Mirvetuximab Soravtansine + Carboplatin for Ovarian Cancer

Recruiting at 71 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

125 Participants Needed

Trial Summary

What is the purpose of this trial?

IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.

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.

What data supports the effectiveness of the drug Mirvetuximab Soravtansine combined with Carboplatin for ovarian cancer?

Mirvetuximab Soravtansine has shown promising results in treating ovarian cancer, particularly in patients with platinum-resistant disease, with a 32.4% response rate and a median response duration of 6.9 months. Additionally, when combined with another drug, bevacizumab, it demonstrated a 64% response rate, indicating its potential effectiveness in combination therapies. ^{1 2 3 4 5}

Is the combination of Mirvetuximab Soravtansine and Carboplatin safe for humans?

The combination of Mirvetuximab Soravtansine and Carboplatin has been studied for safety in ovarian cancer patients. Mirvetuximab Soravtansine can cause low-grade eye and stomach-related side effects, which are generally manageable. Corticosteroid eye drops have been used to help manage eye-related side effects. ^{1 2 3 6 7}

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

This drug combination is unique because Mirvetuximab Soravtansine is an antibody-drug conjugate that specifically targets the folate receptor alpha, which is often present in ovarian cancer cells, allowing for targeted delivery of the chemotherapy agent DM4. This targeted approach aims to improve effectiveness and reduce side effects compared to traditional chemotherapy. ^{1 2 3 6 8}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

1. 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]

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 in Platinum-Resistant Ovarian Cancer. [2023]

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

A review of mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer. [2019]

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

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

6. England 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. [2023]

7. United States 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. [2020]

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

Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study. [2023]