A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixeddose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants with Later-lines of Metastatic Colorectal Cancer

Conditions

Metastatic Colorectal Cancer

Brief summary

Overall Survival (OS) in randomized participants with PD-L1 CPS (combined positive score;) ≥ 1, OS in all randomized participants

Detailed description

ORR (objective response rate) by BICR (blinded independent central review) per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1 and all randomized participants, respectively, PFS (progression-free survival) by BICR per RECIST v1.1 in randomized participants with PD-L1 CPS≥ 1 and all randomized participants, respectively, DoR (duration of response;) by BICR per RECIST v1.1 in responders with PD-L1 CPS ≥ 1 and all responders, respectively, Rate of AEs (adverse events), SAEs (serious adverse events), select AEs and IMAEs (immune-mediated adverse events), AEs leading to discontinuation and abnormalities in specific clinical laboratory assessments, QoLTUDD-physical function (TUDDPF), which is defined as time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in randomized participants with PD-L1 CPS ≥ 1 and all randomized participants, respectively, TUDD-quality of life (TUDD-QoL), which is defined as time until definitive deterioration in the EORTC QLQ-C30 global health status/QoL scale score in randomized participants with PD-L1 CPS ≥ 1 and all randomized participants, Respectively, PFS, ORR, DoR by investigator per RECIST v1.1 in randomized participants with PD-L1 CPS = 1 and all randomized participants, respectively

Related papers

No related papers found yet.

Interventions

DRUGLonsurf 15 mg/6.14 mg film-coated tablets

DRUGRelatlimab + Nivolumab Fixed Dose Combination (FDC)

DRUGLonsurf 20 mg/8.19 mg film-coated tablets

DRUGStivarga 40 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS) in randomized participants with PD-L1 CPS (combined positive score;) ≥ 1, OS in all randomized participants	—

Secondary

Measure	Time frame
ORR (objective response rate) by BICR (blinded independent central review) per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1 and all randomized participants, respectively, PFS (progression-free survival) by BICR per RECIST v1.1 in randomized participants with PD-L1 CPS≥ 1 and all randomized participants, respectively, DoR (duration of response;) by BICR per RECIST v1.1 in responders with PD-L1 CPS ≥ 1 and all responders, respectively, Rate of AEs (adverse events), SAEs (serious adverse events), select AEs and IMAEs (immune-mediated adverse events), AEs leading to discontinuation and abnormalities in specific clinical laboratory assessments, QoLTUDD-physical function (TUDDPF), which is defined as time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in randomized participants with PD-L1 CPS ≥ 1 and all randomized participants, respectively, TUDD-quality of life (TUDD-QoL), which is defined as time until definitive deteriora	—

Measure

Time frame

ORR (objective response rate) by BICR (blinded independent central review) per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1 and all randomized participants, respectively, PFS (progression-free survival) by BICR per RECIST v1.1 in randomized participants with PD-L1 CPS≥ 1 and all randomized participants, respectively, DoR (duration of response;) by BICR per RECIST v1.1 in responders with PD-L1 CPS ≥ 1 and all responders, respectively, Rate of AEs (adverse events), SAEs (serious adverse events), select AEs and IMAEs (immune-mediated adverse events), AEs leading to discontinuation and abnormalities in specific clinical laboratory assessments, QoLTUDD-physical function (TUDDPF), which is defined as time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in randomized participants with PD-L1 CPS ≥ 1 and all randomized participants, respectively, TUDD-quality of life (TUDD-QoL), which is defined as time until definitive deteriora

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Countries

Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed