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Mirvetuximab + Olaparib for Ovarian Cancer
Study Summary
This trial tests a new therapy combo for ovarian cancer that could be effective & tolerable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Safety Lead In
- Group 2: Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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