Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03642067|
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : November 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Microsatellite Stable (MSS) Colorectal Adenocarcinomas Colorectal Adenocarcinoma||Drug: Nivolumab Drug: Relatlimab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase A Phase 2 Study Evaluating Response and Biomarkers in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer Treated With Nivolumab in Combination With Relatlimab|
|Actual Study Start Date :||February 11, 2019|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
Experimental: Nivolumab and Relatlimab
Patients will receive treatment every 28 days for up to 2 years. Nivolumab (480 mg) will be administered IV on day 1 (28 day cycle). Relatlimab (160 mg) will be administered IV on day 1 (28 day cycle).
Nivolumab (480 mg) will be administered IV on day 1 (28 day cycle).
Other Name: anti-PD-1, OPDIVO
Relatlimab (160 mg) will be administered IV on day 1 (28 day cycle).
Other Name: BMS-986016
- Objective response rate (ORR) [ Time Frame: 4 years ]The proportion of subjects with partial response (PR) or complete response (CR) according to RECIST 1.1.
- Number of participants experiencing study drug-related toxicities [ Time Frame: 4 years ]Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642067
|Contact: Susan Sartorius-Mergenthaler, RN||410-614-3644||Sartosu@jhmi.edu|
|Contact: Jane Zorzi, RN||410-614-5818||Jzorzi1@jhmi.edu|
|Principal Investigator:||Dung Le, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|