Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma
ConditionMelanoma (Skin)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, Irvine
About this trial
This is a phase II, open label clinical trial determining efficacy of Fianlimab in combination with Cemiplimab in subjects with Melanoma. These are subjects who will have surgery to remove their cancer.
Eligibility criteria
Qualifiers
≥18 years at the time of signing informed consent form (ICF) and able to independently complete informed consent. A certified translator must be used in the completion of informed consent for non-English speaking individuals.
Patients must have surgically resectable, macroscopic Stage IIIB-D cutaneous melanoma or oligometastatic resectable stage IV (M1a, M1b, and M1c) melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria. Patients are eligible at the time of the initial diagnosis or recurrence after previous surgery. Patients should have > 1 RECIST measurable lesion.
Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at initial screening.
Life expectancy of at least 12 weeks.
Disqualifiers
Participants with visceral, bone, or brain metastases.
Participants with a local recurrence in scar or surgical bed of the primary melanoma as the sole site of disease.
Participants with N1a or N2a only disease.
Participants with a diagnosis of acral, ocular or mucosal melanoma.
Trial design
Treatments tested in this trial
- Fianlimab
- Cemiplimab
Treatment groups
35 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of California, Irvine
Lead sponsor
UC Cancer Consortium
Collaborator
Source ClinicalTrials.gov