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

• Conditions: epithelial ovarian cancer; high grade serous ovarian cancer; ovarian cancer; 10038594

• Registration Number: NL-OMON54480
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

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 <= 1cm above the
diaphragm or in the groins
• Extensive abdominal spread of tumor
• WHO/ECOG performance status 0-1

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the immune response enhanced or induced by<br /><br>autologous tumor lysate-loaded XP-DC in epithelial ovarian<br /><br>cancer patients.</p><br>

Secondary Outcome Measures

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