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A Study of Nivolumab and Nivolumab Combinations in Recurrent and Metastatic Colon Cancer
EU CTIS ID: 2024-516004-42-01
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- •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
You likely can't join if
- •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.
See the full eligibility 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
- •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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.