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Monoclonal Antibodies

Talimogene Laherparepvec + Panitumumab for Skin Cancer

Phase 1
Waitlist Available
Led By Adam C Berger, MD, FACS
Research Sponsored by Rutgers, The State University of New Jersey
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 up to two years
Awards & highlights

Study Summary

This trial is testing talimogene laherparepvec (a gene-modified virus vaccine) + panitumumab (a monoclonal antibody) to see if it is more effective than panitumumab alone in treating patients with squamous cell carcinoma of the skin that has spread.

Who is the study for?
Adults with advanced or metastatic squamous cell carcinoma of the skin, not treatable by surgery or radiation, may join. They should have measurable disease and be in relatively good health without severe autoimmune disorders or a need for high-dose steroids. Prior treatments are okay if there's documented cancer progression. Pregnant women and those unwilling to use contraception are excluded.Check my eligibility
What is being tested?
The trial is testing talimogene laherparepvec (a gene-modified virus vaccine) combined with panitumumab (an antibody therapy) against squamous cell carcinoma of the skin. It aims to see if this combo is more effective than panitumumab alone in treating this type of cancer.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms from the vaccine, and skin reactions due to panitumumab. There might also be allergic reactions related to either treatment and potential issues affecting lung health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from initial response until document progression up to two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from initial response until document progression up to two 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 With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Response Rate to Panitumumab as Measured by Evaluation of the Criteria in Solid Tumors (RECIST) 1.1.
Secondary outcome measures
Best Overall Response Rate (ORR) of Participants From Start to Progression of Disease
Change in Overall Survival (OS) Measured by the Kaplan-Meier
Deoxyribonucleic Acid Mutation Signature in Tumor Tissue
+11 more

Side effects data

From 2014 Phase 3 trial • 31 Patients • NCT01368276
67%
Cough
67%
Fatigue
33%
Injection site mass
33%
Influenza like illness
33%
Dyspnoea
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, panitumumab)Experimental Treatment2 Interventions
Patients receive talimogene laherparepvec IM on day 1. Patients then receive talimogene laherparepvec IM and panitumumab IV over 30-90 minutes on day 22. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive up to 3 additional cycles of treatment per physician discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab
2020
Completed Phase 3
~6490
Talimogene Laherparepvec
2008
Completed Phase 3
~640

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,227 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,148 Total Patients Enrolled
Adam C Berger, MD, FACSPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Media Library

Panitumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04163952 — Phase 1
Squamous Cell Carcinoma Research Study Groups: Treatment (talimogene laherparepvec, panitumumab)
Squamous Cell Carcinoma Clinical Trial 2023: Panitumumab Highlights & Side Effects. Trial Name: NCT04163952 — Phase 1
Panitumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04163952 — Phase 1

Frequently Asked Questions

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

What potential adverse effects could arise from using Talimogene Laherparepvec?

"Due to the preliminary nature of this trial, our team assigned Talimogene Laherparepvec a 1 on the Safety Scale, indicating limited evidence for safety and effectiveness."

Answered by AI

Is this experiment still accepting new recruits?

"This clinical trial is not currently seeking out participants. It was first posted on 1/31/2020 and last modified on 5/9/2022. For those looking for other medical studies, 2587 trials are recruiting patients with recurrent skin squamous cell carcinoma while 54 studies are calling for volunteers to participate in Talimogene Laherparepvec research initiatives."

Answered by AI

What type of medical condition is Talimogene Laherparepvec primarily utilized to manage?

"Before initiating surgery, Talimogene Laherparepvec can be utilized to treat instances of progression following fluoropyrimidine, oxaliplatin and irinotecan treatment along with any unresectable skin lesions."

Answered by AI

What is the maximum number of participants allowed in this medical experiment?

"Sadly, this particular trial is no longer accepting participants. This study was initially available on January 31st 2020 and last updated on May 9th 2022; nevertheless, those searching for other clinical trials may be interested to know that there are currently 2587 medical studies actively recruiting individuals with recurrent skin squamous cell carcinoma and 54 investigations involving Talimogene Laherparepvec."

Answered by AI

How does this trial distinguish itself from other similar investigations?

"Currently, 54 clinical trials for Talimogene Laherparepvec are running in 193 cities and 18 countries. The pioneering study was launched by Amgen back in 2011 with 75 volunteers participating to reach Phase 2 approval of the drug. Since then, 114 studies have been completed."

Answered by AI

Has Talimogene Laherparepvec been evaluated in any prior experiments?

"At present, 54 active trials are investigating Talimogene Laherparepvec with 3 of them in the final phase. Although a few clinical studies for this drug occur in Santa Monica, California, there is an expansive network of 801 sites engaging in research related to it."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin
Adam Berger, MD 2020. "Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04163952.
~1 spots leftby Apr 2025
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