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MUC1 Dendritic Cell Vaccine

Phase 2

Epithelial Ovarian Cancer | Monoclonal antibody | Oncology |Immutep Limited|Last Updated: Dec 8, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

MUC1 Dendritic Cell Vaccine · 1 trial · 1 indication

Phase 2 1
NCT01617629Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 StudyEpithelial Ovarian Cancer
COMPLETED9 Analytics
PHASE2COMPLETED
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
Epithelial Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
First dose of study vaccine to 30 days past last dose (Approximately 1 Year)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cvac Treatment GroupEXPERIMENTALParticipants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.

Interventions

NameTypeDescription
MUC1 Dendritic Cell Vaccine (Cvac)BIOLOGICALThe recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac). Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Female patients ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in CAN-003 * Able and willing to undergo mononuclear cell (MNC) collection (if required for patients who do not have ...

Countries:United StatesAustralia
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Frequently asked questions about MUC1 Dendritic Cell Vaccine

What is MUC1 Dendritic Cell Vaccine used for in epithelial ovarian cancer?

MUC1 Dendritic Cell Vaccine is an investigational cancer vaccine being studied for the treatment of epithelial ovarian cancer. It is designed to target the MUC1 antigen, which is expressed on tumor cells. The vaccine is currently in Phase 2 clinical development and has been evaluated in a completed clinical trial.

Who is developing MUC1 Dendritic Cell Vaccine?

MUC1 Dendritic Cell Vaccine is being developed by Immutep Limited, a biopharmaceutical company. The company's stock is traded under the ticker symbol IMMP. The vaccine is currently in Phase 2 clinical development for the treatment of epithelial ovarian cancer.

What phase is MUC1 Dendritic Cell Vaccine in?

MUC1 Dendritic Cell Vaccine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The vaccine is being studied for the treatment of epithelial ovarian cancer, and one Phase 2 clinical trial has been completed.

What clinical trials has MUC1 Dendritic Cell Vaccine been in?

MUC1 Dendritic Cell Vaccine has been evaluated in one clinical trial with the identifier NCT01617629. This Phase 2 study, titled 'Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study,' was completed and enrolled 9 female patients with epithelial ovarian cancer in the United States and Australia.

Is MUC1 Dendritic Cell Vaccine a monoclonal antibody?

MUC1 Dendritic Cell Vaccine is classified as a monoclonal antibody modality, though it functions as a cancer vaccine. It is designed to target the MUC1 antigen, which is present on ovarian cancer cells. The vaccine is currently in Phase 2 clinical development for epithelial ovarian cancer.