ClinicalTrials.gg
Status unknownNCT04634747Updated Apr 20, 2022

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

A Phase 2 interventional study of PVX-410 in Metastatic Triple-Negative Breast Carcinoma, sponsored by OncoPep, Inc.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-20.

Sponsored by OncoPep, Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Metastatic Triple-Negative Breast Carcinoma
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In context

Triple Negative Breast Neoplasms

1,163 studies on the registry are indexed under Triple Negative Breast Neoplasms; 447 are open to participants now.

This study's planned enrollment of 53 is below the median of 61 across 1,001 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

OncoPep, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (estimated)

Study arms

  • Experimental
    PVX-410/pembrolizumab/chemotherapy

    Drug: PVX-410

Interventions

  • PVX-410 in combination with pembrolizumab and chemotherapy

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What researchers measure

Primary outcomes

  1. Progression Free Survival

    Time frame: 8 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04634747
Lead sponsor
OncoPep, Inc.
Responsible party
Sponsor
First posted
Nov 18, 2020
Start date
Apr 30, 2022 (estimated)
Primary completion
Apr 1, 2023 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Apr 20, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: XBP1-US/XBP1-SP/CD138/CS1 Multipeptide Vaccine PVX-410

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