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
- Conditions
- Metastatic Colorectal Cancer10017990
- Registration Number
- NL-OMON56215
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PFS means the length of time a patient lives with their cancer from the point<br /><br>of diagnosis or start of treatment without it getting worse. It is a good<br /><br>indicator of how well the treatment is working and is often used as a standard<br /><br>measure in clinical trials. PFS will be assessed by Blinded Independent Central<br /><br>Review (BICR).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Objective response rate or ORR is defined as the number of patients having a<br /><br>reduction in tumour size of a certain size and for a defined length of time.<br /><br>Disease control rate or DCR is defined as the percentage of patients with<br /><br>advanced or metastatic cancer who have achieved complete response, partial<br /><br>response and stable disease to a therapeutic intervention in clinical trials of<br /><br>anticancer agents.<br /><br>Overall survival means the length of time a patient lives with their cancer<br /><br>from the point of diagnosis or start of treatment. It is a good indicator of<br /><br>how well the treatment is working and is often used as a standard measure in<br /><br>clinical trials.</p><br>