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

Phase 2
18 Years
Not Enrolling
MSI Positive Colorectal Cancer, MSI Negative Colorectal Cancer, MSI Positive Non-Colorectal Cancers

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Trial Information

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

Inclusion Criteria:

1. Arm 1 only: Patients with MSI positive colorectal cancer

2. Arm 2 only: Patients with MSI negative colorectal cancer

3. Arm 3 only: Patients with MSI positive non-colorectal cancer

4. Have measurable disease

5. ECOG Performance Status of 0 to 1

6. Adequate organ function as defined by study-specified laboratory tests

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

8. Signed informed consent form

9. Willing and able to comply with study procedures

10. Agree to have a biopsy of their cancer

Exclusion Criteria:

1. Currently have or have history of certain study-specified heart, liver, kidney, lung,
neurological, immune or other medical conditions

2. Systemically active steroid use

3. Patients on home oxygen

4. Patients who have had prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies

5. Another investigational product within 28 days prior to receiving study drug

6. Pregnant or lactating

7. Conditions, including alcohol or drug dependence, or intercurrent illness that would
affect the patient's ability to comply with study visits and procedures

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immune-related progression free survival (irPFS) rate at 20 weeks in patients with MSI positive and negative colorectal adenocarcinoma using immune related response criteria (irRC)

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Dung Le, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2013

Completion Date:

Related Keywords:

  • MSI Positive Colorectal Cancer
  • MSI Negative Colorectal Cancer
  • MSI Positive Non-Colorectal Cancers
  • Colorectal Neoplasms
  • Microsatellite Instability



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410