Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer

NCT00402025 | Completed Phase 1 Results

• 1 other identifier: 005/04
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to assess the safety of injections of talimogene laherparepvec into patients with pancreatic cancer that cannot be removed by surgery. The study will also test whether the injections are effective in treating the tumor.

Conditions

Pancreatic Cancer

Keywords

Metastatic; Pancreas; Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Events

  A serious adverse event is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.

  From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.

• Number of Participants With Talimogene Laherparepvec Detected in Blood and Urine

  Samples of blood and urine collected before and up to 24 hours after dosing were tested for the presence of talimogene laherparepvec deoxyribonucleic acid (DNA) using a validated quantitative polymerase chain reaction (qPCR) assay.

  Treatment Day 1 predose and 2, 6, 12 and 24 hours postdose, and Week 3 and 6 at (predose and 2 hours postdose.

• Number of Participants Positive for Anti-herpes Simplex Virus-1 (HSV-1) Antibodies

  Anti-HSV-1 antibodies were detected using an enzyme-linked immunosorbent assay (ELISA).

  Week 0 (Day 1, predose) and Week 3

Secondary Outcomes (3)

• Change From Baseline in Sum of Longest Diameters of Injected Tumors

  Baseline and Week 6, 12 and 18

• Number of Participants With Overall Objective Response

  Every 6 weeks until 12 weeks after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.

• Change From Baseline in Pain Intensity

  Baseline and Weeks 3 and 6

Study Arms (1)

Talimogene Laherparepvec

EXPERIMENTAL

Participants received 3 doses of talimogene laherparepvec administered by direct injection 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until week 15 in a regimen of at least 3 weeks between doses.

Biological: Talimogene Laherparepvec

Interventions

Talimogene Laherparepvec BIOLOGICAL

Talimogene laherparepvec administered by direct injection into pancreatic tumors using EUS-guided FNI, up to a maximum of 4 mL per treatment.

Also known as: OncoVEX^GM-CSF, T-VEC, IMLYGIC

Talimogene Laherparepvec

Eligibility Criteria

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

You may qualify if:

• cytological or histological proof of adenocarcinoma of the pancreas
• unresectable, locally advanced disease (isolated liver metastases are permitted)
• tumors of at least 1 cm diameter at screening
• measurable disease using Response Evaluation Criteria In Solid Tumors (RECIST) criteria
• failure of either standard therapy, OR any one of the following:
• no alternative therapeutic of higher curative potential is available;
• investigator determination that patient could not tolerate alternative therapeutic due to unacceptable toxicity; or,
• patient refusal to be treated with available alternative therapeutic
• age \> 18 years
• life expectancy \> 3 months
• adequate bone marrow function as indicated by:
• White blood cells (WBC) ≥ 3.0 x 10\^9/L
• platelets ≥ 100 x 10\^9/L
• hemoglobin ≥ 8.5 gm/dL
• adequate liver function as indicated by:

You may not qualify if:

• history of other malignancy within two years prior to screening, except for prostate cancer (T1c, T2ab with definitive treatment, prostate-specific antigen (PSA) \< 1 ng/ml, and without ongoing hormone suppression) or adequately treated in situ carcinoma of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin
• cystic form of pancreatic cancer; microcystic disease may be eligible upon discussion with Medical Monitor
• Common Terminology Criteria for Adverse Events (CTCAE) version 3 grade 2 or greater clinical pancreatitis within 8 weeks prior to dosing with OncoVEX\^GM-CSF
• other than metastases limited to the liver, imaging evidence of metastatic disease to any other organ or tissue
• any serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
• evidence of compromised immune function including but not limited to:
• clinically significant absolute lymphocyte count \< Lower Limit of Normal (LLN)
• known human immunodeficiency virus (HIV), acute or chronic active hepatitis B, or hepatitis C infection;
• concurrently taking HIV antiviral medications (e.g. protease inhibitors, azidothymidine, etc.)
• received intravenous (IV), intramuscular (IM) or subcutaneous (SC) human gamma globulin within 6 months prior to dosing with OncoVEX\^GM-CSF
• patients taking immunosuppressive agents (e.g. cyclosporine, tacrolimus, or oral or systemic corticosteroids at a dose of \> 10 mg/day of prednisone or equivalent).
• pregnancy, lactation or lack of effective contraception in women of child-bearing potential (e.g., not post menopausal for \> 2 years, or had tubal ligation); lack of effective contraception in men if the partner is of child-bearing potential; women must have been practicing an effective contraceptive method for at least three months prior to entry in to the trial (hormonal contraception or intrauterine device in conjunction with a barrier method); men must use a condom or be surgically sterilized
• patients with active bacterial or viral infections that require treatment with systemic antibiotics or antiviral agents within 2 weeks prior to the first dose of OncoVEX\^GM-CSF); (note: patients with active cold sores or other HSV1 infections must wait until those lesions have crusted over before receiving OncoVEX\^GM-CSF)
• surgery requiring general or spinal anesthesia within four weeks prior to dosing with OncoVEX\^GM-CSF
• Treatment with an investigational agent within 4 weeks prior to the first dose of OncoVEX\^GM-CSF

Sponsors & Collaborators

• BioVex Limited: lead

Study Sites (3)

UCI Medical Center

Orange, California, 92868, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Mary Crowely Medical Research Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Adenocarcinoma

Interventions

talimogene laherparepvec

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Study Director
• Organization: Amgen, Inc.

866-572-6436

Study Officials

• Neil N Senzer, MD

  Mary Crowley Medical Research Center

  PRINCIPAL INVESTIGATOR

• Robert Coffin, PhD

  BioVex Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Study Start: November 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 15, 2016
• Results First Posted: April 15, 2016

Record last verified: 2016-04

Locations

US (3)