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

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

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.

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Prometheus Inc.

  collaborator INDUSTRY

• Iovance Biotherapeutics, Inc.

  collaborator INDUSTRY

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Amod Sarnaik, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-08

Primary Completion

2020-08-30

Completion

2020-08-30

FDA Drug

Yes

Countries

• United States

Study Locations