Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic 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: 18 weeks, 1 year
- Procedures mentioned: Biopsies, Urine samples, MRI scans, CT scans
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
- "Biomarkers of response to therapy will be assessed based on the research biopsies performed at baseline, following the chemotherapy run-in (Part A) and following nab-paclitaxel + durvalumab (MEDI4736) + tremelimumab +/- neoantigen vaccine (Part B)."
- "Treatment repeats every 21 days for up to 18 weeks (6 cycles) in the absence of disease progression or unacceptable toxicity."
- "Patients undergo tumor biopsy, blood and urine sample collection, computed tomography (CT) scan and magnetic resonance imaging (MRI) on study."
- "After completion of study treatment, patients are followed up every 3 months for 1 year, then annually thereafter."
- 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 is for adults with triple negative breast cancer that has spread to other parts of the body. It tests whether adding a vaccine made for each patient to chemotherapy with nab-paclitaxel and two immune treatments, durvalumab and tremelimumab, works better than these treatments alone.
This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.
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 years old and have triple negative breast cancer that has spread. Tumor tests must show low or no ER and PR hormone receptors and negative HER2 and PD-L1 results.
- Have cancer that doctors can measure or check, and enough tumor tissue for testing. A new biopsy, which removes a tissue sample, may be needed.
- Have had no treatment for triple negative breast cancer that has spread. If you had taxane chemotherapy after surgery, you must have stayed cancer-free for at least 12 months after it ended.
- Be able to do most daily activities, weigh more than 30 kg (about 66 pounds), and be expected to live at least 12 weeks.
- Meet the study’s blood count, liver, and kidney test requirements.
- If you could become pregnant, have a negative pregnancy test and agree to use birth control during the study and for 180 days after durvalumab and tremelimumab end.
- If you have HIV, have no virus detected in your blood, a CD4 immune cell count above 250, and a stable HIV treatment plan.
- Be willing and able to follow study visits and treatments and give written consent. A caregiver or legal guardian may consent for someone who cannot make this decision.
Who can't join
- Cannot receive carboplatin plus gemcitabine as the first treatment for your cancer that has spread.
- Had certain cancer treatments within 30 days, or 42 days for some drugs, or had immune treatment for cancer that has spread.
- Still have moderate or worse side effects from past cancer treatment. Some exceptions apply; hormone-related side effects must be stable on replacement treatment for at least 2 weeks.
- Are taking another experimental treatment or received one within the past 30 days.
- Received a live vaccine within 6 months before study entry or within 30 days of durvalumab and tremelimumab. Live vaccines are also not allowed during treatment or for 30 days afterward.
- Had major surgery within 28 days before the first dose. Some surgery to relieve symptoms is allowed.
- Used medicine that weakens the immune system within 14 days before the first dose. Some steroid uses are allowed.
- Have pressure on the spinal cord, active cancer spread to the brain, or cancer in the lining around the brain and spinal cord. Some treated brain tumors may be allowed, but the supplied rules for this exception are cut off.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Patients must have a histologically confirmed diagnosis of metastatic invasive triple negative breast cancer. Patients with clinical and/or radiologic suspicion of metastatic TNBC can be consented prior to this confirmation. * Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 OR less than 1% positive staining cells in the invasive component of the tumor. * HER2 negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+. * PD-L1 negative by a Clinical Laboratory Improvement Act (CLIA) approved laboratory using compatible assays appropriate for treatment decisions. * Patients may have measurable or evaluable disease. * Patients must be willing to undergo biopsy and have accessible lesions for a new biopsy, or they must have sufficient tissue available from a biopsy performed for standard of care (specifications below). If patient does not have enough archived tissue available, a new biopsy is required. A tumor specimen obtained from relapsed primary, metastatic, or locally advanced sites of disease (if applicable) must be submitted. Acceptable samples include core needle biopsies for deep tumor tissue (minimum 4 cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Formalin-fixed, paraffin-embedded (FFPE) tumor specimens in paraffin blocks are preferred; FFPE tumor tissue sections on slides may be provided if sufficient material (15 x 10μ, unstained) is available. Fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable. * No prior therapy for metastatic TNBC. Patients who have received taxane-based adjuvant therapy are required to have a disease-free interval of at least 12 months after completion of taxane therapy. * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of durvalumab (MEDI4736) and tremelimumab in combination with neoantigen vaccine in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 60%). * Body weight \> 30 kg. * Must have a life expectancy of at least 12 weeks. * Absolute neutrophil count \>= 1,500/mcL. * Platelets \>= 100,000/mcL. * Hemoglobin \>= 9.0 g/dL. * Serum bilirubin =\< 1.5 x institutional upper limit of normal. * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =\< 5 x institutional upper limit of normal. * Calculated creatinine clearance \> 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance. * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: * Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). * Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). * The effects of durvalumab (MEDI4736) and tremelimumab and neoantigen vaccine on the developing human fetus are unknown. For this reason and because these agents may be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 180 days after completion of durvalumab (MEDI4736) and tremelimumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * Human immunodeficiency virus (HIV)-positive patients are eligible provided they have a negative viral load, CD4 count \> 250, and are on a stable antiretroviral regimen. * Ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity who have a close caregiver or legal guardian are also eligible with the consent of the caregiver/guardian. Exclusion Criteria: * Patients who are not considered to be candidates for carboplatin + gemcitabine for first line therapy of their metastatic triple negative breast cancer are not eligible. * Patients who have had chemotherapy, radiotherapy (to more than 30% of the bone marrow), or biologic therapy within 30 days (42 days for nitrosoureas or mitomycin C) prior to entering the study. * Patients who have received prior immunotherapy for metastatic disease. * Patients who have not recovered from grade \>= 2 adverse events due to prior anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. * Patients with grade \>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician. * Patients with grade \>= 2 endocrinological adverse events (AEs), (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus), must have been on a stable dose of supplemental therapy for at least 2 weeks before screening to be eligible for this study, and the endocrinological AE must be stable in the opinion of the treating physician. * Patients who are receiving any other investigational agents or who have received an investigational agent within the last 30 days. * Receipt of live attenuated vaccination within 6 months prior to study entry or within 30 days of receiving durvalumab (MEDI4736) and tremelimumab. * Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment. * Major surgical procedure within 28 days prior to the first dose of durvalumab (MEDI4736) and tremelimumab. Local surgery of isolated lesions for palliative intent is acceptable. * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab (MEDI4736) or tremelimumab. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids or local steroid injections (e.g. intra-articular injection) * Systemic corticosteroids at physiological doses which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid * Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication) * Steroids for symptoms from brain metastases as defined. * Spinal cord compression or active brain metastases and/or carcinomatous meningitis. Subjects who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to registration are eligible if they meet all of the following criteria: * Residual neurological symptoms have resolved to grade =\< 2 * On stable doses of dexamethasone, if applicable and if acceptable in the opinion of the treating physician * Follow-up MRI performed after surgery or completion of radiation therapy and prior to registration shows no new lesions. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab (MEDI4736) and tremelimumab. Known allergy, or history of serious adverse reaction to vaccines, such as anaphylaxis, hives or respiratory difficulty. * Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) \>= 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 \[+/- 3\] minutes apart). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, evidence of any acute or chronic viral illness or disease, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because durvalumab (MEDI4736) and tremelimumab has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with durvalumab (MEDI4736) and tremelimumab, breastfeeding should be discontinued if the mother is treated with durvalumab (MEDI4736) and tremelimumab. These potential risks may also apply to other agents used in this study. A negative serum pregnancy test is required no more than 7 days before study entry. * 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. * History of pneumonitis or interstitial lung disease. * History of active primary immunodeficiency. * Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis \[TB\] testing in line with local practice), hepatitis B (known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). * The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met: * Patient has undergone potentially curative therapy for all prior malignancies. * Patients have been considered disease free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix). * Patients with a strong likelihood of non-adherence (such as difficulties in adhering to follow-up schedule due to geographic distance from the treatment facility) should not be knowingly registered. * History of allogeneic organ transplantation.
Study sites (30)
CA
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, CA 92868More trials in Orange
- University of California Davis Comprehensive Cancer Center · Sacramento, CA 95817More trials in Sacramento
CO
- UCHealth University of Colorado Hospital · Aurora, CO 80045Site Public Contact · Study contact · 720-848-0650Jennifer R. Diamond · Principal investigatorMore trials in Aurora
CT
- Smilow Cancer Hospital Care Center at Saint Francis · Hartford, CT 06105More trials in Hartford
- Yale University · New Haven, CT 06520More trials in New Haven
FL
- UM Sylvester Comprehensive Cancer Center at Aventura · Aventura, FL 33180Site Public Contact · Study contact · 954-461-2180Alejandra T. Perez · Principal investigatorMore trials in Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, FL 33146Site Public Contact · Study contact · 305-243-2647Alejandra T. Perez · Principal investigatorMore trials in Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, FL 33442Site Public Contact · Study contact · 305-243-2647Alejandra T. Perez · Principal investigatorMore trials in Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, FL 33136Site Public Contact · Study contact · 305-243-2647Alejandra T. Perez · Principal investigatorMore trials in Miami
- UM Sylvester Comprehensive Cancer Center at Kendall · Miami, FL 33176Site Public Contact · Study contact · 305-243-2647Alejandra T. Perez · Principal investigatorMore trials in Miami
- UM Sylvester Comprehensive Cancer Center at Plantation · Plantation, FL 33324Site Public Contact · Study contact · 305-243-2647Alejandra T. Perez · Principal investigatorMore trials in Plantation
- Moffitt Cancer Center-International Plaza · Tampa, FL 33607Site Public Contact · Study contact · 800-679-0775 · ClinicalTrials@moffitt.orgAixa E. Soyano · Principal investigatorMore trials in Tampa
- Moffitt Cancer Center - McKinley Campus · Tampa, FL 33612Site Public Contact · Study contact · 800-679-0775 · ClinicalTrials@moffitt.orgAixa E. Soyano · Principal investigatorMore trials in Tampa
- Moffitt Cancer Center · Tampa, FL 33612Site Public Contact · Study contact · 800-679-0775 · ClinicalTrials@moffitt.orgAixa E. Soyano · Principal investigatorMore trials in Tampa
- Moffitt Cancer Center at Wesley Chapel · Wesley Chapel, FL 33544Site Public Contact · Study contact · 800-679-0775 · ClinicalTrials@moffitt.orgAixa E. Soyano · Principal investigatorMore trials in Wesley Chapel
MD
- Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, MD 21287Site Public Contact · Study contact · 410-955-8804 · jhcccro@jhmi.eduCesar A. Santa-Maria · Principal investigatorMore trials in Baltimore
MO
- Siteman Cancer Center at Saint Peters Hospital · City of Saint Peters, MO 63376Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduWilliam E. Gillanders · Principal investigatorMore trials in City of Saint Peters
- Siteman Cancer Center at West County Hospital · Creve Coeur, MO 63141Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduWilliam E. Gillanders · Principal investigatorMore trials in Creve Coeur
- Washington University School of Medicine · St Louis, MO 63110Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduWilliam E. Gillanders · Principal investigatorMore trials in St Louis
- Siteman Cancer Center-South County · St Louis, MO 63129Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduWilliam E. Gillanders · Principal investigatorMore trials in St Louis
- Siteman Cancer Center at Christian Hospital · St Louis, MO 63136Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduWilliam E. Gillanders · Principal investigatorMore trials in St Louis
NC
- Wake Forest University at Clemmons · Clemmons, NC 27012Site Public Contact · Study contact · 888-716-9259Emily H. Douglas · Principal investigatorMore trials in Clemmons
- Wake Forest University Health Sciences · Winston-Salem, NC 27157Site Public Contact · Study contact · 336-713-6771Emily H. Douglas · Principal investigatorMore trials in Winston-Salem
NH
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center · Lebanon, NH 03756More trials in Lebanon
NY
- NYP/Weill Cornell Medical Center · New York, NY 10065Site Public Contact · Study contact · 212-746-1848Massimo Cristofanilli · Principal investigatorMore trials in New York
OH
- Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Site Public Contact · Study contact · 800-293-5066 · Jamesline@osumc.eduKai C. Johnson · Principal investigatorMore trials in Columbus
OK
- University of Oklahoma Health Sciences Center · Oklahoma City, OK 73104More trials in Oklahoma City
PA
- UPMC Hillman Cancer Center · Pittsburgh, PA 15232Site Public Contact · Study contact · 412-647-8073Julia Foldi · Principal investigatorMore trials in Pittsburgh
TX
- University of Texas Medical Branch · Galveston, TX 77555-0565Site Public Contact · Study contact · 409-772-1950 · clinical.research@utmb.eduAvi B. Markowitz · Principal investigatorMore trials in Galveston
VA
- VCU Massey Comprehensive Cancer Center · Richmond, VA 23298Site Public Contact · Study contact · 804-628-6430 · CTOclinops@vcu.eduMasey M. Ross · Principal investigatorMore trials in Richmond