Study on V940 and Pembrolizumab for Treating Advanced Melanoma
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06961006
This clinical trial is exploring whether a new treatment combination of V940 and pembrolizumab can help stop advanced melanoma, a type of skin cancer, from growing or spreading. The study compares this combination to a placebo with pembrolizumab to see if it helps patients live longer without the cancer progressing.
Patient Parameters
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Program Overview
The purpose of this study is to find out if combining V940, a new treatment designed to help the immune system target cancer, with pembrolizumab, an existing immunotherapy, can better control advanced melanoma compared to using pembrolizumab with a placebo. Melanoma is a serious skin cancer that has spread to other parts of the body and cannot be removed by surgery. Researchers want to see if this new combination can help patients live longer without their cancer growing or spreading.
Eligibility Criteria
Inclusion Criteria
- Have advanced melanoma (Stage III or IV) that cannot be removed by surgery, confirmed by medical tests.
- Have not received treatment for melanoma, except for certain previous therapies that did not result in a relapse within 12 months after stopping treatment.
- Have been tested for a specific gene mutation (BRAF V600) or have results from previous tests.
- Have at least one tumor that can be measured by scans.
- Provide a tumor sample for genetic and biomarker analysis.
- If living with HIV, must have it well controlled with medication.
- If positive for hepatitis B, must have been on antiviral treatment for at least 4 weeks and have an undetectable viral load.
- If previously infected with hepatitis C, must have an undetectable viral load at screening.
Exclusion Criteria
- Have significant heart failure within the past 6 months, unless well controlled.
- Have HIV with a history of certain related diseases.
- Have melanoma in the eyes or mucous membranes.
- Have received blood transfusions or certain growth factors within 2 weeks before the study.
- Have previously been treated with specific immune therapies, with some exceptions.
- Have had other cancer treatments for melanoma before joining the study, with some exceptions.
- Have had radiation therapy within 2 weeks before starting the study or have ongoing side effects from radiation.
- Have received a live vaccine within 30 days before starting the study.
- Have previously been treated with another cancer vaccine.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group ( Site 4042) | 72762 | Springdale | Arkansas |
| UCSF Medical Center at Mission Bay ( Site 4044) | 94158 | San Francisco | California |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047) | 07601 | Hackensack | New Jersey |
| Inova Schar Cancer Institute ( Site 4046) | 22031 | Fairfax | Virginia |
| Fred Hutchinson Cancer Center ( Site 4041) | 98109 | Seattle | Washington |
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