Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Vaccine + Chemotherapy + Immunotherapy for Breast Cancer
Phase 2
Recruiting
Led By William E Gillanders
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A tumor specimen obtained from relapsed metastatic or locally advanced 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. Fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of part b to progression or death, assessed at 6 and 12 months
Awards & highlights
Study Summary
This trial is testing how well a combination of chemotherapy drugs, immunotherapy drugs, and a personalized vaccine work in treating patients with metastatic triple negative breast cancer.
Who is the study for?
This trial is for adults with metastatic triple negative breast cancer. Participants must have a specific tumor profile (PD-L1 negative, HER2 negative, ER and PR less than Allred score of 3 or <1% positive staining), adequate organ function, no prior therapy for metastatic TNBC unless there's been a disease-free interval post-taxane therapy, and an ECOG performance status <=1. Pregnant women and those with certain medical conditions or treatments are excluded.Check my eligibility
What is being tested?
The study tests if adding a personalized vaccine to chemotherapy drugs nab-paclitaxel and carboplatin along with immunotherapy agents durvalumab and tremelimumab improves outcomes in patients with advanced triple-negative breast cancer. It compares the effects of this combination treatment both with and without the experimental neoantigen vaccine.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions from antibodies durvalumab and tremelimumab, fatigue, blood disorders like low platelet counts or anemia, increased risk of infections due to immune modulation by the treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a biopsy sample from my advanced or relapsed cancer.
Select...
I agree to use birth control or abstain from sex during and up to 180 days after the study.
Select...
My breast cancer is not driven by estrogen or progesterone.
Select...
My cancer is HER2 negative based on specific tests.
Select...
My cancer is PD-L1 negative according to an FDA-approved test.
Select...
I am 18 years old or older.
Select...
My kidney function, measured by creatinine clearance, is adequate.
Select...
I am post-menopausal or not currently pregnant.
Select...
I am mostly self-sufficient and can carry out daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initiation of part b to progression or death, assessed at 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of part b to progression or death, assessed at 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Clinical benefit rate (complete response, partial response, stable disease)
Clinical response rate
Incidence of adverse events
+1 moreOther outcome measures
Immune response
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (neoantigen vaccine, durvalumab, nab-paclitaxel)Experimental Treatment11 Interventions
PART A: Patients receive gemcitabine hydrochloride IV over 30 minutes and carboplatin IV on days 1 and 8 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients with progression of disease within the first 18 weeks may switch and receive nab-paclitaxel IV on days 1, 8, and 15 of each cycle for 2 cycles at the discretion of the treating physician.
PART B: Patients receive personalized synthetic long peptide vaccine and poly-ICLC SC on days 1, 4, 8, 15, 22, 50, and 78 in the absence of disease progression or unacceptable toxicity. Patients also receive tremelimumab IV on day 1 of cycles 1-4, durvalumab IV on day 1 of each cycle and nab-paclitaxel IV on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor biopsy, blood sample collection, CT scan and MRI on study.
Group II: Arm II (durvalumab, nab-paclitaxel)Active Control9 Interventions
PART A: Patients receive gemcitabine hydrochloride IV over 30 minutes and carboplatin IV on days 1 and 8 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with progression of disease within the first 18 weeks may switch and receive nab-paclitaxel IV on days 1, 8, and 15 of each remaining cycle.
PART B: Patients receive tremelimumab IV over on day 1 of cycles 1-4, durvalumab IV on day 1 of each cycle and nab-paclitaxel IV on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, blood sample collection, CT scan and MRI on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1730
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2720
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Tremelimumab
2017
Completed Phase 2
~3380
Carboplatin
2014
Completed Phase 3
~6670
Nab-paclitaxel
2014
Completed Phase 3
~2030
Durvalumab
2017
Completed Phase 2
~3870
Poly ICLC
2014
Completed Phase 2
~270
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,612 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
William E GillandersPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
67 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin level is at least 9.0 grams per deciliter.I do not have brain metastases or any known central nervous system disease.I haven't taken immunosuppressive drugs in the last 14 days.Your bilirubin levels in the blood should not be higher than 1.5 times the upper limit of normal.I haven't had a live vaccine in the 6 months before joining the study or within 30 days of starting treatment.Your heart's electrical activity, measured by a test called an ECG, shows a prolonged QT interval.I do not have any serious ongoing illnesses that my doctor is still trying to control.I can provide a biopsy sample from my advanced or relapsed cancer.I have triple-negative breast cancer and haven't been treated for its advanced stage. I had taxane therapy but have been disease-free for over a year.You have enough white blood cells called neutrophils.Your liver enzymes must not be too high, unless you have cancer that has spread to your liver.I agree to use birth control or abstain from sex during and up to 180 days after the study.I am willing and able to follow the study's treatment and visit schedule.I am HIV-positive with a controlled viral load, CD4 count over 250, and on stable medication.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am considered a candidate for carboplatin + gemcitabine for my metastatic triple negative breast cancer.I have recovered from serious side effects of cancer treatment, except for hair loss or skin changes.I haven't had chemotherapy, radiotherapy to a large part of my bone marrow, or biologic therapy in the last 30 days.My breast cancer is not driven by estrogen or progesterone.I am not pregnant or breastfeeding, and I have a recent negative pregnancy test.I have been cancer-free for at least a year, except for certain skin cancers or early cervical cancer.I have been diagnosed with metastatic triple negative breast cancer.My cancer is HER2 negative based on specific tests.My cancer can be measured or seen on tests.I am 18 years old or older.I do not have an active infection like TB, hepatitis B, or hepatitis C.I had cancer before, but I meet the survivor criteria for this study.My cancer is PD-L1 negative according to an FDA-approved test.My kidney function, measured by creatinine clearance, is adequate.I have received an organ transplant from another person.I have moderate to severe nerve pain or damage.You have had serious allergic reactions to drugs similar to durvalumab and tremelimumab, or to vaccines in the past.I haven't had major surgery in the last 28 days, except for minor surgeries for symptom relief.You weigh more than 30 kilograms.I have completed treatment aimed at curing any previous cancers.I am post-menopausal or not currently pregnant.I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.I have received immunotherapy for my cancer after it spread.Your platelet count is at least 100,000 per microliter.I am mostly self-sufficient and can carry out daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (durvalumab, nab-paclitaxel)
- Group 2: Arm I (neoantigen vaccine, durvalumab, nab-paclitaxel)
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.
Are there any vacancies for participants in this exploration?
"Affirmative. According to information on clinicaltrials.gov, this medical study first posted in December 14th 2018 is currently accepting participants. 70 total patients are needed at 14 distinct sites."
Answered by AI
What is the upper bound of participants involved in this research?
"Affirmative. Clinicaltrials.gov's information confirms that this medical trial is presently recruiting, having been initially posted on December 14th 2018 and last edited on November 30th 2022. 70 participants are needed from a total of 14 different clinical sites."
Answered by AI
Does the Personalized Synthetic Long Peptide Vaccine pose any danger to users?
"The Personalized Synthetic Long Peptide Vaccine has a safety rating of 2 due to the Phase 2 trial results, which contain limited evidence that it is safe but no data proving its efficacy."
Answered by AI
What illnesses can be targeted with Personalized Synthetic Long Peptide Vaccine?
"Personalized Synthetic Long Peptide Vaccine can be utilized to protect against central volume depletion, prior anthracycline-based adjuvant therapy and hypoalbuminemia."
Answered by AI
How many healthcare facilities in the US are currently conducting this research?
"This clinical trial is recruiting patients from several medical centres, including Yale University in New Haven, Connecticut; UC Irvine Health/Chao Family Comprehensive Cancer Center in Orange, California; and the Siteman Cancer Center at Saint Peters Hospital in Saint Peters Colorado. Additionally, 14 other sites are participating as well."
Answered by AI
Has the efficacy of Personalized Synthetic Long Peptide Vaccine been tested in prior research endeavors?
"Since its inception in 1997, the Personalized Synthetic Long Peptide Vaccine has been studied extensively: 2469 clinical trials have been completed and 1708 are still active. Many of these studies take place at City of Hope Comprehensive Cancer Center in New Haven, Connecticut."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
65+
What site did they apply to?
UC Irvine Health/Chao Family Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger