Epithelial Ovarian CancerPhase 2CANVASNCT01521143
Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment
A Phase 2 study testing Cvac in people with Epithelial Ovarian Cancer, run by Prima BioMed Ltd at 8 sites in 2 countries.
Trial summary
As < 10% of the necessary patients required by the protocol were recruited and the data were not intended to support a labeling claim, it was determined that the abbreviated clinical study report (CSR) was the appropriate reporting format. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Cvac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 2012to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Females ≥ 18 years of age at screening with a confirmed diagnosis of Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- Undergone optimal debulking surgery, defined as ≤ 1 cm of residual tumor.
- Undergone standard platinum and taxane first-line chemotherapy.
- Signed an informed consent form (ICF).
- Completed study procedures within the study timelines.
- Mucin 1-positive tumor as determined by central immunohistopathology.
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- Adequate renal function in the opinion of the investigator based on serum creatinine and/or glomerular filtration rate.
- Adequate liver function, defined as serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) ≤ 2× ULN and serum bilirubin ≤ 1.5 × ULN, unless Gilbert's syndrome had been previously confirmed for the patient.
- Adequate bone marrow function, defined as white blood cells (WBCs) ≥ 3.0 K/µL, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, hemoglobin ≥ 9 g/dL, and platelets ≥ 100 × 109/L.
- Life expectancy of at least 12 months at the time of screening as judged by the investigator.
- Not pregnant, and if of childbearing potential, agreed to use a highly effective method of birth control (implanted, injectable, or oral combination hormonal method alone or in possible combinations, intrauterine device, vasectomized partner, or abstinence) prior to study entry, for the duration of the study, and for 3 months after the last dose of study agent. Male partners of a study patient must use a condom in addition to the acceptable method of contraception for the female partner, as specified above.
- Females ≥ 18 years of age at screening with a confirmed diagnosis of epithelial ovarian, fallopian tube, or peritoneal cancer.
- Underwent standard cytoreductive surgery and first-line chemotherapy containing platinum before first relapse and were in complete remission for at least 6 months prior to relapse.
- Relapsed once and then underwent standard platinum-based second-line chemotherapy (at least 3 cycles is required) with or without a second bulk-reducing surgery.
- Second remission defined as:
- No definitive evidence of disease (NED) on computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis;
- CA-125 ≤ upper limit of normal (ULN) or 90% reduction in CA-125 since start of second-line chemotherapy;
- Negative physical exam (ie, no clinical signs).
- Life expectancy ≥ 3 months in the opinion of the investigator.
- Signed an informed consent form (ICF).
- Willing and able to complete study procedures within the expected study timelines.
- Mucin 1-positive tumor as determined by central immunohistopathology.
- Histologically documented EOC, fallopian tube, or peritoneal cancer (patients with pseudomyxoma, mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, patients with low malignant potential tumors, and with clear cell or mucinous histology are excluded).
- Adequate end-organ and hematological function as defined by:
- Adequate bone marrow function: white blood cells (WBCs) ≥ 3.0 K/µL, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, hemoglobin ≥ 9 g/dL, and platelets ≥ 100 × 109/L.
- Adequate renal function, defined as serum creatinine ≤ 1.5 × ULN.
- Adequate liver function, defined as serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) ≤ 2 × ULN and serum bilirubin ≤ 1.5 × ULN.
- Generally well-controlled blood pressure with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg prior to randomization (antihypertensive medications are permitted). Low-dose chronic hormonal or steroidal treatments are also permitted.
- Not pregnant, and if of childbearing potential, agrees to use a highly effective method of birth control (implanted, injectable, or oral combination hormonal method alone or in possible combinations, intrauterine device, vasectomized partner, or abstinence) prior to study entry, for the duration of the study, and for 3 months after the last dose of study agent. Male partners of a study patient must use a condom in addition to the acceptable method of contraception for the female partner, as specified above.
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 (applicable at the baseline visit only).
Who cannot join
- Non-epithelial ovarian cancer, including ovarian germ cell, sarcoma, mixed Müllerian tumors, or mucinous carcinoma of the peritoneum.
- Malignancy other than epithelial ovarian cancer, except those that had been in complete response for a minimum of 3 years, and except carcinoma in-situ of the cervix or basal cell and squamous cell carcinomas of the skin that had been adequately treated.
- Treatment with any investigational product (for any condition) within 4 weeks of screening.
- Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose.
- Evidence of severe or uncontrolled cardiac disease, including myocardial infarction or unstable angina within 6 months of screening, congestive heart failure, or ventricular arrhythmias requiring medication.
- Clinically significant abnormalities as measured by electrocardiogram (ECG).
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- Active uncontrolled infection.
- Uncontrolled hypertension.
- Diagnosed immunodeficiency or autoimmune disorder.
- Infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV), or active and infectious hepatitis B virus (HBV) infection.
- Pregnant or lactating.
- Evidence or history of central nervous system metastasis.
- Known hypersensitivity to any of the components of the study agent.
- Active or latent infection with Mycobacterium tuberculosis in any body tissue (especially renal and/or lung).
- Any other health condition that would preclude participation in the study in the judgment of the principal investigator.
- Part B: Second Remission
- More than 2 previous lines of chemotherapy for EOC, fallopian tube, or peritoneal cancer.
- Primary platinum-refractory or platinum-resistant disease (ie, patients who progress prior to cessation of induction therapy [platinum refractory] or recur within 6 months after cessation [platinum resistant]).
- Treatment with any investigational product (for any condition) within 4 weeks of screening. Enrolled in or has not completed at least 28 days of treatment (prior to screening) since ending another investigational device or drug treatment, or currently receiving other investigational treatments.
- Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose.
- Evidence of severe or uncontrolled cardiac disease, including myocardial infarction or unstable angina within 6 months of screening, congestive heart failure, or ventricular arrhythmias requiring medication.
- Diagnosed immunodeficiency or autoimmune disorder.
- Infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV), or active and infectious hepatitis B virus (HBV) infection.
- Pregnant or lactating.
- Evidence or history of central nervous system metastasis.
- Known hypersensitivity to any of the components of the study agent.
- Any unresolved persistent toxicities from prior systemic therapy that are either Grade 3 or Grade 4 (except alopecia) per the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Intent to treat patient with both an anti-angiogenesis therapy (such as bevacizumab) and a poly (ADP-ribose) polymerase (PARP) inhibitor as part of maintenance therapy. Only one or the other are permitted while the patient is on study and must be started between the Baseline visit and Visit 1 (first treatment visit) if it will be used as part of the patient's maintenance therapy regimen.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
University Gynecologic Oncology
Atlanta, Georgia, 30342
Collaborative Research Group
Boynton Beach, Florida, 33435
LAC-USC Medical Center
Los Angeles, California, 90033
Women's Cancer Center
Morristown, New Jersey, 07962
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Australia2 sites
Greenslopes Private Hospital
Greenslopes
Royal Brisbane and Women's Hospital
Herston
About this study
Official title: A Randomized Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein [Mucin 1-glutathione S-transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients With Epithelial Ovarian Cancer (EOC) in Complete Remission Following First-line Chemotherapy (A) and Patients With EOC in Second Remission (B)
As < 10% of the necessary patients required by the protocol were recruited and the data were not intended to support a labeling claim, it was determined that the abbreviated clinical study report (CSR) was the appropriate reporting format. No efficacy analyses were performed as the trial was terminated early with incomplete enrollment of < 10%.
The purpose of this study is to determine if an investigational cell therapy called Cvac can help epithelial ovarian cancer (EOC) from returning when administered to patients who are in complete remission after surgical removal of their tumor followed by standard first-line (Part A) or second-line (Part B) chemotherapy. Following remission, patients will undergo leukapheresis for the manufacture of the study agent. After completion of chemotherapy and confirmation of remission, patients will enter the treatment phase of the study.
Read the detailed description
This study proposes a nontoxic immunotherapeutic approach to extend overall survival in patients in complete remission. Most patients with ovarian cancer achieve complete clinical remission after optimal debulking surgery and first-line platinum-based chemotherapy. However, most patients, despite high response rates to first-line treatment, will relapse and undergo subsequent chemotherapy. Generally, the progression-free interval between treatments becomes shorter with each relapse, and the patient eventually dies of the disease.
For production of Cvac, each patient's cells were enriched using cell separation techniques. The patient's cells were cultured for 5 days with granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-4 (IL-4) in AIM V® serum-free tissue culture medium (Thermo Fisher Scientific) to cultivate the growth of dendritic cells (DC). The culture was pulsed overnight with the antigen (mannosylated mucin 1 fusion protein [M-FP]) to arm the DCs to the specific mucin 1 antigen. After harvesting, the M-FP-pulsed DCs were formulated as a finished product (Cvac) in 1 mL aliquots, diluted in 5% human serum albumin (HSA) and 10% dimethyl sulfoxide (DMSO) at an approximate concentration of 60 × 10^6 viable DCs/mL. The vials were cryopreserved and stored in the vapor phase of liquid nitrogen at the manufacturing facility.
Different participants were enrolled in the 2 parts of the study.
Part A
To be eligible for participation, patients were diagnosed with stage III or IV epithelial ovarian cancer, underwent optimal debulking surgery (≤ 1 cm of residual disease), underwent platinum and taxane chemotherapy, with or without bevacizumab, and had a tumor that overexpressed mucin 1, as well as met all other study inclusion and exclusion criteria at screening.
Patients who met all study inclusion and exclusion criteria were randomized in a 1:1 double-blinded fashion to either the Cvac (active) group or the placebo (control) group. After randomization, patients underwent mononuclear cell (MNC) collection for production of the study agent and then began first-line chemotherapy. After completion of chemotherapy and confirmation of complete clinical and radiological remission (Baseline), patients were entered into the treatment phase of the study.
A total of 76 patients were recruited and randomized at centers in Europe, North America, and Australia.
Part B
To be eligible for participation, patients had first-line platinum-based chemotherapy with a complete response lasting for at least 6 months prior to relapse and achieved second remission following standard platinum-based second-line chemotherapy with or without a second bulk-reducing surgery, and had a tumor that over-expressed mucin 1, as well as met all other study inclusion and exclusion criteria.
Patients who met all study inclusion and exclusion criteria were randomized in a 1:1 fashion to either the Cvac (active) group or the observational standard of care (control) group. After randomization, only patients randomized to Cvac underwent MNC collection for production of the study agent. After confirmation of no evidence of disease at the Baseline visit, patients were entered into the treatment phase of the study.
A total of 15 patients were recruited and randomized at centers in Europe.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Cvac, Placebo
- Keywords
- EOC
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CvacBiological
Injections were done at 4 anatomical sites, 1 injection in each of the upper portions of both arms and both thighs.
PlaceboBiological
Injections were done at 4 anatomical sites, 1 injection in each of the upper portions of both arms and both thighs.
Placebo consisted of the Cvac formulation buffer (5% HSA, 10% DMSO) with 0.9% simethicone provided in 1 mL vials that had been cryopreserved and stored at the manufacturing facility.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Cvac | Experimental | Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL. Receives: Biological: Cvac |
| Part A - Placebo | Placebo comparator | Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Receives: Biological: Placebo |
| Part B - Cvac | Experimental | Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL. Receives: Biological: Cvac |
| Part B - Observational standard of care | No intervention | Participants in this group did not receive any treatment during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A - Overall Survival
Overall survival was defined as the number of days from Baseline to the date of death from any cause.
Measured: Baseline to the end of the study (up to 3 years, 2 months)
Secondary outcomes (5)
Part A - Time to Next Treatment
Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.
Measured: Baseline to the end of the study (up to 3 years, 2 months)
Part A - Progression-free Survival
Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.
Measured: Baseline to the end of the study (up to 3 years, 2 months)
Part B - Overall Survival
Overall survival was defined as the number of days from Baseline to the date of death from any cause.
Measured: Baseline to the end of the study (up to 3 years, 2 months)
Part B - Time to Next Treatment
Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.
Measured: Baseline to the end of the study (up to 3 years, 2 months)
Part B - Progression-free Survival
Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.
Measured: Baseline to the end of the study (up to 3 years, 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: The study was terminated due to company restructuring and changes in drug development priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prima BioMed Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521143
- Sponsor's protocol ID
- CAN-004
- Acronym
- CANVAS
- Status last verified
- Dec 2016
- First submitted
- 17 Jan 2012
- Last updated
- 14 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein [Mucin 1-glutathione S-transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients With Epithelial Ovarian Cancer (EOC) in Complete Remission Following First-line Chemotherapy (A) and Patients With EOC in Second Remission (B)
- ClinicalTrials.gov ID
- NCT01521143
- Acronym / sponsor ID
- CANVAS / CAN-004
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- EOC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to company restructuring and changes in drug development priorities.
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Prima BioMed LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Posted 14 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As < 10% of the necessary patients required by the protocol were recruited and the data were not intended to support a labeling claim, it was determined that the abbreviated clinical study report (CSR) was the appropriate reporting format. No efficacy analyses were performed as the trial was terminated early with incomplete enrollment of < 10%.
The purpose of this study is to determine if an investigational cell therapy called Cvac can help epithelial ovarian cancer (EOC) from returning when administered to patients who are in complete remission after surgical removal of their tumor followed by standard first-line (Part A) or second-line (Part B) chemotherapy. Following remission, patients will undergo leukapheresis for the manufacture of the study agent. After completion of chemotherapy and confirmation of remission, patients will enter the treatment phase of the study.
Detailed description
This study proposes a nontoxic immunotherapeutic approach to extend overall survival in patients in complete remission. Most patients with ovarian cancer achieve complete clinical remission after optimal debulking surgery and first-line platinum-based chemotherapy. However, most patients, despite high response rates to first-line treatment, will relapse and undergo subsequent chemotherapy. Generally, the progression-free interval between treatments becomes shorter with each relapse, and the patient eventually dies of the disease.
For production of Cvac, each patient's cells were enriched using cell separation techniques. The patient's cells were cultured for 5 days with granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-4 (IL-4) in AIM V® serum-free tissue culture medium (Thermo Fisher Scientific) to cultivate the growth of dendritic cells (DC). The culture was pulsed overnight with the antigen (mannosylated mucin 1 fusion protein [M-FP]) to arm the DCs to the specific mucin 1 antigen. After harvesting, the M-FP-pulsed DCs were formulated as a finished product (Cvac) in 1 mL aliquots, diluted in 5% human serum albumin (HSA) and 10% dimethyl sulfoxide (DMSO) at an approximate concentration of 60 × 10^6 viable DCs/mL. The vials were cryopreserved and stored in the vapor phase of liquid nitrogen at the manufacturing facility.
Different participants were enrolled in the 2 parts of the study.
Part A
To be eligible for participation, patients were diagnosed with stage III or IV epithelial ovarian cancer, underwent optimal debulking surgery (≤ 1 cm of residual disease), underwent platinum and taxane chemotherapy, with or without bevacizumab, and had a tumor that overexpressed mucin 1, as well as met all other study inclusion and exclusion criteria at screening.
Patients who met all study inclusion and exclusion criteria were randomized in a 1:1 double-blinded fashion to either the Cvac (active) group or the placebo (control) group. After randomization, patients underwent mononuclear cell (MNC) collection for production of the study agent and then began first-line chemotherapy. After completion of chemotherapy and confirmation of complete clinical and radiological remission (Baseline), patients were entered into the treatment phase of the study.
A total of 76 patients were recruited and randomized at centers in Europe, North America, and Australia.
Part B
To be eligible for participation, patients had first-line platinum-based chemotherapy with a complete response lasting for at least 6 months prior to relapse and achieved second remission following standard platinum-based second-line chemotherapy with or without a second bulk-reducing surgery, and had a tumor that over-expressed mucin 1, as well as met all other study inclusion and exclusion criteria.
Patients who met all study inclusion and exclusion criteria were randomized in a 1:1 fashion to either the Cvac (active) group or the observational standard of care (control) group. After randomization, only patients randomized to Cvac underwent MNC collection for production of the study agent. After confirmation of no evidence of disease at the Baseline visit, patients were entered into the treatment phase of the study.
A total of 15 patients were recruited and randomized at centers in Europe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A - Cvac | Experimental | Biological: CvacParticipants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL. |
| Part A - Placebo | Placebo comparator | Biological: PlaceboParticipants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. |
| Part B - Cvac | Experimental | Biological: CvacParticipants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL. |
| Part B - Observational standard of care | No intervention | –Participants in this group did not receive any treatment during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Females ≥ 18 years of age at screening with a confirmed diagnosis of Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- Undergone optimal debulking surgery, defined as ≤ 1 cm of residual tumor.
- Undergone standard platinum and taxane first-line chemotherapy.
- Signed an informed consent form (ICF).
- Completed study procedures within the study timelines.
Key exclusion criteria (28 listed)
- Non-epithelial ovarian cancer, including ovarian germ cell, sarcoma, mixed Müllerian tumors, or mucinous carcinoma of the peritoneum.
- Malignancy other than epithelial ovarian cancer, except those that had been in complete response for a minimum of 3 years, and except carcinoma in-situ of the cervix or basal cell and squamous cell carcinomas of the skin that had been adequately treated.
- Treatment with any investigational product (for any condition) within 4 weeks of screening.
- Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose.
- Evidence of severe or uncontrolled cardiac disease, including myocardial infarction or unstable angina within 6 months of screening, congestive heart failure, or ventricular arrhythmias requiring medication.
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 |
|---|---|---|
| CvacInjections were done at 4 anatomical sites, 1 injection in each of the upper portions of both arms and both thighs. | Biological | Part A - Cvac, Part B - Cvac |
| PlaceboInjections were done at 4 anatomical sites, 1 injection in each of the upper portions of both arms and both thighs. Placebo consisted of the Cvac formulation buffer (5% HSA, 10% DMSO) with 0.9% simethicone provided in 1 mL vials that had been cryopreserved and stored at the manufacturing facility. | Biological | Part A - Placebo |
Primary outcome
Part A - Overall Survival
Time frame: Baseline to the end of the study (up to 3 years, 2 months)
Overall survival was defined as the number of days from Baseline to the date of death from any cause.
5 secondary outcomes
Part A - Time to Next Treatment
Time frame: Baseline to the end of the study (up to 3 years, 2 months)
Part A - Progression-free Survival
Time frame: Baseline to the end of the study (up to 3 years, 2 months)
Part B - Overall Survival
Time frame: Baseline to the end of the study (up to 3 years, 2 months)
Part B - Time to Next Treatment
Time frame: Baseline to the end of the study (up to 3 years, 2 months)
Part B - Progression-free Survival
Time frame: Baseline to the end of the study (up to 3 years, 2 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cvac in people with Epithelial Ovarian Cancer, run by Prima BioMed Ltd at 8 sites in 2 countries.
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 30 inclusion and 28 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: stopped early, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia. 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?
Yes. Results are posted in the registry (first posted 14 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A - Overall Survival (time frame: Baseline to the end of the study (up to 3 years, 2 months)). 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 14 Dec 2016.