A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT05479045
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Ovarian Cancer Stage 3
  • Ovarian Cancer Stage III
  • Ovarian Cancer Stage IV

Eligibility Criteria

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

Interventions

  • NY-ESO-1 Peptide vaccine — BIOLOGICAL
    300 mcg of NY-ESO-1 peptide, 100 micrograms (mcg) granulocyte-macrophage colony-stimulating factor (GM-CSF) and 1 milliliter (mL) of Montanide ISA-51 adjuvant. The first two doses will be administered subcutaneously in a 2 week interval and thereafter, remaining three doses will be administered every 3 weeks.
  • Toripalimab-tpzi — DRUG
    240 milligrams (mg), intravenously, every 3 weeks starting with the second dose of NY-ESO-1 Peptide vaccine

Study Details

This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC).

Key Dates

Start date
Sep 30, 2026
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NY-ESO-1 Peptide vaccine plus Toripalimab-tpzi

Primary Outcome Measure

Median Progression Free Survival [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Alan Zwart
[email protected]
202-687-0344
Samir N Khleif, MD (PRINCIPAL_INVESTIGATOR)
John Theurer Cancer CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777

Find similar trials in Washington D.C., DC

By research site
MedStar Georgetown University Hospital· Washington D.C., DCJohn Theurer Cancer Center· Hackensack, NJ

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