Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted
NCT04185311 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2023-08-15
Summary
This phase I trial studies talimogene laherparepvec given together with ipilimumab and nivolumab before surgery in patients with triple-negative or estrogen receptor positive, HER2 negative localized breast cancer. Ipilimumab and Nivolumab are immune checkpoint inhibitors that enhance immune response towards cancer cells. Talimogene laherparepvec is a modifies human herpes virus 1 that is an oncolytic virus targeting cancer cells and makes tumor microenvironment more immunogenic to promote immune response against cancer. This study will assess the safety and efficacy of talimogene laherparepvec, ipilimumab, and nivolumab, and provide an insight for further improvement of immunotherapy in breast cancer.
Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- HER2/Neu Negative
- Invasive Ductal Carcinoma, Not Otherwise Specified
- Progesterone Receptor Negative
- Prognostic Stage 0 Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Triple-Negative Breast Carcinoma
Interventions
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Talimogene Laherparepvec
Given intratumorally
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Jonsson Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
John A Glaspy · UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-10
- Primary Completion
- 2023-05-17
- Completion
- 2023-05-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of Pembrolizumab and Cryoablation in People With Breast Cancer
NCT06246968 ·Status: RECRUITING ·Phase: PHASE1
-
Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer
NCT03599453 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/Neu-Positive Metastatic Breast Cancer
NCT00077376 ·Status: COMPLETED ·Phase: PHASE2
-
Phase IIb Study Evaluating Immunogenic Chemotherapy Combined with Ipilimumab and Nivolumab in Breast Cancer
NCT03409198 ·Status: COMPLETED ·Phase: PHASE2
-
Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer
NCT03101748 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab
NCT03135171 ·Status: COMPLETED ·Phase: PHASE1
-
Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
NCT06318897 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)
NCT04191135 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer
NCT01491737 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer
NCT06637306 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
NCT04683679 ·Status: RECRUITING ·Phase: PHASE2
-
Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer
NCT02849496 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Monoclonal Antibody Plus Chemotherapy in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2
NCT00019812 ·Status: COMPLETED ·Phase: PHASE2
-
Laboratory-Treated T Cells After Second-Line Chemotherapy in Treating Patients With HER2/Neu-Negative Metastatic Breast Cancer
NCT01022138 ·Status: TERMINATED ·Phase: PHASE2
-
Implantable Microdevice for TNBC - Pilot Study
NCT05774886 ·Status: WITHDRAWN ·Phase: PHASE1
-
NeoCARD: Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer Patients
NCT06845319 ·Status: RECRUITING ·Phase: PHASE2
-
Cryoablation, Atezolizumab/Nab-paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
NCT04249167 ·Status: WITHDRAWN ·Phase: EARLY_PHASE1
-
Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
NCT02957968 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
NCT04481113 ·Status: COMPLETED ·Phase: PHASE1
-
Trastuzumab and Flavopiridol in Treating Patients With Metastatic Breast Cancer
NCT00039455 ·Status: TERMINATED ·Phase: PHASE1
-
Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy
NCT01384253 ·Status: COMPLETED ·Phase: PHASE1
-
Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer
NCT06910072 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer
NCT05112536 ·Status: COMPLETED ·Phase: PHASE2
-
Trastuzumab and Ixabepilone in Treating Women With HER2-Positive Metastatic Breast Cancer
NCT00079326 ·Status: TERMINATED ·Phase: PHASE2
-
Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer
NCT03106077 ·Status: COMPLETED ·Phase: PHASE2