Carboplatin + Mirvetuximab Soravtansine for Ovarian Cancer

Recruiting at 31 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Noninfectious lung disease, Ocular disorders, Other malignancy, others

Stay on Your Current Meds You can continue your current medications while participating

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: 18-27 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for advanced ovarian cancer, specifically targeting tumors with the protein folate receptor alpha (FRα). The trial aims to assess the safety and effectiveness of carboplatin and an investigational drug, mirvetuximab soravtansine (a type of targeted therapy), when used together before surgery. Participants will receive these drugs through an IV every three weeks. Suitable candidates have advanced-stage ovarian cancer with high FRα expression and have not undergone significant prior cancer treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that combining carboplatin and mirvetuximab soravtansine is generally safe for patients. In earlier studies, this treatment effectively targeted cancer and did not cause serious side effects for most individuals. Some patients experienced mild to moderate side effects, which were usually manageable. These results from previous studies provide insight into the treatment's safety. However, as this is a Phase 2 trial, the researchers are still testing to learn more about the treatment's safety and effectiveness. ^{1 2 3 4 5}

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

Researchers are excited about the combination of carboplatin and mirvetuximab soravtansine for treating ovarian cancer because of its unique approach. Unlike standard treatments that rely solely on chemotherapy, mirvetuximab soravtansine is an antibody-drug conjugate that targets and delivers a potent anti-tumor agent directly to cancer cells, minimizing damage to healthy cells. This targeted delivery could enhance the effectiveness of carboplatin while potentially reducing side effects, offering a promising new option for patients.

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

Studies have shown that using carboplatin with mirvetuximab soravtansine holds promise for treating certain types of ovarian cancer. Research indicates that these drugs work well together, especially when cancer cells have a specific protein called folate receptor alpha (FRα). In earlier trials, about 71% of patients with this type of cancer responded positively to the treatment. The combination demonstrated strong anti-tumor activity, effectively shrinking or controlling cancer growth. This evidence suggests that carboplatin and mirvetuximab soravtansine could be an effective option for those with FRα-positive ovarian cancer. Participants in this trial will receive this combination treatment to further evaluate its effectiveness. ^{1 4 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses a protein called folate receptor alpha (FRα). Participants must have measurable disease, be in good physical condition (ECOG 0-1), and be suitable candidates for neoadjuvant chemotherapy.

Inclusion Criteria

My doctor thinks I am a good candidate for chemotherapy before surgery.

My cancer can be measured by specific medical criteria.

I am fully active or can carry out light work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 cycles

18-27 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Mirvetuximab Soravtansine

Trial Overview The study tests the combination of Carboplatin and Mirvetuximab Soravtansine given through IV every three weeks for up to six to nine cycles. It aims to assess safety and effectiveness in killing cancer cells by targeting FRα. The trial will enroll around 140 participants over approximately three years.

How Is the Trial Designed?

Group I: Carboplatin + Mirvetuximab Soravtansine Experimental Treatment 3 Interventions

Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion.

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

GOG Foundation

Collaborator

Trials

48

Recruited

18,500+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0090825824000714

Phase 1b study of mirvetuximab soravtansine, a folate ... The efficacy outcomes observed with this mirvetuximab soravtansine plus carboplatin and bevacizumab triplet regimen are promising compared with those ...

2. clinicaltrials.gov clinicaltrials.gov/study/nct05456685

Study Details | nct05456685 | Mirvetuximab Soravtansine ... This Phase 2 study is designed to evaluate the efficacy and safety of MIRV in combination with carboplatin followed by MIRV continuation in FRα-positive ...

3. international-journal-of-gynecological-cancer.com international-journal-of-gynecological-cancer.com/article/S1048-891X(25)00793-5/fulltext

18/#499 Mirvetuximab soravtansine and carboplatin for ... MIRV and carbo demonstrated anti-tumor activity in patients with recurrent FRα-positive PSOC. MIRV 6 mg/kg AIBW and carbo AUC5 was selected as the phase 2 dose.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30093227/

Safety and activity findings from a phase 1b escalation ... These data demonstrate that mirvetuximab soravtansine combined with carboplatin is a well-tolerated and highly active regimen in recurrent, platinum-sensitive ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT375316

A randomized phase II trial of mirvetuximab soravtansine ... Preliminary data for the combination of MIRV with carboplatin exist from the Phase 1b FORWARD II trial, which resulted in an ORR of 71%, observed in 17 pts ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0090825818310813

Safety and activity findings from a phase 1b escalation ... These data demonstrate that mirvetuximab soravtansine combined with carboplatin is a well-tolerated and highly active regimen in recurrent, platinum-sensitive ...

7. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(24)00071-4/fulltext

Phase 1b study of mirvetuximab soravtansine, a folate ... Evaluate the antitumor activity and safety profile of the triplet combination of mirvetuximab soravtansine (MIRV), carboplatin, and bevacizumab ...

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

Results From the SORAYA Study - ASCO Publications MIRV demonstrated consistent clinically meaningful antitumor activity and favorable tolerability and safety in patients with FRα-high PROC who had received up ...