Actively Recruiting
A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care
Led by Peking University Third Hospital · Updated on 2021-05-03
75
Participants Needed
1
Research Sites
313 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
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
Official 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 the time written informed consent is obtained
- Newly diagnosed, histologically confirmed FIGO stage III or IV epithelial ovarian carcinoma (high-grade serous or high-grade endometrioid)
- After primary or interval debulking surgery; residual disease after surgery with optimal resection as R0 (no macroscopic residual disease) or R1 (macroscopic residual disease <1 cm)
- Known BRCA status; if unknown, BRCA testing results must be available before randomization
- Laboratory criteria: white blood cells >4000/mm3, neutrophil count >1500/mm3, hemoglobin ≥8 g/dL, platelet count ≥100,000/mm3, total bilirubin <2× upper limit of normal, serum 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 0-2
- Patients of child-bearing potential and their partners who are sexually active must agree to use two highly effective forms of contraception from signing informed consent until 6 months after last dose of first-line platinum-based chemotherapy or investigational medicinal product, whichever is later
- Signed informed consent and ability to understand the content
You will not qualify if you...
- Non-epithelial ovarian carcinoma or mixed epithelial histology
- Borderline tumors (tumors of low malignant potential)
- First-line platinum-based adjuvant chemotherapy already started after surgery
- Intention to treat with intraperitoneal chemotherapy
- Previous or concurrent radiotherapy to the abdomen and pelvis
- Major surgery other than debulking surgery within 3 weeks before informed consent or not recovered from effects of major surgery
- Other malignancy except those in complete remission for at least 3 years or treated carcinoma in situ of cervix or non-melanoma skin carcinomas
- Prior use of any immunotherapy
- Symptomatic uncontrolled brain or leptomeningeal metastases
- Serious co-morbidities including HIV, active hepatitis B or C, active infections, significant cardiovascular disease, severe chronic obstructive pulmonary disease, or other serious uncontrolled medical disorders
- Active autoimmune disease requiring treatment
- History of severe primary immune deficiencies
- History of severe allergic reactions following vaccination
- Psychiatric or social conditions preventing study participation
- Known allergy to investigational product components
- Systemic immunosuppressive therapy except short-term or low-dose steroids
- Participation in clinical trials with experimental therapy within 4 weeks before consent
- Pregnant or breastfeeding or planning pregnancy during study
- Refusal to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
Y
Yuan LI, Master
CONTACT
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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