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Clinical Trials/EUCTR2018-000040-26-NO
EUCTR2018-000040-26-NO
Active, not recruiting
Phase 1

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

Bristol-Myers Squibb International Corporation0 sites974 target enrollmentJuly 26, 2019
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ConditionsMicrosatellite Instability High (MSI-H) or Mismatch Repair DeficientMetastatic Colorectal Cancer (dMMR)MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsOpdivo (100 mg/10 ml)Yervoy (200mg/40ml)Oxaliplatin Bendalis 5mg/ml (100mg vial)Oncofolic 50mg/ml (400mg vial)Erbitux 5 mg/mL (500mg vial)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Microsatellite Instability High (MSI-H) or Mismatch Repair DeficientMetastatic Colorectal Cancer (dMMR)
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
974
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 26, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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
  • •\-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

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

Outcomes

Primary Outcomes

Not specified

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