Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer
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
- Time periods mentioned: 5 years
- Procedures mentioned: Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "MO-03 will be given at a dose of 4 x 10e9 CFU per capsule, 1 capsule taken orally twice daily."
- "Post-surgery, patients will come in for a 2-week follow-up and then enter survival follow-up annually for 5 years."
- 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 MO-03, a pill containing live microbes, with chemotherapy and pembrolizumab for high-risk, early-stage triple-negative breast cancer. It is for adults age 18 or older. Patients take MO-03 twice a day until the day before breast surgery.
This is a single-arm and single site phase II trial combination of chemotherapy and pembrolizumab with LBP MO-03 in 50 trial participants with early triple negative breast cancer. MO-03 will be given at a dose of 4 x 10e9 CFU per capsule, 1 capsule taken orally twice daily. Patients will receive standard of care pembrolizumab 200 mg every 3 weeks in concurrent with a regimen of chemotherapy. Please refer to Table 2 for a summary of the chemo-immunotherapy with pembrolizumab containing regimens. Patients will continue to take MO-03 up until the day prior to surgery (lumpectomy or mastectomy). Post-surgery, patients will come in for a 2-week follow-up and then enter survival follow-up annually for 5 years.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older; men and women may join.
- Have high-risk, early-stage triple-negative breast cancer that meets the study’s tumor and lymph node rules and has not spread to distant parts of the body.
- Agree to provide tumor tissue from the first biopsy and any cancer left at surgery.
- Be fully active or able to do light work despite some limits on hard physical activity.
- Have organs that work well enough, based on tests within 28 days before treatment.
- For one treatment plan, have adequate heart function, including a heart pumping test result of at least 50%.
- If able to become pregnant, have a negative pregnancy test and use birth control during treatment and for 120 days after the last MO-03 dose. Men must use birth control and not donate sperm during this time.
- Sign a consent form and be able to follow the study’s rules.
Who can't join
- Have uncontrolled diabetes or high blood pressure, recent major surgery or severe infection within the study’s 14-day limits, or another condition that makes the study unsafe.
- Have HIV without effective treatment and an undetectable virus level, or chronic hepatitis B without the required virus control. Active tuberculosis also rules out joining.
- Have had treatment for this breast cancer, including cancer drugs, breast surgery, or radiation; have ever used an immune checkpoint inhibitor; or have recent use of an experimental drug or device.
- Have certain immune system problems, use immune-suppressing medicines, have an autoimmune disease needing body-wide treatment in the past 2 years, or have certain lung inflammation. Some hormone replacement treatments are allowed.
- Use warfarin, other live microbe treatments, or probiotic pills; receive a live vaccine during the restricted period; or have an allergy to a study drug or its ingredients.
- Be pregnant, breastfeeding, or planning to become pregnant or father a child through 120 days after the last trial treatment.
- Have a past cancer that does not meet the allowed exceptions, active cancer in the brain or its lining, or a transplant of tissue or an organ from another person. Some treated, stable brain cancers are allowed.
- Have a mental health or substance use problem that would prevent following the study’s rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Female or male age ≥ 18 years of age. * Patients with high-risk early stage triple negative breast cancer. Triple negative status will be defined as ER≤10%, PR≤10%, HER2 negative (by FISH) per ASCO-CAP guidelines. * Clinically staging T1c any N M0 or any T N1-3 M0. * Willing to provide FFPE from baseline standard of care biopsy and post-treatment residual tumor at the time of surgery. * ECOG 0-1 * Patients must have adequate organ function as defined in the following. Specimens must be collected within 28 days prior to the start of study treatment. * For patients who will receive regimen 1 only: Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction ≥ 50% as assessed by either ECHO or MUGA within 28 days prior to the start of treatment. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better. * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 28 days of the start of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of MO-03 and refrain from donating sperm during this period. * Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies: i. Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR ii. Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose of MO-03. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration. * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated. Note: No testing for Hepatitis B is required unless mandated by local health authority. * Participant must not have uncontrolled diabetes or hypertension in the opinion of treating investigator. * Participant must not have had a major surgery within 14 days prior to screening. * Participant must not have severe infection within 14 days prior to enrollment. * Prohibited Treatments and/or Therapies: * Any prior chemotherapy, biological therapy, immunotherapy for the current breast cancer diagnosis prior to start of study intervention * Prior use of immune checkpoint inhibitor is prohibited * Prior breast surgery or radiation therapy for current invasive breast cancer * Participants must not have a diagnosis of immunodeficiency and be 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 enrollment. * Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to enrollment (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroidreplacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Participants must not have a history of (non-infectious) pneumonitis that required steroids or has current (non-infectious) pneumonitis. * Any live vaccine within 30 days prior to the first dose of study drug and for 3 months after chemo-immunotherapy. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. * Participants on any dose of warfarin. Use of low molecular weight heparin, antithrombin agents, anti-platelet agents or factor Xa inhibitors is allowed * Participants may not use any other live biotherapeutic products (LBP) or supplementary use of probiotics in pill form during their participation in the study (e.g., Ferring's Rebyota, Vowst) * Participants may not be currently participating in or participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. * Known allergy to any of the components within the study agents and/or their excipients (i.e., corn starch, lactose, microcrystalline cellulose, croscarmellose sodium or magnesium stearate). * Medical history and concurrent diseases: * Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least five years * Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (Note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis * Known history of active TB (Mycobacterium tuberculosis) * Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g., recovery from major surgery, completion of treatment for severe infection). * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Has had an allogenic tissue/solid organ transplant.
Study sites (3)
CA
- Cedars-Sinai Medical Center Beverly Hills · Beverly Hills, CA 90211Clinical Trial Recruitment Navigator · Study contact · 310-423-5842 · GroupCancerTrialInformation@cshs.orgYuan Yuan, MD · Principal investigatorPhilomena McAndrew, MD · Sub-investigatorKarissa Britten, MD · Sub-investigatorMore trials in Beverly Hills
- CS Cancer at Valley Oncology Medical Group · Tarzana, CA 91356Ryan Ponec, MD · Sub-investigatorNatasha Banerjee, MD · Sub-investigatorMazen Jizzini, MD · Sub-investigatorMore trials in Tarzana
- Hunt Cancer Institute, an Affiliate of CS Cancer · Torrance, CA 90505Sarah Valdez · Study contact · 3107503300 ext. 73422 · sarah.valdez@tmphysicians.comDavid Chan, MD · Sub-investigatorVanessa Dickey, MD · Sub-investigatorHugo Hool, MD · Sub-investigatorMore trials in Torrance