A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma (NCT06594991) | Clinical Trial Compass
RecruitingPhase 2
A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma
United States88 participantsStarted 2024-09-10
Plain-language summary
The purpose of this study is to test whether the combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment that causes few or mild side effects for locally advanced or metastatic, unresectable, refractory melanoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years at the time of informed consent
* Patient/legal authorized representative (LAR) must be able to provide informed consent.
* Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III/IV or metastatic stage IV cutaneous or mucosal melanoma that has progressed on PD-1/PD-L1 therapy:
o For Cohort A, the patient's melanoma must have progressed on prior PD-1 monotherapy
* For Cohort B, the patient's melanoma must have progressed on prior combination PD-1 + LAG-3 blockade
* Note: Intervening lines of targeted therapy, chemotherapy, bispecific (e.g. IMCgp100) and cell-based therapies are permitted between last ICI-based therapy and the start of study therapy
* Note: For cohort A, peptide and mRNA vaccines may have been combined with PD-1 monotherapy as long as no other checkpoint inhibitors were concomitantly administered. For cohort B, peptide and mRNA vaccines may have been combined with combined PD-1 + LAG-3 blockade as long as no other checkpoint inhibitors were concomitantly administered Note: Prior PD-1 monotherapy (Cohort A) or PD-1 and LAG-3 blockade (Cohort B) may have been given in the neoadjuvant or adjuvant setting as long as progression is documented within 3 months of the final dose neoadjuvant/adjuvant therapy
* Patients must have measurable disease as defined by RECIST v1.1 o Note: Lesions previously injected with Talimogene laherparepvec or other local therapies may not be selected…
What they're measuring
1
Determine best objective response rate (ORR) (cohort A)
Timeframe: 6 weeks
2
Determine best objective response rate (ORR) (cohort B)