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Phase 2 Study of Cemiplimab, Fianlimab, and Ipilimumab for Resectable Melanoma

This Phase 2 study, called PROSECCO, is looking at a combination of three drugs—cemiplimab, fianlimab, and ipilimumab—for people with melanoma that can be surgically removed. This includes stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) melanoma. The main goal is to see how safe this drug combination is and what side effects it might cause. Researchers will also look at how well the treatment shrinks tumors before surgery. This study is for adults aged 18 and older. The study is currently recruiting about 20 participants.

Study design
This is a Phase 2, single-arm study, meaning all 20 participants will receive the same treatment. It is an interventional study, where participants receive the study drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be monitored through study completion, which is an average of 1 year. Other outcomes like survival will also be tracked over time.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07511036

PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~20 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:CemiplimabLpilimumabFianlimab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Melanoma

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Rodabe N Amaria, MD · PRINCIPAL_INVESTIGATOR · UT MD Anderson

Who to contact

Rodabe N Amaria, MD
[email protected]
(713) 792-2921
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pregnancy testing and contraception are required for WOCBP.
Pregnancy testing and contraception are not required for women who are post-menopausal or permanently sterile.
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together. 10. WOCPB must not agree to donate eggs for purposes of assisted reproduction during the entire study and until 6 months after last treatment 11. All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose 12. Willing and able to comply with clinic visits and study-related procedures 13. Provide informed consent signed by study patient or legally acceptable representative

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0