drugset / Trial / NCT03353831
Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse.
Timeline
- Start
- 2018-09-11
- Primary completion
- 2025-03-11
- Completion
- 2025-03-11
Outcome
Missed primary endpoint
paper the hazard ratio for OS was 0.83 (95% CI, 0.68 to 1.01; P = .06 PMID 41337696 ↗
paper the hazard ratio for PFS was 0.87 (95% CI, 0.73 to 1.04; P = .12 PMID 41337696 ↗
paper Combining atezolizumab with bevacizumab and chemotherapy did not significantly improve OS or PFS PMID 41337696 ↗
Publications
- Harter P, Marme F, Redondo A, Reuss A, Lindemann K, Kurzeder C, Van Nieuwenhuysen E, Marth C, Pietzner K, Ray-Coquard I, Garcia-Duran C, Jonuskiene G, Heitz F, Bellier C, Perez-Fidalgo JA, El-Balat A, Selle F, Romero I, Wimberger P, Follana P, Pardo B, de Gregorio N, Joly F, Gaba L, Burges A, Fabbro M, Hasenburg A, Fehm T, Schmalfeldt B, Pautier P. Atezolizumab With Bevacizumab and Nonplatinum Chemotherapy for Recurrent Ovarian Cancer: Final Results From the Placebo-Controlled AGO-OVAR 2.29/ENGOT-ov34 Phase III Trial. J Clin Oncol. 2026 Jan 10;44(2):103-116. doi: 10.1200/JCO-25-01210. Epub 2025 Dec 3.
- Harter P, Pautier P, Van Nieuwenhuysen E, Reuss A, Redondo A, Lindemann K, Kurzeder C, Petru E, Heitz F, Sehouli J, Degregorio N, Wimberger P, Burges A, Cron N, Ledermann J, Lorusso D, Paoletti X, Marme F. Atezolizumab in combination with bevacizumab and chemotherapy versus bevacizumab and chemotherapy in recurrent ovarian cancer - a randomized phase III trial (AGO-OVAR 2.29/ENGOT-ov34). Int J Gynecol Cancer. 2020 Dec;30(12):1997-2001. doi: 10.1136/ijgc-2020-001572. Epub 2020 Jun 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 840 mg | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | PLD | Unknown | 40 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |