Nivolumab With Chemotherapy in Pleural Mesothelioma After Surgery

Phase 2 Completed 92 enrolled Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Bristol-Myers Squibb · collab University Hospital Heidelberg · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Patients with malignant pleural mesothelioma stage I-III who have undergone cytoreductive surgery with curative intend consisting of extended pleurectomy / decortication (eP/D) with or without hyperthermic intrathoracic chemoperfusion (HITOC) who will receive a maximum treatment duration of 16 cycles (4 cycles of chemotherapy in both arms + 12 cycles maintenance immunotherapy in treatment arm B). The main objective of the trial is Time-to-next-treatment (TNT), as well as safety and tolerability.

Timeline

Start: 2019-02-04
Primary completion: 2025-01-30
Completion: 2025-01-30

Publications

Shah R, Klotz LV, Chung I, Feisst M, Schneider MA, Riedel J, Bischoff H, Eichhorn ME, Thomas M. A Phase II Trial of Nivolumab With Chemotherapy Followed by Maintenance Nivolumab in Patients With Pleural Mesothelioma After Surgery: The NICITA Study Protocol. Clin Lung Cancer. 2021 Mar;22(2):142-146. doi: 10.1016/j.cllc.2020.10.005. Epub 2020 Oct 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Nivolumab With Chemotherapy in Pleural Mesothelioma After Surgery

Summary

Timeline

Publications

Drugs

Indications