A Study of Pembrolizumab in Patients With Relapsed Or Metastatic Osteosarcoma Not Eligible for Curative Surgery

Phase 2 Terminated 12 enrolled Oslo University Hospital Italian Sarcoma Group · collab Merck Sharp & Dohme LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a phase II, single arm, open-label, interventional trial of pembrolizumab (MK-3475) in patients with osteosarcoma who have experienced disease relapse or progression after at least one line of systemic treatment, and who are not eligible for curative surgery.

Timeline

Start: 2017-05-30
Primary completion: 2018-11-26
Completion: 2019-01-31

Outcome

Missed primary endpoint

Stopped: “Inclusion of patients was stopped because ≤2 patients had clinical benefit.”

paper No patients had clinical benefit at 18 weeks of treatment, and patient enrollment was stopped after completion of stage 1. PMID 33580363 ↗

Publications

Boye K, Longhi A, Guren T, Lorenz S, Naess S, Pierini M, Taksdal I, Lobmaier I, Cesari M, Paioli A, Londalen AM, Setola E, Hompland I, Meza-Zepeda LA, Sundby Hall K, Palmerini E. Pembrolizumab in advanced osteosarcoma: results of a single-arm, open-label, phase 2 trial. Cancer Immunol Immunother. 2021 Sep;70(9):2617-2624. doi: 10.1007/s00262-021-02876-w. Epub 2021 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous