In short
This article explores the ongoing clinical trials of BMS-986288, a novel immunotherapy drug being studied for the treatment of advanced solid cancers. The research aims to evaluate the safety and effectiveness of BMS-986288 when used alone and in combination with other drugs, particularly Nivolumab. This groundbreaking study offers hope for patients with advanced malignant tumors who may benefit from innovative treatment approaches.
At a glance
- Study Type
- Phase 1/2 First-in-human study
- Main Drug
- BMS-986288
- Combination Drugs
- Nivolumab, Regorafenib
- Target Condition
- Advanced solid cancers
- Study Arms
- BMS-986288 Monotherapy, BMS-986288 + Nivolumab, BMS-986288 + Nivolumab + Regorafenib
- Primary Outcomes
- Safety (Adverse Events), Efficacy (Objective Response Rate)
- Secondary Outcomes
- Pharmacokinetics, Duration of Response, Progression-Free Survival, Overall Survival
What is BMS-986288?
BMS-986288 is an investigational immunotherapy drug being studied for the treatment of advanced solid cancers. Immunotherapy is a type of cancer treatment that helps your immune system fight cancer cells. This drug is currently in clinical trials, which means it's being tested to see if it's safe and effective for patients.
How is BMS-986288 Being Studied?
A clinical trial is being conducted to evaluate BMS-986288 both alone and in combination with other drugs. The main purposes of this study are:
- To determine if BMS-986288 is safe to use in patients with advanced solid tumors
- To see how well patients tolerate the drug
- To evaluate its effectiveness in treating certain types of advanced cancers
Treatment Arms in the Study
The study is divided into different treatment arms:
- Arm A: BMS-986288 Monotherapy - Patients receive only BMS-986288
- Arm B: BMS-986288 in combination with Nivolumab - Patients receive BMS-986288 along with Nivolumab (also known as Opdivo or BMS-936558), which is an approved immunotherapy drug
- Arm C: BMS-986288 in combination with Nivolumab and Regorafenib - Patients receive BMS-986288, Nivolumab, and Regorafenib, which is another approved cancer drug
Primary Outcomes of the Study
The main things researchers are looking at in this study include:
- Safety measures: This includes monitoring for side effects, serious adverse events, and any reactions that might limit the dose of the drug
- Effectiveness: They will measure how well tumors respond to the treatment using a standard called RECIST v1.1 (Response Evaluation Criteria in Solid Tumors)
Secondary Outcomes of the Study
In addition to the primary outcomes, researchers will also look at:
- How the drug moves through the body: This includes how quickly it's absorbed, how long it stays in the body, and how it's eliminated
- More detailed effectiveness measures: Such as how long the drug's effects last, how long patients live without their cancer getting worse, and overall survival rates
Safety Monitoring
Patient safety is a top priority in this study. Researchers will closely monitor:
- Any side effects or adverse events
- Serious adverse events that might require hospitalization
- Any side effects that might cause a patient to stop treatment
- Any treatment-related events that could lead to death
This monitoring will continue for up to 100 days after the last dose of the study treatment.