V940 + Pembrolizumab for Skin Cancer

Recruiting at 6 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Immunotherapy

Must not be taking: Anticancer therapy, Live vaccines

Disqualifiers: Heart failure, Ocular melanoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Researchers want to learn if V940 with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. V940 is a study treatment designed to help a person's immune system attack their specific cancer. Pembrolizumab is an immunotherapy. The goal of this study is to learn if people who receive V940 with pembrolizumab live longer without the cancer growing or spreading than people who receive placebo with pembrolizumab. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.

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 advanced melanoma that has spread and can't be removed by surgery. Participants must not have been treated for melanoma, except certain therapies if no relapse occurred within a year after stopping them. They should have at least one measurable tumor and provide tissue samples. People with well-controlled HIV on therapy or past hepatitis C are eligible; those with active hepatitis B can join if they're on antiviral treatment.

Inclusion Criteria

Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

My melanoma is at stage III or IV and cannot be removed with surgery.

I have HIV and it is well controlled with medication.

Exclusion Criteria

I have had treatment for melanoma before, but there may be exceptions.

I haven't received blood products or colony-stimulating factors in the last 2 weeks.

I am HIV-positive with a history of Kaposi's sarcoma or Multicentric Castleman's Disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive V940 or placebo via IM injection every 3 weeks for up to 9 doses (approximately 27 weeks) and pembrolizumab via IV infusion every 6 weeks for up to 17 doses, or until disease progression or discontinuation

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab
• V940

Trial Overview The study tests whether V940 combined with pembrolizumab extends the time patients live without their melanoma growing compared to placebo plus pembrolizumab. Pembrolizumab is an existing immunotherapy, while V940 is new and aims to boost the immune system's ability to fight cancer.

How Is the Trial Designed?

Group I: V940 + Pembrolizumab Experimental Treatment 2 Interventions

Participants will receive 1 mg of V940 via intramuscular (IM) injection every 3 weeks (q3w) for up to 9 doses (up to approximately 27 weeks) plus 400 mg of pembrolizumab via intravenous (IV) infusion every 6 weeks (q6w) for up to 17 doses, or for a total treatment duration of up to approximately 2 years, or until disease progression or discontinuation.

Group II: Placebo + Pembrolizumab Active Control 2 Interventions

Participants will receive placebo via IM injection q3w for up to 9 doses (up to approximately 27 weeks) plus 400 mg of pembrolizumab via IV infusion q6w for up to 17 doses, or for a total treatment duration of up to approximately 2 years, or until disease progression or discontinuation.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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