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

Part of paid clinical trials in Germantown, Tennessee.

Sponsor
West Cancer Center
Study ID
NCT03088176
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Talimogene Laherparepvec 1 Million Pfu/Ml Inj,Susp,1Ml,Vil — DRUG
    Up to 4mL administered on C1D1 intratumorally
  • Talimogene Laherparep 100 Mil Pfu/Ml 1Ml — DRUG
    Up to 4 ML administered on Week 4 Day 1 and every 2 weeks thereafter
  • Dabrafenib — DRUG
    150mg PO qday
  • Trametinib — DRUG
    2mg PO qday

Study Details

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.

Key Dates

Start date
Jun 25, 2017
Status verified
Oct 2020
Primary completion
Nov 30, 2020
Completion
Jun 30, 2021

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination
    Talimogene laherperepvec intratumoral injection up to 4ml of 10\^6 PFU/mL on Day 1, followed by up to 4mL of 10\^8 PFU/mL 3 weeks later, followed by every 2 weeks thereafter for up to two years. Dabrafenib 150mg orally twice daily for up to two years Trametinib 2mg orally once daily for up to two years

Primary Outcome Measure

Rate of Dose Limiting Toxicities (DLT) [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
West Cancer CenterGermantownTennessee38138-

Find similar trials in Germantown, TN

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
West Cancer Center· Germantown, TN

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