200 Participants Needed

Pembrolizumab Combo for Melanoma

Recruiting at 36 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Merck Sharp & Dohme Corp.
Must be taking: Pembrolizumab, ATRA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

MD

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

My melanoma diagnosis was confirmed through lab tests.
I have had 3 or fewer treatments for my advanced melanoma.
I am a male willing to use contraception if I take lenvatinib or ATRA.
See 7 more

Exclusion Criteria

I have not had major surgery within the last 3 weeks.
I have a history of hepatitis B.
I have an autoimmune disease treated with medication in the last 2 years.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive investigational treatments in different arms, including pembrolizumab with quavonlimab, vibostolimab, lenvatinib, or ATRA, for up to approximately 2 years

Up to 104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 28 months

Treatment Details

Interventions

  • ATRA
  • Lenvatinib
  • Pembrolizumab
  • Quavonlimab
  • Vibostolimab
Trial Overview The study tests the safety and effectiveness of combining Pembrolizumab with other investigational drugs (Lenvatinib, ATRA, Quavonlimab, Vibostolimab) in treating melanoma resistant to standard PD-1 inhibitor therapy. It aims to find better options than current treatments by comparing different drug combinations.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Pembrolizumab + all-trans retinoic acid (ATRA)Experimental Treatment1 Intervention
Participants will receive pembrolizumab IV plus ATRA orally at specified doses on specified days for a total treatment duration of up to approximately 2 years
Group II: Pembrolizumab + Quavonlimab + VibostolimabExperimental Treatment3 Interventions
Participants will receive pembrolizumab intravenously (IV) plus quavonlimab IV plus vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Group III: Pembrolizumab + Quavonlimab + LenvatinibExperimental Treatment3 Interventions
Participants will receive pembrolizumab IV plus quavonlimab IV plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
  • 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
🇪🇺
Approved in European Union as KEYTRUDA for:
  • 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
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • 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

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

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 profile image

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

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Findings from Research

Pembrolizumab is a monoclonal antibody that effectively blocks the PD-1 receptor on T cells, enhancing their ability to attack cancer cells, particularly in melanoma patients.
In a Phase I study involving 411 patients, pembrolizumab demonstrated high durable response rates with minimal toxicity, indicating its potential as a safe and effective treatment option for melanoma.
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma.Hersey, P., Gowrishankar, K.[2017]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]

References

Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Pembrolizumab superior to ipilimumab in melanoma. [2017]
Pembrolizumab: first global approval. [2021]
Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. [2022]
Pembrolizumab in the management of metastatic melanoma. [2020]
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
KEYNOTE-022: Pembrolizumab with trametinib in patients with BRAF wild-type melanoma or advanced solid tumours irrespective of BRAF mutation. [2022]
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