Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cvac · 1 trial · 1 indication
Progression-free survival was defined as the time from randomization to the date of documented disease progression or death from any cause, whichever occurred earlier. Disease progression occurred when a patient met either the Gynecologic Cancer Intergroup (GCIG) cancer-antigen (CA)-125 definition or the Response Evaluation Criteria in Solid Tumors (RECIST) radiological definition of progressive disease. The GCIG CA-125 definition of disease progression was defined as a CA-125 level ≥ 2 × the upper limit of normal documented on 2 occasions at least 1 week apart. The radiological RECIST criteria of disease progression was defined as the appearance of new lesions or an overall increase ≥ 20% or at least 5 mm in existing tumors.
| Arm | Type | Description |
|---|---|---|
| Non-randomized Cvac | EXPERIMENTAL | Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained \~ 60 × 10\^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below. |
| Randomized Cvac | EXPERIMENTAL | Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained \~ 60 × 10\^6 dendritic cells. |
| Observational standard of care | NO_INTERVENTION | Participants in this group did not receive any treatment during the study. |
| Name | Type | Description |
|---|---|---|
| Cvac | BIOLOGICAL | Cvac consists of autologous dendritic cells (DCs) incubated with the antigen, mannosylated fusion protein (M-FP), to target the DCs to the specific mucin 1 antigen. |
Inclusion Criteria: * Female subjects ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer who have previously undergone surgical cytoreduction and received first or second line conventional chemotherapy and are currently in co...
Cvac is being studied for the treatment of epithelial ovarian cancer. It was evaluated in patients in remission, a setting where the goal is to help the immune system recognize and act against residual disease. It is an investigational therapy and is not an approved treatment for ovarian cancer.
Cvac is being developed by Immutep Limited, an Australian immunotherapy company that trades under the ticker IMMP. Immutep's pipeline is focused on oncology and autoimmune disease, and Cvac is one of its ovarian cancer programs.
Cvac has been studied in a Phase 2 clinical trial in epithelial ovarian cancer. That trial has completed, and no trials of Cvac are currently listed as active. Cvac is an investigational agent and has not been approved by the FDA for any indication.
Cvac was evaluated in a single Phase 2 study, NCT01068509, titled Ovarian Cancer Vaccine for Patients in Remission. The trial enrolled 63 female patients aged 18 years and older with epithelial ovarian cancer across sites in the United States and Australia. It was randomized and used a no-treatment control, and it has completed.
Cvac is a monoclonal antibody-based therapy designed to stimulate an immune response against ovarian cancer cells. It was tested in patients whose disease was in remission, with the aim of targeting residual cancer cells. The specific molecular target of Cvac has not been publicly disclosed.