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A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer (RELATIVITY-123)

  • Clinicaltrials.gov identifier

    NCT05328908

  • Recruitment Status

    Recruiting

  • First Posted

    April 14, 2022

  • Last update posted

    June 6, 2022

Study Description

Brief summary:

The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of late-line microsatellite stable (MSS) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.

  • Condition or Disease:Colorectal Neoplasms
  • Intervention/Treatment: Drug: Nivolumab-relatlimab FDC
    Drug: Regorafenib
    Drug: TAS-102
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 700 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer
  • Actual Study Start Date: April 2022
  • Estimated Primary Completion Date: January 2025
  • Estimated Study Completion Date: May 2028

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC)
Drug: Nivolumab-relatlimab FDC
Specified dose on specified days
Active Comparator: Arm B: Investigator's Choice
Treatment with Regorafenib or TAS-102
Drug: Regorafenib
Specified dose on specified days

Drug: TAS-102
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 1 [ Time Frame: Up to 5 years after last participant randomized ]
  • 2. OS in all randomized participants [ Time Frame: Up to 5 years after last participant randomized ]
  • Secondary Outcome Measures: 1. Objective response rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in randomized participants with PD-L1 CPS ≥ 1 [ Time Frame: Up to 5 years after last participant randomized ]
  • 2. ORR by BICR per RECIST v1.1 in all randomized participants [ Time Frame: Up to 5 years after last participant randomized ]
  • 3. Progression-free survival (PFS) by BICR per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1 [ Time Frame: Up to 5 years after last participant randomized ]
  • 4. PFS by BICR per RECIST v1.1 in all randomized participants [ Time Frame: Up to 5 years after last participant randomized ]
  • 5. Duration of response (DoR) by BICR per RECIST v1.1 in responders with PD-L1 CPS ≥ 1 [ Time Frame: Up to 5 years after last participant randomized ]
  • 6. DoR by BICR per RECIST v1.1 in all responders [ Time Frame: Up to 5 years after last participant randomized ]
  • 7. Number of participants with adverse events (AEs) [ Time Frame: Up to 135 days after participant's last dose ]
  • 8. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 135 days after participant's last dose ]
  • 9. Number of participants with immune-mediated adverse events (IMAEs) [ Time Frame: Up to 135 days after participant's last dose ]
  • 10. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 135 day's after participant's last dose ]
  • 11. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 135 days after participant's last dose ]
  • 12. DeFS-QoL: The time from randomization to death or at least a 15-points worsening from baseline in the EORTC QLQ-C30 GHS/QoL scale, with no subsequent improvement above the 15-point worsening from baseline score [ Time Frame: Up to 5 years after last participant randomized ]
    DeFS-QoL = Deterioration Free Survival-Quality of Life. The EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire-Core 30 (QLQ-C30) consists of 30 questions incorporated into 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, pain, nausea and vomiting), a global health status / Quality of Life scale, and six single symptom items. All of the scale and single-item measures range in score from 0 to 100, where a higher score represents a higher response level. High functional scores indicates more favorable outcomes and a higher score on the symptom domains indicates higher symptom burden/less favorable patient outcome.
  • 13. DeFS-PF: The time from randomization to death or at least a 10-points worsening from baseline in the EORTC QLQ-C30 physical function scale, with no subsequent improvement above the 10-point worsening from baseline score [ Time Frame: Up to 5 years after last participant randomized ]
    DeFS-PF = Deterioration Free Survival-Physical Function. The EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire-Core 30 (QLQ-C30) consists of 30 questions incorporated into 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, pain, nausea and vomiting), a global health status / Quality of Life scale, and six single symptom items. All of the scale and single-item measures range in score from 0 to 100, where a higher score represents a higher response level. High functional scores indicates more favorable outcomes and a higher score on the symptom domains indicates higher symptom burden/less favorable patient outcome.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry Must have historically or locally confirmed tumor microsatellite stability (stable) (MSS) / proficient mismatch repair (pMMR) status Participants must have: progressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if KRAS wild-type), if approved in the respective country, or; been intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures Must have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements Must have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately Exclusion Criteria: Prior treatment with either an immunotherapy or with regorafenib or with TAS-102 Untreated central nervous system (CNS) metastases, participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) History of refractory hypertension not controlled with anti-hypertensive therapy, myocarditis (regardless of etiology), uncontrolled arrhythmias, acute coronary syndrome within 6 months prior to dosing, Class II congestive heart failure (as per the New York Heart Association Functional Classification), interstitial lung disease/pneumonitis or an active, known or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Arkansas
Local Institution
Rogers

United States, California
City Of Hope
Duarte

United States, California
Local Institution
Los Angeles

United States, Connecticut
Local Institution
Norwich

United States, Florida
Local Institution
Miami

United States, Georgia
Northside Hospital
Atlanta

United States, Idaho
Local Institution
Boise

United States, Illinois
Local Institution
Chicago

United States, Indiana
Fort Wayne Medical Oncology & Hematology
Fort Wayne

United States, Michigan
Local Institution
Ann Arbor

United States, Minnesota
Mayo Clinic Hospital
Rochester

United States, New Jersey
Local Institution
East Brunswick

United States, North Carolina
Local Institution
Durham

United States, Ohio
Local Institution
Cincinnati

United States, Ohio
Local Institution
Columbus

United States, Ohio
Local Institution
Columbus

United States, Pennsylvania
Local Institution
Philadelphia

United States, South Carolina
Local Institution
Charleston

United States, South Dakota
Local Institution
Sioux Falls

United States, Texas
Local Institution
Fort Worth

United States, Wisconsin
Local Institution
Madison

Argentina, Buenos Aires
Local Institution - 0022
Ciudad Autonoma Buenos Aires

Argentina, Buenos Aires
Local Institution
Ciudad Autónoma Buenos Aires

Argentina, RIO Negro
Local Institution
Viedma

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Buenos Aires

Australia, New South Wales
Local Institution
Wagga Wagga

Australia, New South Wales
Local Institution
Westmead

Australia, Queensland
Local Institution
Greenslopes Qld

Australia, South Australia
Local Institution - 0002
Woodville South

Australia, Victoria
Local Institution
Clayton

Australia, Victoria
Local Institution
Melbourne

Australia, Western Australia
Local Institution
Perth

Austria
Local Institution
Graz

Austria
Local Institution
Klagenfurt

Belgium
Local Institution
Edegem

Belgium
Local Institution
Gent

Belgium
Local Institution
Leuven

Belgium
Local Institution
Woluwé-Saint-Lambert

Canada, Alberta
Local Institution
Edmonton

Canada, Ontario
Local Institution
Ottawa

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Montreal

Canada, Quebec
Local Institution
Montreal

Canada, Quebec
Local Institution
Sherbrooke

Chile, Metropolitana
Local Institution
Santiago

Chile, Metropolitana
Local Institution
Santiago

China, Beijing
Local Institution - 0122
Beijing

China, Hunan
Local Institution - 0125
Changsha

Czechia
Local Institution
Horovice

Czechia
Local Institution
Hradec Kralove

Czechia
Local Institution
Olomouc

Czechia
Local Institution
Prague 5

France
Local Institution
Bordeaux

France
Local Institution
Caen

France
Local Institution
Dijon

France
Local Institution
Levallois-Perret

France
Local Institution
Lyon

France
Local Institution
Paris cedex 12

France
Local Institution
Suresnes

Germany
Local Institution
Berlin

Germany
Local Institution
Essen

Germany
Local Institution
Frankfurt A. Main

Germany
Local Institution
Hamburg

Germany
Local Institution
Mannheim

Germany
Local Institution
Muenchen

Germany
Local Institution
Reutlingen

Germany
Local Institution
Wuerzburg

Italy
Local Institution
Catania

Italy
Local Institution
Genova

Italy
Local Institution
Milano

Italy
Local Institution
Milano

Italy
Local Institution
Napoli

Italy
Local Institution
Napoli

Italy
Local Institution - 0136
Padova

Italy
Local Institution
Reggio Emilia

Japan, Chiba
Local Institution
Chiba-shi

Japan, Chiba
Local Institution
Kashiwa-shi

Japan, Ehime
Local Institution
Matsuyama-shi

Japan, Hokkaido
Local Institution
Sapporo-shi

Japan, Kanagawa
Local Institution
Kawasaki-shi

Japan, Osaka
Local Institution
Suita-shi

Japan, Saitama
Local Institution
Hidaka-Shi

Japan, Saitama
Local Institution
Kitaadachi-gun

Japan, Shizuoka
Local Institution
Sunto-gun

Japan, Tokyo
Local Institution
Chuo-ku

Japan, Tokyo
Local Institution
Koto-ku

Japan
Local Institution
Osaka

Korea, Republic of
Local Institution
Goyangsi Ilsandonggu

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Songpa-gu, Seoul

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution
Utrecht

Poland
Local Institution
Krakow

Poland
Local Institution
Warszawa

Poland
Local Institution
Warszawa

Poland
Local Institution
Warszawa

Puerto Rico
Local Institution - 0106
San Juan

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Spain
Local Institution
A Coruña

Spain
Local Institution
Badalona

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Sevilla

Spain
Local Institution
Zaragoza

Sweden
Local Institution
Goteborg

Sweden
Local Institution
Malmo

Sweden
Local Institution
Stockholm

Sweden
Local Institution
Uppsala

Switzerland
Local Institution
Aarau

Switzerland
Local Institution
Bern

Taiwan
Local Institution
Kao-Hsiung

Taiwan
Local Institution
Tainan

Taiwan
Local Institution
Tainan

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05328908 History of Changes
  • Other Study ID Numbers: CA224-123, 2021-004285-35
  • First Posted: April 14, 2022 Key Record Dates
  • Last Update Posted: June 6, 2022
  • Last Verified: June 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Micro-satellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)
    Relatlimab
    Nivolumab
    BMS-986213
    Regorafenib
    Stivarga
    Lonsurf
  • Additional relevant MeSH terms: Colorectal Neoplasms
    Intestinal Neoplasms
    Gastrointestinal Neoplasms
    Digestive System Neoplasms
    Neoplasms by Site
    Neoplasms
    Digestive System Diseases
    Gastrointestinal Diseases
    Colonic Diseases
    Intestinal Diseases
    Rectal Diseases