Induction of neoantigen specific cytotoxic T cells by autologous tumor lysate-loaded specialized crosspresenting dendritic cells in epithelial ovarian cancer patients treated with neoadjuvant chemotherapy, the NEODOC study

Induction of neo*antigen specific cytotoxic T cells by autologous tumor lysate-loaded specialized cross*presenting dendritic cells in epithelial ovarian cancer patients treated with neoadjuvant chemotherapy, the NEODOC study - NEOadjuvant Dendritic cell vaccination for Ovarian Cancer (NEODOC)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54480

Enrollment

Registered

2023-02-07

Start date

2023-03-17

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epithelial ovarian cancer high grade serous ovarian cancer ovarian cancer

Interventions

Patients are treated with standard (neo-)adjuvant chemotherapy and debulking surgery. On day 14 of every 21 days cycle of chemotherapy (6 cycles in total), autologous whole tumor lysate-loaded XP-DC

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age over 18 years old • Histologically confirmed primary epithelial ovarian cancer • Not amenable by primary debulking surgery and in need of neoadjuvant chemotherapy and interval debulking • High-grade serous histology • FIGO stage IIIb, IIIc, IVa or IVb if only lymph nodes

Exclusion criteria

Exclusion criteria: • Recurrent ovarian cancer • History of any second malignancy, with the exception of adequately treated basal cell carcinoma, cervical cancer > 5 years ago or early stage breast cancer >10 years ago. • Any serious clinical condition that may interfere with the safe administration of DC vaccinations or renders patient ineligible for combined carboplatin-paclitaxel chemotherapies • Active infection of Hepatitis B, C, HIV and syphilis or any other serious active infection • Known allergy to shell fish • Auto immune disease (exception: vitiligo is permitted) • Chronic treatment with systemic immunosuppressive drugs (i.e. more than 10 mg prednisolone equivalent)

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the immune response enhanced or induced by autologous tumor lysate-loaded XP-DC in epithelial ovarian cancer patients.	—

Secondary

Measure	Time frame
Secondary endpoints are - the safety and feasibility of tumor lysate-loaded XP-DC vaccinations. Safety will be evaluated by adverse events, WHO/ECOG performance status, physical examinations and laboratory tests. Toxicity will be assessed according to CTCAE version 4.3; - changes in the immunological landscape in tumor material and mutational status after chemotherapy combined with vaccination with DC vaccines; - clinical efficacy (number with pathological response to chemotherapy, number with complete interval debulking, progression free survival, overall survival;	—

Measure

Time frame

Secondary endpoints are - the safety and feasibility of tumor lysate-loaded XP-DC vaccinations. Safety will be evaluated by adverse events, WHO/ECOG performance status, physical examinations and laboratory tests. Toxicity will be assessed according to CTCAE version 4.3; - changes in the immunological landscape in tumor material and mutational status after chemotherapy combined with vaccination with DC vaccines; - clinical efficacy (number with pathological response to chemotherapy, number with complete interval debulking, progression free survival, overall survival;

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)

Induction of neo*antigen specific cytotoxic T cells by autologous tumor lysate-loaded specialized cross*presenting dendritic cells in epithelial ovarian cancer patients treated with neoadjuvant chemotherapy, the NEODOC study