A Study of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Colon Cancer

• Conditions: MSI Positive Colorectal CancerMSI Negative Colorectal Cancer; MedDRA version: 16.1Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003939-30-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-23
• Last Update Posted: 7 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

?Men and women ? 18 years of age
?ECOG performance status 0 to 1.
?Histologically confirmed colorectal cancer.
?Measurable disease by CT or MRI.
?Testing for MSI Status
?Adequate organ function as defined by study-specific laboratory tests
?Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with WOCBP.
?Signed informed consent
?Willing and able to comply with study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 69

Exclusion Criteria

?Active brain metastases or leptomeningeal metastases are not allowed.
?Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
?Prior malignancy active within the previous 3 years except for locally curable cancers
?Subjects with active, known or suspected autoimmune disease.
?Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to examine if nivolumab alone or in combination with ipilimumab will demonstrate a meaningful objective response rate in patients with recurrent and metastatic colon cancer who also have a specific biomarker in their tumors.;Secondary Objective: To evaluate the IRRC objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with metastatic MSI-H CRC;Primary end point(s): The primary endpoint is objective response rate (ORR) in all MSI-H subjects as determined by investigators.;Timepoint(s) of evaluation of this end point: The final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject?s first dose of study therapy.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoint is ORR in all MSI-H subjects based on IRRC determination.;Timepoint(s) of evaluation of this end point: The final analysis of the secondary endpoint will occur at the time of the primary endpoint analysis.