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

NCT02310971 | Withdrawn Phase 2 DMC

• 1 other identifier: CAN-301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pancreatic Carcinoma Stage I; Pancreatic Carcinoma Stage II

Keywords

Adenocarcinoma, resected

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

Other Outcomes (4)

• Evaluation of the time to next treatment (TTNT)

  Baseline until end of Progression free survival for up to 36 months

• Evaluation of the immunologic response to Cvac administration in this patient population

  Baseline until end of Progression free survival for up to 36 months

• Investigation of biomarkers, including tumor and immune characteristics, of clinical efficacy of Cvac in this patient population

  Baseline until end of Progression free survival for up to 36 months

Study Arms (1)

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

Biological: CVac

Interventions

CVac BIOLOGICAL

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

Biologic/Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Prima BioMed Ltd: lead

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2014
• First Posted: December 8, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 3, 2015

Record last verified: 2015-03