Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study of Maintenance DCVAC/OvCa After First-line Chemotherapy in Newly Diagnosed FIGO III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Led by Peking University Third Hospital · Updated on 2021-05-03
75
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
S
SOTIO a.s.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of maintenance DCVAC/OvCa therapy after first-line chemotherapy combined with standard care in women newly diagnosed with advanced (FIGO stage III or IV) ovarian, fallopian tube, or primary peritoneal carcinoma. This randomized, double-blind, placebo-controlled Phase 2 study aims to verify preliminary results for this approach in treating these cancers. The study compares two groups: one receiving DCVAC/OvCa, an active cellular immunotherapy made from a patient's own immune cells and tumor cells, and another receiving a placebo. Both treatments follow first-line chemotherapy and standard care. Participants are randomly assigned to either group and neither the participants nor researchers know who receives which treatment during the study. Participants will be monitored from randomization with follow-up for about two years to assess progression-free survival, measuring the time until disease progression or death. The study includes various assessments such as medical exams, laboratory tests, and safety monitoring. Participants must meet detailed eligibility criteria and will be followed closely to evaluate treatment effects and safety throughout the study period.
CONDITIONS
Brief Title
A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eighteen years of age or older at time of consent
- Newly diagnosed, histologically confirmed FIGO stage III or IV epithelial ovarian carcinoma (high-grade serous or high-grade endometrioid), fallopian tube carcinoma, or primary peritoneal carcinoma
- Completed primary or interval debulking surgery with residual disease classified as R0 (no macroscopic residual disease) or R1 (residual disease <1 cm)
- Known BRCA mutation status or willing to have BRCA testing before randomization
- Laboratory values within specified limits including white blood cells >4000/mm3, neutrophils >1500/mm3, hemoglobin ≥8 g/dL, platelet count ≥100,000/mm3, total bilirubin <2× upper limit of normal, liver enzymes and creatinine <2× upper limit of normal, blood urea nitrogen <2× upper limit of normal
- Adequate coagulation parameters: activated partial thromboplastin time ≤1.5× upper limit of normal, international normalized ratio ≤1.5
- ECOG performance status 0 to 2
- Use of two highly effective contraception methods if of child-bearing potential and sexually active, from consent until 6 months after last chemotherapy or investigational treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Non-epithelial ovarian carcinoma or mixed epithelial histology
- Borderline tumors of low malignant potential
- Started first-line platinum-based chemotherapy after surgery
- Planned intraperitoneal chemotherapy
- Prior or concurrent abdominal or pelvic radiotherapy
- Major surgery (other than debulking) within 3 weeks before consent or incomplete recovery from surgery
- Other malignancies except those in complete remission for at least 3 years or treated carcinoma in situ of cervix or non-melanoma skin cancers
- Previous immunotherapy treatment
- Symptomatic uncontrolled brain or leptomeningeal metastases
- Certain serious medical conditions including active infections, significant heart disease, severe lung disease, autoimmune diseases needing treatment, severe immune deficiencies, and allergies to study treatment components
- Use of systemic immunosuppressive therapy except limited steroids
- Participation in another experimental therapy trial within 4 weeks before consent
- Pregnant, breastfeeding, or planning pregnancy during study
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to approximately 2 years
Participants receive either the DCVAC/OvCa immunotherapy or placebo after first-line chemotherapy as maintenance treatment.
Regular visits as per treatment schedule
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
Y
Yuan LI, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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