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Bms-986288

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.

Table of Contents

What is BMS-986288?

BMS-986288 is an investigational immunotherapy drug being studied for the treatment of advanced solid cancers[1]. 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[1]. 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[1]:

  1. Arm A: BMS-986288 Monotherapy – Patients receive only BMS-986288
  2. 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
  3. 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[1]:

  • 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[1]:

  • 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[1]:

  • 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.

Aspect Details
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

FAQ

  • What is BMS-986288? BMS-986288 is an investigational immunotherapy drug being studied for the treatment of advanced solid cancers. It is being tested both alone and in combination with other drugs to determine its safety and effectiveness in fighting cancer.
  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to determine whether BMS-986288, both by itself and in combination with Nivolumab, is safe and tolerable in treating select advanced solid tumors.
  • What other drugs are being studied alongside BMS-986288? In addition to BMS-986288, the study is investigating its combination with Nivolumab (also known as Opdivo or BMS-936558). In one part of the study, a combination of BMS-986288, Nivolumab, and Regorafenib is also being explored.
  • What are the primary outcomes being measured in this study? The primary outcomes include measuring the incidence of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities, AEs leading to discontinuation or death, and the objective response rate (ORR) of the treatment.
  • Who can participate in this clinical trial? This clinical trial is designed for patients with advanced cancer, specifically those with advanced solid tumors. However, exact eligibility criteria would be determined by the study investigators and may include factors such as cancer type, stage, and previous treatments.

Ongoing Clinical Trials on Bms-986288

  • Study of BMS-986288 and Nivolumab for Patients with Advanced Solid Tumors

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France Italy Spain

Glossary

  • Immunotherapy: A type of cancer treatment that helps your immune system fight cancer cells.
  • Advanced Solid Cancers: Cancers that have spread from where they started to other parts of the body and are usually difficult to treat.
  • Nivolumab: An immunotherapy drug (also known as Opdivo) that works by helping the immune system attack cancer cells.
  • Regorafenib: A targeted therapy drug used to treat certain types of cancer by blocking proteins that help cancer cells grow.
  • Adverse Events (AEs): Any unwanted or harmful medical occurrences in a patient receiving a drug, which may or may not be related to the treatment.
  • Serious Adverse Events (SAEs): Adverse events that result in death, are life-threatening, require hospitalization, or cause significant disability.
  • Dose Limiting Toxicities (DLT): Side effects of a drug that are severe enough to prevent an increase in dosage or require a decrease in dosage.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.

References

  1. https://clinicaltrials.gov/study/NCT03994601