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PVX-410

Phase 1

Breast Cancer | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Oct 1, 2025

Development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jul 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

PVX-410 · 1 trial · 1 indication

Phase 1 1
NCT02826434Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast CancerBreast Cancer
ACTIVE NOT_RECRUITING22 Analytics
PHASE1ACTIVE NOT_RECRUITING
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose Limiting Toxicity Rate of PVX-410 in Combination With Durvalumab
4 Weeks

To assess the safety of the vaccine and PDL1 inhibitor.

Secondary Endpoints

Immune Response Rate of cluster designation 8 (CD8)+ Cytotoxic T Lymphocytes (CTLs) to Vaccine-Specific Peptides
14 weeks from first dose
Disease-Free Survival
Up to approximately 5 years
Adverse events according to Common Toxicology Criteria for Adverse Events (CTCAE 4.0) will be assessed for the PVX-410 vaccine regimen alone versus PVX-410 vaccine regimen plus durvalumab
From the start of treatment until 30 days after the end of treatment, up to approximately 14 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PVX-410 and DurvalumabEXPERIMENTALEach patient will receive 6 PVX-410 vaccine injections and 2 infusions of Durvalumab. * The injection of PVX-410 will be co-administered with Hiltonol every 2 weeks for 6 injections. * The infusion of Durvalumab will be given on the day of the 4th and 6th PVX-410 injection, for a total of 2 infusions.

Interventions

NameTypeDescription
PVX-410BIOLOGICALThis is a Vaccine that will be injected intramuscularly as a mixture with an adjuvant.
DurvalumabBIOLOGICALThis is an intravenous infusion of a monoclonal antibody.
HiltonolDRUGThis is an intramuscular injection of an adjuvant to enhance the immune response to vaccine.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Written informed consent and any locally-required authorization obtained from the patient prior to performing any protocol-related procedures, including Screening evaluations. * Females, ≥18 years at time of study entry. * HLA-A2 positive by deoxyribonucleic acid (DNA) sequenc...

Countries:United States
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