TPIV200/huFR-1 (A Multi-Epitope Anti-Folate Receptor Vaccine) Plus Anti-PD-L1 MEDI4736 (Durvalumab) in Patients With Platinum Resistant Ovarian Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02764333
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase 2 clinical trial, which tests two investigational drugs: TPIV200/huFR-1 (also called TPIV200), which is a vaccine consisting of proteins from the folate receptor alpha mixed with GM-CSF, and durvalumab (MEDI4736) , which is an antibody drug that help un-block parts of the immune system. The aim of this study is to find out whether these drugs, when given together are safe, and whether they are effective in treating cancer.

Key Dates

Start date
May 6, 2016
Status verified
Jan 2021
Primary completion
Jan 20, 2021
Completion
Jan 20, 2021

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: vaccine
    Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center at Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering Cancer Center @ CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer Center at RockvilleRockville CentreNew York11570-

Find similar trials in Basking Ridge, NJ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Memorial Sloan Kettering Cancer Center at Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Cancer Center @ Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center at Rockville· Rockville Centre, NY

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