Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Vaccines

Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.

The 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).

MUC1 Dendritic Cell Vaccine (Cvac)

Heidy Gray, MD

James Mason, MD

Peter Eisenberg, MD

Giuseppe Del Priore, MD

Fernando Recio, MD

Jeffery Goh, MBBS, FRACP

The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer eligible for study participation due to disease progression.

Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study

An Open-Label Safety Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein Coupled to Oxidized Polymannose) for Epithelial Ovarian Cancer Patients Who Have Progressed During the CAN-003 Study

Overall survival was defined as the time from randomization until death from any cause.

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.

Prima BioMed Ltd

Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.

MUC1 Dendritic Cell Vaccine (Cvac): The 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).

Cvac Treatment Group

Age, Continuous

Sex: Female, Male

White

Race/Ethnicity, Customized

Safety population included all participants who enrolled in the study.

Marc Voigt

Adverse Events

Serious Adverse Events

Safety Population included all participants who enrolled in the study.

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

Due to the few patients, Overall Survival could not be calculated.

Overall Survival

Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.

MUC1 Dendritic Cell Vaccine (Cvac): The 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).

Overall Study

Digestive System Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

Cvac will be administered via intradermal injection, every 4 weeks for the first 3 doses and thereafter every 12 weeks for 3 additional doses for a total of 6

CVac

The purpose of this study is to assess the safety and tolerability of CVac, an investigational cell therapy, in patients with resected stage I or II adenocarcinoma of the pancreas who have completed surgery with or without front-line chemotherapy or radiation therapy.

After confirmation of non-measurable disease patients will undergo leukapheresis for manufacture of the study agent.

A total of approximately 40 patients at up to 30 clinical sites will be screened for eligibility into the study within 6 weeks of completing treatment, including R0 (complete resection with no microscopic residual tumor) or R1 (complete resection with no grossly visible tumor but microscopically positive margins) surgery for stage I or stage II adenocarcinoma of the pancreas with or without chemotherapy and radiation. Eligible patients must have no measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Eisenhauer 2009) and tumor marker carbohydrate antigen 19-9 \[CA 19-9\] not greater than 2 × the upper limit of normal (ULN) following surgery with or without chemotherapy or radiation. Prior surgery, neoadjuvant chemotherapy, adjuvant chemotherapy, and radiation therapy are allowed.

Cvac as Maintenance Treatment Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas

A Phase 2 Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein [Mucin 1-Glutathione S-Transferase] Coupled to Oxidized Polymannose) in Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas

Descriptive statistics will be used to summarize the changes in immunologic Response.

Immunologic parameters will be evaluated as exploratory efficacy endpoints. Plasma, serum, and tissue (i.e., tumor sample collected during surgery) samples will be collected and will be used for immunological assays.

Quality-of-life scores will be calculated based on the QLQ-C30 and Module QLQ-PAN26 scoring manuals. The QoL scores will be summarized. descriptively. Data permitting, the QoL scores may be evaluated longitudinally using a linear mixed-effects model for repeated measurements.

Safety analyses will be performed on the Safety Population. Safety and tolerability will be summarized using descriptive statistics and or listed and assessed by adverse events, vital signs, 12 lead ECG, relevant changes in physical examination.

The efficacy endpoints for this pilot study include OS and PFS, PFS is defined as the time from baseline to the date of radiological scan used to determine Progressive disease evaluated approximately every 12 weeks after baseline.

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.

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.

Participants in this group did not receive any treatment during the study.

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.

Cvac

Heidi Gray, MD

Mark Moradi, MD

Jonathan Berek, MD, MMS

Nana Tchabo, MD

Jennifer Young, MD

Angeles Secord, MD

Peter Rose, MD

Benedict Benigno, MD

John Chan, MD

Paul Mitchell, MB ChB

Linda Mileshkin, MBBS

Margaret Davy, MBBS, CGO

Jeffrey Goh, MBBS, FRACP

Marco Matos, FRACP

The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning.

Study objectives

Primary objectives:

* To confirm the safety of administering Cvac in this population.
* To determine the effects of Cvac on progression-free survival (PFS).

Secondary objectives:

* To determine overall survival (OS) for ovarian cancer patients who receive Cvac after achieving remission in the first or second-line setting.
* Evaluation of host immunologic response to Cvac administration.

An initial cohort of 7 patients were treated with Cvac in an open-label phase to confirm the safety and consistency of manufacturing between Cvac drug product manufactured in the United States (US) and Australia. After the manufacturing characteristics of Cvac were confirmed to be consistent and each patient in the initial cohort had completed 1 injection cycle of Cvac with no serious or treatment-related Grade 3 or 4 adverse events (AEs), 56 patients were enrolled and randomized (1:1) to either Cvac or observational standard of care (OSC).

Ovarian Cancer Vaccine for Patients in Remission

A Randomized, Open-label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac™) for Epithelial Ovarian Cancer Patients in First or Second Remission

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.

Mucin 1 antibodies were assessed in serum samples using a quantitative enzyme-linked immunosorbent assay (ELISA). Detection was achieved with electrochemiluminescence.

Intracellular cytokine staining (ICS) for IL2, IL4, IL17, tumor necrosis factor (TNF), and interferon gamma (IFNg) was done in both CD4+ and CD8+ cells from serum samples collected at Weeks, 20, 56, and 104. Intracellular cytokine staining data were acquired with 8-color flow cytometry on a BD LSR II flow cytometer and a high-throughput screening microplate reader.

Safety population: All participants who received at least 1 dose of Cvac or were assigned to the observational standard of care group and were assessed at Week 20 (7 participants in the initial cohort, 26 of 29 participants randomized to Cvac, and 24 of 27 participants randomized to observational standard of care).

Non-randomized Cvac

Randomized Cvac

Observational Standard of Care

Total

All participants: All participants enrolled in the study.

Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study	NCT01617629	Epithelial Ovar...	MUC1 Dendritic ...	18 Years -	Prima BioMed Ltd
Cvac as Maintenance Treatment Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas	NCT02310971	Pancreatic Carc... Pancreatic Carc...	CVac	18 Years -	Prima BioMed Ltd
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study	NCT01617629	Epithelial Ovar...	MUC1 Dendritic ...	18 Years -	Prima BioMed Ltd
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study	NCT01617629	Epithelial Ovar...	MUC1 Dendritic ...	18 Years -	Prima BioMed Ltd
Ovarian Cancer Vaccine for Patients in Remission	NCT01068509	Epithelial Ovar...	Cvac	18 Years -	Prima BioMed Ltd

Spots Global Cancer Trial Database for cvac

Every month we try and update this database with for cvac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cvac

Every month we try and update this database with for cvac cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cvac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.