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Virus Therapy

Talimogene Laherparepvec for Peritoneal Surface Dissemination from Gastrointestinal or Ovarian Cancer (TEMPO Trial)

Phase 1
Waitlist Available
Led By Dan Blazer, MD
Research Sponsored by Dan Blazer III, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuous, approximately every 4 weeks minimum until end of study estimated at 4 years
Awards & highlights

TEMPO Trial Summary

This study is evaluating whether a virus which infects tumors may help treat tumors.

Eligible Conditions
  • Peritoneal Surface Dissemination from Gastrointestinal or Ovarian Cancer

TEMPO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuous, approximately every 4 weeks minimum until end of study estimated at 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and continuous, approximately every 4 weeks minimum until end of study estimated at 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Most Tolerable Dose (MTD) for talimogene laherparepvec
Non-dose limiting toxicities for talimogene laherparepvec

Side effects data

From 2014 Phase 3 trial • 31 Patients • NCT01368276
67%
Cough
67%
Fatigue
33%
Injection site mass
33%
Influenza like illness
33%
Dyspnoea
33%
Flushing
33%
Chills
33%
Ecchymosis
33%
Urticaria
33%
Diarrhoea
33%
Nausea
33%
Vomiting
33%
Oedema peripheral
33%
Pyrexia
33%
Folliculitis
33%
Oral herpes
33%
Pneumonia
33%
Upper respiratory tract infection
33%
Lipoma
33%
Haemoptysis
33%
Hypopnoea
33%
Oropharyngeal pain
33%
Blood blister
33%
Hyperhidrosis
33%
Night sweats
33%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
GM-CSF
Talimogene Laherparepvec

TEMPO Trial Design

1Treatment groups
Experimental Treatment
Group I: DoseExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talimogene Laherparepvec
2008
Completed Phase 3
~640

Find a Location

Who is running the clinical trial?

Dan Blazer III, M.D.Lead Sponsor
Dan Blazer, MDPrincipal Investigator - Duke University
Duke Raleigh Hospital
Duke University School Of Medicine (Medical School)
University Of Mi Hosps (Residency)
1 Previous Clinical Trials
164 Total Patients Enrolled
John H Stewart, MDStudy ChairUniversity of Illinois College of Medicine at Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies
Dan Blazer III, M.D. 2019. "Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03663712.
~3 spots leftby Apr 2025
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