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Checkpoint Inhibitor

Talimogene Laherparepvec for Breast Cancer

Phase 1

Waitlist Available

Led By John A Glaspy

Research Sponsored by Jonsson Comprehensive Cancer Center

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 2 years

Awards & highlights

Study Summary

This trial is studying a combination of 3 drugs given before surgery to see if it is safe and effective in treating patients with localized breast cancer.

Eligible Conditions

Breast Cancer
Ductal Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Incidence and severity of adverse events (AEs)

Secondary outcome measures

histopathological evaluation of changes of tumor for inflammatory infiltration and tumor necrosis

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%

Study treatment Arm

GM-CSF

Talimogene Laherparepvec

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (talimogene laherparepvec, nivolumab, ipilimumab)Experimental Treatment3 Interventions

Participants receive talimogene laherparepvec intratumorally on days 1, 22, and 36, nivolumab IV over 60 minutes on days 1, 15, 29, and 43, and ipilimumab IV over 90 minutes on days 1 and 43 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

Nivolumab

2014

Completed Phase 3

~4750

Ipilimumab

2014

Completed Phase 3

~2620

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,044 Total Patients Enrolled

24 Trials studying Breast Cancer

1,758 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,661 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

John A GlaspyPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Frequently Asked Questions

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

What is the maximum number of participants being considered for this research?

"At present, this medical trial is not looking for applicants. It was first announced on July 10th 2019 and last edited September 22nd 20202. If you are interested in alternative studies, there are currently 4579 investigations recruiting patients with breast cancer, and 782 that seek volunteers for Talimogene Laherparepvec treatment."

Answered by AI

Has Talimogene Laherparepvec been given the green light by the FDA?

"Talimogene Laherparepvec was rated a 1 on our organization's scale due to the relative lack of data regarding its efficacy and safety, as this is a Phase 1 trial."

Answered by AI

To what malady does Talimogene Laherparepvec provide the most beneficial relief?

"Talimogene Laherparepvec is the standard anti-angiogenic therapy for most conditions, and can be utilized to tackle malignant neoplasms, inoperable melanoma, and squamous cell carcinomas."

Answered by AI

Is enrollment for this research endeavor currently open?

"From the information available on clinicaltrials.gov, this medical trial has ceased recruitment of patients as it was last edited in September 2022. However, we are pleased to report that there presently exist 5361 other trials actively recruiting participants."

Answered by AI

Could you provide further insight into past experiments concerning Talimogene Laherparepvec?

"Presently, there are 782 separate medical investigations assessing the efficacy of Talimogene Laherparepvec with 86 trials in Phase 3. A majority of these tests occur in Pittsburgh, PA; however, a total of 42954 clinical trial sites exist across the world that offer this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted

2019. "Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04185311.