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

NCT05479045 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-16

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

BIOLOGICAL

NY-ESO-1 Peptide vaccine

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.

DRUG

Toripalimab-tpzi

240 milligrams (mg), intravenously, every 3 weeks starting with the second dose of NY-ESO-1 Peptide vaccine

Sponsors & Collaborators

  • Coherus Oncology, Inc.

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Samir N Khleif, MD · Georgetown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05479045 on ClinicalTrials.gov