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Study of Favezelimab Combined with Pembrolizumab (MK-4280A) for Patients with Selected Solid Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This is a study examining the effects of treatments for malignant neoplasms (cancers). The study has two groups: Cohort A focuses on patients with cutaneous squamous cell carcinoma (a type of skin cancer), while Cohort B includes patients with endometrial cancer (cancer of the uterine lining). The purpose of this research is to evaluate the effectiveness of a drug combination called MK-4280A, which contains favezelimab and pembrolizumab, in treating these specific cancers.

In Cohort A, patients with skin cancer will receive either MK-4280A or pembrolizumab alone before surgery. In Cohort B, patients with endometrial cancer who have already received previous treatment will receive either MK-4280A or pembrolizumab, both in combination with another medication called lenvatinib. The study will monitor how patients respond to these treatments by measuring tumor shrinkage and tracking any side effects that may occur.

This is a randomized, double-blind study, which means patients will be randomly assigned to different treatment groups, and neither the patients nor the researchers will know which specific treatment each patient is receiving during the study. This design helps ensure the results are not influenced by expectations about the treatments.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Eligibility Confirmation and Enrollment
Before joining the study, your eligibility will be confirmed based on your specific medical condition and other criteria.
You will be assigned to either Cohort A (for patients with cutaneous squamous cell carcinoma, a type of skin cancer) or Cohort B (for patients with endometrial cancer that has progressed after previous treatment).
Step 2
Randomization
You will be randomly assigned to receive one of the study treatments. This is done in a double-blind manner, which means neither you nor your doctor will know which specific treatment you are receiving.
Step 3
Treatment Administration - Cohort A
If you are in Cohort A, you will receive either:
• MK-4280A (a combination of favezelimab and pembrolizumab) OR
• Pembrolizumab alone (also known as KEYTRUDA, which is given as a 25 mg/mL solution for infusion)
These medications are administered through an intravenous infusion (directly into your vein).
Step 4
Treatment Administration - Cohort B
If you are in Cohort B, you will receive either:
• Lenvatinib in combination with MK-4280A OR
• Lenvatinib in combination with pembrolizumab
Lenvatinib is taken as a capsule by mouth, while the other medications are given as intravenous infusions.
Step 5
Regular Monitoring and Assessment
Throughout the study, you will have regular appointments for health assessments, which may include:
• Blood tests to check your organ function
• Imaging scans to evaluate your tumor response to treatment using RECIST 1.1 criteria (a standardized way to measure changes in tumor size)
• Monitoring for side effects, also called adverse events
Step 6
Surgery for Cohort A Patients
If you are in Cohort A, after receiving the study treatment, you will undergo surgery to remove your tumor.
Your removed tumor will be examined to determine if there was a pathologic complete response (complete disappearance of cancer cells) or major pathologic response (significant reduction in cancer cells).
Step 7
Study Completion or Discontinuation
You will continue treatment until one of the following occurs:
• Your disease progresses
• You experience unacceptable side effects
• You decide to withdraw from the study
• The study ends (scheduled to conclude by February 27, 2028)
If side effects become too severe, your participation may be discontinued for your safety.

Who can join the trial?

17 criteria

For Cohort A (studying MK-4280A or pembrolizumab): You must have a confirmed diagnosis of resectable cutaneous squamous cell carcinoma (a type of skin cancer) as your primary cancer.
For Cohort B (studying lenvatinib combinations): You must have endometrial cancer (EC) that is not deficient in mismatch repair proteins, with advanced disease (stage IVB, recurrent, or metastatic) that can't be cured with surgery or radiation.
For Cohort B: You must have been assigned female at birth and be at least 18 years old.
For Cohort A: You can be any gender and must be at least 18 years old.
For Cohort A: You must have Stage II to Stage IV disease without distant metastasis (M1).
For Cohort A: You must not have received any previous systemic treatment (like chemotherapy).
For Cohort B: Your cancer must have progressed after receiving one prior platinum-based chemotherapy treatment.
For Cohort B: You must have measurable disease that can be evaluated using RECIST 1.1 criteria (a standard way to measure tumors).
For Cohort B: You must have well-controlled blood pressure without medication.
You must agree to follow contraception guidelines if you can become pregnant.
You must have a life expectancy of more than 3 years as determined by your doctor.
You must have adequate organ function.
You must have good performance status (ECOG 0 or 1), meaning you're able to care for yourself and are up and about more than 50% of waking hours.
If you have hepatitis B, you must have been on antiviral therapy for at least 4 weeks with undetectable virus before randomization.
If you have hepatitis C, you must have undetectable virus levels at screening.
If you have HIV, it must be well-controlled on stable antiretroviral therapy.
For Cohort A: You must provide a tumor tissue sample from either archived tissue, new surgical removal, or a biopsy from a tumor that hasn't been previously treated with radiation.

Who cannot join the trial?

13 criteria

Has a history of cancer that has spread to the central nervous system (brain or spinal cord) or has active symptoms suggesting spread to the central nervous system.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent (medications that affect how the immune system works against cancer).
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks before the first dose of study treatment.
Has received prior radiation therapy within 2 weeks of the first dose of study treatment.
Has an active autoimmune disease that has required systemic treatment in the past 2 years (a condition where your immune system attacks your own body).
Has a history of non-infectious pneumonitis (lung inflammation not caused by infection) that required steroids or has current pneumonitis.
Has an active infection requiring systemic therapy.
Has received a live vaccine within 30 days prior to the first dose of study treatment.
Has severe kidney disease requiring dialysis.
Has known history of Human Immunodeficiency Virus (HIV) infection.
Has known active Hepatitis B or Hepatitis C infection.
Is pregnant or breastfeeding.
Has severe heart problems or uncontrolled high blood pressure.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Academisch Ziekenhuis Maastricht
Maastricht, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

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Investigated drugs

Favezelimab
is a medication that targets a protein called LAG-3 (Lymphocyte-Activation Gene 3) which is found on immune cells. It works by helping your immune system fight cancer more effectively by removing a "brake" that cancer cells can use to hide from your immune system.
Pembrolizumab
is an immunotherapy medication that helps your immune system detect and fight cancer cells. It works by blocking a protein called PD-1, which normally prevents your immune system from attacking your own cells. By blocking PD-1, pembrolizumab allows your immune system to better recognize and destroy cancer cells.
MK-4280A
is a combination medication that contains both favezelimab and pembrolizumab. This combination approach targets two different immune checkpoint proteins (LAG-3 and PD-1) at the same time, potentially providing a stronger anti-cancer effect than either medication alone.
Lenvatinib
is a targeted therapy medication that works by blocking certain proteins (called kinases) that help cancer cells grow and divide. It can also prevent the formation of new blood vessels that tumors need to grow. In this trial, lenvatinib is being tested in combination with other treatments to see if the combination works better than single treatments alone.

What is already known about the treatment

Favezelimab
A monoclonal antibody being investigated in combination with pembrolizumab (as MK-4280A) for treating various solid tumors. It is administered intravenously during clinical trials, with research focusing on its potential in advanced cancers. Favezelimab works by targeting the LAG-3 (Lymphocyte-activation gene 3) pathway, enhancing the immune system's ability to recognize and attack cancer cells. As an immunotherapy agent, it belongs to the class of immune checkpoint inhibitors that help overcome cancer's ability to evade immune detection.
Pembrolizumab
An FDA-approved immunotherapy medication administered intravenously that is widely used in cancer treatment. It works by blocking the PD-1 pathway, which cancer cells often use to evade the immune system, thereby enabling T-cells to recognize and attack tumor cells. Pembrolizumab is approved for multiple cancer types including melanoma, lung cancer, and head and neck cancers. It belongs to a class of drugs called immune checkpoint inhibitors and is often used as a first-line or subsequent treatment for advanced cancers.
Lenvatinib
An oral medication taken daily as a tablet that works by inhibiting multiple receptor tyrosine kinases involved in tumor growth and abnormal blood vessel formation. It is FDA-approved for treating certain types of thyroid cancer, hepatocellular carcinoma, and in combination with other therapies for endometrial cancer. Lenvatinib belongs to the class of targeted therapies called tyrosine kinase inhibitors and works by blocking the blood supply to tumors while directly inhibiting cancer cell growth.

Investigated diseases

Neoplasm malignant – A malignant neoplasm is a cancerous growth or tumor that can invade surrounding tissues and potentially spread to other parts of the body. It begins when cells grow uncontrollably, developing into abnormal masses that can disrupt normal organ function. These growths are characterized by their ability to metastasize, meaning cancer cells can break away from the primary tumor and travel through the bloodstream or lymphatic system to form new tumors elsewhere. Malignant neoplasms vary widely in their behavior and progression depending on the type of tissue involved, their location, and molecular characteristics. As they grow, these tumors can cause symptoms by pressing on nearby structures, invading vital organs, or interfering with normal physiological processes.