Pembrolizumab Combo for Melanoma
Trial Summary
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 participate if you have received prior systemic anticancer therapy within 4 weeks before randomization or if you are on immunosuppressive therapy within 7 days before the first dose.
What data supports the effectiveness of the drug pembrolizumab for melanoma?
Research shows that pembrolizumab, a drug that helps the immune system fight cancer, has been effective in treating melanoma, with high response rates and low side effects in a large study of 411 patients. It has also been found to work better than another treatment, ipilimumab, for advanced melanoma.12345
Is pembrolizumab safe for use in humans?
Pembrolizumab has been shown to be generally safe in humans, with common side effects including fatigue, rash, itching, and diarrhea. Some less common but serious side effects can include immune-related issues like inflammation of the lungs (pneumonitis), liver (hepatitis), or thyroid problems.26789
What makes the drug pembrolizumab unique for treating melanoma?
Pembrolizumab is unique because it is the first anti-PD-1 therapy approved in the US for advanced melanoma, working by blocking the PD-1 receptor on T cells to enhance the immune system's ability to fight cancer cells. It has shown high response rates with minimal side effects and is being tested in combination with other treatments to improve outcomes.123510
What is the purpose of this trial?
Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.As of Amendment 4 (effective date: 05JAN2022), a third arm has been opened to participant enrollment, treatment with pembrolizumab and all-trans retinoic acid (ATRA). Enrollment into the first two arms, treatment with pembrolizumab + quavonlimab+ vibostolimab and treatment with pembrolizumab + quavonlimab + lenvatinib has been completed per protocol as of September 2021.
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
This trial is for adults with advanced melanoma that has worsened despite treatment with PD-1 inhibitors. Participants must have adequate organ function, not be pregnant or breastfeeding, and agree to use contraception if necessary. They should not have had more than three prior treatments for their melanoma and must have recovered from the major side effects of previous therapies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive investigational treatments in different arms, including pembrolizumab with quavonlimab, vibostolimab, lenvatinib, or ATRA, for up to approximately 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ATRA
- Lenvatinib
- Pembrolizumab
- Quavonlimab
- Vibostolimab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
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
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