Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies (TEMPO)
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|ClinicalTrials.gov Identifier: NCT03663712|
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : November 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Peritoneal Surface Dissemination From Gastrointestinal or Recurrent, Platinum-resistant Ovarian Cancer That Cannot be Completely Resected||Biological: Talimogene Laherparepvec||Phase 1|
This is a non-randomized, open-label Phase I trial in patients with Stage IV peritoneal surface dissemination from gastrointestinal or recurrent, platinum-resistant ovarian tumors enrolled at Duke Cancer Institute. All subjects will complete an extensive medical history, baseline physical examination and clinical assessment to ensure subject eligibility requirements within 4 weeks of starting study drug. All eligible patients must have a peritoneal catheter placed at least 2 weeks prior to the initiation of therapy. All patients will receive an initial loading dose of TVEC 4x106 Plaque Forming Units (PFU) on Cycle 1 Day 1 to enable the formation of protective antibodies as described in the currently approved treatment protocol for the treatment of cutaneous melanoma. Three weeks after the initial loading dose, patients will receive TVEC at the dose level for the cohort for which they are enrolled every 2 weeks for up to 4 doses. The length of the first cycle is 5 weeks and subsequent cycles are 2 weeks in duration.
The first portion of the study, the Dose Escalation cohort, will evaluate the toxicity profile of TVEC in patients with peritoneal surface dissemination from gastrointestinal or recurrent, platinum-resistant ovarian tumors. Using a standard '3+3' dose escalation design, there are up to three dose levels that may be explored. Dose escalation will be dependent on dose-limiting toxicity (DLT) within the cohorts.
Once the MTD has been determined, an additional 6 subjects will be enrolled to the dose expansion cohort. All subjects will receive an initial loading dose of TVEC 4x106 PFU on Cycle 1 Day 1. Three weeks after the initial loading dose, patients will receive TVEC at the MTD every 2 weeks for up to 4 doses. The length of the first cycle is 5 weeks and the subsequent cycles are 2 weeks in duration. There are a total of four cycles.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies|
|Actual Study Start Date :||May 9, 2019|
|Actual Primary Completion Date :||October 13, 2022|
|Actual Study Completion Date :||October 13, 2022|
Drug: Talimogene Laherparepvec
There will be two parts to this phase I study: 1) Dose Escalation Cohort; 2.) Dose Expansion Cohort
In the Dose Escalation Cohort, three subjects will be enrolled at the starting dose of 4x106 PFU, and the dosing will continue in the standard '3+3' dose escalation scheme. If the starting dose is tolerated, enrollment will continue at 4x107 and 4x108 PFU. Once the MTD is determined, six subjects will be enrolled to the Dose Expansion Cohort at the MTD. All subjects will be dosed with talimogene laherparepvec intraperitoneal (IP) once every 2 weeks for up to 4 doses (in addition to the initial seroconversion dose, which all patients will receive).
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
Other Name: (T-VEC)
- Most Tolerable Dose (MTD) for talimogene laherparepvec [ Time Frame: MTD for the study will be determined at the completion of Phase I dose escalation cohort; estimated as 1 year ]The MTD across three dose levels will be determined and the safety analyses will be performed on the safety population
- Non-dose limiting toxicities for talimogene laherparepvec [ Time Frame: Continuous, approximately every 4 weeks minimum until end of study estimated at 4 years ]Adverse events will be recorded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663712
|United States, Illinois|
|University of Illinois College of Medicine at Chicago|
|Chicago, Illinois, United States, 60612|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Wake Forest University School of Medicine|
|Winston-Salem, North Carolina, United States, 27013|
|Principal Investigator:||Dan Blazer, MD||Duke University|
|Study Chair:||John H Stewart, MD||University of Illinois College of Medicine at Chicago|