Trial record 2 of 34 for:    Study of MK-3475

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01876511
First received: June 10, 2013
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
MSI Positive Colorectal Cancer
MSI Negative Colorectal Cancer
MSI Positive Non-Colorectal Cancers
Drug: MK-3475
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Objective response rate (irORR) at 20 weeks in patients with MSI positive and negative colorectal adenocarcinoma using immune related response criteria (irRC) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Immune-related progression free survival (irPFS) rate in patients with MSI positive non-colorectal adenocarcinoma using immune related response criteria (irRC) at 20 weeks [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • irPFS and PFS in patients with MSI positive and negative tumors at 28 weeks using irRC and RECIST 1.1 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Best overall response rate and disease control rate in patients with MSI positive and negative tumors [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Number of participants experiencing immune-related toxicities (IRAEs) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Does MSI as a marker predict treatment response [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Identify alternative markers of MSI status. This includes but is not limited to MLH 1, MSH 2, MSH 6, PMS2, BRAF pV600E, and TGFBR2. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 71
Study Start Date: September 2013
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSI Positive Colorectal Cancer Drug: MK-3475
MK-3475 10 mg/kg every 14 days
Experimental: MSI Negative Colorectal Cancer Drug: MK-3475
MK-3475 10 mg/kg every 14 days
Experimental: MSI Positive Non-Colorectal Cancer Drug: MK-3475
MK-3475 10 mg/kg every 14 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876511

Locations
United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: George Fisher, MD       georgeaf@stanford.edu   
Principal Investigator: George Fisher, MD         
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Holly Kemberling, RN    443-287-5013    hkember1@jhmi.edu   
Principal Investigator: Dung Le, MD         
United States, Ohio
Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Richard Goldberg, MD       Richard.goldberg@osumc.edu   
Principal Investigator: Richard Goldberg, MD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Todd Crocenzi, MD       Todd.Crocenzi@providence.org   
Principal Investigator: Todd Crocenzi, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Dung Le, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01876511     History of Changes
Other Study ID Numbers: J1365, MK-3475-016, NA_00085756
Study First Received: June 10, 2013
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
MSI
MSS
MLH 1
MSH 2
MSH 6
PMS2
BRAF pV600E
TGFBR2

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014