BMS-986504 + Standard Therapy for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety of a new drug, BMS-986504, in combination with standard cancer treatments. It targets individuals with advanced or metastatic bladder cancer and related cancers. Participants will receive various treatment combinations, including BMS-986504, Ipilimumab, and Nivolumab (both immunotherapy drugs), based on their specific cancer type. Suitable candidates for this trial have been diagnosed with specific cancers, such as bladder cancer, that cannot be surgically removed and exhibit a genetic feature called MTAP deletion. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new drug.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BMS-986504 was well-tolerated in earlier studies. Most side effects were mild or moderate, with only a small number of patients experiencing more serious issues. Specifically, 14% of patients experienced treatment-related side effects, mostly mild. This suggests that BMS-986504, when combined with standard cancer treatments, is generally safe for participants.
The FDA has already approved Ipilimumab and Nivolumab for various cancers, indicating thorough testing and a determination of safety for humans. Like all medications, they can have side effects, but they help the immune system recognize and fight cancer cells more effectively.
Overall, the combination of these treatments remains under study, but current data suggests they are generally well-tolerated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about BMS-986504 combined with standard therapies for bladder cancer because this novel treatment introduces a potentially groundbreaking mechanism of action. While current treatments like chemotherapy and immune checkpoint inhibitors work by targeting cancer cells or boosting the immune response, BMS-986504 is designed to enhance the effects of these existing therapies, potentially leading to better outcomes. By combining BMS-986504 with drugs like ipilimumab, nivolumab, gemcitabine, and carboplatin or cisplatin, the treatment aims to improve the body's ability to fight cancer more effectively. This could provide new hope for patients, especially those who have not experienced success with standard options.
What evidence suggests that this trial's treatments could be effective for metastatic/advanced unresectable MTAP-deleted solid tumor cancer?
Research has shown that BMS-986504 may help treat cancers with MTAP deletions. In a specific type of lung cancer, nearly one-third of patients experienced tumor shrinkage with this treatment. Additionally, 80% of these patients had their disease stabilize, meaning the cancer did not worsen. The treatment targets a weakness in cancer cells caused by a genetic deletion, aiming to stop their growth. Early studies also found that it was well tolerated in patients with advanced solid tumors. In this trial, participants with urothelial carcinoma (a type of bladder cancer) will receive either BMS-986504 combined with gemcitabine and carboplatin or BMS-986504 combined with gemcitabine and cisplatin, followed by BMS-986504 monotherapy. These findings suggest that BMS-986504 could be effective for certain cancers, including bladder cancer, especially when used with other treatments.13467
Who Is on the Research Team?
Michael Offin, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BMS-986504 in combination with standard disease-specific anticancer medication
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986504
- Ipilimumab
- Nivolumab
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants will receive either BMS-986504 + gemcitabine and carboplatin or BMS-986504 + gemcitabine and cisplatin. After that, BMS-986504 monotherapy is continued.
Participants will receive BMS-986504 + FOLFOX and nivolumab.
Participants will receive BMS-986504 + ipilimumab and nivolumab.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
A Study of BMS-986504 With Standard-of-Care Therapy for ...
The researchers are doing this study to test the safety of BMS-986504 in combination with standard disease-specific anticancer medication in ...
A Study of BMS-986504 With Standard-of-Care Therapy for ...
Full Title A Phase 1a/1b Basket Trial of BMS-986504 with Standard-of-Care Therapy For Patients with Select Metastatic MTAP-deleted Solid Tumors Purpose To ...
BMS-986504 Demonstrates Durable Responses in MTAP- ...
Among clinically evaluable patients in the NSCLC cohort (n=35), BMS-986504 demonstrated a 29% overall response rate (ORR) and a 80% disease ...
A Randomized Phase 2/3 Study of BMS-986504 in ...
The purpose of this study is to compare the clinical benefit of the combination of BMS-986504 (a selective MTA-cooperative inhibitor of PRMT5) plus ...
Abstract CT079: Pharmacodynamic (PD) and exploratory ...
BMS-986504 was well tolerated and showed clinical activity in heavily pretreated pts across multiple advanced solid tumors with homozygous MTAP-del.
A Study of BMS-986504 with Standard-of-Care Therapy for ...
It works by killing, stopping or slowing the growth of cancer cells. Giving BMS-986504 in combination with standard of care therapies may be safe, tolerable, ...
NCT07492680 | A Study of BMS-986504 Monotherapy and ...
The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and ...
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