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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
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 • NCT0136827667%
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, 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
~2610
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
361 Previous Clinical Trials
27,742 Total Patients Enrolled
24 Trials studying Breast Cancer
1,752 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,358 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
John A GlaspyPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
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