NCT05887609

An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Ovary Cancer
• Peritoneal Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	Mirvetuximab Soravtansine-gynx	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).
DRUG	Olaparib	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.

Timeline

• Start date: 2023-10-03
• Primary completion: 2029-01-31
• Completion: 2031-01-31
• First posted: 2023-06-05
• Last updated: 2026-04-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study