← Back to Search

Mirvetuximab + Olaparib for Ovarian Cancer

Phase 2

Recruiting

Led By Bradley Corr, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test

Must not have

Patients with known untreated or symptomatic central nervous system (CNS) metastases

Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new therapy combo for ovarian cancer that could be effective & tolerable.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical reactions from monoclonal antibodies like MIRV such as allergic responses, infusion-related symptoms; Olaparib might cause nausea, fatigue, blood cell count changes among others. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

My cancer returned more than 6 months after my last platinum-based treatment.

Select...

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

Select...

I am a woman and I am 18 years old or older.

Select...

My last chemotherapy used platinum-based drugs.

Select...

I completed between 4 and 8 cycles of my last chemotherapy.

Select...

My last platinum-based treatment for cancer showed a positive response or no progression.

Select...

My tumor shows high or medium levels of FRalpha.

Select...

I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.

Select...

I have been tested for BRCA mutation and received PARP inhibitors if positive.

Select...

I have had platinum-based chemotherapy before for my recurring cancer.

Select...

My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have untreated or symptomatic brain metastases.

Select...

I am not taking strong or moderate CYP3A inhibitors.

Select...

I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

Select...

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

Select...

I have had cancer other than my current diagnosis within the last 3 years.

Select...

I have lasting side effects from cancer treatment, but not hair loss.

Select...

I am not taking any strong or moderate drugs that affect liver enzymes.

Select...

I have had a bone marrow or double umbilical cord blood transplant.

Select...

I have been treated with MIRV or drugs targeting FRα before.

Select...

I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.

Select...

I have a serious heart condition.

Select...

I have advanced liver disease.

Select...

I have been diagnosed with a non-infectious lung condition without infection.

Select...

I have a condition that affects how my body absorbs pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To measure progression free survival (PFS) with the use of MIRV combined with Olaparib in women with recurrent platinum sensitive ovarian, peritoneal, and fallopian tube cancer.

Secondary study objectives

Determine Duration of Response

Determine Overall Response Rate

Determine Overall Survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment2 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 InExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Mirvetuximab Soravtansine

2017

Completed Phase 3