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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overOtherJ1365
MK-3475-016, NA_00085756, NCT01876511

Trial Description

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 Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Merck and Company, Incorporated

Dung Le, MDPrincipal Investigator

Trial Sites

U.S.A.
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Holly Kemberling, RN Ph: 443-287-5013
  Email: hkember1@jhmi.edu
 Dung Le, MDPrincipal Investigator
Oregon
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 Todd Crocenzi, MD
  Email: Todd.Crocenzi@providence.org
 Todd S. CrocenziPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01876511
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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