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Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy

NCT04163094 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-06-29

No results posted yet for this study

Summary

This is a first-in-human, open label phase I study in ovarian cancer patients with primary disease eligible for standard-of-care treatment with neo-adjuvant chemotherapy, i.e. 3 cycles carboplatin/paclitaxel, interval surgery and 3 additional cycles carboplatin/paclitaxel. Eight doses of the W\_ova1 vaccine will be administered prior and in combination with the (neo-)adjuvant chemotherapy to induce an anti-tumor immune response. Systemic immune responses are determined using peripheral blood mononuclear cells collected before, during and after vaccinations. Intratumoral accumulation of T-cells recognizing vaccine-encoded TAAs will be determined before vaccination in a tumor biopsy and after the 3 cycles of chemotherapy and the 5th vaccination using tumor tissue derived from interval surgery. \[18F\]FB-IL2 PET-CT will be used for the non-invasive assessment of T-cell activation and correlated to immunohistochemistry tumor tissue data from pre-treatment biopsy and interval debulking surgery

Conditions

Interventions

DRUG

W_ova1 Vaccine

Patients will be treated with a W\_ova1 vaccine that includes 3 OC TAA RNA-LPX products.

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • H. W. Nijman, MD/PhD · University Medical Center Groningen, UMCG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2023-06-26
Completion
2023-06-26

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163094 on ClinicalTrials.gov