Pancreatic Carcinoma Stage IPhase 2NCT02310971
Cvac as Maintenance Treatment Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas
A Phase 2 study testing CVac in people with Pancreatic Carcinoma Stage I and Pancreatic Carcinoma Stage II, run by Prima BioMed Ltd.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Carcinoma Stage I, Pancreatic Carcinoma Stage II
- What is being tested?
- CVac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically diagnosed adenocarcinoma of the pancreas, stage I or stage II disease
- Postoperative confirmed R0 or R1 resection status with no evidence of residual disease based on radiographic Imaging
- CA 19-9 less than 2 × the ULN by the central laboratory
- No greater than 6 weeks since completion of prior therapy, which includes surgery with or without radiation or chemotherapy
- Mucin 1-positive tumor as determined by central immunohistopathology. Sites will be asked to submit archival tissue (patients may start the study if tissue is available at an outside hospital, but not yet requested or received)
- Signed an informed consent form (ICF)
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- Willing and able to complete study procedures within the study timelines
- Life expectancy of at least 6 months in the investigator's opinion
- ≥ 18 years of Age
- ECOG performance status < 2 (Karnofsky ≥ 70%)
- Normal organ and marrow function: serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN and serum bilirubin ≤ 1.5 × ULN unless Gilbert's syndrome has previously been confirmed for the patient, white blood cells (WBCs) ≥ 3.0 K/µL, absolute neutrophil count (ANC) ≥ 1.0 × 109/L, hemoglobin ≥ 8 g/dL, and platelets ≥ 100 × 109/L
- 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 Cvac. 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
Who cannot join
- Active, acute, or chronic clinically significant infections or bleeding
- Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) or history of congestive heart failure (≥ Grade 2)
- Active angina pectoris, stroke, or recent myocardial infarction (within 6 months)
- Additional uncontrolled, serious medical or psychiatric illness
- Evidence or history of central nervous system metastases
- Inadequate renal function defined as a creatinine clearance < 60 mL/min as determined by the central laboratory
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- Additional malignancy diagnosed within 5 years of study enrollment, except carcinoma in situ of the cervix or basal cell and squamous cell carcinomas of the skin
- Treatment with any other investigational agent (for any condition) within 4 weeks of Screening
- Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum [TPHA])
- Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose
- Active autoimmune disease; any previous autoimmune disease must not require chronic treatment in the 6 months prior to screening
- Germany only:
- Oversensitivity to the substances or another component of the investigational medicinal product
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- CVac
- Keywords
- Adenocarcinoma, resected
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVacBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Biologic/Vaccine | Experimental | 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 Receives: Biological: CVac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety and tolerability of CVac. (adverse events, vital signs, 12 lead ECG, relevant changes in physical examination)
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.
Measured: 10-12 months
Secondary outcomes (1)
Assessment of Progression-Free Survival (PFS) and Overall Survival (OS) following the initiation of Cvac in this patient population
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.
Measured: Participants will be followed from baseline until death from any cause or end of study, whichever comes first, assessed approximately every 12 weeks for up to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: The trial has been terminated per Sponsor direction due to longer than expected clinical and regulatory approvals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Carcinoma Stage IStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02310971
- Sponsor's protocol ID
- CAN-301
- Status last verified
- Mar 2015
- First submitted
- 15 Nov 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02310971
- Acronym / sponsor ID
- CAN-301
- Keywords
- Adenocarcinoma, resected
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial has been terminated per Sponsor direction due to longer than expected clinical and regulatory approvals.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Prima BioMed LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biologic/Vaccine | Experimental | Biological: CVacCvac 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically diagnosed adenocarcinoma of the pancreas, stage I or stage II disease
- Postoperative confirmed R0 or R1 resection status with no evidence of residual disease based on radiographic Imaging
- CA 19-9 less than 2 × the ULN by the central laboratory
- No greater than 6 weeks since completion of prior therapy, which includes surgery with or without radiation or chemotherapy
- Mucin 1-positive tumor as determined by central immunohistopathology. Sites will be asked to submit archival tissue (patients may start the study if tissue is available at an outside hospital, but not yet requested or received)
Key exclusion criteria (13 listed)
- Active, acute, or chronic clinically significant infections or bleeding
- Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) or history of congestive heart failure (≥ Grade 2)
- Active angina pectoris, stroke, or recent myocardial infarction (within 6 months)
- Additional uncontrolled, serious medical or psychiatric illness
- Evidence or history of central nervous system metastases
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 |
|---|---|---|
| CVacCvac 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 | Biological | Biologic/Vaccine |
Primary outcome
Assessment of safety and tolerability of CVac. (adverse events, vital signs, 12 lead ECG, relevant changes in physical examination)
Time frame: 10-12 months
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.
1 secondary outcome
Assessment of Progression-Free Survival (PFS) and Overall Survival (OS) following the initiation of Cvac in this patient population
Time frame: Participants will be followed from baseline until death from any cause or end of study, whichever comes first, assessed approximately every 12 weeks for up to 36 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVac in people with Pancreatic Carcinoma Stage I and Pancreatic Carcinoma Stage II, run by Prima BioMed Ltd.
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 12 inclusion and 13 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: withdrawn, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assessment of safety and tolerability of CVac. (adverse events, vital signs, 12 lead ECG, relevant changes in physical examination) (time frame: 10-12 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 3 Apr 2015.