Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer

Phase 1/2 Completed 48 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayer · collab Bristol-Myers Squibb · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

A phase I/II study of PI3Kinase inhibition (copanlisib) and anti-PD-1 antibody nivolumab in relapsed/refractory solid tumors with expansions in mismatch-repair proficient (MSS) colorectal cancer.

Timeline

Start: 2019-01-17
Primary completion: 2022-06-14
Completion: 2025-06-30

Publications

Morschhauser F, Machiels JP, Salles G, Rottey S, Rule SAJ, Cunningham D, Peyrade F, Fruchart C, Arkenau HT, Genvresse I, Liu L, Kochert K, Shen K, Kneip C, Pena CE, Grevel J, Zhang J, Cisternas G, Reschke S, Granvil C, Awada A. On-Target Pharmacodynamic Activity of the PI3K Inhibitor Copanlisib in Paired Biopsies from Patients with Malignant Lymphoma and Advanced Solid Tumors. Mol Cancer Ther. 2020 Feb;19(2):468-478. doi: 10.1158/1535-7163.MCT-19-0466. Epub 2019 Oct 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Copanlisib	Small molecule	45 mg	Intravenous
Subject	Copanlisib	Small molecule	60 mg	Intravenous
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous

Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer

Summary

Timeline

Publications

Drugs

Indications