New cocktail of drugs and vaccines takes on advanced ovarian cancer
NCT ID NCT07634094
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a new, intensive treatment plan for 28 people with advanced ovarian cancer. The approach combines chemotherapy given into the abdomen and vein, a special vaccine made from the patient's own immune cells, and the immunotherapy drug Keytruda. The goal is to see if this powerful mix can destroy more cancer before surgery and help keep the cancer away longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of chemotherapy drugs (paclitaxel and cisplatin), a chemokine modulatory regimen (rintatolimod and interferon-alpha), an autologous dendritic cell vaccine (αDC1), the immunotherapy drug pembrolizumab (Keytruda), and the anti-inflammatory drug celecoxib.
- What this could lead to
- If successful, this could lead to a more effective treatment approach for advanced ovarian cancer, potentially increasing the chance of eliminating all visible cancer before surgery and delaying cancer return.
- What could go wrong
- This is an early phase 2 trial with only 28 participants, so results may not apply to all patients. The combination of multiple strong treatments also raises the risk of serious side effects, and it is unknown if the added benefit will outweigh these risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must have advanced stage (III-IV) epithelial carcinoma or carcinosarcoma of ovarian, tubal or peritoneal origin. a. Histologic documentation of the original primary tumor is required via a pathology report. 2. Patients must be eligible for cancer-related definitive therapy with neoadjuvant chemotherapy. 3. Patients must be chemo-naive and receiving therapy in primary first-line neoadjuvant setting. 4. Patients must have ECOG performance of 0-1. 5. Patients must be reasonable candidate for interval debulking surgery as well as for IP platinum-based combination chemotherapy regimen, with no prior evidence of clinically significant intra-abdominal adhesions, persistent abdominal wall infections, renal disease or bowel obstruction. 6. At least one lesion must be considered to be large enough for biopsy and resection to yield greater than 2 grams of tumor for tumor loading of αDC1's and immunoassays at the discretion of the treating investigator and/or surgeon. 7. Patients must have measurable disease per iRECIST criteria. 8. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods. 9. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: a. Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. 10. Patients must be willing to undergo leukapheresis. 11. Patients must be willing to adhere to protocol requirements. 12. Patients must have adequate: 1. Bone marrow function: * 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: \- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) 3. Hepatic 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. Exclusion Criteria: 1. Patients with sarcoma. 2. Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis). 3. Patients with a known allergy to cisplatin or taxane chemotherapy. Patients with carboplatin allergy may be included if they tolerate a test dose of IV cisplatin given in monitored floor conditions. Patients who are allergic to paclitaxel can be alternatively treated with abraxane. 4. Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids. a. Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained. 5. Patients with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies. 6. Patients with uncontrolled diseases other than cancer will be excluded. 7. Patients who have contraindications to the use of NSAID's like chronic renal failure, coronary artery disease, or bleeding ulcers. 8. Patients who have contraindications to the use of interferon α-2b (Bioferon), including hypersensitivity to interferon-α or any component of the product, autoimmune hepatitis, and decompensated liver disease. 9. Patients with tumors of low malignant potential, except ovarian pseudomyxoma or with no peritoneal disease. 10. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. 11. Patients with previous pelvic radiation therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UMPC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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Other studies related to the condition(s) this trial covers.
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