Mirvetuximab + Bevacizumab for Ovarian Cancer

(GLORIOSA Trial)

Recruiting at 317 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Platinum-based chemotherapy

Must not be taking: Folate supplements

Disqualifiers: Other cancers, Cardiac disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 years

418 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that patients must have stabilized or recovered from all prior therapy-related toxicities before starting the study treatment.

What data supports the effectiveness of the drug combination Mirvetuximab and Bevacizumab for ovarian cancer?

Research shows that the combination of Mirvetuximab and Bevacizumab has a 64% response rate and a median progression-free survival of 10.6 months in women with recurrent ovarian cancer with high folate receptor alpha expression. This suggests the drug combination may be effective for this specific group of patients. ^{1 2 3 4 5}

Is the combination of Mirvetuximab and Bevacizumab safe for treating ovarian cancer?

The combination of Mirvetuximab and Bevacizumab has been studied for safety in ovarian cancer patients. It may cause eye problems, lung inflammation, nerve damage, and risks to unborn babies. These side effects were noted in studies, so it's important to discuss them with your doctor. ^{1 2 5 6 7}

What makes the drug Mirvetuximab Soravtansine unique for treating ovarian cancer?

Mirvetuximab Soravtansine is unique because it is an antibody-drug conjugate (ADC) that specifically targets folate receptor alpha (FRα), which is often overexpressed in ovarian cancer cells. This drug, combined with bevacizumab, has shown promising results in patients with platinum-resistant ovarian cancer, achieving a high response rate and progression-free survival, even in those with high FRα expression. ^{1 2 3 5 6}

Research Team

Abbvie INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

I agree to use effective birth control methods if I can have children.

My blood, liver, and kidney functions are all within normal ranges.

FCBP must have a negative pregnancy test within 4 days before the first dose of therapy

Exclusion Criteria

I have mild to severe numbness, tingling, or pain in my hands or feet.

Clinically significant proteinuria

I cannot start treatment with a high dose of bevacizumab.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mirvetuximab Soravtansine in combination with Bevacizumab or Bevacizumab alone as maintenance therapy

Up to 4 years

Follow-up

Participants are monitored for safety, efficacy, and overall survival after treatment

Up to 7 years

Treatment Details

Interventions

• Bevacizumab
• Mirvetuximab Soravtansine

Trial Overview 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.

Participant Groups

Group I: Arm 1 Experimental Treatment 1 Intervention

Mirvetuximab Soravtansine (MIRV) plus Bevacizumab

Group II: Arm 2 Active Control 1 Intervention

Bevacizumab monotherapy

Mirvetuximab Soravtansine is already approved in United States for the following indications:

Approved in United States as Elahere for:

• Platinum-resistant epithelial ovarian cancer
• Fallopian tube cancer
• Primary peritoneal cancer

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

ImmunoGen, Inc.

Lead Sponsor

Trials

33

Recruited

4,000+

GOG Foundation

Collaborator

Trials

48

Recruited

18,500+

Findings from Research

The combination of mirvetuximab soravtansine and bevacizumab showed significant antitumor activity in patients with platinum-resistant ovarian cancer, achieving an objective response rate of 44% among 94 patients, with a median duration of response of 9.7 months.

The treatment was well-tolerated, with common side effects like blurred vision, diarrhea, and nausea being mostly mild, indicating a favorable safety profile for this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. Gilbert, L., Oaknin, A., Matulonis, UA., et al.[2023]

Mirvetuximab soravtansine is an antibody-drug conjugate that received FDA accelerated approval for treating recurrent platinum-resistant high-grade serous ovarian cancer (HGSOC), showing an overall response rate of 32.4% and a median duration of response of 6.9 months in the SORAYA trial.

The treatment has a favorable safety profile, with primarily low-grade ocular and gastrointestinal toxicities, making it a promising option for patients with high FRα expression in their tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirvetuximab soravtansine for platinum-resistant epithelial ovarian cancer. Porter, RL., Matulonis, UA.[2023]

In a study presented at the 2020 ASCO Virtual Scientific Program, the combination of mirvetuximab soravtansine and bevacizumab showed a remarkable overall response rate of 64% in patients with platinum-agnostic ovarian cancer.

This high response rate indicates that this treatment combination may be effective for ovarian cancer patients regardless of their previous response to platinum-based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirvetuximab Soravtansine Combination Yields Encouraging Response Rates in Ovarian Cancer. Fowler, M.[2021]

Mirvetuximab soravtansine (MIRV) demonstrated a 34.2% objective response rate and a progression-free survival of 5.82 months in 605 patients with advanced or recurrent ovarian cancer, indicating its efficacy as a second-line treatment.

The overall incidence of adverse events (AEs) was 87.4%, with 27.1% experiencing grade ≥3 AEs, primarily including vision blurring, nausea, and diarrhea, suggesting that while MIRV is effective, it does come with a notable risk of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and toxicity of mirvetuximab soravtansine, a novel antibody-drug conjugate, in the treatment of advanced or recurrent ovarian cancer: a meta-analysis. Xu, K., Wang, T., Pan, S., et al.[2023]

The combination of mirvetuximab soravtansine and bevacizumab shows promising efficacy in treating women with recurrent ovarian cancer that has high folate receptor alpha (FRα) expression, achieving a 64% objective response rate.

Patients treated with this combination therapy experienced a median progression-free survival of 10.6 months, indicating a significant benefit regardless of their platinum sensitivity status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Significant Activity" for ADC in Ovarian Cancer. [2022]

Mirvetuximab soravtansine-gynx (Elahere) has received accelerated approval for treating adult patients with folate receptor α-positive, platinum-resistant ovarian cancer after one to three prior treatments, indicating its efficacy in a challenging patient population.

The drug carries significant safety warnings, including risks of ocular toxicity, pneumonitis, peripheral neuropathy, and embryo-fetal toxicity, which are important considerations for patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Drug Treats Female Reproductive Cancers. Aschenbrenner, DS.[2023]

In a study involving 18 patients with recurrent ovarian cancer, the combination of mirvetuximab soravtansine and carboplatin showed a high objective response rate of 71%, indicating significant antitumor activity.

The treatment was generally well-tolerated, with most adverse events being mild, suggesting a favorable safety profile for this combination therapy in patients with platinum-sensitive ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. Moore, KN., O'Malley, DM., Vergote, I., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Mirvetuximab soravtansine for platinum-resistant epithelial ovarian cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Mirvetuximab Soravtansine Combination Yields Encouraging Response Rates in Ovarian Cancer. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The efficacy and toxicity of mirvetuximab soravtansine, a novel antibody-drug conjugate, in the treatment of advanced or recurrent ovarian cancer: a meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

"Significant Activity" for ADC in Ovarian Cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

New Drug Treats Female Reproductive Cancers. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. [2019]