West Cancer Center

MELANOMA: Metastatic/Unresectable: Non-visceral: "20120324"

A phase II, multicenter, single-arm trial to evaluate the biodistribution and shedding of talimogene laherparepvec in subjects with unresected, stage IIIB to IVM1c melanoma

Title

Amgen 20120324

Study Title

A phase II, multicenter, single-arm trial to evaluate the biodistribution and shedding of talimogene laherparepvec in subjects with unresected, stage IIIB to IVM1c melanoma

Site Link

NCT02014441

Malignancy

Melanoma, Skin Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Any (1st, 2nd, 3rd, etc.)

Investigational Agent

T-VEC (talimogene laherparepvec)

Drug Class

oncolytic virus

Ari VanderWalde, MD

Sponsor

Amgen

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02014441?term=20120324&rank=1

Key Eligibility Criteria Details

Unresectable IIIB, IIIC, or IV�disease._
Cutaneous, subcutaneous, or nodal disease amenable to intralesional therapy
ECOG PS 0-1
No primary ocular or mucosal melanoma
No symptomatic autoimmune disease
At least one injectable lesion below the waist

Objective

Primary- Biodistribution: Secondary- ORR, Safety, drug clearance, drug shedding

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Any

Dosing Frequency

T-VEC 10^6 PFU day1, then 10^8 PFU/ml on week 4 and then q2wks

Control Agents

N/A

Study Protocol

Randomized