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NCT07634094

Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Kalinski, Pawel, MD, PhD
~28 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:PaclitaxelCisplatinBioferonRintatolimodαDC1 VaccinePembrolizumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Limiting Toxicities (DLT)
Measured over Up to 2 months
+1 more outcome measured

Conditions

Ovarian Cancer

Explore related trials

Malignant Ovarian Neoplasm

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Robert Edwards, MD · PRINCIPAL_INVESTIGATOR · UPMC Magee Womens Hospital

Who to contact

Kelsey Mitch, RN, BSN
[email protected]
4126412357
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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) greater than or equal to 1,500/μL
Platelets greater than or equal to 100,000/μL
Hemoglobin greater than or equal to 8.0 g/dL 2. Renal function:
Bilirubin less than or equal to 1.5 x ULN
SGOT and alkaline phosphatase less than or equal to 2.5 x ULN 13. Patients who have signed informed consent and authorization permitting release of personal health information. 14. Patients must be ≥ 18 years of age. 15. Patient must be able to swallow oral medication and have no absorption related medical concern as deemed by the investigator.

What this trial measures

  • Dose Limiting Toxicities (DLT)Up to 2 months

    Proportion of patients in the safety cohort (chemoimmunotherapy combined with the αDC1 vaccine) experiencing a dose-limiting toxicity (DLT). A DLT will be any adverse event that is at least possibly related to the study treatment and prevents surgery or delays surgery by more than 4 weeks, or that prevents the initiation of the next cycle of treatment on schedule due to toxicity in the prior cycle. The DLT period will be 2 cycles of treatment.

  • Complete Pathologic Response (pCR)Up to 5 years

    Percentage of patients who show no detectable cancer (cells) in tissue samples after neoadjuvant treatment as assessed at the time of the interval debulking procedure. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in SLD compared to baseline, confirmed on a follow-up scan.