Programmed Cell Death 1 + Selected Cell Therapy With Durvalumab (MEDI4736) and Tremelimumab in Metastatic Melanoma

EARLY_PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

August 15, 2020

Primary Completion Date

February 28, 2022

Study Completion Date

February 28, 2025

Conditions
Malignant Melanoma
Interventions
DRUG

tremelimumab/durvalumab, ipilimumab/nivolumab and nivolumab monotherapy

"Subjects will receive 1 cycle of tremelimumab/durvalumab~* Subjects will undergo resection to obtain tumor for generation of autologous tumor infiltrating lymphocytes (TIL) cultures and blood draw to obtain peripheral blood mononuclear cell (PBMC)s~* TIL and PBMC will undergo immunoselection based on binding to an anti-programmed cell death 1 (PD-1) antibody and then will be expanded ex vivo.~Subjects will receive 3 cycles of ipilimumab/nivolumab~• Subjects will undergo staging with computer tomography (CT) chest/abdomen/pelvis and brain magnetic resonance imaging (MRI) or CT scan.~subjects with stable disease will continue with nivolumab monotherapy; Subjects with progressive disease will proceed to cell therapy."

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Yale University

OTHER