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A Phase 1/2 Study of BMS-986449 with and without Nivolumab in Participants with Solid Tumors
EU CTIS ID: 2023-503484-42-00
What this study is testing
To characterize the safety and tolerability of oral BMS-986449 as monotherapy and in combination with nivolumab, to participants with advanced cancer.
- Phase I and Phase II (Integrated)- First administration to humans
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
- Participants ≥18 years of age with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor - Part 1A, participants may have a solid malignancy of any histology - Part1B is restricted to participants with NSCLC - Part 1C is restricted to participants with TNBC
- Participants must have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
- Participants must have measurable disease per RECIST v 1.1.
- Tumor biopsy must be obtained for all participants (unless medically precluded)
You likely can't join if
- Participants with active, known or suspected autoimmune disease.
- Participants with a condition requiring systemic treatment with corticosteroids within 14 days or other immunosuppressive medications within 30 days of randomization
- Participant with prior organ or tissue allograft
- Participants with history of ≥ Gr 3 toxicity related to prior T cell agonist or checkpoint inhibitor therapy (eg, anti-CTLA-4, or anti-PD-1/PD-L1 treatment, or any other antibody or drug specifically targeting T cell co-stimulation or other immune checkpoint pathways).
- Participants with any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
- Participants with untreated or symptomatic CNS metastases or leptomeningeal metastases.
The study team makes the final eligibility decision.
Where it's taking place
- United States
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. 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.