Back to resultsPhase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer
Primary Purpose
Metastatic Triple-Negative Breast Carcinoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PVX-410
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Triple-Negative Breast Carcinoma
Eligibility Criteria
Inclusion Criteria:
- HLA A2 Positive PDL1 Positive Treatment naive, triple negative breast cancer
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PVX-410/pembrolizumab/chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Progression Free Survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04634747
Brief Title
Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer
Official Title
A Single-Arm, Open-Label, Multi-Center Phase II Study to Evaluate the Combination of PVX-410 + Pembrolizumab + Chemotherapy for Frontline Therapy of Metastatic, PD-L1+ Triple-Negative Breast Cancer (TNBC) in HLA-A2-Positive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2022 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncoPep, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluating the combination of the investigational, multi-peptide cancer vaccine PVX-410 in combination with pembrolizumab and chemotherapy in treatment naive patients with metastatic, triple negative breast cancer who are PDL1 and HLA A2 positive.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Triple-Negative Breast Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PVX-410/pembrolizumab/chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PVX-410
Intervention Description
PVX-410 in combination with pembrolizumab and chemotherapy
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- HLA A2 Positive PDL1 Positive Treatment naive, triple negative breast cancer
Exclusion Criteria:
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer
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