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Trial · NCT04209855

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1Mirvetuximab Soravtansine5.5995% Confidence Interval 4.34 to 5.88months
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1Investigator's Choice (IC) Chemotherapy3.9895% Confidence Interval 2.86 to 4.47months
Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1Mirvetuximab Soravtansine41.995% Confidence Interval 35.4 to 48.6percentage of participants
Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1Investigator's Choice (IC) Chemotherapy15.995% Confidence Interval 11.4 to 21.4percentage of participants
Overall Survival Assessed by the Investigator Using RECIST v1.1Mirvetuximab Soravtansine16.8595% Confidence Interval 14.36 to 19.78months
Overall Survival Assessed by the Investigator Using RECIST v1.1Investigator's Choice (IC) Chemotherapy13.3495% Confidence Interval 11.37 to 15.15months
Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
Mirvetuximab Soravtansine34Participants
Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
Investigator's Choice (IC) Chemotherapy23Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)Mirvetuximab Soravtansine211Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)Investigator's Choice (IC) Chemotherapy194Participants
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1Mirvetuximab Soravtansine6.9395% Confidence Interval 5.78 to 8.84months
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1Investigator's Choice (IC) Chemotherapy4.4495% Confidence Interval 4.17 to 5.75months
Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) CriteriaMirvetuximab Soravtansine58.095% Confidence Interval 50.5 to 65.3percentage of participants
Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) CriteriaInvestigator's Choice (IC) Chemotherapy30.195% Confidence Interval 23.1 to 38.0percentage of participants
Time to Second Progression-Free Survival (PFS 2)Mirvetuximab Soravtansine11.0195% Confidence Interval 9.30 to 12.02months
Time to Second Progression-Free Survival (PFS 2)Investigator's Choice (IC) Chemotherapy7.5995% Confidence Interval 6.60 to 8.84months

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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