RecruitingPhase 2NCT04834544

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

A Randomized, Double-blind, Placebo-controlled, 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.


Sponsor

Peking University Third Hospital

Enrollment

75 participants

Start Date

Apr 19, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immune cell vaccine called DCVAC/OvCa — which trains the immune system to recognize and attack ovarian cancer cells — as a maintenance therapy after chemotherapy improves outcomes for women with advanced ovarian cancer. It is randomized, meaning participants are randomly assigned to receive the vaccine or not. **You may be eligible if...** - You are 18 years or older - You have been newly diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer (FIGO stage III or IV, high-grade type) - You have had surgery (either primary or interval) with minimal remaining disease - You have had or are about to complete first-line platinum-based chemotherapy - Your BRCA status is known or being tested **You may NOT be eligible if...** - Your cancer has progressed on first-line chemotherapy - You have poor blood counts or significant organ dysfunction - You have received prior cancer immunotherapy - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTDCVAC/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_PRODUCTPlacebo

Placebo


Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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NCT04834544


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