PVX-410 + Durvalumab for Triple Negative Breast Cancer

Palo Alto (17 mi)

Overseen bySteven Isakoff, MD, PhD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Massachusetts General Hospital

Stay on your current meds

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this research study is to evaluate Immunotherapy with a peptide vaccine and Programmed Death Ligand 1 (PD-L1) inhibitor as a possible adjuvant treatment for Stage II or III Triple Negative Breast Cancer. This research study is studying the safety, tolerability, and immune response of these treatments. The names of the study interventions involved in this study are: * PVX-410 Vaccine * Durvalumab (MEDI4736)

Eligibility Criteria

This trial is for women over 18 with Stage II or III Triple Negative Breast Cancer who've finished their planned cancer therapy. They must not have HIV, hepatitis B/C, autoimmune diseases, or certain medical conditions that could affect the study. Participants need to be HLA-A2 positive and willing to use birth control if they can have children.

Inclusion Criteria

My genetic test shows I am HLA-A2 positive.

My breast cancer is triple negative, not responding to hormones or HER2.

I have finished all treatments for Stage II or III triple-negative breast cancer.

I am fully active or can carry out light work.

I am not pregnant or cannot become pregnant.

Exclusion Criteria

My cancer is stage IV, confirmed by tests.

I am currently undergoing or planning to start cancer treatment soon.

I have or had Crohn's disease or ulcerative colitis.

I received my last cancer treatment less than 4 weeks ago, or more than 6 months ago.

I have no lasting side effects from cancer treatment above mild.

I have been treated with a PD1 or PD-L1 inhibitor before.

My cancer has a type known for better outcomes.

I have or had an autoimmune disease that needed treatment.

I haven't taken immunosuppressive drugs in the last 28 days, except for allowed ones.

I have received an organ transplant from another person.

I have not received a live vaccine within the last 30 days.

I have been previously diagnosed with tuberculosis.

I weigh less than 30 kg.

Treatment Details

The trial tests a combination of PVX-410 vaccine and Durvalumab (MEDI4736), a PD-L1 inhibitor, as additional treatment after standard care for breast cancer. It aims to assess safety, tolerability, and how well the immune system responds to these treatments in patients.

1Treatment groups

Experimental Treatment

Group I: PVX-410 and DurvalumabExperimental Treatment3 Interventions

Each 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.