Mirvetuximab + Bevacizumab for Ovarian Cancer

(GLORIOSA Trial)

Recruiting at 597 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

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

520 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, mirvetuximab soravtansine (Elahere) and bevacizumab (Avastin), as maintenance therapy for certain types of ovarian cancer. The researchers aim to determine if these drugs can safely and effectively aid women whose cancer recurred after initial platinum-based chemotherapy and who have high levels of folate receptor-alpha. Participants will receive either both drugs or bevacizumab alone to compare outcomes. Women with ovarian, primary peritoneal, or fallopian tube cancer who responded well to initial treatment might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of mirvetuximab soravtansine and bevacizumab is generally well-tolerated. Earlier studies found this combination safe for patients who had previously received extensive treatment for ovarian cancer. While some side effects occurred, most patients managed them effectively.

For mirvetuximab soravtansine alone, another study found it safe for individuals with high levels of folate receptor-alpha (FRα), common in certain ovarian cancers. This study also confirmed its safety when used independently.

Since this trial is in Phase 3, the treatment has already demonstrated some safety in earlier phases. Phase 3 trials focus on confirming safety and effectiveness in a larger group. Earlier research suggests the treatment is expected to be safe, but the current trial aims to provide more detailed safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Researchers are excited about Mirvetuximab Soravtansine for ovarian cancer because it offers a novel approach by combining a monoclonal antibody with a cancer-killing agent, specifically targeting cancer cells while sparing healthy ones. Unlike standard treatments like chemotherapy, Mirvetuximab Soravtansine is designed to hone in on folate receptor alpha, which is often overexpressed in ovarian cancer cells, potentially leading to more effective and less toxic treatment. Additionally, in combination with Bevacizumab, which targets blood vessel growth in tumors, this treatment could enhance effectiveness by attacking the cancer from multiple angles.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

This trial will compare the combination of mirvetuximab soravtansine and bevacizumab with bevacizumab monotherapy for treating ovarian cancer with high levels of the protein folate receptor-alpha (FRα). Research has shown that combining mirvetuximab soravtansine and bevacizumab is promising, as it can extend patient survival and slow cancer growth. Mirvetuximab soravtansine attaches to the FRα protein on cancer cells and delivers a potent drug to kill them. Patients with FRα-positive ovarian tumors who used mirvetuximab lived longer than those who did not. Bevacizumab aids by inhibiting blood vessel growth in tumors, enhancing treatment effectiveness. Together, these drugs offer a robust approach to managing certain types of ovarian cancer. ^{2 3 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 (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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39082675/

Maintenance with mirvetuximab soravtansine plus ... The main purpose of this trial is to determine if MIRV plus bevacizumab leads to better patient survival and decreases cancer growth and spread when compared ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2309169

Mirvetuximab Soravtansine in FRα-Positive, Platinum- ... Here, we report the results of a trial that investigated the efficacy and safety of single-agent MIRV as compared with the investigator's choice ...

3. onclive.com onclive.com/view/final-piccolo-data-underscore-mirvetuximab-soravtansine-s-efficacy-in-later-line-fr-platinum-sensitive-ovarian-cancer

Final PICCOLO Data Underscore Mirvetuximab ... Mirvetuximab soravtansine continues to show efficacy and safety in final analysis of the phase 2 PICCOLO study.

4. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/fda-elahere-platinum-resistant-ovarian-cancer

Mirvetuximab Soravtansine-Gynx Approved for Ovarian ... Results showed that people with FR-α-positive, platinum-resistant ovarian tumors who were treated with Elahere lived longer overall than people ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825825008893

Safety and efficacy of mirvetuximab soravtansine, a folate ... Patients with epithelial ovarian cancer (EOC) have poor outcomes; most tumors will relapse within several years and develop resistance to platinum-based therapy ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40700855/

Safety and efficacy of mirvetuximab soravtansine, a folate ... Conclusions: MIRV plus pembrolizumab demonstrated anti-cancer efficacy and a tolerable safety profile in heavily pretreated patients with PROC.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352578925000633

Early experience and assessment of real-world toxicities ... Mirvetuximab soravtansine (MIRV) recently emerged as a promising therapeutic option for patients with platinum resistant ovarian cancer (PROC).