Mirvetuximab Soravtansine for Ovarian Cancer

Recruiting at 39 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Endometrioid, Clear cell, Stroke, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of Mirvetuximab Soravtansine, a new cancer treatment targeting specific protein markers on cancer cells, for individuals with advanced ovarian, primary peritoneal, or fallopian tube cancer that hasn't responded well to standard platinum-based treatments. Participants will receive the drug on different schedules to determine the most effective regimen. This trial may suit those whose cancer has returned after standard treatments and who have tumor markers called folate receptor alpha (FRα), which this drug targets. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a promising option for those seeking new therapies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

A previous study with 682 participants found that Mirvetuximab Soravtansine (MIRV) was well tolerated. Most side effects were mild and primarily affected the stomach and intestines. Another study confirmed its favorable safety profile in patients with advanced ovarian cancer, showing few treatment-related issues. Additionally, research on 46 patients showed that side effects were mostly minor, classified as Grade 1 or 2, the least severe. These findings suggest that MIRV is generally safe for treating ovarian cancer. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for ovarian cancer?

Most treatments for ovarian cancer, like chemotherapy or targeted therapies such as bevacizumab and PARP inhibitors, work by attacking rapidly dividing cells or inhibiting specific proteins involved in cancer growth. However, Mirvetuximab Soravtansine is different because it is an antibody-drug conjugate that specifically targets the folate receptor alpha, which is overexpressed in many ovarian cancer cells. This targeted approach allows for the delivery of a potent cytotoxic agent directly to the cancer cells, potentially reducing damage to healthy tissues. Researchers are excited about this treatment because it offers a more precise method of attacking cancer cells while potentially minimizing side effects compared to traditional chemotherapy.

What evidence suggests that Mirvetuximab Soravtansine might be an effective treatment for ovarian cancer?

Research has shown that Mirvetuximab Soravtansine (MIRV) could effectively treat ovarian cancer unresponsive to platinum-based chemotherapy. Studies indicate that MIRV outperforms standard chemotherapy for patients whose cancer cells exhibit high levels of the protein folate receptor alpha (FRα). For these patients, the treatment has resulted in an average survival time of 15 months, a significant outcome for this challenging cancer. In this trial, participants will receive MIRV in different treatment arms, including a standard dose, a lower dose, and varying doses for those with hepatic impairment. MIRV targets cancer cells specifically, delivering a potent drug directly to them, enhancing the effectiveness of killing cancer cells. It has also proven both effective and safe for patients who have undergone multiple treatments. These findings offer hope for those facing aggressive ovarian cancer that resists other treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for individuals with advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers that are resistant to platinum-based treatments. Participants must have a certain level of physical fitness (ECOG PS of 0 or 1), have had specific prior treatments and disease progression, and their tumors must express high levels of folate receptor alpha.

Inclusion Criteria

I am eligible for both groups in the study.

It has been 6 months since my last platinum-based treatment.

My cancer has worsened after my last treatment, as shown by scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mirvetuximab Soravtansine on different schedules depending on the cohort: either on day 1 every 21 days or on days 1 and 15 every 28 days

Up to 24 months

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mirvetuximab Soravtansine

Trial Overview The study tests Mirvetuximab Soravtansine (MIRV), an experimental drug targeting cancer cells with a protein called folate receptor alpha. There are two groups receiving MIRV on different schedules in the Randomized Phase 2 Cohort and another group for those with abnormal liver function to find the right starting dose.

How Is the Trial Designed?

Group I: Randomized Phase 2 Cohort: Arm B Experimental Treatment 1 Intervention

Participants will receive Mirvetuximab Soravtansine at a lower dose than the standard dose on Day 1 and Day 15 of a 28-day cycle .

Group II: Randomized Phase 2 Cohort: Arm A Experimental Treatment 1 Intervention

Participants will receive Mirvetuximab Soravtansine at the standard dose on Day 1 of a 21-day cycle.

Group III: Hepatic Impairment Cohort : Mirvetuximab Soravtansine Experimental Treatment 1 Intervention

Participants will receive Mirvetuximab Soravtansine on Day 1 of a 21-day cycle. Different doses will be given to groups of patients to identify a safe and effective dose.

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

Citations

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

Mirvetuximab Soravtansine in FRα-Positive, Platinum- ... Among participants with platinum-resistant, FRα-positive ovarian cancer, treatment with MIRV showed a significant benefit over chemotherapy with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38858103/

high platinum-resistant ovarian cancer: final overall survival ... Results: At data cut-off (December 22, 2022; n=105), final median overall survival was 15.0 months (95% CI, 11.5 to 18.7).

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. 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 ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)04948-2/fulltext

the single-arm phase II PICCOLO trial MIRV as ≥3L treatment in heavily pretreated recurrent FRα-positive PSOC demonstrated notable efficacy and tolerable safety, including among ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39461270/

Safety and tolerability of mirvetuximab soravtansine ... As demonstrated among 682 participants, the safety profile of MIRV is well tolerated and consists primarily of low-grade gastrointestinal, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0090825823000203

Safety and efficacy of mirvetuximab soravtansine, a folate ... Mirvetuximab soravtansine exhibits a differentiated and favorable safety profile in patients with advanced ovarian cancer [16] with low treatment-related ...

8. news.abbvie.com news.abbvie.com/2016-05-18-ImmunoGen-Reports-Efficacy-and-Safety-Data-from-a-46-Patient-Cohort-of-Mirvetuximab-Soravtansine-in-FR-Positive-Ovarian-Cancer

ImmunoGen Reports Efficacy and Safety Data from a 46 ... Mirvetuximab soravtansine was generally well tolerated, with most side effects Grade 1 or 2 (least severe grades). Of particular note, incidence ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2022/761310Orig1s000MultidisciplineR.pdf

761310Orig1s000 - accessdata.fda.gov of safety data from a larger cohort of ovarian cancer patients treated with the recommended dose for mirvetuximab was also conducted. The ...

10. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.01900

Results From the SORAYA Study - ASCO Publications The clinical experience to date in ovarian cancer with MIRV has shown encouraging antitumor activity and a tolerable safety profile, primarily ...