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Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment (CANVAS)

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ClinicalTrials.gov Identifier: NCT01521143
Recruitment Status : Terminated (The study was terminated due to company restructuring and changes in drug development priorities.)
First Posted : January 30, 2012
Results First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Prima BioMed Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Epithelial Ovarian Cancer
Interventions Biological: Cvac
Biological: Placebo
Enrollment 91
Recruitment Details Different participants were enrolled in the 2 parts of the study.
Pre-assignment Details  
Arm/Group Title Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Hide Arm/Group Description 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. 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. 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. Participants in this group did not receive any treatment during the study.
Period Title: Overall Study
Started 40 36 8 7
Received Treatment 20 20 3 4
Completed 11 10 0 0
Not Completed 29 26 8 7
Arm/Group Title Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care Total
Hide Arm/Group Description 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. 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. 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. Participants in this group did not receive any treatment during the study. Total of all reporting groups
Overall Number of Baseline Participants 20 20 3 4 47
Hide Baseline Analysis Population Description
Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo. Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
45-65 years of age Number Analyzed 20 participants 20 participants 3 participants 4 participants 47 participants
20 20 3 4 47
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 3 participants 4 participants 47 participants
Female
20
 100.0%
20
 100.0%
3
 100.0%
4
 100.0%
47
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Part A - Overall Survival
Hide Description Overall survival was defined as the number of days from Baseline to the date of death from any cause.
Time Frame Baseline to the end of the study (up to 3 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Arm/Group Title Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Hide Arm/Group Description:
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.
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.
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.
Participants in this group did not receive any treatment during the study.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Part A - Time to Next Treatment
Hide Description 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.
Time Frame Baseline to the end of the study (up to 3 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Arm/Group Title Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Hide Arm/Group Description:
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.
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.
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.
Participants in this group did not receive any treatment during the study.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Part A - Progression-free Survival
Hide Description 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.
Time Frame Baseline to the end of the study (up to 3 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Arm/Group Title Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Hide Arm/Group Description:
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.
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.
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.
Participants in this group did not receive any treatment during the study.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Part B - Overall Survival
Hide Description Overall survival was defined as the number of days from Baseline to the date of death from any cause.
Time Frame Baseline to the end of the study (up to 3 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Arm/Group Title Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Hide Arm/Group Description:
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.
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.
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.
Participants in this group did not receive any treatment during the study.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Part B - Time to Next Treatment
Hide Description 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.
Time Frame Baseline to the end of the study (up to 3 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Arm/Group Title Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Hide Arm/Group Description:
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.
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.
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.
Participants in this group did not receive any treatment during the study.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Part B - Progression-free Survival
Hide Description 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.
Time Frame Baseline to the end of the study (up to 3 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.
Arm/Group Title Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Hide Arm/Group Description:
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.
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.
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.
Participants in this group did not receive any treatment during the study.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description

Part A - Safety population: All randomized participants who received at least 1 dose of Cvac or placebo.

Part B - Safety population: All randomized participants who received at least 1 dose of Cvac (Cvac group) or were evaluated at least once (observational standard of care group).

 
Arm/Group Title Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Hide Arm/Group Description 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. 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. 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. Participants in this group did not receive any treatment during the study.
All-Cause Mortality
Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/20 (25.00%)   7/20 (35.00%)   0/3 (0.00%)   0/4 (0.00%) 
Blood and lymphatic system disorders         
Anaemia  1  1/20 (5.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Thrombocytopenia  1  1/20 (5.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Ascites  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Constipation  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Nausea  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Small intestinal perforation  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
General disorders         
Fat necrosis  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Hernia  1  1/20 (5.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Clostridial infection  1  0/20 (0.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Herpes dermatitis  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications         
Poisoning  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Investigations         
Biopsy liver  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Blood creatinine increased  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Surgical and medical procedures         
Stoma care  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Vascular disorders         
Lymphocele  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A - Cvac Part A - Placebo Part B - Cvac Part B - Observational Standard of Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/20 (85.00%)   13/20 (65.00%)   2/3 (66.67%)   0/4 (0.00%) 
Blood and lymphatic system disorders         
Lymphopenia  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Cardiac disorders         
Atrioventricular block second degree  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Palpitations  1  0/20 (0.00%)  0/20 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Ear and labyrinth disorders         
Tinnitus  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Endocrine disorders         
Autoimmune thyroiditis  1  0/20 (0.00%)  0/20 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Eye disorders         
Visual impairment  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Abdomianl pain lower  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Abdominal adhesions  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Abdominal discomfort  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Abdominal distension  1  1/20 (5.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Abdominal hernia  1  2/20 (10.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Abdominal pain  1  1/20 (5.00%)  2/20 (10.00%)  0/3 (0.00%)  0/4 (0.00%) 
Abdominal pain upper  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Constipation  1  2/20 (10.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Diarrhea  1  1/20 (5.00%)  3/20 (15.00%)  0/3 (0.00%)  0/4 (0.00%) 
Flatulence  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Gastritis erosive  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Intestinal obstruction  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Lip blister  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Nausea  1  0/20 (0.00%)  4/20 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Vomiting  1  0/20 (0.00%)  2/20 (10.00%)  0/3 (0.00%)  0/4 (0.00%) 
General disorders         
Asthenia  1  1/20 (5.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Chest pain  1  1/20 (5.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Chills  1  2/20 (10.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Edema  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Fatigue  1  0/20 (0.00%)  2/20 (10.00%)  0/3 (0.00%)  0/4 (0.00%) 
Feeling hot  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Hernia  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Influenza like illness  1  2/20 (10.00%)  0/20 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Infusion site erythema  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Infusion site pain  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Injection site discomfort  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Injection site erythema  1  5/20 (25.00%)  4/20 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Injection site hematoma  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Injection site nodule  1  2/20 (10.00%)  2/20 (10.00%)  0/3 (0.00%)  0/4 (0.00%) 
Injection site pain  1  3/20 (15.00%)  2/20 (10.00%)  0/3 (0.00%)  0/4 (0.00%) 
Injection site reaction  1  2/20 (10.00%)  2/20 (10.00%)  1/3 (33.33%)  0/4 (0.00%) 
Injection site reaction  1  0/20 (0.00%)  0/20 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Local swelling  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Nodule  1  0/20 (0.00%)  1/20 (5.00%)  0/3 (0.00%)  0/4 (0.00%) 
Pain  1  1/20 (5.00%)  0/20 (0.00%)  0/3 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  0/20 (0.00%)  0/20 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pleural effusion  1  0/20 (0.00%)  0/20 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
For study centers in Australia, no publication of the study results may be made until publication of the results of the study from all centers or until 2 years after study completion, whichever is sooner. For study centers in the USA, no submission for publication or public disclosure of the results by will be made until the results from all centers have been received and analyzed by the sponsor, or the multi-center study has been terminated or abandoned at all centers.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marc Voigt
Organization: Prima BioMed, Ltd.
Phone: 49 173 6771602
EMail: marc.voigt@primabiomed.com.au
Layout table for additonal information
Responsible Party: Prima BioMed Ltd
ClinicalTrials.gov Identifier: NCT01521143     History of Changes
Other Study ID Numbers: CAN-004
First Submitted: January 17, 2012
First Posted: January 30, 2012
Results First Submitted: November 16, 2016
Results First Posted: December 14, 2016
Last Update Posted: December 14, 2016