← Back to Search

Monoclonal Antibodies

Talimogene Laherparepvec for Liver Cancer (MASTERKEY-318 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

MASTERKEY-318 Trial Summary

This trial is testing the safety of a cancer treatment that involves injecting a virus into liver tumors and combining it with a drug that strengthens the immune system. The trial is also testing whether this treatment is effective for different types of cancer.

Eligible Conditions

Liver Cancer
Liver Metastases
Lymph Nodes

MASTERKEY-318 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)

Part 2 Only: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

Part 2 Only: Objective Response Rate (ORR)

Secondary outcome measures

Efficacy Progression-free survival (PFS)

Efficacy: Best overall response (BOR)

Efficacy: Disease control rate (DCR)

+10 more

Side effects data

From 2014 Phase 3 trial • 31 Patients • NCT01368276

67%

Cough

67%

Fatigue

33%

Influenza like illness

33%

Dyspnoea

33%

Injection site mass

33%

Flushing

33%

Chills

33%

Ecchymosis

33%

Urticaria

33%

Diarrhoea

33%

Nausea

33%

Vomiting

33%

Oedema peripheral

33%

Pyrexia

33%

Folliculitis

33%

Oral herpes

33%

Pneumonia

33%

Upper respiratory tract infection

33%

Lipoma

33%

Haemoptysis

33%

Hypopnoea

33%

Oropharyngeal pain

33%

Blood blister

33%

Hyperhidrosis

33%

Night sweats

33%

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

GM-CSF

Talimogene Laherparepvec

MASTERKEY-318 Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase Ib/II Talimogene Laherparepvec + PembrolizumabExperimental Treatment2 Interventions

Combination treatment of Talimogene Laherparepvec and Pembrolizumab

Group II: Phase Ib/II Talimogene LaherparepvecExperimental Treatment1 Intervention

Talimogene Laherparepvec

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talimogene Laherparepvec

2008

Completed Phase 3

~640

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,362 Previous Clinical Trials

1,385,436 Total Patients Enrolled

1 Trials studying Liver Cancer

21 Patients Enrolled for Liver Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,878 Previous Clinical Trials

5,053,108 Total Patients Enrolled

2 Trials studying Liver Cancer

133 Patients Enrolled for Liver Cancer

MDStudy DirectorAmgen

905 Previous Clinical Trials

922,969 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being given this opportunity to participate in the trial?

"Unfortunately, this particular clinical trial is no longer recruiting patients. If you are interested in other trials, 861 studies involving neoplasms and hepatic diseases are currently enrolling participants. Additionally, there are 1018 active trials for Talimogene Laherparepvec underway."

Answered by AI

How many different sites are coordinating this trial?

"A number of locations across the country are enrolling patients for this clinical trial, including but not limited to: Memorial Sloan Kettering Cancer Center in New york City, University of California Los Angeles near Santa Monica, and HonorHealth Research Institute situated in Scottsdale, Arizona."

Answered by AI

How is Talimogene Laherparepvec most often utilized?

"Talimogene Laherparepvec is an approved treatment for patients with malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

Are there any more spots open for this clinical trial?

"Recruitment for this clinical trial has concluded. The study was originally posted on February 5th, 2016 and updated September 12th, 2022. However, there are 861 other trials involving neoplasms, hepatic actively recruiting patients and 1018 studies for Talimogene Laherparepvec admitting participants."

Answered by AI

What are Talimogene Laherparepvec's clinical trial results thus far?

"There are presently 1,018 active clinical trials researching Talimogene Laherparepvec with 122 of them in Phase 3. Many of the ongoing Houston-based clinical trials for Talimogene Laherparepvec are being conducted at 36,144 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611

2016. "Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02509507.