Dendritic Cell Vaccination With Standard Postoperative Chemotherapy for the Treatment of Adult Ovarian Cancer

Study Overview
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Brief Summary
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Effective treatments are desperately needed for ovarian cancer patients. This phase I clinical trial assesses the safety of a novel personalized dendritic-cell vaccine administered to ovarian cancer patients. Secondary outcomes will be evaluated such as patient pharmacodynamics， progression-free survival and overall survival.

Detailed Description
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This is a single arm, non-randomized phase I study to evaluate the safety and feasibility of delivering a novel dendritic cell vaccine in 6 to 12 (n=6-12) adult patients diagnosed with ovarian cancer after undergoing surgical resection. The vaccine contains both tumor-associated antigen and patient specific neoantigens. Standard-of-care chemotherapy therapy will be followed as per routine,during which patients enrolled into this study will receive a personalized vaccine in addition to standard of care. Effective adjuvant therapies are urgently needed for these patients given that high rate of recurrence still occurs after standard of care with poor prognosis among ovarian cancer patients. The study is constructed in a 3+3 algorithm for two steps of dose escalation with rigorous and mandatory safety monitoring.

Official Title
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Dendritic Cell Vaccination for the Adult Ovarian Cancer

Conditions
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Recurrent Ovarian Cancer

Intervention / Treatment
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* Biological: dendritic cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old female patients； Histopathologically diagnosed recurrent stage III/IV epithelial ovarian cancer; Normal liver, heart as well as kidney functions and blood chemistry; Predicted survival for more than 6 months； Provision of signed and dated informed consent form. Exclusion Criteria: Allergic to human albumin, an excipient of the manufactured dendric cell vaccine； Predicted survival for less than 6 months； Diagnosed with brain metastasis and other diseases unsuitable for cell therapy including but not limited to Myelodysplastic Syndromes、Acute Myeloid Leukemia and Systemic Lupus Erythematosus; Diagnosed with viral diseases including but not limited to HIV, TP, HCV and HBV ； Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline; Other conditions deemed unsuitable for this study by the leading investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>This arm will evaluate the safety of administering a total dendritic cell dose of 5x106. A total of 3 to 6 patients will be enrolled. If this dose is associated with unacceptable side effects, as detailed in the study protocol, no further patients will be enrolled at this dose. | Biological: dendritic cell<br>* Biological: Dendritic Cell Immunotherapy Adult patients with histopathologically diagnosed Ovarian Cancer will be eligible for this novel, personalized dendritic cell vaccine during course of standard of care chemotherapy. If unacceptable side effects are observed at a total dose of 5x106, as detailed in the study protocol, then a cohort of 3-6 enrolled patients will receive a de-escalated total dendritic cell dose of 2.5x106. If no unacceptable side effects are identified at a total dose of 5x106, as detailed in the study protocol, then a cohort of 3-6 enrolled patients will receive an escalated total dendritic cell dose of 1X107.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Patients will be monitored for adverse events as dictated by CTCAE version 5. | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics | percentage of antigen-specific T cells in peripheral blood. | up to 1 week | 
| PFS | Progression-free survival | up to 18 months | 
| OS | Overall survival | up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoantigen, dendritic cell vaccine