A Study of Nivolumab and Nivolumab Combinations in Recurrent and Metastatic Colon Cancer

Phase 1

• Conditions: MSI Positive Colorectal CancerMSI Negative Colorectal Cancer; MedDRA version: 21.0Level: 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-BE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-28
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 375

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
a. Subjects with microsatellite instability high (MSI-H) tumors will enroll in the MSI-H Cohort (mStage and cStage groups), the C3 Cohort, and the C5 Cohort.
b. Subjects with phenotypes that are non-microsatellite instability high (non-MSI-H) will enroll in the non- MSI-H Safety Cohort and the C6, C4 Cohorts.
•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
-Subjects enrolled into the C3 Cohort must have not had treatment for their metastatic disease
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 259
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 116

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