Mirvetuximab + Olaparib for Ovarian Cancer

Recruiting at 4 trial locations

Overseen By Evamaria Kent Bravo, MS

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Must not be taking: CYP3A inhibitors, CYP3A inducers

Disqualifiers: Ocular disorders, Cardiac disease, 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: 4

Duration: 12 months

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of two drugs, Mirvetuximab and Olaparib, can help control ovarian cancer after initial treatment. The goal is to determine if these medicines can work together to manage platinum-sensitive ovarian cancer, which responds well to previous platinum-based treatments. Women who have responded well to platinum therapy but still have some cancer cells may be suitable for this study. Participants will receive Mirvetuximab (an antibody-drug conjugate) through an IV and Olaparib (a PARP inhibitor) as pills, continuing treatment as long as it remains effective and tolerated. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in ovarian cancer treatment.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for specific drugs. If you are taking strong or moderate CYP3A inhibitors, you need to stop them 2 weeks before starting the study treatment. If you are on strong or moderate CYP3A inducers, the washout period is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.

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

Research has shown that Mirvetuximab Soravtansine (MIRV) is generally safe for patients with ovarian cancer. The FDA has approved it for a type of ovarian cancer that does not respond to platinum-based treatments, indicating its safety in earlier studies.

Studies have demonstrated that MIRV remains effective even for patients who have undergone multiple treatments. Most people find its side effects manageable, and no major safety concerns have been reported.

Olaparib, the other treatment in this trial, is also used for ovarian cancer. It is generally well-tolerated, though some people might experience side effects like nausea or tiredness.

So far, combining MIRV and Olaparib appears to be a safe option. Early results from similar studies suggest that patients can handle this combination without serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for ovarian cancer involve chemotherapy and surgery, but this new combo of Mirvetuximab Soravtansine and Olaparib is different. Mirvetuximab Soravtansine is an antibody-drug conjugate that targets folate receptor alpha, which is often overexpressed in ovarian cancer cells, delivering a potent cancer-killing agent directly to the tumor. Olaparib is a PARP inhibitor that blocks cancer cells from repairing their DNA, making them more vulnerable to damage. Together, these treatments could offer a more targeted approach, potentially leading to better outcomes with fewer side effects, which is why researchers are excited about their potential.

What evidence suggests that the combination of Mirvetuximab and Olaparib could be an effective treatment for ovarian cancer?

In this trial, all participants will receive a combination of mirvetuximab soravtansine (MIRV) and Olaparib. Previous studies have shown that MIRV produces promising results for ovarian cancer patients with high levels of a protein called folate receptor alpha, helping them live longer. One study found that MIRV worked well even for patients who had already received many treatments, demonstrating both success and safety. Olaparib, another well-researched drug, is known to help treat ovarian cancer, especially in patients with certain genetic traits. The combination of MIRV and Olaparib is expected to be effective because each drug attacks cancer cells differently, potentially leading to better results than using either drug alone. Together, they might offer a strong ongoing treatment for recurrent ovarian cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Bradley R. Corr

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for women over 18 with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer that responded to platinum therapy. They must have completed 4-8 cycles of chemotherapy and not be pregnant or breastfeeding. Participants need normal organ function and can't join if they've had certain severe reactions to previous treatments, are taking drugs that interact poorly with the study medication, or have specific health conditions.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

Provision to sign and date the consent form

My kidney function, measured by creatinine clearance, is good.

Exclusion Criteria

Women who are pregnant or breastfeeding, and who do not agree to use a highly effective contraceptive method(s) while on study drug and for at least 3 months after the last dose of MIRV

I have untreated or symptomatic brain metastases.

I am not taking strong or moderate CYP3A inhibitors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead In

Initial phase to assess safety of the treatment combination

3 weeks

1 visit (in-person)

Treatment

Participants receive MIRV and Olaparib until progression, unacceptable toxicity, withdrawal, or death

12 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Mirvetuximab Soravtansine
• Olaparib

Trial Overview

The trial tests a combination of Mirvetuximab Soravtansine (MIRV) and Olaparib as maintenance therapy in patients with recurrent ovarian cancer who previously responded well to platinum-based chemotherapy. The hypothesis suggests this combo could be effective and tolerable for keeping the cancer at bay after initial treatment success.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 2 Interventions

All patients will receive MIRV at 5mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle (Q3W). All patients will receive Olaparib at 300mg taken orally twice daily with or without food. Dosage and administration will follow current single-agent Olaparib package insert dosage and administration guidelines. Patients will continue to receive MIRV and Olaparib until PD, unacceptable toxicity, withdrawal of consent, or death, whichever comes first. If toxicity deems the patient to discontinue one drug, the patient may continue the other drug until PD, unacceptable toxicity, withdrawal of consent, or death, whichever comes first.

Group II: Safety Lead In Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

AbbVie

Industry 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.

Industry Sponsor

Trials

33

Recruited

4,000+

Published Research Related to This Trial

The OPINION study is evaluating the safety and efficacy of olaparib as a maintenance therapy for women with high-grade serous or endometrioid platinum-sensitive relapsed ovarian cancer who do not have BRCA mutations, involving patients who have undergone at least two prior lines of platinum-based chemotherapy.

The primary goal of the study is to assess progression-free survival, which will help determine how effective olaparib is in delaying cancer progression in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olaparib maintenance monotherapy in platinum-sensitive, relapsed ovarian cancer without germline BRCA mutations: OPINION Phase IIIb study design. Poveda, AM., Davidson, R., Blakeley, C., et al.[2020]

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]

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]

Mirvetuximab soravtansine-gynx received accelerated FDA approval for treating FRα-positive, platinum-resistant ovarian cancer, showing an overall response rate of 31.7% in a study of 104 patients, with a median response duration of 6.9 months.

The treatment carries significant safety warnings, including risks of severe ocular toxicity, pneumonitis, and peripheral neuropathy, highlighting the importance of monitoring for these adverse effects during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer. Dilawari, A., Shah, M., Ison, G., et al.[2023]

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 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]

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]

Olaparib, a PARP inhibitor, showed a 36% objective response rate in women with relapsed ovarian cancer and a germline BRCA1/2 mutation, even after they had undergone multiple lines of chemotherapy, indicating its efficacy in this challenging patient population.

The median duration of response to olaparib was 7.4 months, and the safety profile was consistent across patients who had received three or more lines of prior chemotherapy, with similar rates of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Matulonis, UA., Penson, RT., Domchek, SM., et al.[2022]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12239798/

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What were the results? In the Phase III MIRASOL trial, MIRV improved overall survival for patients with ovarian cancer with high folate receptor alpha ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0923753424049482

The efficacy and safety of mirvetuximab soravtansine in ...

MIRV as ≥3L treatment in heavily pretreated recurrent FRα-positive PSOC demonstrated notable efficacy and tolerable safety, including among those with prior PD ...

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clinicaltrials.gov

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NCT05887609 | An Evaluation of Maintenance Therapy ...

The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive ...

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jhoonline.biomedcentral.com

jhoonline.biomedcentral.com/articles/10.1186/s13045-025-01686-2

Mirvetuximab soravtansine: current and future applications

In platinum-resistant ovarian cancer, the Phase I study (NCT01609556) demonstrated a 26.1% objective response rate and a median progression-free ...

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elaherehcp.com

elaherehcp.com/efficacy/confirmatory-study-data

ELAHERE® efficacy and success rate for FRα positive ovarian ...

Phase 3 MIRASOL trial: updated overall survival results of mirvetuximab soravtansine (MIRV) versus investigator's choice (IC) chemotherapy in patients (pts) ...

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news.abbvie.com

news.abbvie.com/2025-03-15-ELAHERE-R-mirvetuximab-soravtansine-gynx-Shows-Consistent-Survival-Benefit-in-Long-Term-Analysis-for-Certain-Ovarian-Cancer-Patients

ELAHERE® (mirvetuximab soravtansine-gynx) Shows ...

Final data analysis from Phase 3 MIRASOL trial after 30.5-month median follow-up demonstrated 32% reduction in risk of death with ELAHERE ...