West Cancer Center

MELANOMA: Metastatic; 1st line; T-VEC+PD-1; \"MASTERKEY-265\"

A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected,Stage IIIB to IVM1c Melanoma (MASTERKEY-265)_

Title

Amgen 20110265

Study Title

A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected,Stage IIIB to IVM1c Melanoma (MASTERKEY-265)_

Site Link

NCT02263508

Malignancy

Melanoma, skin cancer

Stage

Stage 4

Disease Setting

Metastatic/palliative

Line Of Therapy

1st line

Investigational Agent

Talimogene laherparepvec, pembrolizumab

Drug Class

oncolytic virus, PD-1 inhibitor

Ari VanderWalde, MD

Sponsor

Amgen

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

NCT02263508

Key Eligibility Criteria Details

Unresected Stage IIIB, IIIC, or IV melanoma
No prior therapy for metastatic disease
At least 6 months from adjuvant therapy
No clinically active CNS disease
ECOG PS 0-1
Measurable (at least 1 lesion >1cm)
Injectable (total cutaneous/subcut/nodal lesions >1cm in aggregate)
No prior ipilimumab, PD-1 inhibitors, T-VEC or tumor vaccines
Previous BRAF or MEK inhibitors allowed if BRAF mutated
No primary uveal or mucosal melanoma
No prior intrathoracic XRT

Objective

Primary- PFS and OS: Secondary- ORR, BOR, durable response rate, DOR, DCR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Melanoma, any BRAF status

Dosing Frequency

every 2-3 weeks

Control Agents

placebo and pembrolizumab

Study Protocol

Randomized

Yes