Skip to main content
OpenTrials
Terminated

NCT Number: NCT05328908

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

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.

Terminated

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Neoplasms Brain Diseases Central Nervous System Diseases Cerebellar Diseases Colonic Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurodegenerative Diseases Rectal Diseases Spinal Cord Diseases Spinocerebellar Degenerations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0026, Ciudad Autónoma Buenos Aires, B, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry.
  • Participants must have:.

i) 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 in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;.

ii) 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.

Treatment and study plan

Nivolumab-relatlimab FDC

Drug

Specified dose on specified days

Other names: BMS-986213

regorafenib

Drug

Specified dose on specified days

Other names: Stivarga

TAS-102

Drug

Specified dose on specified days

Other names: Trifluridine/Tipiracil, Lonsurf

Primary outcomes

  1. Overall Survival (OS)

    Time frame: From date of randomization to the date of death due to any cause (Up to approxaimtely 38 months)

    OS is defined as the time from date of randomization to the date of death due to any cause.

Secondary outcomes

  1. Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)

    Time frame: From randomization until the date of objectively documented response (Up to approximately 38 months)

    ORR is defined as the percent of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR).

    CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions.

  2. Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)

    Time frame: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)

    PFS is defined as the time from randomization to first documented progression (PD) or death due to any cause, whichever is earlier.

    PD=At least a 20% increase in the sum of diameters of target lesions.

  3. Duration of Response (DoR) Per Blinded Independent Central Review (BICR)

    Time frame: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)

    DoR is defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented tumor progression as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.

    CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions. PD=At least a 20% increase in the sum of diameters of target lesions.

  4. Number of Participants With Adverse Events (AEs)

    Time frame: From first dose until 30 days post last dose (Up to 24 months)

    AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, results in a congenital abnormality or birth defect, or is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may require medical or surgical intervention to prevent any of the outcomes listed above.

  5. Number of Participants With Select Adverse Events (AEs)

    Time frame: From first dose until 30 days post last dose (Up to 24 months)

    AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.

  6. Number of Participants With Immune Mediated Adverse Events (IMAEs)

    Time frame: From first dose until 30 days post last dose (Up to 24 months)

    AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.

  7. Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4

    Time frame: From first dose until 30 days post last dose (Up to 24 months)

    Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.

  8. Time Until Definitive Deterioration - Quality of Life (TUDD-QoL)

    Time frame: From randomization until the first date of a definititve clincial decline from baseline in QoL scale score (Up to approximately 38 months)

    TUDD-QoL is defined as time from randomization until the first date of a definitive clinically meaningful decline from baseline in EORTC QLQ-C30 health status/QoL scale score. A definitive deterioration is defined as when all subsequent PRO assessments after a deterioration also reach or exceed the pre-defined meaningful change threshold. A decrease in score of at least 15 points from baseline will be considered to be the meaningful change threshold (MCT) for the global health status/quality-of-life and scale.

  9. Time Until Definitive Deterioration - Physical Function (TUDD-PF)

    Time frame: From randomization until the first date of a definititve clincial decline from baseline in PF scale score (Up to approximately 38 months)

    TUDD-PF is defined as time from randomization until the first date of a definitive clinically meaningful decline from baseline in EORTC QLQ-C30 physical function scale score. A definitive deterioration is defined as when all subsequent PRO assessments after a deterioration also reach or exceed the pre-defined meaningful change threshold. A 10-point decrease from baseline will be considered the meaning change threshold (MCT) for the physical function scale.

  10. Progression Free Survival (PFS) Per Investigator

    Time frame: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)

    PFS is defined as the time from randomization to first documented progression (PD) or death due to any cause, whichever is earlier.

    PD=At least a 20% increase in the sum of diameters of target lesions.

  11. Objective Response Rate (ORR) Per Investigator

    Time frame: From randomization until the date of objectively documented response (Up to approximately 38 months)

    ORR is defined as the percent of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR).

    CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions.

  12. Duration of Response (DoR) Per Investigator

    Time frame: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)

    DoR is defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented tumor progression as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.

    CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions. PD=At least a 20% increase in the sum of diameters of target lesions.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: RELATIVITY-123

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2022
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.