αDC1 Vaccine + Pembrolizumab for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial proposes to evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced stage ovarian cancer (III-IV) in the primary neoadjuvant setting. It was previously determined the tolerable dose of IPC-CKM. This study will add intradermal (ID) autologous αDC1 vaccines (known to be nontoxic) to the tolerable IPC-CKM regimen and systemic Keytruda (pembrolizumab). To optimize the pattern of immunity, all patients will also receive oral celecoxib (COX2 inhibitor).
Who Is on the Research Team?
Robert Edwards, MD
Principal Investigator
UPMC Magee Womens Hospital
Are You a Good Fit for This Trial?
This trial is for adults with advanced stage (III-IV) ovarian, fallopian tube, or peritoneal cancer who have not had chemotherapy before. Participants must be healthy enough for surgery and chemotherapy, have measurable disease, and agree to use effective birth control during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intensive locoregional chemoimmunotherapy, intradermal autologous αDC1 vaccines, and systemic pembrolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Bioferon (Interferon-alpha)
- Celecoxib
- Cisplatin
- Debulking Procedure
- Paclitaxel
- Pembrolizumab
- Rintatolimod
- αDC1 Vaccine
Trial Overview
The trial is testing a combination of treatments: chemo drugs (cisplatin, paclitaxel), immune therapies (αDC1 vaccine, pembrolizumab/Keytruda), rintatolimod, interferon-alpha, celecoxib, and surgery. All patients receive these in a set sequence to see if this approach helps fight advanced ovarian cancer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kalinski, Pawel, MD, PhD
Lead Sponsor
Northwest Biotherapeutics
Industry Sponsor
AIM ImmunoTech Inc.
Industry Sponsor
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