NCT02652455

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

A Pilot Clinical Trial Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Pilot Study is to investigate the safety, side effects, and benefits of tumor- infiltrating lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab is a type of immunotherapy - a drug that is used to boost the ability of the immune system to fight cancer, infection, and other diseases. The primary endpoints of this pilot trial will be the safety and feasibility of the treatment regimens.

Conditions

• Melanoma (Skin)
• Skin Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-08
• Primary completion: 2020-08-30
• Completion: 2020-08-30
• First posted: 2016-01-11
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study