A PHASE 2 AND PHASE 3 PERI-OPERATIVE TRIAL OF FIANLIMAB AND CEMIPLIMAB COMPARED WITH ANTI-PD1 ALONE IN PATIENTS WITH RESECTABLE STAGE III AND IV MELANOMA (R3767-ONC-2208)
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a “study drug” or called “study drugs” when combined) compared with an approved medication called pembrolizumab. These types of study drugs are collectively known as immune checkpoint inhibitors. The study is focused on participants with a type of skin cancer known as melanoma.
The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab as peri-operative therapy in participants with high-risk melanoma.
Main Inclusion/Exclusion:
- All patients must be either stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per AJCC 8th edition (Amin 2017) and have histologically confirmed cutaneous melanoma that is deemed completely surgically resectable.
- Patients with stage IIIA and M1d disease are excluded
- ECOG PS 0 or 1
- Clinically detectable is defined as disease which is clinically apparent and measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST). Resectable nodal metastases should be a minimum short-axis diameter of 1.5 cm, whereas the minimum size for other metastases should be 1 cm.
Indications:
- Patients with resectable Stage III and Stage IV melanoma
Contact: cajwciclinicaltrials@providence.org