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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.

Must not have

Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

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.

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

No Placebo-Only Group

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.

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.

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 below

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I can provide a biopsy sample from my advanced or relapsed cancer.

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I agree to use birth control or abstain from sex during and up to 180 days after the study.

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My breast cancer is not driven by estrogen or progesterone.

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My cancer is HER2 negative based on specific tests.

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My cancer is PD-L1 negative according to an FDA-approved test.

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I am 18 years old or older.

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My kidney function, measured by creatinine clearance, is adequate.

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I am post-menopausal or not currently pregnant.

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I am mostly self-sufficient and can carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have brain metastases or any known central nervous system disease.

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I do not have any serious ongoing illnesses that my doctor is still trying to control.

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I am considered a candidate for carboplatin + gemcitabine for my metastatic triple negative breast cancer.

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I am not pregnant or breastfeeding, and I have a recent negative pregnancy test.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I have received an organ transplant from another person.

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I have completed treatment aimed at curing any previous cancers.

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I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.

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I have received immunotherapy for my cancer after it spread.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of part b to progression or death, assessed at 6 and 12 months for reporting.