CA209-8HW A Phase 3 Randomized Clinical Trial of Nivolumab alone, Nivolumab in Combination with Ipilimumab, or Investigator’s Choice Chemotherapy in Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer

Conditions

Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient Metastatic Colorectal Cancer (dMMR)

Brief summary

Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed), PFS by BICR (arm B vs C, 1L, centrally confirmed)

Detailed description

Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed), Overall Survival (OS) (arm B vs A, all lines, centrally confirmed), PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed), PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing), PFS by BICR (arm B vs A, 1L, centrally confirmed), ORR by BICR (arm B vs C, 1L, centrally confirmed), ORR by BICR (arm B vs A, 1L, centrally confirmed), OS (arm B vs A, 1L, centrally confirmed), PFS by BICR (arm A vs C, 1L, centrally confirmed), OS (arm B vs C, 1L, centrally confirmed), ORR by BICR (arm A vs C, 1L, centrally confirmed), OS (arm A vs C, 1L, centrally confirmed), PFS by Investigator (arm A, B and C, 1L, centrally confirmed), PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing), PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing), PFS by BICR (arm B vs C, 1L, by each central test), PFS by BICR (arm B vs A, all lines, by each central test), PFS by BICR (crossover cohort, centrally confirmed), ORR by BICR (crossover cohort, centrally confirmed)

Related papers

No related papers found yet.

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

DRUGFLUOROURACIL

DRUGDISODIUM FOLINATE

DRUGAvastin 25 mg/ml concentrate for solution for infusion

DRUGIrinotecan Bendalis 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed), PFS by BICR (arm B vs C, 1L, centrally confirmed)	—

Secondary

Measure	Time frame
Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed), Overall Survival (OS) (arm B vs A, all lines, centrally confirmed), PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed), PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing), PFS by BICR (arm B vs A, 1L, centrally confirmed), ORR by BICR (arm B vs C, 1L, centrally confirmed), ORR by BICR (arm B vs A, 1L, centrally confirmed), OS (arm B vs A, 1L, centrally confirmed), PFS by BICR (arm A vs C, 1L, centrally confirmed), OS (arm B vs C, 1L, centrally confirmed), ORR by BICR (arm A vs C, 1L, centrally confirmed), OS (arm A vs C, 1L, centrally confirmed), PFS by Investigator (arm A, B and C, 1L, centrally confirmed), PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing), PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local te	—

Measure

Time frame

Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed), Overall Survival (OS) (arm B vs A, all lines, centrally confirmed), PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed), PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing), PFS by BICR (arm B vs A, 1L, centrally confirmed), ORR by BICR (arm B vs C, 1L, centrally confirmed), ORR by BICR (arm B vs A, 1L, centrally confirmed), OS (arm B vs A, 1L, centrally confirmed), PFS by BICR (arm A vs C, 1L, centrally confirmed), OS (arm B vs C, 1L, centrally confirmed), ORR by BICR (arm A vs C, 1L, centrally confirmed), OS (arm A vs C, 1L, centrally confirmed), PFS by Investigator (arm A, B and C, 1L, centrally confirmed), PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing), PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local te

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Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Romania, Spain

Outcome results

None listed