Phase 1
N=17
Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00402025 ↗Enrolled (actual)
17
Serious AEs
82.4%
Results posted
Apr 2016
Primary outcome: Primary: Number of Participants With Adverse Events — 3; 4; 10; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Talimogene Laherparepvec (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioVex Limited
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
3; 4; 10; 2; 3; 9 | — |
| PRIMARY Number of Participants With Talimogene Laherparepvec Detected in Blood and Urine |
0; 4; 1; 1; 2; 4 | — |
| PRIMARY Number of Participants Positive for Anti-herpes Simplex Virus-1 (HSV-1) Antibodies |
2; 3; 6; 3; 3; 6 | — |
| SECONDARY Change From Baseline in Sum of Longest Diameters of Injected Tumors |
2.5; 18.0; -3.3; 0.0; 18.0; NA | — |
| SECONDARY Number of Participants With Overall Objective Response |
0; 0; 0 | — |
| SECONDARY Change From Baseline in Pain Intensity |
1.250; 2.575 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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:
- bilirubin 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
- serum carbohydrate antigen (CA)19.9 levels > 3000 U/mL at screening
- evidence of ascites on screening abdominal computed tomography (CT) scan
Data sourced from ClinicalTrials.gov (NCT00402025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.