Phase 2 Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors

Status: Completed
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will be looking at whether MK-3475 (an antibody that blocks negative signals to T cells) is effective (anti-tumor activity) and safe in three different patient populations. These include: 1. patients with MSI positive colon cancer, 2. patients with MSI negative colon cancer and 3. patients with other MSI positive cancers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Cohort A only: Patients with microsatellite instability (MSI) positive colorectal cancer

• Cohort B only: Patients with MSI negative colorectal cancer

• Cohort C only: Patients with MSI positive non-colorectal cancer -

• Have measurable disease

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

• Adequate organ function as defined by study-specified laboratory tests

• Must use acceptable form of birth control through the study and for 28 days after final dose of study drug

• Signed informed consent form

• Willing and able to comply with study procedures

• Agree to have a biopsy of participants' cancer

• Patients with colon cancer must have received at least two prior cancer therapy regimens.

• Patients with other cancer types must have received at least one prior cancer therapy

• Progressive disease

Locations
United States
California
Stanford University
Stanford
Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore
Investigator Thoracic and Gastrointestinal Oncology Branch, Center for Cancer Research, NIH
Bethesda
Ohio
Ohio State University
Columbus
Oregon
Providence Portland Medical Center
Portland
Pennsylvania
University of Pennsylvania, Abramson Cancer Center
Philadelphia
University of Pittsburgh Cancer Institute
Pittsburgh
Time Frame
Start Date: 2013-09
Completion Date: 2019-08
Participants
Target number of participants: 113
Treatments
Experimental: Cohort A: MSI Positive Colorectal Cancer
Experimental: Cohort B: MSI Negative Colorectal Cancer
Experimental: Cohort C: MSI Positive Non-Colorectal Cancer
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov

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