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A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)
A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

NCT04008030

Active Not RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Metastatic Colorectal Cancer

Interventions: Ipilimumab, Oxaliplatin, Leucovorin, Fluorouracil, Irinotecan

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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 microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice
* Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

Exclusion Criteria:

* 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
Locations (157)
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • Denver, Colorado, United States
  • Arlington Heights, Illinois, United States
  • New York, New York, United States
  • Portland, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Dallas, Texas, United States
  • Roanoke, Virginia, United States
  • Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
  • Viedma, Río Negro Province, Argentina
  • Buenos Aires, Argentina
  • CABA, Argentina
  • CABA, Argentina
  • Westmead, New South Wales, Australia
  • Woolloongabba, Queensland, Australia
  • Elizabeth Vale, South Australia, Australia
  • Clayton, Victoria, Australia
  • Heidelberg, Victoria, Australia
  • Graz, Austria
  • Linz, Austria
  • Salzburg, Austria
  • Vienna, Austria
  • Wiener Neustadt, Austria
  • Bonheiden, Antwerpen, Belgium
  • Anderlecht, Bruxelles-Capitale, Région de, Belgium
  • Leuven, Belgium
  • Ipatinga, Minas Gerais, Brazil
  • Natal, Rio Grande do Norte, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • + 127 more on CT.gov