Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
IIT2021-01-Shiao-CSF1Ri: Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
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
- Female only
- 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 study tests pembrolizumab with radiation and a drug that blocks CSF-1R in women with high-risk triple-negative breast cancer. It is for women planning cancer treatment before surgery. Researchers will check whether treatment leaves no invasive cancer in the breast and lymph nodes and how safe it is.
This is an open-label prospective, single institution, Phase II study of pembrolizumab in combination with radiation therapy and CSF-1R inhibition in patients with high-risk TNBC. The primary objective is to assess the pathologic complete response (pCR) rate where pCR is defined as the absence of invasive disease in the breast and lymph nodes at the time of standard of care (SOC) treatment. Secondary objectives include evaluating the change in tumor infiltrating lymphocytes (TILs), safety and tolerability of the combination, progression-free survival, event-free survival, overall survival, and node clearance.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be a woman age 18 or older with triple-negative breast cancer confirmed by a tissue or cell test, and plan to have treatment before surgery.
- Have at least one of these: few immune cells in the tumor (sTIL score 40% or less), cancer in lymph nodes, a CPS score below 10, or PD-L1 tumor testing below 1%.
- Sign a consent form and be able to follow study rules, including research blood draws and use of stored tumor tissue.
- If stored tumor tissue is not available, agree to a new tumor biopsy taken within 42 days before radiation starts.
- Be fully active or able to do light work despite limits on hard physical activity.
- Have organs that work well enough for treatment.
- If able to become pregnant, have a negative pregnancy test or a doctor's confirmation of no pregnancy within 14 days before pembrolizumab starts.
- If able to become pregnant, follow the study's birth control rules during treatment and for 120 days after the last study dose.
Who can't join
- Cancer that has spread to distant parts of the body; active cancer in the brain or its lining is also excluded. The listing gives a limited exception for treated, stable brain tumors.
- Recent treatment: radiation or chemotherapy or targeted drugs within 2 weeks, cancer antibody drugs within 4 weeks, or research treatment or devices within 4 weeks. Lasting treatment side effects may also exclude you, with an exception for some nerve damage.
- A weak immune system; immune-suppressing drugs within 7 days; or an autoimmune disease, where the body attacks itself, needing whole-body treatment within 2 years. Hormone replacement treatment is allowed.
- A history of active tuberculosis, HIV, active hepatitis B or C, or a current infection needing whole-body treatment.
- An allergy to pembrolizumab or its ingredients; certain lung inflammation or lung-scarring diseases; a donor tissue or organ transplant; or a live vaccine within 30 days before pembrolizumab starts.
- Another cancer that grew or needed treatment in the past 5 years, except certain treated skin cancers or cervical cancer that has not spread beyond its starting layer.
- Pregnant, breastfeeding, or planning pregnancy during the study or within 120 days after the last treatment dose.
- Another health problem, test result, treatment, mental health condition, or substance use problem that could make participation unsafe, affect results, or prevent following study rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Female patients diagnosed with high-risk triple negative breast cancer (TNBC) with intent for neoadjuvant therapy. * Low tumor-infiltrating lymphocyte (TIL) score, defined as stromal TIL (sTIL) ≤40%; or node-positive; or combined positive score (CPS) \< 10 or PD-L1 tumor positivity \<1%. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study, including consent for research blood draws and use of available archived tissue. * Age ≥ 18 years of age on day of signing informed consent. * Histologically or cytologically-confirmed TNBC (defined as ER \<1%, PR\<1%, her-2-neu 0-1+ by IHC or FISH-negative). * If an archived tumor tissue is unavailable, be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1 of RT. * Have a performance status of 0 or 1 on the ECOG Performance Scale. * Demonstrate adequate organ function. * Female subject of childbearing potential should have a negative serum or urine pregnancy test or documentation of absence of pregnancy by a gynecologist within 14 days of initiating first dose of pembrolizumab (1 week lead-in) for eligibility verification. * Female subjects of childbearing potential should be willing to comply to the contraceptive guidance in Appendix 12.2 during the treatment period through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. Exclusion Criteria: * Evidence of metastatic disease. * Has received prior radiotherapy within 2 weeks of start of study intervention. * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. * Has a known history of active TB (Bacillus Tuberculosis). * Hypersensitivity to pembrolizumab or any of its excipients. * Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., \> Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., \> Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. * Has a known additional malignancy that progressed or required treatment in the last 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain parenchymal metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability. * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has known history of/active, non-infectious pneumonitis requiring treatment with steroids or has history of/active interstitial lung disease. * Has an active infection requiring systemic therapy. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. A WOCBP who has a positive urine pregnancy test within 2 weeks prior to start of study treatment (first dose of pembrolizumab). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: Negative urine or serum pregnancy test is also conducted within 72 hours prior to C1D1 for study procedures but if screening pregnancy test is done within 72 hours of C1D1, it is not required to be repeated.. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has a known history of active Hepatitis B (e.g., HBsAg reactive) or known active Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). * Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of pembrolizumab. Administration of killed vaccines is allowed. * Has had an allogenic tissue/solid organ transplant.
Study sites (1)
CA
- Cedars-Sinai Medical Center · Los Angeles, CA 90048Clinical Trial Recruitment Navigator · Study contact · cancer.trial.info@cshs.orgMore trials in Los Angeles