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Monoclonal Antibodies

Talimogene Laherparepvec + Pembrolizumab for Skin Cancer

Phase 2
Waitlist Available
Led By Siwen Hu-Lieskovan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have pathologically confirmed stage IV or unresectable stage III melanoma; patients must not have disease that is suitable for local therapy, administered with curative intent
Patients must have Zubrod performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 9 weeks following the initiation of treatment, followed by a confirmatory assessment 4 weeks later, and then every 12 weeks for up to 5 years
Awards & highlights

Study Summary

This trial is studying how well talimogene laherparepvec and pembrolizumab work in treating patients with stage III-IV melanoma. Biological therapies use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talimogene laherparepvec and pembrolizumab may work better in treating patients with melanoma by shrinking the tumor.

Who is the study for?
This trial is for adults with stage III-IV melanoma who've had prior treatment with anti-PD-1 or anti-PD-L1 agents and saw their disease progress. They must have measurable disease, be in good physical condition, and agree to provide tissue samples. Exclusions include recent treatments, active autoimmune diseases requiring systemic treatment, uncontrolled illnesses that could limit compliance, pregnancy or nursing women.Check my eligibility
What is being tested?
The study tests talimogene laherparepvec (a biological therapy) combined with pembrolizumab (an immunotherapy antibody), aiming to shrink tumors in advanced melanoma patients. It's a phase II trial exploring if this combination can stimulate the immune system more effectively than current treatments.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site for talimogene laherparepvec and flu-like symptoms. Pembrolizumab might cause fatigue, skin reactions, inflammation of organs like lungs or intestines (colitis), hormonal gland problems (like thyroid issues), and can weaken the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma is at an advanced stage and cannot be removed with surgery.
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I can take care of myself but might not be able to do heavy physical work.
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I agree to provide tissue and blood samples for research and allow them to be stored for future use.
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I have received anti-PD-1 or anti-PD-L1 treatment and my disease progressed after this treatment.
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I had a full physical exam and medical history review within the last 28 days.
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My doctor thinks I can have treatment injected directly into my skin or lymph node lesions.
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I am 18 years old or older.
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My brain cancer has been treated and I haven't needed steroids for over 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 9 weeks following the initiation of treatment, followed by a confirmatory assessment 4 weeks later, and then every 12 weeks for up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 9 weeks following the initiation of treatment, followed by a confirmatory assessment 4 weeks later, and then every 12 weeks for up to 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
Objective response rate (ORR)
Secondary outcome measures
Circulating tumor deoxyribonucleic acid (DNA) profile (ctDNA) fraction
DRR (Cohort A and B)
Durable response rate
+5 more
Other outcome measures
Change in T cell receptor (TCR) clonality levels assessed in peripheral blood (Cohort A)
Body Weight Changes
Change in TCR clonality within tumor assessed in peripheral blood (Cohort B)
+3 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%
0%
Study treatment Arm
GM-CSF
Talimogene Laherparepvec

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (talimogene laherparepvec, pembrolizumab)Experimental Treatment2 Interventions
Patients receive talimogene laherparepvec IL and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
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
~1950

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,604 Total Patients Enrolled
557 Trials studying Melanoma
193,191 Patients Enrolled for Melanoma
Siwen Hu-LieskovanPrincipal InvestigatorSWOG Cancer Research Network
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Melanoma
150 Patients Enrolled for Melanoma

Frequently Asked Questions

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

How many participants are currently enrolled in this experiment?

"This trial is no longer actively recruiting, as the latest update occurred on October 5th 2022. For those seeking alternatives, 816 and 978 investigations are presently enrolling patients with melanoma or Talimogene Laherparepvec respectively."

Answered by AI

What other experiments have been conducted regarding the efficacy of Talimogene Laherparepvec?

"Talimogene Laherparepvec was initially trialled at City of Hope in the year 2010, with 263 clinical studies having been completed to date. Presently there are 978 active examinations being conducted around the world, many of which are taking place in Cincinnati, Ohio."

Answered by AI

Are there any open slots for volunteers in this research project?

"This clinical trial is no longer accepting participants since its last update on October 5th 2022. If you are searching for other studies, 816 trials involving melanoma and 978 investigations focused on Talimogene Laherparepvec are actively recruiting patients."

Answered by AI

Has the FDA sanctioned Talimogene Laherparepvec for therapeutic use?

"As this trial is a Phase 2, there are some safety data points but no efficacy information. Thus, the Power team have assigned Talimogene Laherparepvec a score of two on the 1 - 3 scale."

Answered by AI

In what localities can participants access this experiment?

"Currently, 20 medical centres are hosting this trial. Among these locations are Cincinnati, West Bloomfield and Columbus among other cities. To minimize the burden of travel on participants, we encourage selecting a site near you for clinical participation."

Answered by AI

What types of medical conditions is Talimogene Laherparepvec commonly employed to combat?

"Talimogene Laherparepvec is a commonly used treatment for malignant neoplasms. Additionally, it has been shown to be beneficial in cases of unresectable melanoma, microsatellite instability high and diseases that have worsened due to chemotherapy."

Answered by AI
~6 spots leftby Mar 2025