IMagyn050 YO39523/GOG-3015/ENGOT-ov39 Recruitment Update 12 Jan 2018
Study Design in Primary Surgery Cohort Carboplatin AUC 6 q3wk Previously untreated ovarian, fallopian tube, or peritoneal cancer Post-operative Stage III w/macroscopic residual disease, Stage IV ECOG PS 0-2 Paclitaxel 175 mg/m2 q3wk Bev 15 mg/kg q3wk R 1:1 Bev 15 mg/kg X 16 cycles Placebo q3w X 22 cycles No cross-over Carboplatin AUC 6 q3wk Stratification variables Stage/debulking status ECOG PS PDL1 IC0 vs IC1+ Adjuvant/Neo-adjuvant Paclitaxel 175 mg/m2 q3wk Key points: Patient population are those NOT R0 (Stage 3 & Stage 4) ECOG PS 2 is allowed Bev starts Cycle 2 22 cycle duration is modeled after pivotal Phase 3 bev study (GOG218) Carbo AUC 6, not 5 Must be q3w Taxol, not ddTaxol (based on GOG262) PDL1 testing & results are for statistical purposes only. Results don’t gate entry into the study. Bev 15 mg/kg q3wk Bev 15 mg/kg X 16 cycles Atezo 1200 mg q3w X 22 cycles
Study Design in Neoadjuvant Cohort Previously untreated ovarian, fallopian tube, or peritoneal cancer Stage III / IV, Unresectable advanced stage patients for neoadjuvant therapy ECOG PS 0-2 R 1:1 Carboplatin AUC 6 Bev 15 mg/kg X 16 cycles Placebo q3w X 22 cycles Paclitaxel 175 mg/m2 Bev 15 mg/kg Atezo 1200 mg q3w X 22 cycles No cross-over SURGERY Key Points: Reason for NACT must be disease-related (e.g., location/bulk of disease making patient unresectable to R0), based on Fagotti Interval surgery must be b/w C3 & D4 No bev C3 & C4 b/c of surgery
IMagyn050: Study Outcome Measures Efficacy SEE PROTOCOL SECTION 6.4 Co-Primary PFS time from randomization to PD or death from any cause, whichever occurs first ITT population PDL1+ population OS time from randomization to death from any cause Key Points Survival follow-up (OS) continues after Study drug discontinuation and after Progression/Recurrence (PFS) Including: After progression After AE-related treatment discontinuation After stopping Study drug for any reason After starting a new regimen upon progression Documentation: Patient discontinued from Study treatment
IMagyn050: Study Outcome Measures Efficacy SEE PROTOCOL SECTION 6.4 Secondary Objective Response (Primary Surgery patients): PR* or CR* in pts with measurable residual disease after primary surgery Duration of Response (Primary Surgery patients): time between first occurrence of CR/PR to time of PD* or death from any cause, whichever comes first Patient-reported Ovarian Cancer Abdominal Symptoms (Neoadjuvant patients): proportion of pts in each arm reporting clinically meaningful improvement in PR-abdominal pain/bloating (≥10 pt decrease from baseline score, EORTC QLQ-OV28) Patient-reported function & HRQoL: (1) Proportion of neoadjuvant pts in each arm reporting clinically meaningful in PR-function & HRQoL (≥10 pt decrease from baseline score, EORTC QLQ-C30); (2) (1) Proportion of primary surgery pts in each arm reporting improving, stable, or worsening PR-function & HRQoL Key points: Key Secondary Endpoint ORR & DOR are for primary surgery patients who have measureable disease; therefore, since measureable disease is not required for entry into the study, this will be a fraction of those patients who are in the primary surgery group, not all of them Abdominal symptoms: We are testing the hypothesis that there will be a greater proportion of pts getting a more efficacious NACT regimen reporting greater abdominal symptomatic relief compared to pts who aren’t getting the more efficacious regimen
IMagyn050 Recruitment Summary (as of 12 Jan 2018)
IMagyn050 Countries Summary (as of 12 Jan 2018) Site Activation Planned Actual Recruitment Planned Actual Australia 3 15 8 Austria 4 10 1 Belgium 38 Brazil 2 7 China 16 150 9 Czech Republic 5 17 Denmark 13 Finland France 39 Germany 20 65 Greece 37 Israel Italy 77 Japan 120 31 Norway 11 Poland 6 Russian Federation 33 South Korea Spain 35 Sweden Turkey USA 99 83 550 106 Region / Community Total Recruitment Planned Actual % of Goal GOG (US) 550 106 19.3% ENGOT (EU) 420 23 5.5% Chugai(Japan) 120 31 25.8% China 150 9 6.0% ROW 60 63 105.0%
Participating sites MITO
Participating sites MaNGO