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Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma

NCT03088176 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-10-12

No results posted yet for this study

Summary

The purpose of the study is to determine safety and tolerability of the combination of talimogene laherparepvec in combination with dabrafenib and trametinib in BRAF mutated advanced melanoma.

Conditions

Interventions

DRUG

Talimogene Laherparepvec 1 Million Pfu/Ml Inj,Susp,1Ml,Vil

Up to 4mL administered on C1D1 intratumorally

DRUG

Talimogene Laherparep 100 Mil Pfu/Ml 1Ml

Up to 4 ML administered on Week 4 Day 1 and every 2 weeks thereafter

DRUG

Dabrafenib

150mg PO qday

DRUG

Trametinib

2mg PO qday

Sponsors & Collaborators

  • University of Tennessee

    collaborator OTHER

  • Amgen

    collaborator INDUSTRY

  • West Cancer Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-25
Primary Completion
2020-11-30
Completion
2021-06-30
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 NCT03088176 on ClinicalTrials.gov