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

Recurrent Ovarian Cancer Clinical Trial

Official title:

Dendritic Cell Vaccination for the Adult Ovarian Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05270720
• Other study ID #: WCSUH2022001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2022
• Source: West China Second University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: March 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old female patients;

2. Histopathologically diagnosed recurrent stage III/IV epithelial ovarian cancer;

3. Normal liver, heart as well as kidney functions and blood chemistry;

4. Predicted survival for more than 6 months;

5. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. Allergic to human albumin, an excipient of the manufactured dendric cell vaccine;

2. Predicted survival for less than 6 months;

3. 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;

4. Diagnosed with viral diseases including but not limited to HIV, TP, HCV and HBV ;

5. Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline;

6. Other conditions deemed unsuitable for this study by the leading investigators.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Recurrent Ovarian Cancer

Intervention

Biological:
• dendritic cell
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.

Locations

Country	Name	City	State
China	west china second University, SICHUAN University, China	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Second University Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Beatriz M. Carreno, Vincent Magrini, Michelle Becker-Hapak, et al. A dendritic cell vaccine increases the breadth and diversity of melanoma neoantigen-specific T cells. Science. 2015, 348(6236):803-808.

Harari A, Graciotti M, Bassani-Sternberg M, Kandalaft LE. Antitumour dendritic cell vaccination in a priming and boosting approach. Nat Rev Drug Discov. 2020 Sep;19(9):635-652. doi: 10.1038/s41573-020-0074-8. Epub 2020 Aug 6. Review. — View Citation

Janos L. Tanyi, Sara Bobisse, Eran Ophir, et al. Personalized cancer vaccine effectively mobilizes antitumor T cell immunity in ovarian cancer. Transl. Med. 10, eaao5931 (2018)

Linda M Liau, Keyoumars Ashkan, David D Tran, et al. First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma. J Transl Med. 2018, 16(1):142-151.

Patrick A Ott, Siwen Hu-Lieskovan, Bartosz Chmielowski, et al. A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer. Cell. 2020, 183(2):347-362.

S ´ebastien Anguille, Ann L. Van de Velde, Evelien L. Smits, et al. Dendritic cell vaccination as postremission treatment to prevent or delay relapse in acute myeloid leukemia. BLOOD, 12 OCTOBER 2017 x VOLUME 130, NUMBER 15:1713-1721.

Zhang W, Lu X, Cui P, Piao C, Xiao M, Liu X, Wang Y, Wu X, Liu J, Yang L. Phase I/II clinical trial of a Wilms' tumor 1-targeted dendritic cell vaccination-based immunotherapy in patients with advanced cancer. Cancer Immunol Immunother. 2019 Jan;68(1):121 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events	Patients will be monitored for adverse events as dictated by CTCAE version 5.	up to 18 months
Secondary	Pharmacodynamics	percentage of antigen-specific T cells in peripheral blood.	up to 1 week
Secondary	PFS	Progression-free survival	up to 18 months
Secondary	OS	Overall survival	up to 18 months