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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given IV
Given IV
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, United States
Major Pathologic Response (MPR) Rate by RECIST v1.1
Evaluate the major pathologic response (MPR), defined as pathologic complete response (pCR) + pathologic near complete response (pnCR) after treatment with dual checkpoint blockade in the index lymph node of Cohort 2 and Cohort 3
Time frame: 16 months
Major Pathologic Response (MPR) Rate by RECIST v1.1
Evaluate the MPR rate in the primary cutaneous melanoma site after wide local excision (if wide local excision was deferred after diagnostic biopsy)
Time frame: 16 months
Major Pathologic Response (MPR) Rate by RECIST v1.1
Evaluate the major pathologic response (MPR), defined as pathologic complete response (pCR) + pathologic near complete response (pnCR) in Cohort 1.
Time frame: 16 months
Objective Response Rate (ORR) by RECIST v1.1
Sum of Complete Response (CR) and Partial Response (PR) by RECIST v 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR for each dose cohort.
Time frame: 16 months
Event-Free Survival (EFS)
Determine the event-free survival (EFS) for each cohort. EFS is measured from the date of randomization to the first date of any of the following occurrences: disease progression that preclude surgery, toxicity from neoadjuvant treatment that precludes surgery, inability to surgically resect the primary lesion or undergo TLND, disease progression, toxic effects of adjuvant treatment if indicated, surgical complications, melanoma recurrence after surgery during the follow up period, or death from any cause.
Time frame: 28 months
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
University of California Irvine Medical
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Number of Patients with Adverse Events
Number of Patients who received at least one dose of Fianlimab with Cemiplimab with any reported Adverse Events (AEs) using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.
Time frame: 28 months
Number of Patients with Immune Related Adverse Events
Number of Patients who received at least one dose of Fianlimab with Cemiplimab with reported immune related AEs (irAEs) using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.
Time frame: 28 months
Number of Patients who Discontinued Treatment Due to Reported Adverse Events
Number of Patients who received at least one dose of Fianlimab with Cemiplimab requiring discontinuation of therapy due to reported AEs using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.
Time frame: 28 months