Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer

Phase 1 Completed 20 enrolled H. Lee Moffitt Cancer Center and Research Institute Bristol-Myers Squibb · collab Iovance Biotherapeutics, Inc. · collab Prometheus Inc. · collab Stand Up To Cancer · collab

NaSingle-groupOpen-labelTreatment

Summary

Investigators plan to study 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.

Timeline

Start: 2017-10-11
Primary completion: 2021-02-13
Completion: 2023-06-09

Outcome

Met primary endpoint

paper The end point of safety was met according to the prespecified criteria of ≤17% rate of severe toxicity (95% confidence interval, 3-29%). PMID 34385708 ↗

Publications

Creelan BC, Wang C, Teer JK, Toloza EM, Yao J, Kim S, Landin AM, Mullinax JE, Saller JJ, Saltos AN, Noyes DR, Montoya LB, Curry W, Pilon-Thomas SA, Chiappori AA, Tanvetyanon T, Kaye FJ, Thompson ZJ, Yoder SJ, Fang B, Koomen JM, Sarnaik AA, Chen DT, Conejo-Garcia JR, Haura EB, Antonia SJ. Tumor-infiltrating lymphocyte treatment for anti-PD-1-resistant metastatic lung cancer: a phase 1 trial. Nat Med. 2021 Aug;27(8):1410-1418. doi: 10.1038/s41591-021-01462-y. Epub 2021 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Background	Cyclophosphamide	Other / unclassified	60 mg/kg	Intravenous
Background	Fludarabine	Small molecule	25 mg/m2	Intravenous
Background	aldesleukin	Protein / enzyme biologic	—	—