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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
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 moreTrial 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
3,413 Total Patients Enrolled
4 Trials studying Ovarian Cancer
595 Patients Enrolled for Ovarian Cancer
GOG FoundationNETWORK
42 Previous Clinical Trials
16,323 Total Patients Enrolled
7 Trials studying Ovarian Cancer
2,861 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use effective birth control methods if I can have children.I have mild to severe numbness, tingling, or pain in my hands or feet.I cannot start treatment with a high dose of bevacizumab.I received a dose of bevacizumab after my last triplet therapy before being assigned to a treatment group.I have had severe blood clotting issues in the past.I have brain metastases that are either untreated or causing symptoms.I have a serious heart condition.My condition worsened while on or after platinum-based cancer treatment.I have a history of multiple sclerosis or similar conditions.My blood, liver, and kidney functions are all within normal ranges.I do not have any serious illnesses or active infections.I have a history of liver cirrhosis.I am not pregnant or breastfeeding.I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.I have recovered from side effects of previous cancer treatments.I am suitable for, currently on, or have finished a specific cancer treatment involving platinum.I am fully active or restricted in physically strenuous activity but can do light work.I have ongoing eye conditions needing treatment or a history of corneal issues.My cancer has responded or remained stable with second-line treatment.I am 18 years old or older.I have had issues with my bowels, like blockages or infections.I have been diagnosed with a type of lung disease not caused by infection.I have had a stroke in the last 6 months.My ovarian cancer is of a specific type, such as endometrioid or clear cell.My cancer returned after one platinum-based treatment and responds to platinum.I have had more than one chemotherapy treatment before my current or planned therapy.I've had extensive radiation therapy affecting a lot of my bone marrow.I have had BRCA testing done on my tumor or through a blood test.I have previously been treated with MIRV or drugs targeting FRα.I have had another type of cancer within the last 3 years.I've had 4 to 8 rounds of a specific chemotherapy for my cancer.I had my last major surgery more than 4 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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