MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum- Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

Conditions

Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

Brief summary

PFS, defined as the time from date of randomization until Investigator-assessed progressive disease (PD) or death, whichever occurs first. Results will be summarized by arm − Kaplan-Meier method for survival function estimate − Stratified Cox proportional hazard regression for hazard ratio (HR) estimate − Stratified log-rank test for hypothesis testing

Detailed description

Objective response includes best response of complete response (CR) or partial response (PR) as assessed by the Investigator − Stratified Cochran-Mantel-Haenszel (CMH) test for treatment comparison − Clopper-Pearson method for 95% CI estimation, OS defined as the time from date of randomization until the date of death. Patients alive at the time of analysis will be censored at the last known date known to be alive − Kaplan-Meier method for survival function estimate − Stratified Cox proportional hazard regression for HR estimate − Stratified log-rank test for hypothesis testing, Primary PRO assessment, defined as the number of patients achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of EORTC QLQ-OV28, DOR defined as the time from initial response until Investigator-assessed PD for all patients who achieve a confirmed objective response (PR or CR) − Kaplan-Meier method for survival function estimate − Unstratified Cox proportional hazard regression for HR estimate − Unstratified log-rank test for hypothesis testing, CA-125 response determined using the GCIG criteria defined in the protocol. CA-125 response per GCIG criteria will be determined programmatically, PFS2 defined as the time from date of randomization until second disease progression or death whichever occurs first. Results will be summarized by arm, TEAEs, laboratory test results, physical examination findings, and vital signs

Related papers

No related papers found yet.

Interventions

DRUGPred Forte 1% w/v

DRUGEye Drops Suspension

DRUGTopotecan AHCL 1 mg/ml concentrato per soluzione per infusione

DRUGTopotecan Accord 1 mg/ ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPaclitaxel 6 mg/mL concentrate for solution for infusion

DRUGTopotecan Accord 1 mg/ml koncentratas infuziniam tirpalui

DRUGTopotecan Hospira 4 mg/4 ml concentrate for solution for infusion

DRUGCaelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion

DRUGMirvetuximab Soravtansine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS, defined as the time from date of randomization until Investigator-assessed progressive disease (PD) or death, whichever occurs first. Results will be summarized by arm − Kaplan-Meier method for survival function estimate − Stratified Cox proportional hazard regression for hazard ratio (HR) estimate − Stratified log-rank test for hypothesis testing	—

Secondary

Measure	Time frame
Objective response includes best response of complete response (CR) or partial response (PR) as assessed by the Investigator − Stratified Cochran-Mantel-Haenszel (CMH) test for treatment comparison − Clopper-Pearson method for 95% CI estimation, OS defined as the time from date of randomization until the date of death. Patients alive at the time of analysis will be censored at the last known date known to be alive − Kaplan-Meier method for survival function estimate − Stratified Cox proportional hazard regression for HR estimate − Stratified log-rank test for hypothesis testing, Primary PRO assessment, defined as the number of patients achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of EORTC QLQ-OV28, DOR defined as the time from initial response until Investigator-assessed PD for all patients who achieve a confirmed objective response (PR or CR) − Kaplan-Meier method for survival function estimate − Unstratified Cox proportional hazard re	—

Measure

Time frame

Objective response includes best response of complete response (CR) or partial response (PR) as assessed by the Investigator − Stratified Cochran-Mantel-Haenszel (CMH) test for treatment comparison − Clopper-Pearson method for 95% CI estimation, OS defined as the time from date of randomization until the date of death. Patients alive at the time of analysis will be censored at the last known date known to be alive − Kaplan-Meier method for survival function estimate − Stratified Cox proportional hazard regression for HR estimate − Stratified log-rank test for hypothesis testing, Primary PRO assessment, defined as the number of patients achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of EORTC QLQ-OV28, DOR defined as the time from initial response until Investigator-assessed PD for all patients who achieve a confirmed objective response (PR or CR) − Kaplan-Meier method for survival function estimate − Unstratified Cox proportional hazard re

—

Countries

France

Outcome results

None listed