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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02652455
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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.
  • Surgery to Remove Tumor for Growth of TIL — PROCEDURE
    All participants: Tumor sample taken for growth of TILs. Growing the TILs takes about 4-8 weeks.
  • CD137 — DRUG
    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.
  • Cyclophosphamide — DRUG
    All participants: Lymphodepleting chemotherapy intravenously, beginning 3 to 6 weeks after tumor collection for TIL growth.
  • Fludarabine — DRUG
    All participants: Lymphodepleting chemotherapy intravenously, beginning after first 2 days of cyclophosphamide.
  • TIL Infusion — BIOLOGICAL
    After completing one week of lymphodepleting chemotherapy, all participants will be admitted back into the hospital for IV infusion of the TIL cells.
  • Interleukin-2 — DRUG
    After TIL infusion, in-patient high dose IL-2 treatment.

Study Details

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.

Key Dates

Start date
Mar 8, 2016
Status verified
Aug 2025
Primary completion
Aug 30, 2020
Completion
Aug 30, 2020

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PD-1, CD137 and Adoptive Cell Therapy
    Combination Therapy and Immunotherapy as described in intervention descriptions. 1. Nivolumab Treatment: The first 6 participants will not have pre-treatment with nivolumab and instead will be scheduled for the removal of their tumor sample for tumor Infiltrating lymphocytes (TIL) growth in the lab. The second 6 participants will receive 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. 2. Surgery to remove tumor for growth of TIL followed by: TIL growth process; lymphodepleting chemotherapy with cyclophosphamide and fludarabine; TIL infusion; Interleukin-2 treatment.

Primary Outcome Measure

Occurrence of Study Related Adverse Events [ Time Frame: Up to 27 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

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