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Table 3 Ongoing phase III trials on combination maintenance therapy in frontline settings

From: Maintenance therapy for newly diagnosed epithelial ovarian cancer– a review

Trial

Trial design

ClinicalTrials.gov identifier

No of patients

Patient population

Treatment arms

Primary end point

Estimated study completion date

IMagyn050/GOG 3015/ENGOT-OV39

2-arm, phase III, randomised trial

NCT03038100

1300

Newly diagnosed stage III/IV OC

1. CT + BEV + atezolizumab ➔ BEV + atezolizumab

2. CT + BEV + placebo ➔ BEV + placebo

PFS and OS (ITT and PD-L1+ populations)

December 2022

ATHENA/GOG-3020/ENGOT-OV45

4-arm, phase III, randomised maintenance trial

NCT03522246

1012

Newly diagnosed stage III/IV EOC in response after completing CRS (PDS or IDS) and first-line platinum-based chemotherapy

1. Rucaparib + nivolumab

2. Rucaparib + placebo

3. Placebo + nivolumab

4. Placebo + placebo

Investigator-assessed PFS

December 2024

DUO-O/AGO-OVAR23/ENGOT-OV46

2-cohort, phase III, randomised trial: double-blind 3-arm trial in non-BRCA-mutated and single open-label cohort in BRCA-mutated

NCT03737643

1374

Newly diagnosed stage III/IV OC, candidate for CRS (PDS or IDS), bevacizumab eligible

1. CT + BEV + placebo ➔ BEV + placebo + placebo

2. CT + BEV + durvalumab ➔ + BEV + durvalumab + placebo

3. CT + BEV + durvalumab ➔ BEV + durvalumab + olaparib

4. Tumour BRCA-mutated cohort: CP + BEV (optional) + durvalumab ➔ BEV (optional) + durvalumab + olaparib

PFS in non-tBRCA HRD positive and all non-tBRCA patients patients

June 2023

ENGOT-OV43/GOG-3036/KEYLYNK-001

3-arm randomised trial

NCT03740165

1086

Newly diagnosed non-BRCA-mutated stage III/IV EOC having undergone PDS or eligible for PDS or IDS, candidate for CP

1. CT + pembrolizumab ➔ pembrolizumab + olaparib

2. CT + pembrolizumab ➔ pembrolizumab + placebo (optional BEV)

3. CT+ placebo ➔ placebo + placebo (optional BEV)

Investigator-assessed PFS and OS

October 2023

FIRST/ENGOT-OV44

3-arm randomised trial

NCT03602859

912

Newly diagnosed stage III/IV non-mucinous EOC

1. CT + placebo ➔ placebo + placebo

2. CT + placebo ➔ niraparib + placebo

3. CT + dostarlimab ➔ niraparib + dostarlimab

Investigator-assessed PFS

July 2023

MAMOC

2-arm randomised trial

NCT04227522

190

Non-BRCA-mutated

1. CT + BEV ➔ BEV ➔ rucaparib

2. CT + BEV ➔ BEV ➔ placebo

PFS

January 2023

  1. BRCA BReast CAncer gene, BEV Bevacizumab, CT Chemotherapy, CRS Cytoreductive surgery, EOC Epithelial ovarian cancer, IDS Interval debulking surgery, HRD Homologous recombination deficiency, ITT Intention-to-treat population, OS Overall survival, OC Ovarian cancer, PDS Primary debulking surgery, PFS Progression-free survival, PDL-1 Programmed death-ligand 1, tBRCA Tumour BReast CAncer gene