Phase 2 Colorectal Cancer Trial, Completed NCT02060188 Sponsor: Bristol-Myers Squibb Condition: Colorectal Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 385 people across nine treatment groups, all receiving different combinations of immunotherapy drugs (nivolumab, ipilimumab, and others) for colorectal cancer. The trial was measuring what is called the "objective response rate" — that is, the percentage of participants whose tumours shrank by a meaningful amount or disappeared entirely, based on standardised imaging measurements. It is noted that zero participants were recorded as having "completed" the study in the formal sense, meaning all participants fell into the "not completed" category, though no further explanation for this is provided in the reported data. The reported data shows that response rates varied widely depending on which treatment group participants were in. For the primary measure (assessed by the treating doctors), the reported rates ranged from 0% up to 71.1%. Specifically: Cohort 1 (nivolumab alone) reported 40.5%; Cohort 2 (nivolumab + ipilimumab) reported 66.4%; Cohort 3 (a different nivolumab + ipilimumab schedule) reported 71.1%; Cohort 4 (nivolumab + ipilimumab + cobimetinib) reported 3.3%; Cohort 5 (nivolumab + BMS-986016) reported 50.0%; and Cohort 6 (nivolumab + daratumumab) reported 0%. Three sub-groups reported 0%, 0%, and 10.0% respectively. A second, independent review of the same scans (the secondary outcome) produced broadly similar but not identical figures across the six cohorts for which that data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Colorectal Cancer Trial, Completed

NCT02060188
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are generally active and able to carry out daily activities with little to no limitation (confirm with trial site for exact fitness level required)
  • You have been diagnosed with colorectal cancer that has come back or spread to other parts of the body, confirmed by a tissue test
  • Your cancer can be measured on a scan using standard guidelines
  • Your cancer has tested positive for a specific genetic feature called "microsatellite instability," confirmed by an approved laboratory
  • If joining a specific group within the trial (called Cohort C3), you must not have received any treatment yet for your cancer after it spread

Who may not be able to join:

  • Your cancer has spread to the brain or the lining around the brain or spinal cord
  • You have previously received certain types of immunotherapy drugs that target the immune system's "checkpoint" pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 treatments)
  • You have had another cancer that was active in the last 3 years, unless it was a type that can be completely cured with local treatment
  • You currently have an active autoimmune disease (a condition where your immune system attacks your own body)
  • You are currently taking steroid medicines or other drugs that suppress your immune system and have been within the last 14 days before starting the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb

Australian sites

Local Institution - 0040, Westmead, New South Wales
Local Institution - 0039, Southport, Queensland
Local Institution - 0037, Melbourne, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
12 March 2014
Est. completion
22 October 2024

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇮🇪 Ireland 🇮🇹 Italy 🇪🇸 Spain 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov