NCT07511036

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study testing the safety and preliminary efficacy of triplet ICB in treatment naïve patients with clinical stage III or oligometastatic stage IV melanoma with resectable disease.

Detailed description

Primary Objective: • Evaluate the safety of cemiplimab, fianlimab, and ipilimumab combination in resectable clinical stage III or oligometastatic stage IV melanoma patients in the neoadjuvant setting. Primary Endpoints • Incidence of grade 3 or higher toxicities by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6 Secondary Objectives: * Estimation of MPRDetermination of pCR * Determination of objective response rate (ORR) to neoadjuvant therapy * Determination of EFS * Determination of RFS * Assess distant metastasis-free survival (DMFS) * Evaluate overall survival (OS) * Evaluate safety of adjuvant cemiplimab and fianlimab Secondary Endpoints * MPR: defined as ≤10% viable tumor as evaluated by the INMC criteriapCR defined as 0% viable tumor at the time of surgical resection * ORR: Complete response or partial response as evaluated by imaging at baseline and at the completion of neoadjuvant therapy by RECIST 1.1 * EFS: time from study treatment initiation until progression, recurrence, or death * RFS: time from surgery until recurrence or death * DMFS: time from study treatment initiation to time of development of distant metastasis or death * OS: time from study treatment initiation to death * Toxicities by (NCI-CTCAE) version 6 Exploratory Objectives: * Evaluation of pharmacodynamic changes in the tumor microenvironment over the course of neoadjuvant therapy * Evaluation of immunologic changes in the tumor and peripheral blood over the course of neoadjuvant therapy * Evaluation of microbiome changes over the course of neoadjuvant therapy

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Cemiplimab	Given by IV
DRUG	Lpilimumab	Given by IV
DRUG	Fianlimab	Given by IV

Timeline

• Start date: 2026-09-01
• Primary completion: 2028-05-24
• Completion: 2030-05-24
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study