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Personalized Cancer Vaccine (PCV) Strategy in Triple Negative Breast Cancer Patients

ConditionTriple Negative Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine (PCV) strategy with or without CD8-selective IL-2 mutein fusion protein in patients with triple negative breast cancer undergoing neoadjuvant chemoimmunotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

T1c, N1-N2

T2, N0-N2

T3, N0-N2

At least 18 years of age.

Disqualifiers

Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.

Received prior chemotherapy, targeted therapy, or radiation therapy within the past 12 months.

Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor.

Currently receiving any other investigational agents.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Paclitaxel

    Drug

    As part of the KEYNOTE 522 Regimen, given per standard of care.

  • Carboplatin

    Drug

    As part of the KEYNOTE 522 Regimen, given per standard of care.

  • Pembrolizumab

    Drug

    As a part of the KEYNOTE 522 Regimen, given per standard of care. Adjuvant pembrolizumab will be given per standard of care.

  • Doxorubicin

    Drug

    As part of the KEYNOTE 522 Regimen, given per standard of care.

  • Cyclophosphamide

    Drug

    As part of the KEYNOTE 522 Regimen, given per standard of care.

  • Personalized cancer vaccine (PCV)

    Biological/Vaccine

    PCV is given intra-muscular (IM). Each PCV will consists of up to 4 separate injections, with each syringe containing peptides from one of the up to four peptide pools combined with adjuvant poly-ICLC.

  • AB248

    Drug

    AB248 is given intravenously (IV) over 30 minutes at the recommended dose.

  • pVAC tools neoantigen prediction algorithm

    Other intervention

    The pVACtools suite of software tools will be used to identify and prioritize cancer neoantigens based on neoantigen identification algorithms.

  • poly-ICLC

    Drug

    Poly-ICLC is mixed with the personalized cancer vaccine (PCV). The PCV is given intramuscularly (IM) at 1mg dose.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm 1: Neoadjuvant SOC KEYNOTE 522 + Adjuvant PCV + PembrolizumabExperimental treatment 8 interventions
Group B: Arm 2: Neoadjuvant SOC KEYNOTE 522 + Adjuvant PCV + Pembrolizumab+AB248Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Treatment-emergent adverse events (TEAEs)

Treatment-emergent adverse events (TEAEs) will be assessed via CTCAE v6.

Time frame
Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days)
2

Treatment-related adverse events (TRAEs)

Treatment-related adverse events (TRAEs) will be assessed via CTCAE v6.

Time frame
Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days)
3

Serious adverse events (SAEs)

Serious adverse events (SAEs) will be assessed via CTCAE v6.

Time frame
Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days)
4

Feasibility as determined by number of enrolled patients with triple negative breast cancer

Defined as enrolling 24 evaluable patients in 36 months.

Time frame
Completion of enrollment (1 day for patient)

Secondary outcomes

1

Immune response as evaluated by ELISPOT analysis.

Samples will be drawn at Step 0 enrollment, day 1, day 15, day 22, day of surgery, day 43, day 64, day 85, and patients randomized to Arm 2 will have an optional draw at Year 1 follow-up.

Time frame
Step 0 Enrollment to 12 months after PCV completion (estimated time of 18 months and 85 days)
2

Recurrence-free survival (RFS)

Recurrence-free survival is defined as the rate of disease recurrence from Step 1 enrollment until disease recurrence per standard of care assessments or until patient is off study, whichever occurs first.

Time frame
Step 1 enrollment through completion of follow up (estimated time of 5 years and 85 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: