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New treatment option for Epithelial Ovarian Carcinoma
Official title A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care
ClinicalTrials.gov ID: NCT04834544
What this study is testing
What is DCVAC/OvCa?
DCVAC/OvCa is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for epithelial ovarian carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Eighteen years of age or older at the time written informed consent is obtained
- Newly diagnosed, histologically confirmed FIGO stage III or IV EOC (high-grade serous or high-grade endometrioid)
- After primary debulking surgery or after interval debulking surgery; residual disease after surgery with optimal resection as R0 or R1 (R0 is defined...
- Known BRCA status; if BRCA mutation status not known, results of BRCA testing must be available before randomization
- Laboratory criteria: 5.1. White blood cells \>4000/mm3 (4.0×109/L) 5.2. Neutrophil count \>1500/mm3 (1.5×109/L) 5.3. Hemoglobin ≥8 g/dL (80 g/L) 5.4...
You likely can't join if
- Non-epithelial ovarian carcinoma or mixed epithelial histology
- Borderline tumors (tumors of low malignant potential)
- First-line Pt-based adjuvant chemotherapy already started after surgery
- Intention to treat with intraperitoneal chemotherapy
- Previous or concurrent radiotherapy to the abdomen and pelvis
- Major surgery (with the exception of debulking surgery) within 3 weeks before informed consent signature or patient has not recovered from any...
See the full eligibility criteria
- Eighteen years of age or older at the time written informed consent is obtained
- Newly diagnosed, histologically confirmed FIGO stage III or IV EOC (high-grade serous or high-grade endometrioid)
- After primary debulking surgery or after interval debulking surgery; residual disease after surgery with optimal resection as R0 or R1 (R0 is defined as no macroscopic residual disease, R1 is defined as macroscopic...
- Known BRCA status; if BRCA mutation status not known, results of BRCA testing must be available before randomization
- Laboratory criteria: 5.1. White blood cells \>4000/mm3 (4.0×109/L) 5.2. Neutrophil count \>1500/mm3 (1.5×109/L) 5.3. Hemoglobin ≥8 g/dL (80 g/L) 5.4. Platelet count ≥100,000/mm3 (100×109/L) 5.5. Total bilirubin \<2×...
- Adequate coagulation parameters: 6.1. Activated partial thromboplastin time ≤1.5×ULN 6.2. 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 the use of 2 highly effective forms of contraception from the patient's signing of the ICF until 6 months after the last/final...
- Oral contraceptive or hormonal therapy (e.g., hormone implants)
- Placement of an intra-uterine device (IUD) Acceptable non-hormonal birth control methods include:
- Total sexual abstinence from the patient's signing of the ICF until 6 months after the last/final dose of first-line Pt-based adjuvant chemotherapy or IMP, whichever occurs later
- Vasectomized sexual partner plus male condom with spermicide and participant assurance that partner received post-vasectomy confirmation of azoospermia
- Tubal occlusion plus male condom with spermicide
- IUD plus male condom with spermicide. Provided coils are copper-banded. Acceptable hormonal methods include:
- Etonogestrel implants (e.g., Implanon, Norplan) plus male condom with spermicide
- Normal and low dose combined oral pills plus male condom with spermicide
- Norelgestromin/ethinyl estradiol transdermal system plus male condom with spermicide
- Intravaginal device plus male condom with spermicide (e.g., ethinyl estradiol and etonogestrel)
- Cerazette (desogestrel) plus male condom with spermicide. Cerazette is currently the only highly efficacious progesterone-based pill.
- Signed informed consent and ability to comprehend its content
- Non-epithelial ovarian carcinoma or mixed epithelial histology
- Borderline tumors (tumors of low malignant potential)
- First-line Pt-based adjuvant chemotherapy already started after surgery
- Intention to treat with intraperitoneal chemotherapy
- Previous or concurrent radiotherapy to the abdomen and pelvis
- Major surgery (with the exception of debulking surgery) within 3 weeks before informed consent signature or patient has not recovered from any effects of any major surgery
- Malignancy other than EOC, except malignancy that has been in complete remission for a minimum of 3 years and except carcinoma in situ of the cervix or non-melanoma skin carcinomas that have been definitively treated
- Use of any immunotherapy in the past (e.g., anti-PD-1/PD-L1 or other immune checkpoint inhibitors, therapeutic vaccines, adoptive cell therapy, cytokines); in case of uncertainty, discuss with the medical monitor
- Symptomatic uncontrolled brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression may be considered if they have received definitive...
- Co-morbidities: 10.1. HIV positive 10.2. Active hepatitis B (HBV) and/or C (HCV), active syphilis 10.3. Evidence of active bacterial, viral, or fungal infection requiring systemic treatment 10.4. Clinically significant...
- Known hypersensitivity to any constituent of IMP
- Systemic immunosuppressive therapy for any reason (except inhaled / intranasal steroids and short-term systemic steroids \<30 days duration and ≤10 mg prednisone-equivalent per day are allowed)
- Participation in a clinical trial using experimental therapy within the last 4 weeks before informed consent signature
- Pregnant or breast feeding, or expecting to conceive children within the projected duration of the study treatment
- Refusal to sign informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.