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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
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreSide effects data
From 2014 Phase 3 trial • 31 Patients • NCT0136827618%
Pyrexia
18%
Chills
14%
Diarrhoea
14%
Back pain
11%
Dizziness
11%
Upper respiratory tract infection
11%
Vomiting
11%
Oedema peripheral
11%
Vitiligo
11%
Abdominal pain
11%
Fatigue
11%
Skin irritation
7%
Abdominal discomfort
7%
Injection site pain
7%
Myalgia
7%
Nausea
7%
Headache
7%
Ear pain
7%
Oropharyngeal pain
7%
Tumour pain
7%
Pruritus
4%
Pneumonia
4%
Metastatic malignant melanoma
4%
Haemangioma of liver
4%
Disease progression
4%
Vasculitis
4%
Cough
4%
Lipoma
4%
Hypovolaemic shock
4%
Clavicle fracture
4%
Influenza like illness
4%
Lung neoplasm malignant
4%
Cardiac arrest
4%
Dyspnoea
4%
Respiratory failure
4%
Renal failure
4%
Restrictive cardiomyopathy
4%
Pleural effusion
4%
Ecchymosis
4%
Hyperhidrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Talimogene Laherparepvec
GM-CSF
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2017
Completed Phase 3
~7150
Talimogene Laherparepvec
2008
Completed Phase 3
~630
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
449 Previous Clinical Trials
65,800 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,996 Total Patients Enrolled
Adam C Berger, MD, FACSPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had another type of cancer in the past, but it won't affect your participation in this trial unless your treating physician thinks it might. Exceptions include cancers that have been treated and gone into remission for at least three years, in situ carcinoma (like cervical cancer), and skin cancers that have been treated with surgery or radiation. If you have chronic lymphocytic leukemia, you can participate if your blood counts are normal and you're not currently receiving cytotoxic or biologic anticancer treatment, except for supportive treatment like IVIG.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (talimogene laherparepvec, panitumumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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