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A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care

NCT04834544 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-05-03

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled,parallel-group preliminary verifying study about safety and efficacy of maintenance DCVAC/OvCa after first-line chemotherapy added to standard of care in patients with newly diagnosed FIGO III-IV ovarian, fallopian tube, or primary peritoneal carcinoma.

Conditions

Interventions

COMBINATION_PRODUCT

DCVAC/OvCa

An active cellular immunotherapy product containing autologous dendritic cells that are generated ex vivo from patient's monocytes and apoptotic tumor cells prepared from tumor cell lines

COMBINATION_PRODUCT

Placebo

Placebo

Sponsors & Collaborators

  • SOTIO a.s.

    collaborator INDUSTRY

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2024-10-20
Completion
2027-04-20

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT04834544 on ClinicalTrials.gov