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Clinical trial

An Investigational Immuno-therapy Study of Nivolumab, and Nivolumab in Combination With Other Anti-cancer Drugs, in Colon Cancer That Has Come Back or Has Spread (CheckMate142)

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Last updated:7th Mar 2014
Identifier: NCT02060188

Brief Summary:
The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in patients with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.

Detailed Description:
Allocation: The Microsatellite Instability High (MSI-High) and C4 and C6 Cohort Parts of the trial are Non-randomized, The Non-MSI high Dose Escalation Phase part of the trial contained a randomized portion

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 340 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite High (MSI-H) and Non-MSI-H Colon Cancer
Actual Study Start Date: March 7, 2014
Estimated Primary Completion Date: December 3, 2018
Estimated Study Completion Date: December 31, 2019

- Experimental:
Nivolumab Monotherapy
- Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi)
- Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) Cohort C3
- Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) + Cobimetinib Cohort C4
- Experimental: Nivolumab (Nivo) + BMS-986016 Cohort C5
- Experimental: Nivolumab (Nivo) + Daratumumab Cohort C6

Category Value
Date last updated at source 2018-04-30
Study type(s) Interventional
Expected enrolment 340
Study start date 2014-03-07
Estimated primary completion date 2018-12-03

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