Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Hypersensitivity

Fallopian Tube Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endocrine Gland Neoplasms

Ovarian Diseases

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Fallopian Tube Cancer

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Antibodies

Antibodies, Monoclonal

Olaparib

Folic Acid

Immunoglobulins

Mirvetuximab soravtansine

Vitamin B Complex

Maytansine

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Immunoconjugates

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

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.

is an antibody-drug conjugate (ADC) that consists of a high affinity humanized monoclonal antibody against folate receptor α (FRα, the protein product of the folate receptor 1 \[FOLR1\] gene) that is conjugated to a cytotoxic maytansinoid by the hindered disulfide succinimidyl 4-(pyridine-2-yl)disulfanyl)-2-sulfo-butyrate linker (sulfo-SPDB).

Mirvetuximab Soravtansine

Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular functions, such as DNA transcription and DNA repair.

Samantha Hopp

Bradley Corr, MD

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

Single-arm, study design evaluating the maintenance therapy combination Mirvetuximab soravtansine and Olaparib in recurrent platinum-sensitive ovarian, peritoneal, and fallopian tube cancers. A six-patient safety lead in will occur, in which relevant the pharmaceutical company will be informed and included in safety evaluation process.

An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib

A Phase II Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib in Recurrent Platinum Sensitive Ovarian, Peritoneal, and Fallopian Tube Cancer

PFS will be defined as the time from first dose of MIRV and Olaparib until investigator-assessed radiologic PD or death, whichever occurs first

The team will use treatment-emergent adverse events (TEAEs) and laboratory test results, physical examination, or vital signs to determine AEs as described by CTCAE v5.0

Defined by confirmed best response of CR or PR as assessed by the investigator

Defined as the time from initial investigator-assessed response (CR or PR) until progressive disease (PD) as assessed by the investigator

Defined as the time from first dose of MIRV and Olaparib until death

ImmunoGen, Inc.

University of Colorado, Denver

Spots Global Cancer Trial Database for An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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