MedTrace Logo

Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma

NCT02263508 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 713

Last updated 2022-11-14

Study results available
· View outcomes & findings →

Summary

The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma.

The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and overall survival (OS).

Conditions

Interventions

DRUG

Talimogene Laherparepvec

Talimogene laherparepvec administered by intratumoral injection

DRUG

Pembrolizumab

Administered at a dose of 200 mg as an intravenous infusion over approximately 30 minutes.

DRUG

Placebo

Administered by intratumoral injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-08
Primary Completion
2021-03-11
Completion
2021-03-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02263508 on ClinicalTrials.gov