Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

March 8, 2016

Primary Completion Date

August 30, 2020

Study Completion Date

August 30, 2020

Conditions
Melanoma (Skin)Skin Cancer
Interventions
DRUG

Nivolumab

Participants entering the study after the first 6 participants only: Treatment with nivolumab prior to removal of tumor sample for TIL growth. About 2 weeks after their tumor sample has been taken, these participants may receive additional infusions of nivolumab.

PROCEDURE

Surgery to Remove Tumor for Growth of TIL

All participants: Tumor sample taken for growth of TILs. Growing the TILs takes about 4-8 weeks.

DRUG

CD137

All participants: Anti-CD137 agonistic antibody as an agent to augment T cell proliferation in vitro. The growth of the TIL will be accelerated by the use of CD137 activating antibody in the laboratory.

DRUG

Cyclophosphamide

All participants: Lymphodepleting chemotherapy intravenously, beginning 3 to 6 weeks after tumor collection for TIL growth.

DRUG

Fludarabine

All participants: Lymphodepleting chemotherapy intravenously, beginning after first 2 days of cyclophosphamide.

BIOLOGICAL

TIL Infusion

After completing one week of lymphodepleting chemotherapy, all participants will be admitted back into the hospital for IV infusion of the TIL cells.

DRUG

Interleukin-2

After TIL infusion, in-patient high dose IL-2 treatment.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Prometheus Inc.

INDUSTRY

collaborator

Iovance Biotherapeutics, Inc.

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT02652455 - Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma | Biotech Hunter | Biotech Hunter