Nivo versus Nivo/Ipi or versus other chemotherapies to treat colorectal cancer

A Phase 3 Randomized Clinical Trial of Nivolumab alone, Nivolumab in Combination with Ipilimumab, or an Investigator’s Choice Chemotherapy in Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer - CheckMate 8HW: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 8HW

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000040-26-AT

Enrollment

974

Registered

2019-06-05

Start date

2019-09-12

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient Metastatic Colorectal Cancer (dMMR) MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10mL vial- COMMERCIAL Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NIVOLUMAB CAS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study) -Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study) - Known tumor MSI-H or dMMR status per local standard of practice - Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1 - Other protocol-defined inclusion/exclusion criteria apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 682 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 292

Exclusion criteria

Exclusion criteria: - Participants with an active, known or suspected autoimmune disease - History of interstitial lung disease or pneumonitis - Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) - Other protocol-defined inclusion/exclusion criteria apply

Design outcomes

Primary

Measure	Time frame
Main Objective: All lines: 1)To compare PFS by BICR between nivolumab plus ipilimumab arm (arm B) vs nivolumab arm (arm A) 1L: 1)To compare PFS by BICR between nivolumab plus ipilimumab arm (arm B) vs chemotherapy arm (arm C) ;Secondary Objective: To compare: 1)ORR by BICR btw arm B vs arm A 2)OS btw arm B vs A To estimate: 3)PFS by investigator btw arm B vs A 4)PFS by BICR in locally determined dMMR/MSI-H mCRC btw arm B vs A 1L: To compare: 1)PFS by BICR btw arm B vs A 2)ORR by BICR btw arm B vs chemotherapy (arm C) 3)ORR by BICR btw arm B vs A 4)OS btw arm B vs A To estimate: 5)PFS by BICR btw arm A vs C 6)OS btw arm B vs C 7)ORR by BICR btw arm A vs C 8)OS btw arm A vs C 5)PFS by investigator by treatment arms (A, B, C) 9)PFS by BICR in locally determined dMMR/MSI-H mCRC btw arm B vs C 10)PFS by BICR in locally determined dMMR/MSI-H mCRC btw arm B vs A CDx (All lines and 1L): To estimate: 1)PFS by BICR in participants with confirmed dMMR/MSI-H mCRC by each central test in 1L setting btw arm B vs C 2)PFS by BICR in participants with confirmed dMMR/MSI-H mCRC by each central test across All lines btw arm B vs A Crossover cohort: To estimate: 1)PFS by BICR 2)ORR by BICR ;Primary end point(s): 1. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed) 2. PFS by BICR (arm B vs C, 1L, centrally confirmed);Timepoint(s) of evaluation of this end point: 1. Up to 5 years 2. Up to 5 years	—

Measure

Time frame

Main Objective: All lines: 1)To compare PFS by BICR between nivolumab plus ipilimumab arm (arm B) vs nivolumab arm (arm A) 1L: 1)To compare PFS by BICR between nivolumab plus ipilimumab arm (arm B) vs chemotherapy arm (arm C) ;Secondary Objective: To compare: 1)ORR by BICR btw arm B vs arm A 2)OS btw arm B vs A To estimate: 3)PFS by investigator btw arm B vs A 4)PFS by BICR in locally determined dMMR/MSI-H mCRC btw arm B vs A 1L: To compare: 1)PFS by BICR btw arm B vs A 2)ORR by BICR btw arm B vs chemotherapy (arm C) 3)ORR by BICR btw arm B vs A 4)OS btw arm B vs A To estimate: 5)PFS by BICR btw arm A vs C 6)OS btw arm B vs C 7)ORR by BICR btw arm A vs C 8)OS btw arm A vs C 5)PFS by investigator by treatment arms (A, B, C) 9)PFS by BICR in locally determined dMMR/MSI-H mCRC btw arm B vs C 10)PFS by BICR in locally determined dMMR/MSI-H mCRC btw arm B vs A CDx (All lines and 1L): To estimate: 1)PFS by BICR in participants with confirmed dMMR/MSI-H mCRC by each central test in 1L setting btw arm B vs C 2)PFS by BICR in participants with confirmed dMMR/MSI-H mCRC by each central test across All lines btw arm B vs A Crossover cohort: To estimate: 1)PFS by BICR 2)ORR by BICR ;Primary end point(s): 1. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed) 2. PFS by BICR (arm B vs C, 1L, centrally confirmed);Timepoint(s) of evaluation of this end point: 1. Up to 5 years 2. Up to 5 years

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Secondary

Measure	Time frame
Secondary end point(s): 1. Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed) 2. Overall Survival (OS) (arm B vs A, all lines, centrally confirmed) 3. PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed) 4. PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing) 5. PFS by BICR (arm B vs A, 1L, centrally confirmed) 6. ORR by BICR (arm B vs C, 1L, centrally confirmed) 7. ORR by BICR (arm B vs A, 1L, centrally confirmed) 8. OS (arm B vs A, 1L, centrally confirmed) 9. PFS by BICR (arm A vs C, 1L, centrally confirmed) 10. OS (arm B vs C, 1L, centrally confirmed) 11. ORR by BICR (arm A vs C, 1L, centrally confirmed) 12. OS (arm A vs C, 1L, centrally confirmed) 13. PFS by Investigator (arm A, B and C, 1L, centrally confirmed) 14. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing) 15. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing) 16. PFS by BICR (arm B vs C, 1L, by each central test) 17. PFS by BICR (arm B vs A, all lines, by each central test) 18. PFS by BICR (crossover cohort, centrally confirmed) 19. ORR by BICR (crossover cohort, centrally confirmed) ;Timepoint(s) of evaluation of this end point: For all endpoints in section E.5.2: Up to 5 years	—

Measure

Time frame

Secondary end point(s): 1. Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed) 2. Overall Survival (OS) (arm B vs A, all lines, centrally confirmed) 3. PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed) 4. PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing) 5. PFS by BICR (arm B vs A, 1L, centrally confirmed) 6. ORR by BICR (arm B vs C, 1L, centrally confirmed) 7. ORR by BICR (arm B vs A, 1L, centrally confirmed) 8. OS (arm B vs A, 1L, centrally confirmed) 9. PFS by BICR (arm A vs C, 1L, centrally confirmed) 10. OS (arm B vs C, 1L, centrally confirmed) 11. ORR by BICR (arm A vs C, 1L, centrally confirmed) 12. OS (arm A vs C, 1L, centrally confirmed) 13. PFS by Investigator (arm A, B and C, 1L, centrally confirmed) 14. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing) 15. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing) 16. PFS by BICR (arm B vs C, 1L, by each central test) 17. PFS by BICR (arm B vs A, all lines, by each central test) 18. PFS by BICR (crossover cohort, centrally confirmed) 19. ORR by BICR (crossover cohort, centrally confirmed) ;Timepoint(s) of evaluation of this end point: For all endpoints in section E.5.2: Up to 5 years

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Japan, Netherlands, Norway, Poland, Romania, Spain, United Kingdom, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026