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Bms-986408

A groundbreaking clinical trial is underway to evaluate the potential of BMS-986408, a novel drug being studied for the treatment of advanced solid tumors. This phase 1/2 study aims to assess the safety and effectiveness of BMS-986408 when used alone or in combination with other cancer treatments. The trial explores various treatment combinations and seeks to determine the optimal dosage for future studies, offering hope for patients with advanced solid tumors.

Table of Contents

Overview of BMS-986408

BMS-986408 is an investigational drug being studied for the treatment of advanced solid tumors[1]. Solid tumors are abnormal masses of tissue that don’t contain cysts or liquid areas. They can occur in various parts of the body, such as the lungs, breast, colon, or prostate. When these tumors are described as “advanced,” it typically means the cancer has spread beyond its original site or is in a later stage.

Purpose of the Study

The primary goal of this clinical trial is to evaluate the safety profile of BMS-986408 when used alone and in combination with other drugs[1]. The researchers aim to:

  • Determine the maximum tolerated dose (MTD) – This is the highest dose of a drug that can be given without causing unacceptable side effects.
  • Establish the Recommended Phase 2 Dose (RP2D) – This is the optimal dose that balances the drug’s effectiveness and safety for further testing.
  • Understand the pharmacokinetic/pharmacodynamic (PK/PD) relationship – This involves studying how the body processes the drug (pharmacokinetics) and how the drug affects the body (pharmacodynamics).

Treatment Arms and Combinations

The study is divided into several parts, exploring different treatment combinations[1]:

  1. BMS-986408 Monotherapy: This arm tests BMS-986408 alone to understand its effects without other medications.
  2. BMS-986408 with Nivolumab: This combination pairs BMS-986408 with nivolumab, an immunotherapy drug that helps the immune system fight cancer cells.
  3. BMS-986408 with Nivolumab and Ipilimumab: This arm combines BMS-986408 with two immunotherapy drugs, potentially enhancing the immune response against cancer.
  4. BMS-986408 with Nivolumab and Chemotherapy: This combination tests the experimental drug with both immunotherapy and traditional chemotherapy.
  5. BMS-986408 with Rabeprazole: This arm explores the combination of BMS-986408 with rabeprazole, a medication typically used to reduce stomach acid.

Safety and Tolerability

A crucial aspect of this study is assessing the safety of BMS-986408. The researchers will closely monitor[1]:

  • Dose-Limiting Toxicities (DLTs): These are side effects severe enough to prevent increasing the dose of the drug.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of the study drug.
  • Number of deaths: This is a standard safety measure in clinical trials, especially those involving patients with advanced cancers.

Efficacy Measurements

While safety is the primary focus, the study also looks at how well BMS-986408 works against advanced solid tumors[1]:

  • Objective Response Rate (ORR): This measures the proportion of patients whose cancer shrinks or disappears after treatment.
  • Duration of Response (DOR): This indicates how long the beneficial effects of the treatment last.

Both of these measures will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, a standardized way to measure how well a cancer patient responds to treatment.

Pharmacokinetic Assessments

The study will also examine how BMS-986408 behaves in the body[1]:

  • Maximum concentration (Cmax): The highest concentration of the drug in the blood after administration.
  • Time of maximum observed concentration (Tmax): How long it takes to reach the maximum drug concentration in the blood.
  • Area under the concentration-time curve (AUC): This measures the total exposure to the drug over time.

These measurements help researchers understand how the body processes BMS-986408, which is crucial for determining the right dosage and frequency of administration.

Aspect Details
Study Type Phase 1/2 clinical trial
Main Drug BMS-986408
Condition Advanced Solid Tumors
Treatment Arms BMS-986408 alone, BMS-986408 + nivolumab, BMS-986408 + nivolumab + ipilimumab, BMS-986408 + nivolumab + chemotherapy, BMS-986408 + rabeprazole
Primary Outcomes Number of participants with DLTs, AEs, and deaths
Secondary Outcomes Drug concentration measurements (Cmax, Tmax, AUC), ORR, DOR

FAQ

  • What is the main purpose of this clinical trial? The primary purpose of this study is to evaluate the safety profile of BMS-986408 when used alone and in combination with other drugs. It aims to establish the maximum tolerated dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) that optimizes the drug's effectiveness and safety.
  • What types of cancer does this trial focus on? This clinical trial focuses on advanced solid tumors. Solid tumors are abnormal masses of tissue that don't contain cysts or liquid areas, and can occur in various parts of the body such as the lungs, breast, or colon.
  • What other drugs are being combined with BMS-986408 in this study? BMS-986408 is being studied in combination with several other treatments, including nivolumab, ipilimumab, platinum-doublet chemotherapy, and rabeprazole. These combinations are being tested to see if they enhance the effectiveness of the treatment.
  • How is the effectiveness of the treatment being measured? The study measures effectiveness through several outcomes, including the Objective Response Rate (ORR) and Duration of Response (DOR). These are assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, which is a standard way to measure how well a cancer patient responds to treatment.
  • What are some of the safety measures being monitored in this trial? The trial closely monitors safety by tracking the number of participants experiencing Dose-Limiting Toxicities (DLTs), Adverse Events (AEs), and the number of deaths. Additionally, the study measures various aspects of how the drug behaves in the body, such as its maximum concentration and how long it stays in the system.

Ongoing Clinical Trials on Bms-986408

  • Study of BMS-986408 Alone or with Nivolumab and Ipilimumab for Patients with Advanced Solid Tumors

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France Spain

Glossary

  • Advanced Solid Tumors: Cancers that have formed a solid mass of cells and have spread from where they started to other parts of the body or have grown extensively in their original location.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug determined to be safe and potentially effective, which is then used in larger Phase 2 clinical trials.
  • Pharmacokinetic/Pharmacodynamic (PK/PD): The study of how a drug moves through the body (pharmacokinetics) and how the body responds to the drug (pharmacodynamics).
  • Monotherapy: Treatment using a single drug.
  • Dose-Limiting Toxicities (DLTs): Side effects of a treatment that are severe enough to prevent an increase in dose or require a dose reduction.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure cancer patients' response to treatment.

References