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Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies

NCT03663712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-11-20

Study results available
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Summary

The primary objective of this open-label, Phase I, trial is to evaluate the toxicity profile of intraperitoneal talimogene laherparepvec (TVEC) in patients with peritoneal surface dissemination from gastrointestinal or recurrent, platinum-resistant ovarian tumors. The secondary objectives are to evaluate the pharmacokinetic profile and viral shedding of TVEC by measuring viral load in serum and urine as well as viral load in peritoneal washings.

Conditions

  • Peritoneal Surface Malignancy

Interventions

BIOLOGICAL

Talimogene Laherparepvec

TVEC is an oncolytic, genetically modified virus designed to reproduce in tumor tissue and stimulate your immune system to attack the tumor cells

Sponsors & Collaborators

  • Dan Blazer III, M.D.

    lead OTHER

Principal Investigators

  • Dan Blazer, MD · Duke University

  • John H Stewart, MD · University of Illinois College of Medicine at Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2022-10-13
Completion
2022-10-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03663712 on ClinicalTrials.gov