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Bms-986315

This article discusses a clinical trial investigating the use of BMS-986315, a novel drug, in combination with nivolumab and chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC). The study aims to assess the effectiveness and safety of this combination therapy compared to standard treatment approaches in patients with stage IV or recurrent NSCLC.

Table of Contents

What is BMS-986315?

BMS-986315 is a new drug being developed for the treatment of cancer. It’s also known as Anti-NKG2A, which gives us a clue about how it works in the body[1]. This medication is currently being studied in clinical trials to determine its effectiveness and safety in treating a specific type of lung cancer.

What condition does BMS-986315 target?

The primary focus of the current research on BMS-986315 is its potential use in treating Non-Small Cell Lung Cancer (NSCLC). Specifically, the drug is being studied for patients with Stage IV or recurrent NSCLC[1]. NSCLC is the most common type of lung cancer, accounting for about 80-85% of all lung cancer cases. Stage IV means the cancer has spread to other parts of the body, while recurrent means the cancer has come back after initial treatment.

How does BMS-986315 work?

While the exact mechanism of BMS-986315 isn’t fully described in the available information, its alternative name “Anti-NKG2A” suggests it targets a specific protein in the immune system. NKG2A is a receptor found on certain immune cells. By blocking or modifying this receptor, BMS-986315 may help enhance the body’s natural ability to fight cancer cells[1].

Current Clinical Trial

BMS-986315 is currently being studied in a clinical trial. This trial is officially titled “A Randomized, Double-blind, Phase 2 Study of BMS-986315 and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)”[1]. Let’s break down what this means:

  • Randomized: Participants are randomly assigned to different treatment groups.
  • Double-blind: Neither the participants nor the researchers know who is receiving which treatment, which helps prevent bias.
  • Phase 2: This phase tests the drug in a larger group of people to see if it works and to further evaluate its safety.
  • First-line Treatment: This means the treatment is being studied as the initial treatment for newly diagnosed patients.

Combination Therapy Approach

In this study, BMS-986315 is not being used alone. Instead, it’s being tested in combination with other treatments[1]:

  • Nivolumab: Also known as Opdivo or BMS-936558, this is an immunotherapy drug already approved for various cancers.
  • Platinum-based doublet chemotherapy (PDCT): This includes drugs like pemetrexed, cisplatin, carboplatin, and paclitaxel, which are standard chemotherapy medications for NSCLC.

The idea behind this combination approach is to potentially enhance the effectiveness of treatment by attacking the cancer in multiple ways.

Study Design and Objectives

The study is divided into two parts[1]:

  1. Part 1: This part focuses on safety and finding the right dose of BMS-986315. It looks at different dose levels (DL1 and DL2) of BMS-986315 in combination with nivolumab and chemotherapy.
  2. Part 2: This part compares the effectiveness and safety of BMS-986315 (at the dose determined in Part 1) plus nivolumab and chemotherapy against nivolumab and chemotherapy alone.

Potential Benefits and Outcomes

The study aims to measure several important outcomes[1]:

  • Objective Response Rate (ORR): This measures how many patients see their tumors shrink or disappear with treatment.
  • Progression Free Survival (PFS): This looks at how long patients live without their cancer getting worse.
  • Duration of Response (DOR): This measures how long the positive effects of treatment last.
  • Disease Control Rate (DCR): This includes patients whose disease improves, stays stable, or grows more slowly with treatment.

Safety Monitoring

The study closely monitors the safety of BMS-986315 and the combination treatment. Researchers are tracking[1]:

  • Adverse Events (AEs): Any unfavorable medical occurrences during treatment.
  • Treatment-related AEs (TRAEs): Side effects believed to be caused by the study treatments.
  • Serious AEs (SAEs): More severe or life-threatening side effects.
  • Dose Limiting Toxicities (DLTs): Side effects severe enough to limit the dose of medication that can be given.

The study also looks at how the body processes BMS-986315 (pharmacokinetics) and whether patients develop antibodies against the drug, which could affect its effectiveness[1].

Aspect Details
Study Type Randomized, double-blind, Phase 2 clinical trial
Primary Objective Evaluate efficacy and safety of BMS-986315 plus nivolumab with chemotherapy vs. nivolumab with chemotherapy
Target Population Patients with first-line Stage IV or recurrent NSCLC
Treatment Arms Multiple arms testing different dose levels of BMS-986315 with nivolumab and chemotherapy
Primary Outcome Measures Safety assessments (Part 1), Objective Response Rate (Part 2)
Secondary Outcome Measures Progression-Free Survival, Duration of Response, pharmacokinetics, immunogenicity
Key Drugs BMS-986315, Nivolumab, Pemetrexed, Carboplatin, Paclitaxel

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the effectiveness and safety of combining BMS-986315 with nivolumab and platinum-based doublet chemotherapy (PDCT) compared to nivolumab with PDCT alone in treating patients with advanced non-small cell lung cancer (NSCLC).
  • Who can participate in this study? This study is designed for patients with stage IV or recurrent non-small cell lung cancer (NSCLC) who are receiving first-line treatment. Specific eligibility criteria are not provided in the given information, so interested patients should consult with their healthcare providers for more details.
  • What treatments are being tested in this trial? The trial is testing different combinations of treatments, including BMS-986315 (at different dose levels), nivolumab, and various chemotherapy drugs such as pemetrexed, carboplatin, and paclitaxel. The exact combination depends on the study arm and the patient's cancer type.
  • How is the effectiveness of the treatment measured? The effectiveness of the treatment is primarily measured by the Objective Response Rate (ORR) in Part 2 of the study. Secondary measures include Progression-Free Survival (PFS), Duration of Response (DOR), Time to Response (TTR), and Disease Control Rate (DCR).
  • What are the main safety considerations in this trial? The trial closely monitors safety by tracking various types of adverse events (AEs), including treatment-related AEs, serious AEs, and AEs leading to discontinuation or death. The study also looks for dose-limiting toxicities and the development of anti-drug antibodies to BMS-986315.

Ongoing Clinical Trials on Bms-986315

  • Study of BMS-986315 and Nivolumab with Chemotherapy for First-line Treatment in Stage IV or Recurrent Non-Small Cell Lung Cancer Patients

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Poland Romania Spain

Glossary

  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is the most common form, accounting for about 80-85% of all lung cancers. It grows and spreads more slowly than small cell lung cancer.
  • BMS-986315: An experimental drug being tested in this clinical trial, also known as Anti-NKG2A. It is being studied in combination with other treatments for NSCLC.
  • Nivolumab: A type of immunotherapy drug (also known as Opdivo or BMS-936558) that helps the immune system fight cancer cells.
  • Platinum-based doublet chemotherapy (PDCT): A standard chemotherapy regimen that combines a platinum drug (like cisplatin or carboplatin) with another chemotherapy agent.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a decrease in dose.
  • Anti-drug Antibodies: Proteins produced by the immune system that recognize and bind to a specific drug, potentially affecting its effectiveness or safety.

References

  1. https://clinicaltrials.gov/study/NCT06094296