BDC-3042 + Pembrolizumab for Advanced Cancers
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Bolt Biotherapeutics, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
A first-in-human study using BDC-3042 as a single agent and in combination with cemiplimab in patients with advanced malignancies
Do I have to stop taking my current medications to join the trial?
The trial protocol does not specify if you must stop taking your current medications. However, certain conditions and treatments, like systemic immunosuppressive therapy or investigational agents, are excluded. It's best to discuss your specific medications with the trial team.
What data supports the idea that BDC-3042 + Pembrolizumab for Advanced Cancers is an effective drug?
The available research shows that Pembrolizumab, a part of the BDC-3042 + Pembrolizumab combination, has been effective in treating various advanced cancers. For example, it has been approved for treating advanced non-small cell lung cancer, endometrial carcinoma, and esophageal or gastroesophageal cancer. These approvals suggest that Pembrolizumab can help improve outcomes for patients with these types of cancers, indicating its potential effectiveness when combined with BDC-3042 for advanced cancers.12345
What safety data exists for BDC-3042 + Pembrolizumab treatment?
Pembrolizumab (Keytruda) has been associated with several immune-related adverse events (irAEs). These include type 1 diabetes mellitus, which occurs in 0.2% of cases, and pneumonitis, which occurs in 1%-5% of patients. Other common adverse reactions include fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia, and diarrhea. Immune-mediated adverse reactions also include colitis, hepatitis, hypophysitis, and thyroid disorders. The safety profile of pembrolizumab has been evaluated in various clinical trials, including those for non-small cell lung cancer and metastatic melanoma.12678
Is the drug BDC-3042 combined with Pembrolizumab a promising treatment for advanced cancers?
Yes, the drug combination of BDC-3042 and Pembrolizumab is promising for advanced cancers. Pembrolizumab, also known as Keytruda, has shown success in treating various cancers, including lung cancer and melanoma, by helping the immune system fight cancer cells. It has been approved for several cancer types and has demonstrated significant improvements in patient survival rates.125910
Eligibility Criteria
Adults with certain advanced cancers (like ovarian, lung, breast, head and neck, renal cell carcinoma or colorectal cancer) that have worsened despite standard treatments. They must be in relatively good health otherwise, not planning to conceive (or will use effective contraception), and have no serious heart issues or other conditions that could interfere with the trial.Inclusion Criteria
I am using a highly effective birth control method during and 4 weeks after treatment.
I am fully active or restricted in physically strenuous activity but can do light work.
Your disease can be measured using specific guidelines called Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
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Exclusion Criteria
You have had a bad reaction to any part of the BDC-3042 medication or the treatment being studied.
Actively enrolled in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up component of an interventional study
Patient is a lactating mother or pregnant as confirmed by pregnancy tests within 7 days prior to start of study treatment
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Treatment Details
Interventions
- BDC-3042 (Other)
- Pembrolizumab (Monoclonal Antibodies)
Trial OverviewThe study is testing BDC-3042 alone and combined with Pembrolizumab to see how well they work against various advanced cancers. It's a first-in-human trial meaning it's the first time these drugs are being tested in people for safety and effectiveness.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Single agent BDC-3042Experimental Treatment1 Intervention
Escalating doses followed by expansion targeting advanced malignancies
Group II: Combination BDC-3042 plus cemiplimabExperimental Treatment2 Interventions
Escalating doses followed by expansion targeting advanced malignancies
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dana-Farber Cancer InstituteBoston, MA
Stanford Cancer CenterPalo Alto, CA
MD Anderson Cancer CenterHouston, TX
NEXT OncologyAustin, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Bolt Biotherapeutics, Inc.Lead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
References
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]A phase II trial investigating the therapeutic effect of neoadjuvant programmed cell death 1 (PD-1) inhibitor pembrolizumab (MK-3475, KEYTRUDA®) administered prior to surgery for the treatment of non-small cell lung cancer (NSCLC) has been conducted (NCT03197467). We report the first clinical results of a planned interim safety analysis after 15 patients were enrolled.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]New insights into the interaction between the immune system and the tumor microenvironment have led to the development of checkpoint inhibitors that target the PD-1/PD-L1 pathway. Pembrolizumab (MK-3475, lambrolizumab, Keytruda(®)) is a PD-1 inhibitor that has shown clinical activity in a variety of solid tumors and is currently approved for the second-line treatment of PD-L1-positive non-small-cell lung cancer and for unresectable/metastatic melanoma. This article will discuss the results of early-phase trials of pembrolizumab in thoracic malignancies as well as ongoing studies aimed to confirm clinical benefit.
New Approved Use for Keytruda. [2022]Pembrolizumab (Keytruda) is now approved as a single agent to treat advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient in those whose disease has progressed following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
Evaluation of pembrolizumab for the treatment of advanced non-small cell lung cancer: a retrospective, single-centre, single-arm study. [2022]Immune checkpoint inhibitors (ICIs) provided a paradigm shift for advanced non-small cell lung cancer (NSCLC) treatment and improved the clinical prognosis of such patients. Pembrolizumab is a humanized anti-programmed death cell protein 1 (PD-1) monoclonal antibody, approved for the treatment of patients with advanced or metastatic NSCLC. This article investigated and reported on the efficacy and safety of pembrolizumab in the treatment of advanced NSCLC in our center since 2019.
Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. [2023]Pembrolizumab (Keytruda) has been approved to treat metastatic or locally advanced esophageal or gastroesophageal junction cancer. It is used in combination with platinum- and fluoropyrimidine-based chemotherapy.
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]Pembrolizumab (Keytruda; Merck Sharp & Dohme) is a humanized IgG4 monoclonal antibody used in cancer immunotherapy. It targets the programmed cell death-1 (PD-1) receptor, which is important in maintaining self-tolerance. However, immune checkpoint blockade is associated with a risk for immune-related adverse events (irAEs) potentially affecting the endocrine organs. Type 1 diabetes mellitus is a rare irAE of PD-1 inhibitors, occurring in 0.2% of cases.
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]Pembrolizumab (Keytruda) is a monoclonal antibody against the programmed cell death-1 (PD-1) receptor on lymphocytes, which is one of the immune checkpoint inhibitors (ICIs) approved for multiple solid and hematologic malignancies. Although ICIs have proven to be more effective and less toxic compared to chemotherapy, there are reports of adverse side effects with ICIs. For example, pneumonitis is a potentially lethal side effect occurring in 1%-5% of patients who received ICIs in clinical trials, and there are case reports with clinical and radiological features of checkpoint inhibitor-pneumonitis (CIP).
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]On September 4, 2014, the FDA approved pembrolizumab (KEYTRUDA; Merck Sharp & Dohme Corp.) with a recommended dose of 2 mg/kg every 3 weeks by intravenous infusion for the treatment of patients with unresectable or metastatic melanoma who have progressed following treatment with ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on demonstration of objective tumor responses with prolonged response durations in 89 patients enrolled in a randomized, multicenter, open-label, dose-finding, and activity-estimating phase 1 trial. The overall response rate (ORR) by blinded independent central review per RECIST v1.1 was 24% (95% confidence interval, 15-34); with 6 months of follow-up, 86% of responses were ongoing. The most common (≥20%) adverse reactions were fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia, and diarrhea. Immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, hypophysitis, and thyroid disorders. The benefits of the observed ORR with prolonged duration of responses outweighed the risks of immune-mediated adverse reactions in this life-threatening disease and represented an improvement over available therapy. Important regulatory issues in this application were role of durability of response in the evaluation of ORR for accelerated approval, reliance on data from a first-in-human trial, and strategies for dose selection. Clin Cancer Res; 23(19); 5666-70. ©2017 AACR.
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test, as follows: (a) first-line treatment of patients with mNSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and (b) treatment of patients with mNSCLC whose tumors express PD-L1 (TPS ≥1%), with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.Approval was based on two randomized, open-label, active-controlled trials demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients randomized to pembrolizumab compared with chemotherapy. In KEYNOTE-024, patients with previously untreated mNSCLC who received pembrolizumab (200 mg intravenously [IV] every 3 weeks) had a statistically significant improvement in OS (hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.41-0.89; p = .005), and significant improvement in PFS (HR 0.50; 95% CI: 0.37-0.68; p < .001). In KEYNOTE-010, patients with disease progression on or after platinum-containing chemotherapy received pembrolizumab IV 2 mg/kg, 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The HR and p value for OS was 0.71 (95% CI: 0.58-0.88), p < .001 comparing pembrolizumab 2 mg/kg with chemotherapy and the HR and p value for OS was 0.61 (95% CI: 0.49-0.75), p < .001 comparing pembrolizumab 10 mg/kg with chemotherapy.
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]Pembrolizumab (MK-3475) is a monoclonal antibody that binds to the PD-1 receptor on T cells and prevents binding to its ligands PD-L1 and PD-L2. Blocking this receptor frees T cells from the inhibitory effects of PD-L1 and allows them to mediate antitumor effects against cancer cells. In a large Phase I study of 411 patients with melanoma, high durable response rates over a range of doses and schedules have been shown with very little toxicity. A Phase III study of pembrolizumab comparing two schedules of administration with the current standard treatment with the anti-CTLA-4 monoclonal antibody is in progress. Combinations with other checkpoint inhibitors as well as other anticancer agents are also being evaluated. Approval of pembrolizumab for the treatment of melanoma is expected.