Pembrolizumab Combinations for Melanoma

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Substudy 02D 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 02D is to evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. As of amendment 2 (effective 01DEC2022) enrollment into the treatment arm of pembrolizumab and lenvatinib has been discontinued.

Eligibility Criteria

This trial is for adults with Stage IV melanoma that has spread to the brain, who haven't used steroids recently and aren't pregnant or breastfeeding. They must have good organ function and agree to use contraception. People with weakened immune systems, recent surgeries or therapies, active infections, other cancers within 2 years, or certain viral diseases can't join.

Inclusion Criteria

I agree not to breastfeed during the study.

My melanoma is at the most advanced stage, having spread to distant parts of my body.

I am not pregnant or breastfeeding and follow the required contraceptive guidelines.

Exclusion Criteria

I have untreated bleeding in my brain from cancer spread.

I have had pneumonitis treated with steroids or have it now.

I have been treated for an autoimmune disease in the last 2 years.

My cancer has spread to the lining of my brain and spinal cord.

I have undergone whole brain irradiation.

I have another cancer that is getting worse or needed treatment in the last 2 years.

I have a known history of HIV.

I have a history of hepatitis B or C.

I have been diagnosed with eye melanoma.

I have not had major surgery in the last 3 weeks.

I have not received a live vaccine in the last 30 days.

I have received a transplant from another person.

I am currently being treated for an infection.

Treatment Details

The study tests Pembrolizumab alone or combined with Quavonlimab in treating melanoma in the brain. The combination of Pembrolizumab and Lenvatinib was part of the study but is no longer being tested as of December 2022.

2Treatment groups

Experimental Treatment

Group I: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions

Participants will receive pembrolizumab IV plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.

Group II: Coformulation Pembrolizumab/Quavonlimab + LenvatinibExperimental Treatment3 Interventions

Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab and quavonlimab) intravenously (IV) plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.

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

🇺🇸 Approved in United States as Lenvima for: