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New treatment option for Triple Negative Breast Cancer
Official title Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients
ClinicalTrials.gov ID: NCT06353997
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, being studied as a potential treatment for triple negative breast cancer.
Also referred to as KEYTRUDA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase II trial to assess efficacy and feasibility of pembrolizumab + INBRX-106 as an induction therapy preceding neoadjuvant therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years, inclusive of all genders.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 2.
- Patients must have histologically confirmed TNBC (ER/PR ≤ 10% allowed, HER2- as defined by ASCO guidelines). HER2 negative permitted to enroll as IHC...
- Primary breast tumor measurable by ultrasound and at least 1cm.
- Clinically appropriate to receive neoadjuvant pembrolizumab plus chemotherapy (e.g. Keynote-522) planned for curative intent per standard of care (as...
You likely can't join if
- Bilateral breast cancer.
- Prior malignancies that require ongoing active therapy or are at clinically significant risk of systemic recurrence in the opinion of the...
- Suspicion for, or histologically confirmed, metastatic disease.
- Primary tumor with potential for skin ulceration or invasion of the chest wall, or with pain that would suggest rapid progression or imminent...
- Prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor...
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
See the full eligibility criteria
Who can join
- Age ≥ 18 years, inclusive of all genders.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 2.
- Patients must have histologically confirmed TNBC (ER/PR ≤ 10% allowed, HER2- as defined by ASCO guidelines). HER2 negative permitted to enroll as IHC 0, 1, or 2+ with negative ISH.
- Primary breast tumor measurable by ultrasound and at least 1cm.
- Clinically appropriate to receive neoadjuvant pembrolizumab plus chemotherapy (e.g. Keynote-522) planned for curative intent per standard of care (as indicated following study therapy however not mandated on trial for...
- Multifocal/multicentric disease is allowed. If clinically indicated per the standard of care, suspicious sites that do not appear to be part of the same disease process should be biopsied with reconfirmation of...
- No prior therapy of any kind for TNBC.
- Willingness to undergo serial ultrasounds, serial biopsies, and blood draws.
- Patients must have adequate organ function as defined below. Specimens must be collected within 28 days prior to the start of study treatment.
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100 000/µL
- Hemoglobin ≥8.0 g/dL or ≥5.0 mmol/L
- Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
- Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN. Patients with elevated LFTs that are suggestive of Gilbert's disease (a benign process) are eligible.
- AST (SGOT) and ALT (SGPT) ≤2.5 × ULN
- International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic...
- TSH and free T4 levels should be drawn within 14 days prior to start of treatment. Patients must have adequate thyroid function as demonstrated by free T4 values, regardless of TSH.
- Fertile male patients and female patients of childbearing potential must agree to avoid impregnating a partner or becoming pregnant, respectively. They must be willing to employ highly effective contraception methods...
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: Oral. Intravaginal. Transdermal.
- Progestogen-only hormonal contraception associated with inhibition of ovulation: Oral. Injectable. Implantable.
- Intrauterine device (IUD).
- Intrauterine hormone-releasing system (IUS).
- Bilateral tubal occlusion.
- Vasectomized partner. (Only considered to be highly effective contraception if he is the sole sexual partner of the female patient of childbearing potential and if the vasectomized partner has received medical...
- Sexual abstinence. (Only considered to be highly effective contraception if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of...
- WOCBP must have a negative urinary or serum pregnancy test within 72 hours prior to start of treatment. If screening serum pregnancy test collected outside of 72 hours prior to start of treatment, this may be accepted...
- To be eligible by H\&E, the tumor must have a stromal tumor infiltrating lymphocytes (sTILs) score of at least 1% on diagnostic biopsy as defined by the International TILs Working Group...
What rules you out
- Bilateral breast cancer.
- Prior malignancies that require ongoing active therapy or are at clinically significant risk of systemic recurrence in the opinion of the investigator.
- Suspicion for, or histologically confirmed, metastatic disease.
- Primary tumor with potential for skin ulceration or invasion of the chest wall, or with pain that would suggest rapid progression or imminent muscle/skin involvement in the opinion of the enrolling investigator.
- Prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137). Patients who have received these agents more...
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first...
- Received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow...
- Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled...
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Pregnant or breastfeeding.
- History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- History of allogenic tissue/solid organ transplantation.
- Has active autoimmune disease that has required systemic treatment in excess of prednisone 10mg daily or equivalent in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive...
- History or current evidence of any condition, therapy, or clinically significant laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of...
- Active infection requiring systemic therapy with the exception of UTI requiring oral antibiotic therapy and prophylactic anti-viral therapy (e.g. Acyclovir).
- Known history of Human Immunodeficiency Virus (HIV) infection.
- Known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Patients with naturally acquired...
- Any known history of active TB (Bacillus Tuberculosis).
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Portland, Oregon, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Portland, Oregon, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.