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

Phase 2

Not yet recruiting

• Conditions: Metastatic Triple-Negative Breast Carcinoma
• Interventions: Drug: PVX-410

• Registration Number: NCT04634747
• Lead Sponsor: OncoPep, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-18
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20
• Study Start: 2022-04-30
• Primary Completion: 2023-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• HLA A2 Positive PDL1 Positive Treatment naive, triple negative breast cancer

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PVX-410/pembrolizumab/chemotherapy	PVX-410	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	8 months