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Virus Therapy

Injection of TVEC into target lesions - week 1-2 for Keratoacanthoma

Phase 2

Waitlist Available

Led By Clara Curiel, MD

Research Sponsored by University of Arizona

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 8.5-10.5 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment on patients with a low risk form of skin cancer.

Eligible Conditions

Skin Tumors
Skin Lesions
Keratoacanthoma
Skin Cancer
Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8.5-10.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8.5-10.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8.5-10.5 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall response rate

Secondary outcome measures

Assess durable response.

Duration of overall response.

Number of adverse effects to tumors according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0

+7 more

Other outcome measures

Abscopal effect of TVEC

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

Back pain

Abdominal pain

Rash

Hyperhidrosis

Erythema

Tumour pain

Anxiety

Insomnia

Oropharyngeal pain

Weight decreased

Dyspepsia

Injection site erythema

Musculoskeletal pain

Neck pain

Depression

Anaemia

Vitiligo

Muscle spasms

Dyspnoea

Injection site reaction

Injection site swelling

Disease progression

Injection site pruritus

Cellulitis

Gastrointestinal haemorrhage

Intestinal obstruction

Rib fracture

Metastases to central nervous system

Deep vein thrombosis

Pleural effusion

Dehydration

Infected neoplasm

Metastatic malignant melanoma

Cerebral haemorrhage

Convulsion

Mental status changes

Pulmonary embolism

Atrial fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

Talimogene Laherparepvec

GM-CSF

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (talimogene laherparepvec)Experimental Treatment4 Interventions

The subject participation period will be approximately 48 weeks. This will include a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient is 8.5 to 10.5 months. TVEC will be administered by injection with a needle directly into one or more tumors.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Injection of TVEC into target lesions - week 1-2

2018

Completed Phase 2

~20

Injection of TVEC into target lesions 2wks after 2nd injection

2018

Completed Phase 2

~20

Injection of TVEC into target lesions 2wks after 3rd injection

2018

Completed Phase 2

~20

Injection of TVEC into target lesions 3wks after 1st injection

2018

Completed Phase 2

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor

1,370 Previous Clinical Trials

1,377,677 Total Patients Enrolled

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,260 Total Patients Enrolled

Clara Curiel, MDPrincipal InvestigatorUniversity of Arizona

2 Previous Clinical Trials

53 Total Patients Enrolled

Frequently Asked Questions

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

Is this research endeavor currently enrolling participants?

"The clinicaltrials.gov website denotes that this medical trial is no longer accepting patients; the initial posting was made on August 24th 2018 and it has not been updated since September 6th 2022. Nonetheless, there are currently 798 other trials registering participants."

Answered by AI

Is the injection of TVEC into target lesions over a one-to-two week period safe for humans?

"Since Injection of TVEC into target lesions - week 1-2 is currently in Phase 2, meaning there are some preliminary data supporting its safety but none conveying efficacy, we gave it a rating of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

2018. "Study of TVEC in Patients With Cutaneous Squamous Cell Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03714828.