Bringing Hope: New Treatment for Advanced Melanoma in a Clinical Trial
NCT06961006 · RecruitingThis study looks at whether a combination of intismeran autogene and pembrolizumab can help control advanced melanoma, a serious form of skin cancer. The researchers want to see if this treatment can help people live longer without the cancer growing or spreading compared to those receiving a placebo, which is a treatment that looks like the real one but has no active ingredients. Advanced melanoma means the cancer has spread and cannot be removed by surgery. Immunotherapy, like pembrolizumab, helps the body’s immune system fight cancer.
Locations and contact
This trial is running at 38 locations. The first 8 are listed here.
- Highlands Oncology Group ( Site 4042)Springdale, ArkansasRecruiting
- UCSF Medical Center at Mission Bay ( Site 4044)San Francisco, CaliforniaRecruiting
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047)Hackensack, New JerseyRecruiting
- Inova Schar Cancer Institute ( Site 4046)Fairfax, VirginiaRecruiting
- Fred Hutchinson Cancer Center ( Site 4041)Seattle, WashingtonRecruiting
- Blacktown Hospital ( Site 2001)Blacktown, New South Wales, AustraliaRecruiting
- Melanoma Institute Australia ( Site 2000)Wollstonecraft, New South Wales, AustraliaRecruiting
- One Clinical Research ( Site 2002)Nedlands, Western Australia, AustraliaRecruiting
Who can join
Adults aged 18 and older can join the study. Both men and women are welcome. Participants must have advanced melanoma that cannot be surgically removed. They should not have received certain treatments or have specific health conditions, but the trial team will check each person's eligibility to ensure they can join.
What happens during the trial
Participants will be randomly placed in one of two groups. One group receives intismeran autogene and pembrolizumab, while the other group gets a placebo and pembrolizumab. The treatment will last for up to approximately 2 years, with regular injections and infusions.
The trial team
The trial is sponsored by Merck Sharp & Dohme LLC with a Medical Director overseeing the study.
Important dates
The study started on May 29, 2025, and is currently enrolling participants. It is expected to be completed by September 5, 2031.
Additional information
This is a Phase 2 trial, which means it is looking at how well the treatment works and how safe it is. The trial plans to include about 160 participants and is FDA-regulated.
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