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NCT04634747 Clinical Trial

Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer

Metastatic Triple-Negative Breast Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04634747
Other study ID # 2020-001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 30, 2022
Est. completion date April 1, 2025

Study information
Verified date April 2022
Source OncoPep, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 53
Est. completion date April 1, 2025
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - HLA A2 Positive PDL1 Positive Treatment naive, triple negative breast cancer Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PVX-410
PVX-410 in combination with pembrolizumab and chemotherapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
OncoPep, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Progression Free Survival 8 months
See also
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