Arm 1 for Malignant Peritoneal Neoplasm

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Malignant Peritoneal Neoplasm+5 More
Mirvetuximab soravtansine plus Bevacizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of Mirvetuximab Soravtansine in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.

Eligible Conditions
  • Malignant Peritoneal Neoplasm
  • Ovarian Cancer
  • Fallopian Tubes Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Malignant Peritoneal Neoplasm

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Up to 7 years

Up to 4 years
Assess Progression-free survival (PFS)
Up to 7 years
Assess DFS
Assess Duration of response (DOR)
Assess Objective Response Rate (ORR)
Assess Overall survival (OS)
Assess Safety and tolerability
Assess second disease progression (PFS2)
CA-125 response
Patient-reported outcomes using EQ-5D-5L questionnaires
Patient-reported outcomes using the NCCN-FACT Ovarian Symptom Index (NFOSI-18)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Malignant Peritoneal Neoplasm

Trial Design

2 Treatment Groups

Arm 2
1 of 2
Arm 1
1 of 2
Active Control
Experimental Treatment

418 Total Participants · 2 Treatment Groups

Primary Treatment: Arm 1 · No Placebo Group · Phase 3

Arm 1
Drug
Experimental Group · 1 Intervention: Mirvetuximab soravtansine plus Bevacizumab · Intervention Types: Drug
Arm 2
Drug
ActiveComparator Group · 1 Intervention: Bevacizumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 7 years

Who is running the clinical trial?

ImmunoGen, Inc.Lead Sponsor
29 Previous Clinical Trials
3,582 Total Patients Enrolled
3 Trials studying Malignant Peritoneal Neoplasm
634 Patients Enrolled for Malignant Peritoneal Neoplasm
GOG FoundationNETWORK
27 Previous Clinical Trials
11,328 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients with homologous recombination deficient-positive tumors who have received prior PARPi plus bevacizumab treatment are eligible.
You are appropriate for, currently on, or have completed platinum-based triplet therapy in second line (recurrent platinum-sensitive, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.