BCA101 + Pembrolizumab for Cancer
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Bicara Therapeutics
Must not be taking: Anti-EGFR, Anti-TGFβ, Corticosteroids
Disqualifiers: Pregnancy, Breastfeeding, HIV, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial is testing BCA101, a new drug that targets specific cancer growth proteins, in patients with advanced cancers that haven't responded to other treatments. The drug works by blocking proteins that help the cancer grow and spread.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on certain treatments like corticosteroids above a specific dose or certain antiviral therapies. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug BCA101 + Pembrolizumab for cancer?
Pembrolizumab has shown effectiveness in treating various types of cancer, including skin, ovarian, and lung cancers, by helping the immune system attack cancer cells. This suggests it may also be effective when combined with other treatments like BCA101.
12345Is the combination of BCA101 and Pembrolizumab safe for humans?
Pembrolizumab has been shown to have a manageable safety profile in various cancers, with common side effects including diarrhea, fatigue, and nausea. However, specific safety data for the combination of BCA101 and Pembrolizumab is not provided in the available research.
26789What makes the drug BCA101 + Pembrolizumab unique for cancer treatment?
BCA101 (Ficerafusp Alfa) combined with Pembrolizumab is unique because it targets specific proteins involved in cancer growth and immune response, potentially offering a novel approach compared to standard treatments. Pembrolizumab is known for blocking PD-1, a protein that helps cancer cells evade the immune system, while BCA101 may have additional mechanisms that enhance this effect.
25101112Eligibility Criteria
This trial is for patients with advanced solid tumors driven by EGFR, such as certain types of anal, head and neck, lung cancers, and more. Participants must have tried some treatments already without success or been unable to tolerate them. They should be relatively healthy otherwise (performance status ≤1) and willing to undergo tumor biopsies.Inclusion Criteria
My cancer is advanced anal canal squamous carcinoma, and I've had 1-2 treatments.
I can carry out all my self-care but cannot do heavy physical work.
My scans show at least one tumor that can be measured.
+4 more
Exclusion Criteria
I have chronic HBV with active disease and am not on antiviral therapy.
I have not been treated with anti-TGFβ therapy before.
I've had a bad reaction to cetuximab or similar drugs before.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Participants receive escalating doses of BCA101 monotherapy or BCA101 in combination with pembrolizumab to determine the maximum tolerated dose
21 days
Weekly visits for BCA101 monotherapy, every 3 weeks for combination therapy
Expansion Cohorts
Participants receive treatment at the recommended dose in select tumor types to further evaluate safety and efficacy
24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 months
Participant Groups
BCA101 is being tested alone or with Pembrolizumab in this study. BCA101 targets both EGFR and TGFβ which might work well together against tumors that are driven by EGFR. The trial will see how safe it is and how well people can handle it.
2Treatment groups
Experimental Treatment
Group I: BCA101 MonotherapyExperimental Treatment1 Intervention
Route: IV Infusion Frequency: QW Current Dose: 1500mg
Group II: BCA101 + pembrolizumabExperimental Treatment2 Interventions
Route: IV Infusion Frequency: Q3W Dose: 200mg
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rhode Island HospitalProvidence, RI
UCLALos Angeles, CA
Princess Margaret Cancer CentreToronto, Canada
Keck School of Medicine of USCLos Angeles, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Bicara TherapeuticsLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
References
Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. [2019]To evaluate safety, tolerability, and antitumor activity of pembrolizumab monotherapy in patients with programmed death ligand 1 (PD-L1)-expressing advanced ovarian cancer enrolled in the multicohort, phase Ib KEYNOTE-028 trial.
Pembrolizumab for locally advanced and recurrent/metastatic cutaneous squamous cell carcinoma (KEYNOTE-629 study): an open-label, nonrandomized, multicenter, phase II trial. [2022]Pembrolizumab demonstrated clinically meaningful and durable antitumor activity with a manageable safety profile in recurrent/metastatic (R/M) cutaneous squamous cell carcinoma (cSCC).
An Anti-TIGIT Antibody with a PD-1 Inhibitor Shows Promise in Solid Tumors. [2022]Combination of vibostolimab and pembrolizumab is well tolerated and has antitumor activity.
Real-world efficacy and safety of pembrolizumab in patients with non-small cell lung cancer: a retrospective observational study. [2022]Pembrolizumab, a humanized immunoglobulin monoclonal antibody directed against the programmed cell death 1 receptor, demonstrated robust efficacy and a manageable safety profile across multiple tumor types in clinical trials.
Pembrolizumab monotherapy for non-small cell lung cancer (NSCLC): can patient stratification be improved in the UK Tayside population? A retrospective cohort study. [2023]Pembrolizumab is a programmed cell death protein-1 (PD-1) inhibitor used to treat advanced patients with non-small cell lung cancer (NSCLC) with a programmed cell death ligand-1 (PD-L1) tumour proportion score (TPS) ≥50. Further sub-division of TPS-based stratification has not been evaluated in the UK, although smoking-induced tumour mutational burden and the immunogenic effects of prior radiotherapy are suggested to improve response.
First-line pembrolizumab for non-small cell lung cancer patients with PD-L1 ≥50% in a multicenter real-life cohort: The PEMBREIZH study. [2021]The KEYNOTE-024 trial demonstrated that pembrolizumab, a PD-1 inhibitor, significantly improves progression-free survival (PFS) and overall survival (OS) in selected patients with previously untreated advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score (TPS) ≥50% and without EGFR/ALK aberrations. The main aim of this study was to report the efficacy and safety profile of pembrolizumab in real-life conditions.
FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma. [2022]The FDA approved pembrolizumab on June 29, 2020, for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) colorectal cancer with no prior systemic treatment for advanced disease. The approval was based on data from Study Keynote-177, which randomly allocated patients to receive either pembrolizumab or standard of care (SOC) with chemotherapy. Overall survival (OS) and independently assessed progression-free survival (PFS) were the primary endpoints. At the time of the final PFS analysis and second prespecified interim OS analysis, the estimated median PFS was 16.5 months (95% CI: 5.4-32.4) versus 8.2 months (95% CI: 6.1-10.2) in the pembrolizumab and SOC arms, respectively [HR: 0.60 (95% CI: 0.45-0.80); two-sided P = 0.0004]. FDA assessed unblinded OS data during the review of the application and identified no safety concerns that would preclude approval of this supplement. Adverse reactions occurring in >30% of patients receiving pembrolizumab were diarrhea, fatigue/asthenia, and nausea. Adverse reactions occurring in >30% of patients receiving SOC were diarrhea, nausea, fatigue/asthenia, neutropenia, decreased appetite, peripheral neuropathy (high-level term), vomiting, abdominal pain, constipation, and stomatitis. Duration of treatment in the pembrolizumab arm was almost double (median 11.1 months, range 0-30.6 months) than the duration of treatment in patients receiving SOC (median, 5.7 months). Approval of pembrolizumab is likely to change the treatment paradigm for first-line treatment with MSI-H advanced colorectal cancer given the study results and different safety profile.
Pembrolizumab in a BRAF-mutant metastatic melanoma patient following a severe immune-related adverse event with ipilimumab. [2017]Currently, limited data exist on the safety of pembrolizumab in patients with metastatic melanoma who have developed severe immune-related adverse events following treatment with ipilimumab. We report a 45-year-old male patient with BRAF-mutant metastatic melanoma who discontinued treatment with ipilimumab due to treatment-related grade 3 colitis and was subsequently treated with the anti-programmed cell death 1 protein (PD-1) antibody pembrolizumab. He has been on treatment with pembrolizumab for more than 20 months with no major toxicities and has achieved an objective partial response, which is ongoing.
Pembrolizumab. [2022]The development of the cytotoxic T-lymphocyte-associated protein 4 inhibitor ipilimumab and its approval in 2011 for the treatment of metastatic melanoma has heralded a new era in immuno-oncology. Subsequently, novel agents against the programmed death receptor 1 (PD-1)/programmed death receptor ligand 1 (PD-L1) axis have shown significant activity in melanoma and a variety of other tumor types. Pembrolizumab was the first anti-PD-1 antibody to be approved by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with disease progression following ipilimumab, and if BRAF (V600) mutation positive, a BRAF inhibitor. Pembrolizumab has also received breakthrough status for the treatment of EGFR mutation-negative, ALK rearrangement-negative non-small cell lung cancer (NSCLC) that has progressed on or following platinum-based chemotherapy. There remain a number of pivotal trials in progress to further evaluate the optimal use of pembrolizumab alone and in combination for melanoma, NSCLC, and other tumor types. In this article, we review the efficacy and toxicity profile of pembrolizumab and evaluate its future development.
A phase Ib study of pembrolizumab plus chemotherapy in patients with advanced cancer (PembroPlus). [2022]Pembrolizumab (P) is an anti-PD-1 antibody that blocks the interaction between programmed cell death protein 1 (PD-1) on T-cells and PD-L1 and PD-L2 on tumour cells. A phase Ib trial of P plus chemotherapy was undertaken to evaluate the safety and efficacy.
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).
MEDI5752 Suppresses Two Immune Checkpoints. [2022]Preliminary data from a phase I trial of MEDI5752, a bispecific antibody targeting both PD-1 and CTLA4, indicate the drug is well tolerated and active, with durable responses seen across diverse tumor types.