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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)

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: NCT05328908
Recruitment Status : Recruiting
First Posted : April 14, 2022
Last Update Posted : May 16, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) 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 Intervention/treatment Phase
Colorectal Neoplasms Drug: Nivolumab-relatlimab FDC Drug: Regorafenib Drug: TAS-102 Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer
Actual Study Start Date : April 28, 2022
Estimated Primary Completion Date : January 29, 2025
Estimated Study Completion Date : May 31, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC) Drug: Nivolumab-relatlimab FDC
Specified dose on specified days
Other Name: BMS-986213
Active Comparator: Arm B: Investigator's Choice
Treatment with Regorafenib or TAS-102
 Drug: Regorafenib
Specified dose on specified days
Other Name: Stivarga

Drug: TAS-102
Specified dose on specified days
Other Names:
  • Trifluridine/Tipiracil
  • Lonsurf


Outcome Measures
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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. Time Until Definitive Deterioration-Physical Function (TUDD-PF): The time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in randomized participants with PD-L1 CPS ≥ 1 [ Time Frame: Up to follow up visit 2 (approximately 135 days after last dose) ]
    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. TUDD-PF: The time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in all randomized participants [ Time Frame: Up to follow up visit 2 (approximately 135 days after last dose) ]
  14. TUDD-QoL: The time from randomization until definitive deterioration in the EORTC QLQ-C30 global health status/QoL scale score in randomized participants with PD-L1 CPS ≥ 1 [ Time Frame: Up to follow up visit 2 (approximately 135 days after last dose) ]
    QoL = 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.

  15. TUDD-QoL: The time from randomization until definitive deterioration in the EORTC QLQ-C30 global health status/QoL scale score in all randomized participants [ Time Frame: Up to follow up visit 2 (approximately 135 days after last dose) ]
  16. PFS by investigator per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1 [ Time Frame: Up to 5 years after last participant randomized ]
  17. PFS by investigator per RECIST v1.1 in all randomized participants [ Time Frame: Up to 5 years after last participant randomized ]
  18. ORR by investigator per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1 [ Time Frame: Up to 5 years after last participant randomized ]
  19. ORR by investigator per RECIST v1.1 in all randomized participants [ Time Frame: Up to 5 years after last participant randomized ]
  20. DoR by investigator per RECIST v1.1 in responders with PD-L1 CPS ≥ 1 [ Time Frame: Up to 5 years after last participant randomized ]
  21. DoR by investigator per RECIST v1.1 in all randomized participants [ Time Frame: Up to 5 years after last participant randomized ]

Eligibility Criteria
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Information from the National Library of Medicine

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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

  • Participants must have:

    1. 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 available in the respective country, or;
    2. 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
  • Confirmed tumor microsatellite instable high/deficient mismatch repair (MSI-H/dMMR) status as per local standard testing; MSI/MMR test results from initial diagnosis are acceptable.

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
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Information from the National Library of Medicine

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): NCT05328908


Contacts
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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
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05328908    
Other Study ID Numbers: CA224-123
2021-004285-35 ( EudraCT Number )
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: May 2023

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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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
 Trifluridine
Nivolumab
Relatlimab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents