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Mk-0482

This article provides an overview of clinical trials investigating the use of MK-0482 (rolistobart) in patients with advanced non-small cell lung cancer (NSCLC). These trials are part of the KEYMAKER-U01 study, which aims to evaluate the safety and efficacy of MK-0482 in combination with other treatments for NSCLC patients at various stages of their disease journey.

Table of Contents

What is MK-0482 (Rolistobart)?

MK-0482, also known as Rolistobart, is an investigational drug being studied for the treatment of advanced non-small cell lung cancer (NSCLC). It is a biological agent developed by Merck & Co., Inc. and is currently undergoing clinical trials to evaluate its safety and effectiveness in treating NSCLC patients[1].

How Does MK-0482 Work?

While the exact mechanism of action is not fully disclosed in the available information, MK-0482 is being studied in combination with other cancer treatments, particularly pembrolizumab, an immunotherapy drug. This combination approach suggests that MK-0482 may work by enhancing the body’s immune response against cancer cells or by targeting specific pathways involved in cancer growth[2].

Clinical Trials Involving MK-0482

MK-0482 is being investigated in several clinical trials as part of the KEYMAKER-U01 study. These trials are designed to evaluate the drug’s effectiveness in different scenarios:

  • In combination with pembrolizumab and chemotherapy for patients who have not received prior treatment for advanced NSCLC[1].
  • In combination with pembrolizumab for patients with PD-L1 positive advanced NSCLC who have not received prior treatment[2].
  • In combination with pembrolizumab for patients with advanced NSCLC who have previously been treated with anti-PD-(L)1 therapy[3].

Potential Benefits of MK-0482

The main goals of the MK-0482 clinical trials are to:

  1. Improve the objective response rate (ORR), which measures how well tumors respond to treatment[1].
  2. Increase progression-free survival (PFS), which is the length of time during and after treatment that a patient lives with cancer without it worsening[2].
  3. Provide a new treatment option for patients whose cancer has become resistant to existing therapies[3].

How is MK-0482 Administered?

MK-0482 is administered as a solution for intravenous infusion. This means it is given directly into the bloodstream through a vein. The maximum daily dose being studied is 750 mg, with a total treatment period of up to 105 days[1][2][3].

Possible Side Effects

As with any investigational drug, the full range of side effects is not yet known. The clinical trials are designed to evaluate the safety and tolerability of MK-0482 in combination with other treatments. Patients in the trials will be closely monitored for any adverse events[1][2][3].

Who May Be Eligible for MK-0482 Treatment?

Eligibility criteria for the MK-0482 clinical trials include:

  • Patients with confirmed Stage IV squamous or non-squamous NSCLC[1].
  • Patients who have not received prior systemic treatment for metastatic NSCLC (for some trials)[1][2].
  • Patients who have progressed on previous anti-PD-(L)1 therapy (for specific trials)[3].
  • Patients with adequate organ function and who meet other specific health criteria[1][2][3].

Future Research and Considerations

As MK-0482 is still in the investigational stage, more research is needed to fully understand its effectiveness and safety profile. The ongoing clinical trials will provide valuable information about how well the drug works in different patient populations and in combination with other treatments. Patients interested in participating in these trials should discuss the potential risks and benefits with their healthcare providers[1][2][3].

Aspect Details
Study Drug MK-0482 (rolistobart)
Cancer Type Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Design Phase 2, umbrella study with rolling arms
Patient Populations Treatment-naive, PD-L1 positive, and PD-(L)1 refractory NSCLC patients
Primary Objective Estimate Objective Response Rate (ORR)
Secondary Objectives Estimate Progression-Free Survival (PFS), evaluate safety and tolerability
Key Eligibility Criteria Stage IV NSCLC, ability to provide tumor tissue sample, specific criteria for each substudy
Treatment Combinations MK-0482 with pembrolizumab, with or without chemotherapy
Safety Monitoring Adverse events, discontinuation due to adverse events
Maximum Daily Dose 750 mg of MK-0482
Maximum Treatment Period 105 days

FAQ

  • What is MK-0482? MK-0482, also known as rolistobart, is an investigational drug being studied for the treatment of advanced non-small cell lung cancer (NSCLC). It is being tested in combination with other treatments to potentially improve outcomes for patients with this type of cancer.
  • What types of NSCLC patients are being studied in these trials? The trials are studying MK-0482 in different groups of NSCLC patients, including those who have not received prior treatment for metastatic disease, those with PD-L1 positive tumors, and patients who have progressed on previous anti-PD-(L)1 therapy.
  • What is the main goal of these clinical trials? The primary objective of these trials is to estimate the objective response rate (ORR) of the treatment combinations, which measures how well tumors respond to the therapy. This is assessed using specific criteria called RECIST 1.1.
  • What are some of the key eligibility criteria for these trials? Key eligibility criteria include having a confirmed diagnosis of Stage IV NSCLC, not being eligible for approved targeted therapies (for non-squamous NSCLC), and being able to provide a tumor tissue sample. Specific trials may have additional criteria, such as PD-L1 status or prior treatment history.
  • What are the main safety considerations for patients in these trials? Safety is a key focus of these trials. Patients are monitored for adverse events, and there are specific exclusion criteria to ensure patient safety. These include having certain other medical conditions, recent major surgery, or a history of severe immune-related side effects from previous immunotherapies.

Ongoing Clinical Trials on Mk-0482

  • Study of Pembrolizumab with Drug Combination for Patients with Advanced Non-Small Cell Lung Cancer

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Hungary Italy Poland Spain

  • Study to Test Pembrolizumab, MK-4830, and MK-0482 in Patients with Advanced Non-Small Cell Lung Cancer Who Have Not Received Prior Treatment

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Hungary Italy Poland Spain

  • Study of Boserolimab, MK-0482, and Pembrolizumab for Patients with Advanced Non-Small Cell Lung Cancer Resistant to PD-(L)1 Therapy

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Hungary Italy Poland Spain

Glossary

  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is the most common form of the disease, accounting for about 80-85% of all lung cancers. It includes subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.
  • MK-0482 (rolistobart): An investigational drug being studied for the treatment of advanced NSCLC. It is administered as a solution for intravenous infusion.
  • Pembrolizumab: An immunotherapy drug that works by helping the immune system detect and fight cancer cells. It is often used in combination with other treatments in these trials.
  • PD-L1: Programmed death-ligand 1, a protein found on some cancer cells that can help them evade the immune system. Some treatments target this protein to enhance the immune response against cancer.
  • Objective Response Rate (ORR): A measure of how well tumors respond to treatment, typically defined as the proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standardized set of rules used to assess how tumors respond to cancer treatment in clinical trials.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Immune-related Adverse Event (irAE): Side effects related to the immune system that can occur with certain cancer treatments, particularly immunotherapies.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.

References

  1. http://clinicaltrials.eu/trial/study-of-pembrolizumab-with-drug-combination-for-patients-with-advanced-non-small-cell-lung-cancer/
  2. http://clinicaltrials.eu/trial/study-to-test-pembrolizumab-mk-4830-and-mk-0482-in-patients-with-advanced-non-small-cell-lung-cancer-who-have-not-received-prior-treatment/
  3. http://clinicaltrials.eu/trial/study-of-boserolimab-mk-0482-and-pembrolizumab-for-patients-with-advanced-non-small-cell-lung-cancer-resistant-to-pd-l1-therapy/