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Monoclonal Antibodies

Mirvetuximab + Bevacizumab for Ovarian Cancer

Phase 3
Recruiting
Research Sponsored by ImmunoGen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be ≥ 18 years of age
Patients' disease must have relapsed after 1 line of platinum-based chemotherapy and must be platinum-sensitive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Study Summary

This trialtests a new drug for advanced ovarian, peritoneal, or fallopian cancers with high FRα expression.

Who is the study for?
This trial is for adults over 18 with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that responded to first-line platinum chemotherapy and are now on or have completed a second round. They must be in stable condition post-treatment, not pregnant, and willing to use contraception. Excluded are those with more than one prior chemo line, certain health conditions like serious heart disease or active infections, previous adverse reactions to monoclonal antibodies, untreated brain metastases, or recent history of other cancers.Check my eligibility
What is being tested?
GLORIOSA is testing the effectiveness of mirvetuximab soravtansine combined with bevacizumab versus bevacizumab alone as maintenance therapy for patients whose cancer has high folate receptor-alpha expression and who've had a good response to initial treatments. It's an open-label study where everyone knows which treatment they're getting.See study design
What are the potential side effects?
Possible side effects include allergic reactions due to monoclonal antibodies present in both treatments; eye problems from bevacizumab; nerve damage leading to sensory issues; increased risk of infection; blood clots; gastrointestinal complications such as bowel obstruction; lung issues like pneumonitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer returned after one platinum-based treatment and responds to platinum.
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My cancer has responded or remained stable with second-line treatment.
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I agree to use effective birth control methods if I can have children.
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I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.
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I am suitable for, currently on, or have finished a specific cancer treatment involving platinum.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I've had 4 to 8 rounds of a specific chemotherapy for my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess Progression-free survival (PFS)
Secondary outcome measures
Assess Disease-free survival (DFS)
Assess Duration of response (DOR)
Assess Objective Response Rate (ORR)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
Mirvetuximab Soravtansine (MIRV) plus Bevacizumab
Group II: Arm 2Active Control1 Intervention
Bevacizumab monotherapy

Find a Location

Who is running the clinical trial?

ImmunoGen, Inc.Lead Sponsor
31 Previous Clinical Trials
3,576 Total Patients Enrolled
4 Trials studying Ovarian Cancer
595 Patients Enrolled for Ovarian Cancer
GOG FoundationNETWORK
40 Previous Clinical Trials
14,834 Total Patients Enrolled
6 Trials studying Ovarian Cancer
2,261 Patients Enrolled for Ovarian Cancer

Media Library

Mirvetuximab Soravtansine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05445778 — Phase 3
Ovarian Cancer Research Study Groups: Arm 1, Arm 2
Ovarian Cancer Clinical Trial 2023: Mirvetuximab Soravtansine Highlights & Side Effects. Trial Name: NCT05445778 — Phase 3
Mirvetuximab Soravtansine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05445778 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited for this clinical assessment?

"Indeed, the online clinicaltrials.gov registry reveals that this trial is presently accepting patients. It was first advertised on November 1st 2022 and has been recently updated on 11/9/2022. This research project needs 418 participants from a single site to be recruited."

Answered by AI

Is Arm 1 of the study proven to be innocuous for participants?

"Arm 1 is rated as a 3 on a scale of safety, due to the fact that data demonstrating efficacy has been collected and multiple rounds of evidence supporting its security have been procured."

Answered by AI

Is this research project currently enrolling participants?

"Data housed on clinicaltrials.gov affirms that this medical trial is actively enrolling volunteers. The study was initially advertised on November 1st 2022 and last modified nine days later."

Answered by AI

Who else is applying?

What site did they apply to?
University of Alberta - Cross Cancer Institute (CCI)
What portion of applicants met pre-screening criteria?
Met criteria
~279 spots leftby Mar 2027