Epithelial Ovarian CarcinomaPhase 2NCT04834544
A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care
A Phase 2 study testing DCVAC/OvCa in people with Epithelial Ovarian Carcinoma and Fallopian Tube Carcinoma, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
- What is being tested?
- DCVAC/OvCa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2021to 20 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 residual disease with a maximal diameter of <1 cm)
- 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× upper limit of normal (ULN) (benign hereditary hyperbilirubinemias, e.g., Gilbert's syndrome, are permitted) 5.6. Serum alanine aminotransferase, aspartate aminotransferase, and creatinine <2×ULN 5.7. Blood urea nitrogen <2×ULN
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- 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 dose of first-line Pt-based adjuvant chemotherapy or IMP, whichever occurs later:
- Condom with spermicide and one of the following:
- 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
Who cannot join
- 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
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- 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 treatment for this and evidence of clinically stable disease for 28 days.
- 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 cardiovascular disease including: 10.4.1. Symptomatic congestive heart failure 10.4.2. Unstable angina pectoris 10.4.3. Severe cardiac arrhythmia requiring medication 10.4.4. Uncontrolled hypertension 10.4.5. Myocardial infarction or ventricular arrhythmia or stroke within a 6-month period before inclusion, ejection fraction <40% or serious cardiac conduction system disorders, if a pacemaker is not present 10.5. Pericardial effusion of any CTCAE grade 10.6. Severe chronic obstructive pulmonary disease defined as grade C and D according to Global Initiative for Obstructive Lung Disease 10.7. Patients considered a poor medical risk due to other serious, uncontrolled medical disorders, non-malignant systemic diseases or active, uncontrolled infections 10.8. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study treatment, or is not in the best interest of the patient to participate 10.9. Active autoimmune disease requiring treatment 10.10. History of severe forms of primary immune deficiencies 10.11. History of anaphylaxis or other severe reactions following vaccination 10.12. Psychiatric or social conditions which, in the investigator's opinion, would prevent participation in the study
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yuan LI, +86 18610689868, yuanli@bjmu.edu.cn
About this study
Official title: 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.
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.
- Being tested
- DCVAC/OvCa, Placebo
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCVAC/OvCaCombination product
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
PlaceboCombination product
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DCVAC/OvCa arm | Experimental | Not described Receives: Combination Product: DCVAC/OvCa |
| Placebo arm | Placebo comparator | Not described Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival
PFS defined as the time from randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression; progression will be assessed by the investigator per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Measured: From randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression, the follow up period is about 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start19 Apr 2021
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SOTIO a.s.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834544
- Sponsor's protocol ID
- IOV12
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04834544
- Acronym / sponsor ID
- IOV12
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- SOTIO a.s.
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCVAC/OvCa arm | Experimental | Combination Product: DCVAC/OvCa |
| Placebo arm | Placebo comparator | Combination Product: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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 residual disease with a maximal diameter of <1 cm)
- Known BRCA status; if BRCA mutation status not known, results of BRCA testing must be available before randomization
- Laboratory criteria:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCVAC/OvCaAn 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 | DCVAC/OvCa arm |
| PlaceboPlacebo | Combination product | Placebo arm |
Primary outcome
Progress Free Survival
Time frame: From randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression, the follow up period is about 2 years.
PFS defined as the time from randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression; progression will be assessed by the investigator per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DCVAC/OvCa in people with Epithelial Ovarian Carcinoma and Fallopian Tube Carcinoma, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan LI, Master (+86 18610689868, yuanli@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival (time frame: From randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression, the follow up period is about 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.