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

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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. Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements

3. Patients who have had chemotherapy or biological cancer therapy within 2 weeks prior to the first dose of study drug

4. Patients who have had radiation within 4 weeks prior to the first dose of study drug

5. Patients who have undergone major surgery within 4 weeks of dosing of investigational agent

6. Patients who have received another investigational product within 28 days prior to receiving study drug

7. Patients who have received any of the following concomitant therapy: IL-2, interferon, or other non-study immunotherapy regimens, immunosuppressive agents, other investigational therapies or chronic use of systemic corticosteroids within one week prior to first dose of study drug

8. Patients who have received a live vaccine within 4 weeks prior to or after any dose of MK-3475

9. Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration

10. Patient 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

11. Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), CNS or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis).

12. Patients who have known history of infection with HIV, hepatitis B, or hepatitis C

13. Patients with evidence of interstitial lung disease

14. Systemically active steroid use

15. Patients on home oxygen

16. Patients with oxygen saturation of <92% on room air by pulse oximetry

17. Pregnant or lactating

18. 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, MD, Principal Investigator

Trial Sites

U.S.A.

California
Stanford

Stanford Cancer Center

George Fisher, MD
Email: georgeaf@stanford.edu

George A. Fisher
Principal Investigator

Maryland
Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Holly Kemberling, RN
Ph: 443-287-5013
Email: hkember1@jhmi.edu

Dung Le, MD
Principal Investigator

Bethesda

Investigator Thoracic and Gastrointestinal Oncology Branch, Center for Cancer Research, NIH

Tim F. Greten, MD
Email: gretentf@mail.nih.gov

Tim F Greten, MD
Principal Investigator

Ohio
Columbus

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Richard Goldberg, MD
Email: Richard.goldberg@osumc.edu

Richard Goldberg, MD
Principal Investigator

Oregon
Portland

Providence Cancer Center at Providence Portland Medical Center

Todd Crocenzi, MD
Email: Todd.Crocenzi@providence.org

Todd S. Crocenzi
Principal Investigator

Pennsylvania
Pittsburgh

UPMC Cancer Centers

James Lee, MD, PhD
Email: leejj@upmc.edu

James Lee, MD; PhD
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01876511
ClinicalTrials.gov processed this data on April 15, 2015

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.