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T-Vec for Melanoma

Phase 2
Waitlist Available
Led By Michael C Lowe, MD
Research Sponsored by University of California, Davis
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 at surgery
Awards & highlights

Study Summary

This trial will test the effectiveness of Talimogene laherparepvec, an immunotherapy, in the neoadjuvant setting for primary invasive melanoma. This is a phase II study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic response

Side effects data

From 2014 Phase 3 trial • 437 Patients • NCT00769704
50%
Fatigue
48%
Chills
41%
Pyrexia
36%
Nausea
30%
Influenza like illness
28%
Injection site pain
21%
Vomiting
19%
Diarrhoea
19%
Headache
17%
Arthralgia
17%
Myalgia
16%
Pain
16%
Pain in extremity
12%
Constipation
12%
Oedema peripheral
11%
Cough
10%
Upper respiratory tract infection
10%
Decreased appetite
10%
Dizziness
10%
Pruritus
9%
Back pain
9%
Abdominal pain
9%
Rash
8%
Hyperhidrosis
7%
Erythema
7%
Tumour pain
7%
Anxiety
7%
Insomnia
6%
Oropharyngeal pain
6%
Weight decreased
5%
Dyspepsia
5%
Injection site erythema
5%
Musculoskeletal pain
5%
Neck pain
5%
Depression
5%
Anaemia
5%
Vitiligo
4%
Muscle spasms
4%
Dyspnoea
3%
Injection site reaction
3%
Injection site swelling
3%
Disease progression
2%
Injection site pruritus
2%
Cellulitis
1%
Gastrointestinal haemorrhage
1%
Intestinal obstruction
1%
Rib fracture
1%
Metastases to central nervous system
1%
Deep vein thrombosis
1%
Pleural effusion
1%
Dehydration
1%
Infected neoplasm
1%
Metastatic malignant melanoma
1%
Cerebral haemorrhage
1%
Convulsion
1%
Mental status changes
1%
Pulmonary embolism
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Talimogene Laherparepvec
GM-CSF

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (talimogene laherparepvec)Experimental Treatment1 Intervention
This study all subject get the research treatment drug (talimogene laherparepvec)

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,985 Total Patients Enrolled
7 Trials studying Melanoma
482 Patients Enrolled for Melanoma
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,682 Total Patients Enrolled
23 Trials studying Melanoma
19,500 Patients Enrolled for Melanoma
Michael C Lowe, MDPrincipal InvestigatorEmory University Winship Cancer Institute

Media Library

T-Vec Clinical Trial Eligibility Overview. Trial Name: NCT04427306 — Phase 2
Melanoma Research Study Groups: Treatment (talimogene laherparepvec)
Melanoma Clinical Trial 2023: T-Vec Highlights & Side Effects. Trial Name: NCT04427306 — Phase 2
T-Vec 2023 Treatment Timeline for Medical Study. Trial Name: NCT04427306 — Phase 2

Frequently Asked Questions

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

Are participants still being welcomed for this study?

"According to clinicaltrials.gov, this trial is actively seeking participants. It was initially posted on May 21st 2020 and most recently updated June 16th 2022."

Answered by AI

What is the upper limit of individuals participating in this investigation?

"Absolutely. According to the data posted on clinicaltrials.gov, this research project is actively looking for volunteers and was first published on May 21st 2020. The trial has since been updated as of June 16th 2022, intending to recruit a total of 62 individuals from one location."

Answered by AI

Could you elaborate on the other research initiatives that have utilized T-Vec?

"At present, there are 22 clinical trials analyzing the efficacy of T-Vec with 0 Phase 3 studies. The majority of these experiments take place in Santa Monica, California; still, 242 locations globally have been enlisted to conduct investigations into this medication."

Answered by AI

Are there any adverse effects associated with T-Vec treatments?

"Due to the lack of efficacy data, T-Vec was rated two on our safety scale. However, some evidence does exist that proves its safety."

Answered by AI

Is this an inaugural study on the subject?

"Currently, 22 studies on T-Vec are being conducted in 93 cities and 16 nations. In 2015, Amgen initiated the first clinical trial with 30 participants which completed its Phase 1 & 2 stages of drug approval. Since then, 13 more investigations have concluded."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neoadjuvant T-VEC in High Risk Early Melanoma
2020. "Neoadjuvant T-VEC in High Risk Early Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04427306.
~1 spots leftby Apr 2025
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