Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT02652455|
Recruitment Status : Active, not recruiting
First Posted : January 11, 2016
Last Update Posted : August 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin) Skin Cancer||Drug: Nivolumab Procedure: Surgery to Remove Tumor for Growth of TIL Drug: CD137 Drug: Cyclophosphamide Drug: Fludarabine Biological: TIL Infusion Drug: Interleukin-2||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Clinical Trial Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma|
|Actual Study Start Date :||March 2, 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2020|
Experimental: PD-1, CD137 and Adoptive Cell Therapy
Combination Therapy and Immunotherapy as described in intervention descriptions.
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.
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.
All participants: Lymphodepleting chemotherapy intravenously, beginning 3 to 6 weeks after tumor collection for TIL growth.
Other Name: Cytoxan
All participants: Lymphodepleting chemotherapy intravenously, beginning after first 2 days of cyclophosphamide.
Other Name: Fludara
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.
After TIL infusion, in-patient high dose IL-2 treatment.
- Occurrence of Study Related Adverse Events [ Time Frame: Up to 27 months ]Safety will be determined by assessing toxicity based upon Common Terminology Criteria for Adverse Events (CTCAE) v4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652455
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Amod Sarnaik, M.D.||H. Lee Moffitt Cancer Center and Research Institute|