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Cancer Vaccine

Vaccination of High Risk Breast Cancer Patients

Phase 1 & 2

Waitlist Available

Led By Sri Obulareddy, MD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of definitive surgery (4-8 weeks after chemo, which is between week 22 and week 25)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer vaccine called P10s-PADRE along with standard chemotherapy in patients with certain types of breast cancer. The goal is to see if the vaccine can help the immune system better fight the cancer and improve treatment outcomes.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of definitive surgery (4-8 weeks after chemo, which is between week 22 and week 25)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of definitive surgery (4-8 weeks after chemo, which is between week 22 and week 25)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of definitive surgery (4-8 weeks after chemo, which is between week 22 and week 25) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the pCR Rate

Identify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently.

Secondary study objectives

Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD16

Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD69

Activation Profiles of NK Cells: Pre-Immune and Post-Immune NKp46

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part 3 - Chemovax Schedule CExperimental Treatment4 Interventions

Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).

Group II: Part 2 - Chemovax Schedule CExperimental Treatment4 Interventions

Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).

Group III: Part 1 - Chemovax Schedule EExperimental Treatment4 Interventions

Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).

Group IV: Part 1 - Chemovax Schedule DExperimental Treatment4 Interventions

Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).

Group V: Part 1 - Chemovax Schedule CExperimental Treatment4 Interventions

Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).

Group VI: Part 1 - Chemovax Schedule BExperimental Treatment4 Interventions

Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).

Group VII: Part 1 - Chemovax Schedule AExperimental Treatment4 Interventions

Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~8030

P10s-PADRE/ MONTANIDE™ ISA 51 VG

2015

Completed Phase 2

~60