Mirvetuximab Soravtansine + Carboplatin for Ovarian Cancer

Not currently recruiting at 142 trial locations

Overseen By Hye Sook Chon

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: AbbVie

Must be taking: Platinum-based chemotherapy

Must not be taking: Folate supplements

Disqualifiers: More than one chemotherapy, 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: 9

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for ovarian cancer that has returned after initial treatment. Researchers aim to determine the effectiveness of mirvetuximab soravtansine when combined with carboplatin, a common chemotherapy drug, in cancers with specific characteristics. The trial targets individuals with ovarian cancer sensitive to platinum-based chemotherapy who have experienced a recurrence after one round of such treatment. Participants should have cancer that tests positive for a protein called folate receptor-alpha. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must have stabilized or recovered from all prior therapy-related side effects and have discontinued any maintenance therapy at least 4 weeks before starting the trial treatment.

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

Previous studies have shown that mirvetuximab soravtansine (MIRV) is safe. Among 682 participants, it was generally well-tolerated, with most side effects being mild, such as stomach issues and fatigue. Importantly, the FDA has approved MIRV for treating a specific type of ovarian cancer, indicating its safety for that condition.

Carboplatin, a common chemotherapy drug, is generally safe according to research. However, it can cause side effects like nausea and low blood counts, which are typical for chemotherapy treatments.

In summary, both MIRV and carboplatin have been well-studied and are considered safe for treating certain types of cancer. The trial combines these two drugs based on this safety evidence. ^{1 2 3 4 5}

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

Researchers are excited about Mirvetuximab Soravtansine combined with Carboplatin because it targets ovarian cancer cells in a novel way. Unlike traditional chemotherapy that attacks all rapidly dividing cells, Mirvetuximab Soravtansine is an antibody-drug conjugate, which means it specifically delivers a toxic payload to cancer cells with a particular marker, potentially reducing side effects. This targeted approach not only promises to enhance the effectiveness of treatment but also aims to improve the quality of life for patients by sparing healthy cells. Combining it with Carboplatin, a well-established chemotherapy drug, could offer a more powerful treatment option for those battling ovarian cancer.

What evidence suggests that mirvetuximab soravtansine plus carboplatin could be an effective treatment for ovarian cancer?

Research has shown that mirvetuximab soravtansine can help treat certain types of ovarian cancer. Studies have found it effective for patients whose cancer does not respond to platinum-based treatments, leading to better outcomes than standard chemotherapy. Specifically, some studies reported that patients treated with mirvetuximab lived about 15 months on average. In this trial, participants will receive a combination of mirvetuximab soravtansine and carboplatin. Carboplatin is a well-known treatment for ovarian cancer because it helps slow the disease's progress. Together, these treatments might offer a strong option for patients with specific types of recurring ovarian cancer. ^{2 6 7 8 9}

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 high-grade ovarian, primary peritoneal, or fallopian tube cancer that's sensitive to platinum-based chemo and has returned after one treatment round. Participants must have a certain level of tumor cell positivity for FRα, be in good physical condition (ECOG 0-1), and not pregnant. They can't join if they've had more than one chemo round, severe eye conditions, prior MIRV treatments, certain other cancers within the last three years or serious health issues.

Inclusion Criteria

Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method(s) while on study medication and for at least 3 months after the last dose of MIRV and 6 months after the last dose of carboplatin

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

I have had treatment with a PARPi due to my BRCA-positive status.

Exclusion Criteria

You need to take supplements that contain folate.

I have a serious heart condition.

I have ongoing eye problems that need regular treatment or monitoring.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive carboplatin plus mirvetuximab soravtansine for 6 cycles, followed by continuation with mirvetuximab soravtansine alone

18 weeks

6 visits (in-person, every 3 weeks)

Continuation

Participants continue with single-agent mirvetuximab soravtansine if they have stable disease, complete response, or partial response

Up to 3 years

Every 3 weeks (in-person)

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 carboplatin combined with mirvetuximab soravtansine followed by just mirvetuximab soravtansine in patients whose tumors express folate receptor-alpha (FRα) and are recurrent but respond to platinum drugs. It's an open-label phase 2 trial where all participants receive the experimental therapy.

How Is the Trial Designed?

Group I: MIRV + Carboplatin Experimental Treatment 2 Interventions

On Day 1 of every 3-week cycle (Q3W) for 6 cycles, MIRV will be given at the dosage of 6 mg/kg of AIBW along with carboplatin given at area under the AUC5 administered through intravenous (IV) infusion (maximum dosing per National Comprehensive Cancer Network \[NCCN\] guidelines \[NCCN 2021\]). Upon completion of carboplatin plus MIRV treatment, single-agent MIRV will be continued at the tolerated dose on Day 1 Q3W in participants with investigator determined stable disease (SD), complete response (CR) or partial response (PR).

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular 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+

Published Research Related to This Trial

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 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]

Mirvetuximab soravtansine, an antibody-drug conjugate targeting the folate receptor alpha, has shown promising clinical activity in treating platinum-resistant ovarian cancer, which is known for poor outcomes with standard chemotherapy.

This treatment combines a targeted approach with the cytotoxic effects of a chemotherapy agent, potentially offering a new strategy to overcome drug resistance in ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer. Gonzalez-Ochoa, E., Veneziani, AC., Oza, AM.[2023]

Mirvetuximab soravtansine, an antibody-drug conjugate for treating platinum-resistant ovarian cancer, can cause reversible low-grade ocular side effects, such as blurred vision and keratopathy, in about 40% of patients, but no severe ocular events were reported.

Using corticosteroid eye drops as a preventive measure during treatment led to fewer dose reductions and no discontinuations due to ocular adverse events, suggesting that this approach may help manage the ocular toxicity associated with mirvetuximab soravtansine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Prophylactic Corticosteroid Eye Drop Use in the Management of Corneal Abnormalities Induced by the Antibody-Drug Conjugate Mirvetuximab Soravtansine. Matulonis, UA., Birrer, MJ., O'Malley, DM., et al.[2020]

Mirvetuximab soravtansine is a promising antibody-drug conjugate that targets folate receptor-α, showing favorable tolerability and encouraging efficacy, particularly in patients with platinum-resistant ovarian cancer.

Ongoing Phase III and Phase Ib/II trials are currently assessing its effectiveness as a monotherapy and in combination treatments, which will clarify its potential role in treating advanced ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer. Moore, KN., Martin, LP., O'Malley, DM., et al.[2019]

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, a new treatment for folate receptor-α positive ovarian cancer, was studied in 543 patients, showing that it can be administered safely at a standard dose of 6 mg/kg without needing adjustments for most patients, including those with mild to moderate renal or hepatic impairment.

The pharmacokinetic model developed in this study indicates that factors like body weight, serum albumin, and age do not necessitate dose adjustments, ensuring consistent efficacy and safety across diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics of mirvetuximab soravtansine in patients with folate receptor-α positive ovarian cancer: The antibody-drug conjugate, payload and metabolite. Tu, YP., Hanze, E., Zhu, F., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37643542/

Phase III Trial of Carboplatin and Paclitaxel ... - PubMed The relative risk (RR) of progression for the carboplatin plus paclitaxel group was 0.88 (95% confidence interval [CI], 0.75 to 1.03) and the RR ...

2. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2778657

Efficacy and Safety of First-line Single-Agent Carboplatin ... In this randomized clinical trial of 120 vulnerable older patients with ovarian cancer, single-agent carboplatin was less feasible and active than a ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1505067

Weekly vs. Every-3-Week Paclitaxel and Carboplatin for ... In conclusion, our data suggest that weekly paclitaxel did not prolong progression-free survival, as compared with paclitaxel administered every ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/1951412

Efficacy and Safety of Paclitaxel and Carboplatin for ... Conclusion. Current evidence suggests that paclitaxel and carboplatin do not produce more satisfactory results with respect to overall survival ...

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(02)09738-6/fulltext

Paclitaxel plus carboplatin versus standard chemotherapy ... Single-agent carboplatin and CAP are as effective as paclitaxel plus carboplatin as first-line treatment for women requiring chemotherapy for ovarian cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8063137/

Efficacy and Safety of First-line Single-Agent Carboplatin ... At the data cutoff date, 76 patients (63%) had died, most (56 of 76 [74%]) from ovarian cancer. Median OS was not reached (95% CI, 21.0-32.2 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1048891X25009727

A multicenter retrospective study to assess feasibility ... The Elderly Women with Ovarian Cancer (EWOC)-1 trial demonstrated that 3-weekly carboplatin (3wC) resulted in worse survival and feasibility compared with ...

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)55138-9/fulltext

Efficacy and safety of the paclitaxel and carboplatin ... Response rates for platinum-refractory patients and those with early (≥3 and <12 months) and late (>12 months) relapses were 24%, 33% and 70%, respectively. The ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5516

Updated survival analysis from OVATION-2 trial. IMNN-001 demonstrated trends towards material improvement in overall survival and acceptable safety in advanced EOC, especially in HRD+ patients.