Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Carcinosarcoma

Mixed Tumor, Mullerian

Adenoma, Pleomorphic

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Sarcoma

Neoplasms, Connective and Soft Tissue

Adenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Malignant Mixed Mullerian Tumor

Uterine Carcinosarcoma

Adenocarcinoma of the Appendix

Soft Tissue Sarcoma

All Drugs and Chemicals

Antineoplastic Agents

Mirvetuximab soravtansine

Rucaparib

Maytansine

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Immunoconjugates

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

Participants receive mirvetuximab soravtansine IV on day 1 and rucaparib PO BID on days 1 through 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Mirvetuximab Soravtansine

Pharmacokinetic Study

Rucaparib Camsylate

Floor Backes, MD

This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and rucaparib camsylate in treating participants with endometrial, ovarian, fallopian tube or primary peritoneal cancer that has come back. Drugs such as mirvetuximab soravtansine are antibodies linked to a toxic substance and may help find certain tumor cells and kill them without harming normal cells. Rucaparib camsylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving mirvetuximab soravtansine and rucaparib camsylate may work better in treating participants with recurrent endometrial, ovarian, fallopian tube or primary peritoneal cancer.

PRIMARY OBJECTIVES:

I. To determine the recommended phase II dose (RPTD) of combination mirvetuximab soravtansine and rucaparib camsylate (rucaparib) in patients with recurrent endometrial, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

SECONDARY OBJECTIVES:

I. To determine the safety and tolerability of combination mirvetuximab soravtansine and rucaparib in study patients.

II. To explore the objective antitumor activity (complete and partial response) of combination mirvetuximab soravtansine and rucaparib as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in the study population.

III. To measure the progression free survival. IV. To evaluate the pharmacokinetics of mirvetuximab soravtansine and rucaparib in combination.

EXPLORATORY OBJECTIVES:

I. Explore additional biomarkers of response. II. Explore mutation characteristics and frequency with treatment response. III. Evaluate if companion diagnostics can be optimized by combining loss of heterozygosity (LOH) score and level of folate receptor a (FR-alpha) expression, and possible additional predictors of response.

IV. Explore mechanisms of secondary resistance to treatment.

OUTLINE: This is a dose escalation study.

Participants receive mirvetuximab soravtansine intravenously (IV) on day 1 and rucaparib orally (PO) twice daily (BID) on days 1 through 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 30 days and then every 3 months for up to a year.

Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Phase I Study of Mirvetuximab Soravtansine (IMGN853) and Rucaparib for Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Pharmacokinetics determined by analysis of collected blood samples

Will be evaluated descriptively using frequencies and percentages

Response rate determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer	NCT03552471	BRCA1 Gene Muta... BRCA2 Gene Muta... Folate Receptor... Recurrent Fallo... Recurrent Ovari... Recurrent Prima... Recurrent Uteri... Recurrent Uteri... Recurrent Uteri... Platinum Resist...	Laboratory Biom... Mirvetuximab So... Pharmacokinetic... Rucaparib Camsy...	18 Years -	Ohio State University Comprehensive Cancer Center
Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer	NCT03552471	BRCA1 Gene Muta... BRCA2 Gene Muta... Folate Receptor... Recurrent Fallo... Recurrent Ovari... Recurrent Prima... Recurrent Uteri... Recurrent Uteri... Recurrent Uteri... Platinum Resist...	Laboratory Biom... Mirvetuximab So... Pharmacokinetic... Rucaparib Camsy...	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for folate receptor alpha positive