phase 2.

Key facts

Study ID

NCT02178722

Run by

Incyte Corporation

People needed

444

Starts

2014-07-17

Expected to finish

2020-11-06

Last updated by the study team

2022-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with histologically or cytologically non-small cell lung cancer (NSCLC), melanoma, transitional cell carcinoma of the genitourinary (GU) tract, renal cell cancer, triple negative breast cancer, adenocarcinoma of the endometrium or squamous cell carcinoma of the head and neck (Phase 1).
• Subjects with histologically confirmed melanoma, NSCLC, transitional cell carcinoma of the GU tract, TNBC, SCCHN, ovarian cancer, MSI high colorectal cancer (CRC), RCC, gastric cancer, HCC and DLBCL (Phase 2).
• Life expectancy > 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
• Presence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Lugano Classification for subjects with DLBCL.
• Laboratory and medical history parameters within protocol-defined range.
• For Phase 1: Subjects who have advanced or metastatic disease as noted above that have received at least one prior therapy or have advanced or metastatic disease for which no curative treatment is available may be enrolled.
• For Phase 2 expansion cohorts: Subjects with NSCLC, melanoma (checkpoint inhibitor naïve, primary refractory melanoma, relapsed melanoma), transitional cell carcinoma of the GU tract, SCCHN, ovarian cancer, MSI high CRC, RCC, DLBCL, TNBC, gastric cancer, and HCC.
• Phase 2 expansion: NSCLC
• Subjects who have received at least 1 prior platinum-based therapy. Subjects who have a non-platinum-based regimen may be enrolled with medical monitor approval.
• Tumors with epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive treated with a tyrosine kinase inhibitor are permitted; however, subjects should have progressed on or be intolerant to the targeted therapy.
• Subjects must not have received immunotherapy with programmed death receptor-1 (PD-1) or cytotoxic T-lymphocyte antigen (CTLA-4) targeted therapy.
• Phase 2 expansion: Melanoma
• Documentation of V600E-activating BRAF mutation status.
• Prior systemic therapy requirements.
• Melanoma immune checkpoint-naïve: Subjects must not have received immunotherapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy. Exception: Prior anti-CTLA-4 in the adjuvant setting would be permitted.
• Primary refractory melanoma: Subjects must have received prior treatment with anti-PD-1 or anti-PD-L1 therapy (alone or as part of a combination) in the advanced or metastatic setting and have progressive disease as their best response to treatment that is confirmed 4 weeks later.
• Relapsed melanoma: Subjects must have received prior anti-PD-1 or anti-PD-L1 therapy (alone or as part of a combination) in the advanced or metastatic setting and achieved partial response ore complete response but later have confirmed progressive disease.
• Subjects enrolling in the primary refractory or relapsed melanoma must be willing to undergo mandatory pretreatment and on-treatment biopsies.
• Ocular melanoma is excluded.
• Phase 2 expansion: Transitional cell carcinoma of the GU tract
• Metastatic or locally advanced and not amenable to curative therapy with disease progression on or after platinum-based chemotherapy or alternative therapy if platinum-based therapy is not appropriate.
• Prior PD-1 or CTLA-4 targeted therapies are excluded
• Phase 2 expansion: SCCHN
• Histologically confirmed metastatic or recurrent squamous cell carcinoma not amenable to local therapy with curative intent (surgery or radiation with or without chemotherapy). Carcinoma of the nasopharynx, salivary gland, or * *Subjects must have received at least 1 prior systemic chemotherapy regimen that must have included a platinum-based therapy.

You may not qualify if…

• Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) prior to first dose.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). Exception: Prior anti-CTLA-4 in the adjuvant setting for subjects with melanoma would be permitted.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable.
• Has an active autoimmune disease.
• Has evidence of noninfectious pneumonitis that required steroids or current pneumonitis.
• Live vaccine use within 30 days of first dose of study medication.
• Monoamine oxidase inhibitors.

Where it is running

• UC San Diego Moores Cancer Center — La Jolla, California, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• US Davis Cancer Center — Sacramento, California, United States
• University Of Colorado Cancer Center — Aurora, Colorado, United States
• University of Connecticut Health Center Carole And Ray Neag Comprehensive Cancer Center — Farmington, Connecticut, United States
• Miami Cancer Institute at Baptist Health, Inc — Miami, Florida, United States
• Georgia Cancer Specialists affiliated with Northside Hospital Cancer Institute — Atlanta, Georgia, United States
• The University of Chicago Medicine — Chicago, Illinois, United States
• St. Francis Cancer Center — Topeka, Kansas, United States
• Greater Baltimore Cancer Center — Baltimore, Maryland, United States
• St. Agnes Hospital Cancer Institute — Baltimore, Maryland, United States
• The Center for Cancer and Blood Disorders (RCCA MD LLC- Maryland Division) — Bethesda, Maryland, United States
• University of Michigan Hospital and Health Systems — Ann Arbor, Michigan, United States
• Health Partners Institute — Saint Louis Park, Minnesota, United States
• Hackensack University Medical Center - John Theurer Cancer Center — Hackensack, New Jersey, United States
• The Christ Hospital Hematology Oncology, Lindner Research Center — Cincinnati, Ohio, United States
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Greenville Health System Cancer Institute — Greenville, South Carolina, United States
• West Cancer Center — Germantown, Tennessee, United States
• Sarah Cannon Research Institute at Tennessee Oncology — Nashville, Tennessee, United States
• University Of Texas Southwestern Medical Center At Dallas — Dallas, Texas, United States
• Virginia Cancer Specialists — Arlington, Virginia, United States

Full record on ClinicalTrials.gov

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