Skip to main content
MedPathMedPath Home
Clinical Trials/2024-516004-42-01
2024-516004-42-01
Completed
Phase 2

A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations, in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and non-MSI-H Colon Cancer

Bristol Myers Squibb International Corporation4 sites in 2 countries143 target enrollmentStarted: October 1, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 2
Status
Completed
Enrollment
143
Locations
4
Primary Endpoint
Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of this study is to examine if Nivolumab alone, Nivolumab in combination with Ipilimumab, Nivolumab in combination with anti-LAG3 agent (BMS-986016), or Nivolumab in combination with daratumumab will demonstrate a meaningful objective response rate in patients with recurrent and metastatic colon cancer who also have a specific biomarker in their tumors.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Men and women ≥ 18 years of age
  • •ECOG performance status 0 to
  • •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

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.

Outcomes

Primary Outcomes

Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators

Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators

Secondary Outcomes

  • ORR in all MSI-H and non-MSI-H subjects based on IRRC

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

GSM-CT Representative

Scientific

Bristol Myers Squibb International Corporation

Study Sites (4)

Loading locations...

Similar Trials

Recruiting
Phase 2
OGIK2004(NIke Study)
JPRN-jRCTs071210019Okamoto Isamu30
Active, not recruiting
Phase 1
Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer
EUCTR2016-001928-54-DKBristol-Myers Squibb International Corporation489
Active, not recruiting
Phase 1
Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code: 10036909Term: Prostate cancer metastatic Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10076506Term: Castration-resistant prostate cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
CTIS2022-502909-15-00477
Active, not recruiting
Phase 1
Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-001928-54-DEBristol-Myers Squibb International Corporation489
Active, not recruiting
Phase 1
A Study to Evaluate Preliminary Efficacy of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer
EUCTR2016-001928-54-ESBristol-Myers Squibb International Corporation495