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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
SC injection on days 7, 28, then q8w
PO BID, one week on, one week off
Stanford Health Care
Palo Alto, California, United States
Ocala Oncology
Ocala, Florida, United States
NYU Langone Hospital-Long Island
Mineola, New York, United States
NYU Langone: Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Objective Response Rate (ORR)
per RECIST v1.1 criteria
Time frame: up to 13 months
Objective Response Rate (ORR)
per iRECIST criteria
Time frame: up to 13 months
Duration of Response (DOR)
Time frame: up to 23 months
Disease Control Rate (DCR)
Time frame: up to 13 months
Time to Progression (TTP)
Time frame: up to 23 months
Progression Free Survival (PFS)
Time frame: up to 23 months
Progression Free Survival (6m PFS)
Time frame: at 6 months
Overall Survival (OS)
Time frame: up to 23 months
CA-125 Response
monthly measurements
Time frame: up to 13 months
Frequency of adverse events
graded using NCI CTCAE v5.0
Time frame: up to 13 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
PanOncology Trials
San Juan, Puerto Rico