Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
TriHealth Inc.
Study ID
NCT03972046
Phase
PHASE2
Status
Withdrawn

Conditions

  • BRAF Gene Mutation
  • Melanoma (Skin)
  • Melanoma Stage IIIb-IVM1a
  • Metastasis Skin
  • Tumor Skin

Eligibility Criteria

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

Interventions

  • Talimogene laherparepvec (T-Vec) — DRUG
    Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection
  • Dabrafenib (BRAF Inhibitor) — DRUG
    Dabrafenib (BRAF Inhibitor) 150 mg by mouth twice a day
  • Trametinib (MEK Inhibitor) — DRUG
    Trametinib (MEK Inhibitor) 2 mg by mouth once a day

Study Details

This study will investigate whether the use of talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor will result in durable regional and distant recurrence free survival in the neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma.

Key Dates

Start date
Jun 24, 2019
Status verified
Feb 2020
Primary completion
Feb 3, 2020
Completion
Feb 3, 2020

Study Design

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

Arms

  • Experimental: T-Vec + BRAF/MEK
    Participants will begin taking the following 3 medications: BRAF Inhibitor dabrafenib 150 mg by mouth twice a day; MEK inhibitor trametinib 2 mg by mouth once a day; Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection (Dose #1: 10\^6 PFU/mL; Dose #2: 10\^8 PFU/mL 21 (+3) days after first dose; Subsequent doses: 10\^8 PFU/mL every 14 (+/-3) days). Dosing to continue for at least 3 months, or up to 6 months if no plateau in response. May stop earlier than 3 months at physician discretion depending on side effects and response. Ultrasound of tumor nodal basin(s) monthly. Labs every 4 weeks: CBC with differential, CMP, LDH CT of chest/abdomen/pelvis every 3 months. PET CT or brain MRI as needed at discretion of the investigator. Manual tumor measurement in office prior to each injection.

Primary Outcome Measure

Rate of recurrence-free survival [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
TriHealth Cancer Institute - KenwoodCincinnatiOhio45236-

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By research site
TriHealth Cancer Institute - Kenwood· Cincinnati, OH

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