NCT05243524

Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer

Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.) · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2, single arm, study to assess the efficacy and safety of maveropepimut-S (MVP-S) and low-dose cyclophosphamide (CPA) in subjects with recurrent, platinum resistant ovarian cancer.

Detailed description

A Simon two-stage statistical design to assess MVP-S in combination with low dose CPA in platinum-resistant epithelial ovarian cancer patients who have received no greater than 4 previous lines of anti-cancer therapy. MVP-S, previously called DPX-Survivac, was recently evaluated in a small Phase 2 single arm study of ovarian cancer patients known as DeCidE1 (NCT02785250).

Conditions

• Platinum-resistant Epithelial Ovarian Cancer

Interventions

Type	Name	Description
OTHER	Maveropepimut-S	SC injection on days 7, 28, then q8w
DRUG	Cyclophosphamide 50mg	PO BID, one week on, one week off

Timeline

• Start date: 2022-08-05
• Primary completion: 2023-07-24
• Completion: 2023-08-31
• First posted: 2022-02-17
• Last updated: 2023-09-13

Locations

6 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study