Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03086642|
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : November 14, 2019
The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can be given safely to participants with pancreatic cancer that is either too big to be taken out by surgery or has spread to other parts of the body. The study will also see if T-Vec can cause tumor shrinkage or prevent its growth.
The primary objective is to determine the rate of dose limiting toxicity at tested doses of talimogene laherparepvec administered endoscopically to pancreatic tumors, and to identify a maximum tolerated dose (MTD).
Secondary exploratory efficacy endpoints include change in longest diameter in the injected lesion(s), overall response rate (ORR) per RECIST v1.1 and modified immune-related response criteria (mirRC as defined in section 11), progression free survival (PFS) and overall survival (OS) at 6, 12, and 24 months.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Talimogene laherparepvec||Phase 1|
Pancreatic ductal adenocarcinoma (PDA) is an area of great unmet need. PDA accounts for 90% of pancreatic tumors in 2016. The standard of care for pancreas cancer is cytotoxic chemotherapy, but this is not particularly effective with best response rates reported of 20-30% and no significant long-term 5-year survival for patients who are not surgical candidates. Talimogene laherparepvec (previously known as OncoVEXGM-CSF) is an intratumorally delivered oncolytic immunotherapy comprised of an immune-enhanced herpes simplex virus type-1 (HSV-1) that selectively replicates in solid tumors. Talimogene laherparepvec was the first oncolytic viral therapy to be approved by the Federal Drug Administration (FDA) for the treatment of cancer, specifically melanoma. There is the potential that talimogene laherparepvec could exert a systemic effect mitigating the potential of PDA to metastasize.
This is a phase 1 dose escalation study to evaluate the safety of talimogene laherparepvec in PDA. To find out which doses are safe, all participants enrolled in this study will receive up to 4 injections of T-Vec. At least two doses will be evaluated in this study, depending on how many side effects are seen at each dose. Participants will not be able to pick the dose, as this will be determined based on the study experience with participants enrolled previously.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Talimogene Laherparepvec Administered Endoscopically for the Treatment of Locally Advanced or Metastatic Pancreas Cancer Refractory to at Least One Chemotherapy Regimen|
|Actual Study Start Date :||November 16, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2026|
All enrolled patients will receive a test dose of talimogene laherparepvec (10^6 plaque forming units (PFU)/ml) on day 1, followed by treatment doses at escalating concentrations weeks 4, 7, and 10. A biopsy will be obtained during each scheduled endoscopy prior to talimogene laherparepvec injection.
Drug: Talimogene laherparepvec
T-Vec will be administered by intratumoral injection into pancreatic tumors accessible endoscopically with ultrasound guidance (at least one pancreatic lesion must be injected during each treatment).
On day 1 of week 1 the first dose of talimogene laherparepvec will be up to 4.0 mL of 10^6 PFU/mL. The second injection up to 4.0 mL of 10^6, 10^7, or 10^8 PFU/mL should be administered no sooner than day 1 of week 4 but should not be delayed more than 7 days after the scheduled time point. The maximum volume of T-Vec administered at any one time is 4.0 mL for any individual lesion.
- Maximum Tolerated Dose (MTD) [ Time Frame: 36-48 months ]To determine the highest dose of study treatment that does not cause unacceptable side effects.
- Change in size of injected lesion(s) [ Time Frame: baseline, 11 weeks ]To make an exploratory assessment of activity of talimogene laherparepvec in pancreatic cancer, as measured by change in size of the injected lesion(s)
- Overall response rate (ORR) [ Time Frame: Up to 24 months ]The percentage of patients whose cancer shrinks or disappears after treatment.
- Progression-free survival (PFS) [ Time Frame: Up to 24 months ]The length of time during and after the study treatment of cancer, that a patient lives with the disease but it does not get worse.
- Overall survival (OS) [ Time Frame: Up to 24 months ]The length of time from either the date of diagnosis or the start of study treatment for cancer, that patients diagnosed with the disease are still alive.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086642
|Contact: Lisa Olmos, RNfirstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Yvonne M Saenger, MD 646-317-6313 email@example.com|
|Principal Investigator: Yvonne M Saenger, MD|
|Principal Investigator:||Yvonne M Saenger, MD||Columbia University|