A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

Summary

The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).

Timeline

Start

2020-06-30

Primary completion

2021-12-08

Completion

2025-02-24

Outcome

Missed primary endpoint

paper The objective response rate with the tiragolumab-plus-atezolizumab combination was numerically higher than the historical reference but did not reach statistical significance. PMID 38858106 ↗

paper Protocol-defined independent review committee-assessed objective response rates were 19.0% (95% CI 12.6 to 27.0) in 126 patients receiving tiragolumab plus atezolizumab (p=0.0787 vs historical reference) PMID 38858106 ↗

Publications

• Salani R, McCormack M, Kim YM, Ghamande S, Hall SL, Lorusso D, Barraclough L, Gilbert L, Guzman Ramirez A, Lu CH, Sabatier R, Colombo N, Hu Y, Krishnan V, Molinero L, Feng Y, Kim N, Castro M, Lin YG, Monk BJ. A non-comparative, randomized, phase II trial of atezolizumab or atezolizumab plus tiragolumab for programmed death-ligand 1-positive recurrent cervical cancer (SKYSCRAPER-04). Int J Gynecol Cancer. 2024 Aug 5;34(8):1140-1148. doi: 10.1136/ijgc-2024-005588.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Subject	Tiragolumab	Monoclonal antibody	600 mg	Intravenous

Indications