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Mk-4830

MK-4830 is an investigational drug currently being studied in clinical trials for the treatment of various advanced solid tumors. This article explores the ongoing research on MK-4830, both as a monotherapy and in combination with other cancer treatments, particularly pembrolizumab. The trials aim to evaluate the safety, tolerability, and effectiveness of MK-4830 in patients with different types of cancer, including pancreatic adenocarcinoma, glioblastoma, head and neck cancer, lung cancer, and more.

Table of Contents

What is MK-4830?

MK-4830 is a new drug being studied for the treatment of various types of advanced solid tumors[1]. It is currently undergoing clinical trials to evaluate its safety, effectiveness, and potential uses in cancer treatment. MK-4830 is being investigated both as a standalone treatment (monotherapy) and in combination with other cancer drugs, particularly pembrolizumab (also known as KEYTRUDA®)[1].

How is MK-4830 Administered?

MK-4830 is administered intravenously (IV), which means it is given directly into a vein. The drug is typically given once every three weeks (Q3W) in treatment cycles[1]. Each cycle lasts 21 days, and patients may receive up to 35 cycles of treatment, which is approximately two years[1]. The exact dose of MK-4830 may vary depending on the specific arm of the clinical trial and the patient’s response to treatment.

What Conditions Does MK-4830 Treat?

MK-4830 is being studied for the treatment of various advanced solid tumors. These include:

  • Pancreatic adenocarcinoma: A type of pancreatic cancer[1]
  • Glioblastoma (GBM): An aggressive type of brain cancer[1]
  • Head and neck squamous cell carcinoma (HNSCC): Cancers that begin in the squamous cells that line the mouth, nose, and throat[1]
  • Non-small cell lung cancer (NSCLC): The most common type of lung cancer[1]
  • Renal cell carcinoma (RCC): A type of kidney cancer[1]
  • Gastric or gastroesophageal junction adenocarcinoma: Cancers of the stomach or the area where the stomach meets the esophagus[1]
  • Ovarian cancer[1]
  • Triple-negative breast cancer (TNBC): A type of breast cancer that doesn’t have estrogen receptors, progesterone receptors, or HER2 proteins[1]
  • Mesothelioma: A cancer that affects the lining of the lungs, chest wall, or abdomen[1]

Combination Therapies

MK-4830 is being studied in combination with several other cancer treatments to potentially enhance its effectiveness. These combinations include:

  • MK-4830 + Pembrolizumab: This is the most common combination being studied across various cancer types[1]
  • MK-4830 + Pembrolizumab + Carboplatin + Pemetrexed: For non-squamous non-small cell lung cancer[1]
  • MK-4830 + Pembrolizumab + Lenvatinib: For renal cell carcinoma[1]
  • MK-4830 + Pembrolizumab + Paclitaxel: For ovarian cancer and triple-negative breast cancer[1]
  • MK-4830 + Pembrolizumab + Pemetrexed + Cisplatin: For mesothelioma[1]

Clinical Trial Structure

The clinical trial for MK-4830 is divided into several parts:

  • Dose Escalation: This part aims to find the right dose of MK-4830 that is both safe and effective. It includes testing MK-4830 alone and in combination with pembrolizumab[1].
  • Dose Expansion: This part tests the chosen dose in more patients with different types of cancers[1].
  • Dose Expansion in Chinese Participants: This part specifically tests MK-4830 in Chinese patients living in China[1].
  • Coformulation: This part tests a combination of MK-4830 and pembrolizumab in a single formulation[1].

Safety and Side Effects

As with all new drugs, a major focus of the MK-4830 clinical trial is to assess its safety and identify potential side effects. The researchers are closely monitoring for what they call “Dose-Limiting Toxicities” (DLTs), which are side effects severe enough to limit the dose of the drug that can be given[1]. These can include severe changes in blood cell counts, liver function, or other significant medical issues. The study is also tracking how many patients experience any adverse events or have to stop treatment due to side effects[1].

Future Prospects

The development of MK-4830 represents an exciting area of cancer research. If successful, it could provide a new treatment option for patients with various types of advanced solid tumors, particularly those who have not responded well to other treatments. The combination of MK-4830 with other cancer drugs, especially pembrolizumab, may offer enhanced effectiveness in fighting cancer[1]. However, it’s important to remember that MK-4830 is still in the clinical trial phase, and more research is needed to fully understand its benefits and risks.

Aspect Details
Drug Name MK-4830
Study Type Phase 1 Open Label, Multi-Arm, Multicenter Study
Primary Objectives Evaluate safety, tolerability, and preliminary efficacy
Cancer Types Various advanced solid tumors including pancreatic, lung, head and neck, ovarian, and more
Administration Intravenous, every 3 weeks
Combination Therapies Pembrolizumab, carboplatin, pemetrexed, lenvatinib, paclitaxel, cisplatin
Key Outcomes Measured Dose-limiting toxicities, adverse events, objective response rate, pharmacokinetics
Duration Up to approximately 2 years (maximum 35 cycles)

FAQ

  • What is MK-4830? MK-4830 is an experimental drug being tested in clinical trials for the treatment of various advanced solid tumors. It is being studied both as a standalone treatment and in combination with other cancer drugs, particularly pembrolizumab.
  • What types of cancer are being studied with MK-4830? MK-4830 is being investigated for several types of cancer, including pancreatic adenocarcinoma, glioblastoma, head and neck squamous cell carcinoma, non-small-cell lung cancer, renal cell carcinoma, gastric or gastroesophageal junction adenocarcinoma, ovarian cancer, triple-negative breast cancer, and mesothelioma.
  • How is MK-4830 administered? MK-4830 is administered intravenously (through a vein) every three weeks. In combination treatments, it is usually given after the infusion of other drugs like pembrolizumab.
  • What is the main goal of the clinical trials involving MK-4830? The main goals of the clinical trials are to evaluate the safety, tolerability, and preliminary effectiveness of MK-4830. This includes determining the appropriate dosage, assessing potential side effects, and measuring how well the drug works against various types of cancer.
  • Are there any combination treatments being studied with MK-4830? Yes, MK-4830 is being studied in combination with several other treatments. The most common combination is with pembrolizumab, but some trials also include combinations with chemotherapy drugs like carboplatin, pemetrexed, paclitaxel, and cisplatin, as well as targeted therapies like lenvatinib.

Ongoing Clinical Trials on Mk-4830

  • Study on the Effectiveness and Safety of Pembrolizumab, Quavonlimab, and Lenvatinib for Patients with Advanced Small Cell Lung Cancer Needing Second-Line Treatment

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Hungary Italy Poland Spain

  • Study of Lenvatinib, Pembrolizumab, and Chemotherapy Combination for Patients with Advanced Esophageal Cancer Previously Treated with PD-1/PD-L1 Therapy

    Recruiting

    1 1 1
    Investigated drugs:
    Germany Italy Norway

  • Study on Pembrolizumab, Etoposide, and Cisplatin or Carboplatin for First-Line Treatment in Patients with Extensive-Stage Small Cell Lung Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria Hungary Italy Poland Spain

  • Study on the Safety and Effectiveness of Pembrolizumab and Drug Combination for Patients with Stage III Melanoma Eligible for Neoadjuvant Therapy

    Not recruiting

    1 1 1
    Investigated drugs:
    France Italy

  • Study of Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Renal Cell Carcinoma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Hungary The Netherlands Poland Spain

  • Study of Pembrolizumab, MK-4830, and Chemotherapy for Patients with High-Grade Serous Ovarian Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Poland Spain

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

    Not recruiting

    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

    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

    1 1 1
    Investigated drugs:
    Hungary Italy Poland Spain

  • Study Comparing MK-1308A and Pembrolizumab for Patients with Advanced Colorectal Cancer with High Microsatellite Instability or Mismatch Repair Deficiency

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Estonia France Germany Greece +7

Glossary

  • Monotherapy: Treatment using a single drug or method.
  • Pembrolizumab: An immunotherapy drug that helps the immune system detect and fight cancer cells.
  • Intravenous (IV): Administered directly into a vein.
  • Dose escalation: A method of increasing the dose of a drug to determine the safest and most effective amount.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Anti-Drug Antibodies (ADA): Antibodies produced by the immune system against a therapeutic drug, which can potentially reduce its effectiveness.
  • Solid tumor: An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign or malignant.

References

  1. https://clinicaltrials.gov/study/NCT03564691