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Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer

NCT03086642 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-11-22

No results posted yet for this study

Summary

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.

Funding Source - FDA OOPD

Conditions

Interventions

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.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Karie D. Runcie, MD

    lead OTHER

Principal Investigators

  • Karie Runcie, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2021-05-13
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03086642 on ClinicalTrials.gov