NCT04634747

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2022

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

November 12, 2020

Last Update Submit

April 18, 2022

Conditions

Metastatic Triple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    8 months

Study Arms (1)

PVX-410/pembrolizumab/chemotherapy

EXPERIMENTAL
Drug: PVX-410

Interventions

PVX-410DRUG

PVX-410 in combination with pembrolizumab and chemotherapy

PVX-410/pembrolizumab/chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

PVX-410 vaccine

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 18, 2020

Study Start

April 30, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2025

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share