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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function, measured by creatinine clearance, is good.
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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.
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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.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Determine Duration of Response
Determine Overall Response Rate
Determine Overall Survival
+1 moreTrial 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
Mirvetuximab Soravtansine
2017
Completed Phase 3
~250
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
ImmunoGen, Inc.Industry Sponsor
32 Previous Clinical Trials
3,778 Total Patients Enrolled
4 Trials studying Ovarian Cancer
960 Patients Enrolled for Ovarian Cancer
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,473 Total Patients Enrolled
1 Trials studying Ovarian Cancer
16,690 Patients Enrolled for Ovarian Cancer
Bradley Corr, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
178 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.My kidney function, measured by creatinine clearance, is good.I have untreated or symptomatic brain metastases.My cancer returned more than 6 months after my last platinum-based treatment.My blood, liver, and kidney functions are all within normal ranges.I am not taking strong or moderate CYP3A inhibitors.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I have ongoing eye conditions that need regular treatment or monitoring.I have had cancer other than my current diagnosis within the last 3 years.I have lasting side effects from cancer treatment, but not hair loss.I am not taking any strong or moderate drugs that affect liver enzymes.You have had a bad reaction to monoclonal antibodies before.I am a woman and I am 18 years old or older.I do not have any serious, uncontrolled health conditions or infections.I had surgery recently but have recovered from it.You need to have tissue samples from a previous medical procedure to confirm that you have a certain protein called FRalpha.My last chemotherapy used platinum-based drugs.I completed between 4 and 8 cycles of my last chemotherapy.I have had a bone marrow or double umbilical cord blood transplant.I have been treated with MIRV or drugs targeting FRα before.My last platinum-based treatment for cancer showed a positive response or no progression.My tumor shows high or medium levels of FRalpha.I have received hormonal therapy as a separate treatment, not as maintenance.Your kidney function, measured by a blood test, is within a certain range.Your platelet count is at least 100,000 per microliter.I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.My ovarian tumor is of a specific type (clear cell, mucinous, etc.).I have been tested for BRCA mutation and received PARP inhibitors if positive.My cancer has worsened after my last chemotherapy, but stable disease is okay.I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.I have a serious heart condition.I have advanced liver disease.I have not had a stroke in the last 6 months.I have been diagnosed with a non-infectious lung condition without infection.You need to take supplements that contain folate.I have a condition that affects how my body absorbs pills.Your blood albumin level is at least 2 grams per deciliter.I have had platinum-based chemotherapy before for my recurring cancer.I consider my pre/post-surgery treatments as one round of therapy.My maintenance therapy is counted as part of my previous cancer treatment.My treatment was changed due to side effects, not because my cancer got worse.You must have a certain level of a type of white blood cell called neutrophils in your blood.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.Your liver enzymes (AST and ALT) should not be too high unless you have cancer that has spread to your liver.Your bilirubin levels in the blood should be within a certain range, unless you have a specific condition called Gilbert syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Lead In
- Group 2: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are seniors being accepted as participants in this research?
"As this clinical trial's eligibility requirements stipulate, the lowest age of enrollment is 18 and the highest permissible age for patients to join in is 99."
Answered by AI
How potentially hazardous is Safety Lead In for participants?
"Our team has assigned a score of 2 to Safety Lead In, as the Phase 2 trial only provides evidence regarding safety and not efficacy."
Answered by AI
May I be considered for inclusion in this research endeavor?
"This clinical study is searching for 53 participants that meet the criteria of having ovarian cancer and being between 18-99 years old."
Answered by AI
Does this research project need additional participants?
"The information presented on clinicaltrials.gov reveals that this trial, which was first listed in December of 2023 is not actively recruiting patients anymore. Despite the lack of availability for this particular study, 685 other medical studies are still looking to enrol volunteers at present."
Answered by AI
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