BMS-986301 + Immunotherapy for Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called BMS-986301, either alone or with two other drugs, nivolumab and ipilimumab. It targets cancer patients whose disease did not improve with standard treatments. The drugs aim to boost the body's natural defenses to better identify and destroy cancer cells.

Eligibility Criteria

This trial is for adults with certain advanced cancers (like lung, skin, kidney, breast, and bladder cancer) that haven't responded to standard treatments. Participants must be in fairly good physical shape (ECOG score of 0 or 1), have seen their cancer grow despite treatment, and agree to use birth control if necessary. People with other active cancers needing treatment or serious heart disease can't join.

Inclusion Criteria

My cancer is advanced and has not responded to current treatments.

I agree to use birth control methods during the trial, if applicable.

I am fully active or have some restrictions but can still care for myself.

See 1 more

Exclusion Criteria

I have serious heart problems that are not under control.

I am currently being treated for another cancer.

My cancer originated in my brain or spinal cord.

See 1 more

Treatment Details

Interventions

BMS-986301 (Immunotherapy)
Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe study is testing BMS-986301 alone or combined with Nivolumab and Ipilimumab in patients whose cancers didn't respond to therapies that boost the immune system's ability to fight cancer. It aims to find the safest dose, how well people tolerate it, any toxic effects at different doses, and the best way to give these drugs.

Participant Groups

5Treatment groups

Experimental Treatment

Group I: Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + IpilimumabExperimental Treatment3 Interventions

Group II: Part 1B Group 4: Systemic BMS-986301 + Nivolumab + IpilimumabExperimental Treatment3 Interventions

Group III: Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-studyExperimental Treatment3 Interventions

Group IV: Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-studyExperimental Treatment3 Interventions

Group V: Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)Experimental Treatment3 Interventions