MK-4830 + Pembrolizumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer treatment that combines MK-4830 (an experimental treatment) with pembrolizumab and sometimes other drugs. The goal is to determine the safety and effectiveness of this combination for various cancers, such as lung, ovarian, and breast cancers. The trial consists of several parts, each examining different doses and combinations to identify the most effective approach. Individuals with advanced cancers that have not responded to other treatments might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy, radiation, or biological cancer therapy within 4 weeks before starting the trial, and you must not be taking chronic systemic steroids in doses greater than 10 mg daily of prednisone or equivalent within 7 days prior to the first dose of trial treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that MK-4830, whether used alone or with pembrolizumab, is generally safe for patients with advanced solid tumors. This combination has a manageable safety profile, meaning it usually doesn't cause severe side effects for most patients. Early studies confirmed its safety, even at different doses, which reassures those considering joining a trial.
Pembrolizumab, often used with other treatments, has a well-established safety record. It has been tested in many trials and conditions, consistently showing safe results. While side effects can occur, they are usually known and manageable.
In summary, previous studies have shown that both MK-4830 and pembrolizumab are well-tolerated. Participants can expect a reasonable safety profile, with typically manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about MK-4830 combined with pembrolizumab because it introduces a novel action mechanism by targeting the immune checkpoint pathways, potentially enhancing the immune system's ability to fight cancer. Unlike traditional chemotherapy, which attacks rapidly dividing cells, this combination aims to activate the body's own defenses against cancer cells. MK-4830 specifically targets the ILT4 receptor, which may suppress tumor growth and improve outcomes for patients with various advanced cancers. This innovative approach offers hope for more effective and personalized cancer treatment strategies.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that combining MK-4830 with pembrolizumab has promising effects against tumors in patients with advanced solid cancers. In this trial, participants will receive different combinations of MK-4830 and pembrolizumab. Some arms will also include additional treatments such as paclitaxel, carboplatin, pemetrexed, or lenvatinib, depending on the specific cancer type under study. Pembrolizumab alone is already known to extend survival in cancers like lung cancer and melanoma by boosting the immune system to fight cancer cells. The combination with MK-4830 aims to enhance this effect by targeting a specific part of the immune system. Early results suggest this combination could be effective for various cancers, but further research is needed to confirm these findings.14678
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with various advanced solid tumors, including specific types such as pancreatic adenocarcinoma, renal cell cancer, and non-small-cell lung cancer. Participants must have tried certain treatments without success or be ineligible for them. They should have measurable disease, adequate organ function, and agree to contraception if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Evaluation of safety, tolerability, and preliminary efficacy of MK-4830 monotherapy and in combination with pembrolizumab
Dose Expansion
Evaluation of objective response rate (ORR) and safety of MK-4830 in combination with pembrolizumab and other therapies
Coformulation
Evaluation of safety and tolerability of MK-4830A (coformulation of MK-4830 and pembrolizumab)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Lenvatinib
- MK-4830
- MK-4830A
- Paclitaxel
- Pembrolizumab
- Pemetrexed
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University