Informations générales (source: ClinicalTrials.gov)
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 (RELATIVITY-123)
Interventional
Phase 3
Bristol-Myers Squibb (Voir sur ClinicalTrials)
avril 2022
septembre 2025
26 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Jaafar BENNOUNA | 05/05/2025 07:12:12 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Local Institution - 0017 - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0020 - 92300 - Levallois-Perret - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0036 - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0039 - 92151 - Suresnes - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0066 - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0089 - 75012 - Paris - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0090 - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.