INBRX-106 + Pembrolizumab for Breast Cancer
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byDavid Page, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Providence Health & Services
Must not be taking: Immunosuppressants, Corticosteroids
Disqualifiers: Bilateral breast cancer, Metastatic disease, Autoimmune disease, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This is a Phase II trial to assess feasibility of pembrolizumab + INBRX-106 as a chemotherapy-sparing neoadjuvant therapy. One therapeutic arm is being evaluated to provide an informal comparison of pharmacodynamic and clinical effects of concurrent dosing schedule.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or corticosteroids exceeding 10 mg daily of prednisone equivalent, you may need to stop or adjust these medications before starting the trial.
What data supports the effectiveness of the drug INBRX-106 + Pembrolizumab for breast cancer?
Research shows that pembrolizumab, when combined with chemotherapy, improved survival in patients with advanced triple-negative breast cancer. Additionally, pembrolizumab has shown modest but durable responses in certain patients with advanced, PD-L1-positive breast cancer.
12345Is the combination of INBRX-106 and Pembrolizumab safe for humans?
Pembrolizumab, also known as KEYTRUDA, has been shown to have a manageable safety profile in various breast cancer studies, with common side effects including nausea and fatigue. It was generally well tolerated in patients with different types of breast cancer, and no treatment-related deaths were reported.
45678What makes the drug INBRX-106 + Pembrolizumab unique for breast cancer treatment?
INBRX-106 combined with pembrolizumab is unique because it targets the immune system to fight breast cancer, specifically by using pembrolizumab, which is a checkpoint inhibitor that blocks PD-1, a protein that prevents the immune system from attacking cancer cells. This approach is particularly promising for aggressive forms like inflammatory breast cancer, which have limited treatment options.
125910Eligibility Criteria
This trial is for patients with Stage II Triple Negative Breast Cancer (TNBC) who are looking into treatment options that do not involve chemotherapy. Specific eligibility criteria details are not provided, but typically participants would need to meet certain health standards and have no conflicting medical conditions.Inclusion Criteria
Acceptable methods of contraception presented below are in compliance with the Clinical Trial Facilitation and Coordination Group (CTFG) recommendations related to contraception and pregnancy testing in clinical trials, Version 1.1 (September, 2020)
I have not received any treatment for triple-negative breast cancer.
My cancer has not spread to nearby lymph nodes.
+11 more
Exclusion Criteria
Pregnant or breastfeeding
I have never had active tuberculosis.
I have had pneumonitis treated with steroids or currently have it.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive pembrolizumab and INBRX-106 every 3 weeks for up to 6 cycles
18 weeks
6 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
30 days
Long-term follow-up
Participants are monitored for event-free survival and overall survival
Up to 2 years
Participant Groups
The trial is testing a combination of INBRX-106, an experimental drug designed to stimulate the immune system, with Pembrolizumab, an existing immunotherapy medication. It's a Phase II study focusing on the effects of these drugs given together before any surgery without using chemotherapy.
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + INBRX-106Experimental Treatment2 Interventions
Patients will be given pembrolizumab at a dose of 200mg IV in combination with INBRX-106 at a dose of 0.1mg/kg IV every 3 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Providence Portland Cancer Institute - Franz ClinicPortland, OR
Swedish Cancer InstituteSeattle, WA
Ellison Institute of Technology (EITM)Los Angeles, CA
Providence St. Vincent Medical CenterPortland, OR
Loading ...
Who Is Running the Clinical Trial?
Providence Health & ServicesLead Sponsor
Inhibrx Biosciences, IncIndustry Sponsor
Inhibrx, Inc.Industry Sponsor
References
Pre-existing effector T-cell levels and augmented myeloid cell composition denote response to CDK4/6 inhibitor palbociclib and pembrolizumab in hormone receptor-positive metastatic breast cancer. [2021]Single-agent pembrolizumab treatment of hormone receptor-positive metastatic breast cancer (MBC) has demonstrated modest clinical responses. Little is known about potential biomarkers or mechanisms of response to immune checkpoint inhibitors (ICIs) in patients with HR+ MBC. The present study presents novel immune correlates of clinical responses to combined treatment with CDK4/6i and ICI.
Proactive Immunotherapeutic Approaches against Inflammatory Breast Cancer May Improve Patient Outcomes. [2022]Inflammatory breast cancer (IBC) is highly metastatic at the onset of the disease with no IBC-specific treatments, resulting in dismal patient survival. IBC treatment is a clear unmet clinical need. This commentary highlights findings from a recent seminal approach in which pembrolizumab, a checkpoint inhibitor against programmed cell death protein 1 (PD-1), was provided to a triple-negative IBC patient as a neoadjuvant immune therapy combined with anthracycline-taxane-based chemotherapy. We highlight the findings of the case report and offer a perspective on taking a proactive approach to deploy approved immune checkpoint inhibitors. On the basis of our recently published research study, we propose in situ vaccination with direct injection of immunostimulatory agents into the tumor as an option to improve outcomes safely, effectively, and economically for IBC patients.
Health-Related Quality of Life With Pembrolizumab+Chemotherapy Versus Placebo+Chemotherapy for Advanced Triple-Negative Breast Cancer: KEYNOTE-355. [2023]In KEYNOTE-355 (NCT02819518), addition of pembrolizumab to chemotherapy led to statistically significant improvements in progression-free survival and overall survival in patients with advanced triple-negative breast cancer (TNBC) with tumor PD-L1 combined positive score (CPS) ≥10. We report patient-reported outcomes (PROs) from KEYNOTE-355.
Safety and Antitumor Activity of Pembrolizumab in Patients with Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer. [2022]Purpose: We investigated the safety and antitumor activity of the anti-programmed death 1 monoclonal antibody pembrolizumab in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer with programmed death ligand 1-positive (PD-L1-positive) tumors in the phase Ib open-label, multicohort KEYNOTE-028 (NCT02054806) study.Patients and Methods: Patients with ER+/HER2- advanced breast cancer with PD-L1-positive tumors (combined positive score ≥1) received pembrolizumab (10 mg/kg every 2 weeks) up to 2 years or until confirmed progression/intolerable toxicity. Primary endpoints were safety and overall response rate (ORR), based on Response Evaluation Criteria in Solid Tumors, version 1 (RECIST v1.1) as assessed by investigator review.Results: Between April 2014 and January 2015, 25 patients were enrolled. Median number of prior therapies for breast cancer, including endocrine agents, was 9 (range, 3-15). Median follow-up was 9.7 months (range, 0.7-31.8 months). Three patients experienced partial response (PR) and none experienced complete response (CR), resulting in an ORR of 12.0% (95% CI, 2.5%-31.2%); 16% of patients had stable disease (SD) and clinical benefit rate (CR + PR + [SD for ≥24 weeks]) was 20% (95% CI, 7-41). Median duration of response was 12.0 months (range, 7.4-15.9 months). The incidence of treatment-related adverse events was 64%; nausea (20%) and fatigue (12%) were most common and were predominantly grade 1/2. No treatment-related discontinuations or deaths occurred.Conclusions: Pembrolizumab was well tolerated with modest but durable overall response in certain patients with previously treated, advanced, PD-L1-positive, ER+/HER2- breast cancer. Clin Cancer Res; 24(12); 2804-11. ©2018 AACR.
PELICAN-IPC 2015-016/Oncodistinct-003: A Prospective, Multicenter, Open-Label, Randomized, Non-Comparative, Phase II Study of Pembrolizumab in Combination With Neo Adjuvant EC-Paclitaxel Regimen in HER2-Negative Inflammatory Breast Cancer. [2022]Inflammatory breast cancer (IBC) is a highly aggressive entity with a poor outcome and relative resistance to treatment. Despite progresses achieved during the last decades, the survival remains significantly lower than non-IBC. Recent clinical trials assessing PD-1/PD-L1 inhibitors showed promising results in non-IBC. Pembrolizumab, an anti-PD-1 monoclonal antibody, revolutionized the treatment of different cancers. Several recent studies suggested a potential interest of targeting the immune system in IBC by revealing a more frequent PD-L1 expression and an enriched immune microenvironment when compared with non-IBC. Here, we describe the rationale and design of PELICAN-IPC 2015-016/Oncodistinct-003 trial, an open-label, randomized, non-comparative, phase II study assessing efficacy, and safety of pembrolizumab in combination with anthracycline-containing neoadjuvant chemotherapy in HER2-negative IBC. The trial is ongoing. The primary endpoint is the pCR rate (ypT0/Tis, ypN0) in overall population and the co-primary endpoint is safety profile during a run-in phase. Key secondary objectives include tolerability, invasive disease-free, event-free and overall survivals, as well as collection of tumor and blood samples for translational research.
Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial. [2021]Pembrolizumab showed durable antitumour activity and manageable safety in metastatic triple-negative breast cancer in the single-arm KEYNOTE-012 and KEYNOTE-086 trials. In this study, we compared pembrolizumab with chemotherapy for second-line or third-line treatment of patients with metastatic triple-negative breast cancer.
Comparison of three-weekly and six-weekly pembrolizumab United Kingdom prescribing practice for advanced and resected melanoma. [2023]Pembrolizumab is approved for the treatment of advanced and resected melanoma and was originally licensed as a three-weekly infusion (Q3W). In April 2019, a six-weekly infusion schedule (Q6W) was also approved. We retrospectively reviewed pembrolizumab prescribing for patients with melanoma across multiple United Kingdom (UK) centres to compare the safety and efficacy of Q6W with Q3W in real-world clinical practice.
Efficacy and safety of pembrolizumab based therapies in triple-negative breast cancer: A systematic review of clinical trials. [2022]Breast cancer is the most common cause of cancer-related deaths among women. There are a limited number of targeted therapies available for triple-negative breast cancer (TNBC), and chemotherapy is the mainstay of treatment. Among checkpoint inhibitors, atezolizumab is the only drug approved for PD-L1+ TNBC patients. We performed a systematic review to assess the efficacy and safety of PD-1 inhibitor pembrolizumab in triple-negative breast cancer. We included 15 clinical trials in this review. Pembrolizumab was well tolerated by all patients with triple-negative breast cancer. Pembrolizumab was more effective in the treatment of early-stage TNBC patients as compared to placebo, regardless of PD-L1 status. In advanced-stage breast cancer, pembrolizumab was as effective as single-agent chemotherapy with a better safety profile. Pembrolizumab with chemotherapy showed significantly better median progression free survival as compared to chemotherapy in advanced TNBC.
Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. [2022]Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1).
A phase II study of pembrolizumab plus carboplatin in BRCA-related metastatic breast cancer (PEMBRACA). [2023]BRCA1/2-related metastatic breast cancers (mBC) are sensitive to DNA-damage agents and show high tumor-infiltrated lymphocytes. We hypothesized that the association between pembrolizumab and carboplatin could be active in BRCA-related mBC.