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Alkylating agents
Nivolumab + Chemotherapy for Triple-negative Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Mateusz Opyrchal, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 3 years and 12 weeks)
Awards & highlights
Study Summary
This trial is testing a new treatment for early stage triple-negative breast cancer. The hypothesis is that the new treatment will decrease tumor associated macrophages and increase tumor infiltrating lymphocytes, compared to the current standard of care. If the hypothesis is correct, this could improve clinical outcomes for patients with early stage triple-negative breast cancer.
Who is the study for?
This trial is for adults with early stage triple-negative breast cancer who are fit (ECOG ≤ 1), have not had previous treatments, and whose organs function normally. They must be able to consent, follow the study plan, and agree to use contraception if of childbearing potential. Exclusions include certain autoimmune diseases, other cancers unless in remission under conditions, uncontrolled illnesses or infections, recent immunosuppressants use or major surgery.Check my eligibility
What is being tested?
The trial tests if adding nivolumab to standard neoadjuvant chemotherapy before surgery can change immune cells in tumors (decrease TAMs and increase TILs) compared to just chemotherapy alone. This could potentially improve outcomes for patients with localized triple-negative breast cancer.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects like inflammation in various organs including the lungs and intestines, skin reactions, hormone gland problems (like thyroid issues), infusion reactions; fatigue; blood disorders; increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or have some restrictions but can still care for myself.
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My blood tests for bone marrow and organ function are normal.
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I have not received any treatment for my current illness.
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My breast cancer is at stage II or III, and I am eligible for treatment before surgery to remove the cancer.
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My breast cancer is ER-/HER2- and confirmed by tests.
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My tumor is at least 2 cm big.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 3 years and 12 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 3 years and 12 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neoplasms
Percent change in tumor infiltrating lymphocytes (TILs)
Safety of the regimen as measured by incidence of adverse events (safety lead-in only)
Secondary outcome measures
Therapeutic procedure
Compare the percent change of tumor associated macrophages (TAMs) between participants who achieve pCR versus those who do not
Neoplasms
+2 moreSide effects data
From 2019 Phase 1 trial • 19 Patients • NCT0315827267%
Aspartate aminotransferase increased
67%
Pyrexia
67%
Blood creatine phosphokinase increased
33%
Alanine aminotransferase increased
33%
Bladder disorder
33%
Periorbital oedema
33%
Anaemia
33%
Abdominal pain
33%
Cough
33%
Rash maculo-papular
33%
Tumour pain
33%
Fatigue
33%
Rash
33%
Blood alkaline phosphatase increased
33%
Upper limb fracture
33%
Blood creatinine increased
33%
Lipase increased
33%
Arthralgia
33%
Neuropathy peripheral
33%
Dyspnoea
33%
Constipation
33%
Herpes zoster
33%
Amylase increased
33%
Nausea
33%
Anorectal disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
M1 Cohort
M2 Cohort
C1 Cohort
C2 Cohort
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Neoadjuvant chemo + nivolumab + cabiralizumabExperimental Treatment7 Interventions
As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given.
Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.
Group II: Arm A: Neoadjuvant chemo + nivolumabActive Control6 Interventions
-Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood draw
2021
Completed Phase 4
~6290
Tumor biopsy
2014
Completed Phase 2
~240
Nivolumab
2014
Completed Phase 3
~4750
Cabiralizumab
2018
Completed Phase 2
~620
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,694 Total Patients Enrolled
47 Trials studying Breast Cancer
5,168 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,499 Total Patients Enrolled
51 Trials studying Breast Cancer
8,265 Patients Enrolled for Breast Cancer
Mateusz Opyrchal, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
1 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that causes abnormal bleeding or blood clotting.I had cancer other than breast cancer but meet the survivor criteria.I haven't taken any immune-weakening drugs in the last 2 weeks.You have certain autoimmune diseases, but controlled Type 1 diabetes and some skin conditions are okay.I have a history of chronic hepatitis or tested positive for latent tuberculosis.I currently have an infection that is not under control.I have previously received immunotherapy for my cancer.I am willing and able to follow the trial's schedule and tests.There are certain conditions that apply to patients who have HIV.I am 18 years old or older.You have had an autoimmune disease in the past or are at risk of developing one.I do not have serious heart problems.I have a history of lung conditions.I am fully active or have some restrictions but can still care for myself.My cancer has spread to other parts of my body.I have cancer in both breasts.I have not had major surgery in the last 28 days.I have had a bone marrow or organ transplant in the past.I need treatment for fluid buildup in my abdomen.My blood tests for bone marrow and organ function are normal.I have not received any treatment for my current illness.My breast cancer is at stage II or III, and I am eligible for treatment before surgery to remove the cancer.My breast cancer is ER-/HER2- and confirmed by tests.My tumor is at least 2 cm big.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Neoadjuvant chemo + nivolumab + cabiralizumab
- Group 2: Arm A: Neoadjuvant chemo + nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the sample size of this experiment?
"Affirmative, according to the clinicaltrials.gov database this trial is in need of applicants and posted on November 19th 2020 with their last update occurring October 19th 2022. Thirty-one participants are needed from a single location for completion."
Answered by AI
What medical conditions is Cabiralizumab typically prescribed to treat?
"Cabiralizumab is a commonly used medication to treat malignant neoplasms. Additionally, it can be effective at quelling conditions such as unresectable melanoma and squamous cell carcinoma in addition to reducing the risk of recurrence."
Answered by AI
Have there been any other research projects that have utilized Cabiralizumab?
"Currently, 1827 studies are underway for Cabiralizumab. Of those clinical trials, 400 are in the final stage of testing (phase 3). Although many experiments take place in Shanghai and its surrounding areas, 98622 medical centres across the globe have launched investigations into this drug's efficacy."
Answered by AI
Are there any recruitment opportunities for this experiment currently on offer?
"According to data found on clinicaltrials.gov, this research trial is actively recruiting participants. It was posted in November 2020 and most recently updated in October 2022; 31 patients are needed from one medical centre."
Answered by AI
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