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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
Females of childbearing potential must agree to use highly effective contraceptive method(s)
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
Patients with PD while on or following platinum-based triplet therapy
Patients with > Grade 1 peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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 agree to use effective birth control methods if I can have children.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has responded or remained stable with second-line treatment.
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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 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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I've had 4 to 8 rounds of a specific chemotherapy for my cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition worsened while on or after platinum-based cancer treatment.
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I have mild to severe numbness, tingling, or pain in my hands or feet.
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I cannot start treatment with a high dose of bevacizumab.
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I received a dose of bevacizumab after my last triplet therapy before being assigned to a treatment group.
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I have had severe blood clotting issues in the past.
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I have brain metastases that are either untreated or causing symptoms.
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I have a serious heart condition.
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I have a history of multiple sclerosis or similar conditions.
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I do not have any serious illnesses or active infections.
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I have a history of liver cirrhosis.
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I am not pregnant or breastfeeding.
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I have ongoing eye conditions needing treatment or a history of corneal issues.
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I have had issues with my bowels, like blockages or infections.
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I have been diagnosed with a type of lung disease not caused by infection.
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I have had a stroke in the last 6 months.
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My ovarian cancer is of a specific type, such as endometrioid or clear cell.
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I have had more than one chemotherapy treatment before my current or planned therapy.
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I've had extensive radiation therapy affecting a lot of my bone marrow.
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I have previously been treated with MIRV or drugs targeting FRα.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess Progression-free survival (PFS)
Secondary study objectives
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
32 Previous Clinical Trials
3,407 Total Patients Enrolled
GOG FoundationNETWORK
46 Previous Clinical Trials
17,232 Total Patients Enrolled

Media Library

Mirvetuximab Soravtansine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05445778 — Phase 3
Peritoneal Neoplasm Research Study Groups: Arm 1, Arm 2
Peritoneal Neoplasm 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
~226 spots leftby Mar 2027
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