Not yet recruitingPhase 1

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

Phase 1 Clinical Trial of a Personalized Cancer Vaccine (PCV) Strategy +/- AB248 (CD8-selective IL-2 Mutein Fusion Protein) in Patients With a New Diagnosis of Triple Negative Breast Cancer Undergoing Neoadjuvant Chemoimmunotherapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests a cancer vaccine made for each patient, with or without an added drug called a CD8-selective IL-2 mutein fusion protein. It checks safety, whether the treatment can be given, and how the immune system responds. It is for adults with triple negative breast cancer who are getting chemotherapy and immune treatment before surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 with newly diagnosed triple negative breast cancer that has not spread to distant parts of the body. Allowed stages are T1c/N1–N2, T2/N0–N2, or T3/N0–N2.
  • Have enough tumor tissue to make the vaccine, or agree to a biopsy to collect it. If treatment has already started, stored tissue must be available.
  • Have good enough heart function for the KEYNOTE 522 treatment plan. At first screening, you must not have started it or have received it for no more than one month.
  • Have fewer than 10% immune cells called TILs in the tumor sample.
  • Be able to understand and agree to join in writing. A legally approved representative may give consent for you.
  • Before starting the vaccine, have received at least 4 months of KEYNOTE 522 treatment.
  • Before the vaccine, be able to do most daily activities and meet the study's blood count, liver, and kidney test limits.
  • Agree to use birth control, if applicable, before joining, during the study, and for 6 months after the last vaccine dose.

Who can't join

  • Have another cancer that could affect study safety or results; have had chemotherapy, targeted cancer drugs, or radiation in the past 12 months; or have had certain prior immune treatments. The listing separately allows KEYNOTE 522 as described above.
  • Be taking another experimental drug, or have had an allergic reaction to a drug similar to a study drug.
  • Have received a live vaccine within 30 days before the first pembrolizumab dose.
  • Have an illness where the immune system attacks the body that needed whole-body treatment in the past 2 years; have an immune deficiency; or have used immune-suppressing drugs within 7 days before pembrolizumab.
  • Have current lung inflammation called pneumonitis, past non-infectious pneumonitis that needed steroids, or an uncontrolled illness such as an infection or serious heart problem.
  • Have a known history of active tuberculosis or HIV, or hepatitis B or C that does not meet the study's virus-control rules. Treated, cured hepatitis C may be allowed.
  • Be pregnant or breastfeeding. Those who could become pregnant need a negative pregnancy test within 7 days of joining.
  • Before the vaccine, have ongoing severe side effects from KEYNOTE 522, unless the study doctors approve certain cases, or have a heart rhythm test result called QTcF above 470 milliseconds.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Step 0 Inclusion Criteria: * Newly diagnosed, previously untreated, locally advanced non-metastatic triple negative breast cancer (as defined by the most recent ASCO/CAP guidelines). Permissible staging per AJCC is as follows: * T1c, N1-N2 * T2, N0-N2 * T3, N0-N2 * At least 18 years of age. * Adequate tissue available for nucleic acid isolation/PCV design or willing to undergo biopsy if adequate tissue is not available. * Adequate cardiac function per treating physician and a candidate for the KEYNOTE 522 regimen (or receiving the KEYNOTE 522 regimen for no more than one month). Note that patients who are already receiving the KEYNOTE 522 regimen at the time of screening must have adequate archival tissue for nucleic acid isolation/PCV design (biopsy will not be permitted). * TIL percentage \< 10% (performed on SOC biopsy). * Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Step 0 Exclusion Criteria: * 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. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in the study. * Received a live vaccine within 30 days of the first dose of pembrolizumab. * Active autoimmune disease that has required systemic treatment in the past 2 years. * Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab. * History of (non-infectious) pneumonitis that required steroids, or current pneumonitis. * Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry. * Known history of active TB (bacillus tuberculosis). * Known history of HIV. * Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection. * History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection. Step 1 Inclusion Criteria: * ECOG performance status ≤ 1 within 10 days of initiation of PCV * Adequate bone marrow and organ function within 28 days of initiation of PCV as defined below: * Absolute neutrophil count ≥ 1.0 K/cumm * Platelets ≥ 100 K/cumm * Hemoglobin ≥ 8.0 g/dL * Total bilirubin ≤ 1.5 x IULN * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN * Creatinine clearance \> 30 mL/min by Cockcroft-Gault * The effects of the PCV on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after last dose of PCV. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately. * Received at least 4 months of the KEYNOTE 522 regimen. Step 1 Exclusion Criteria: * Currently receiving any other investigational agents. * Pregnant and/or breastfeeding. * Experiencing ongoing AEs related to the SOC KEYNOTE 522 regimen that have not resolved to \< grade 3. Patients may be permitted to enroll with a grade 3 AE with approval of the PI and treating physician. * QTcF \> 470 msec.

Study sites (1)

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