Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Bayer
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called BAY2965501, alone or with pembrolizumab, for people with advanced cancers that are hard to treat. The drug helps the immune system fight cancer by activating certain immune cells. Researchers aim to find the safest and most effective dose and see how well it works against tumors. Pembrolizumab has shown efficacy in treating various cancers, including melanoma, cervical cancer, and head and neck cancer.
What safety data is available for BAY2965501 and Pembrolizumab treatment?The safety data for Pembrolizumab, a component of the treatment, indicates it is generally well tolerated with a favorable safety profile. Common adverse events include fatigue, rash, itching, and diarrhea. Less frequent immune-related adverse events are hypothyroidism, colitis, hepatitis, and pneumonitis. Rare cases of synovitis and pleuropericarditis have also been reported. No specific safety data for BAY2965501 is provided in the research.456710
Is the drug BAY2965501 with Pembrolizumab a promising treatment for advanced cancer?Pembrolizumab, when used with other treatments, has shown promising results in treating advanced cancers like melanoma and lung cancer. It works by helping the immune system fight cancer cells more effectively. This suggests that combining Pembrolizumab with BAY2965501 could be a promising approach for treating advanced cancer.12389
What data supports the idea that BAY2965501 + Pembrolizumab for Advanced Cancer is an effective drug?The available research shows that Pembrolizumab, when used alone, has shown promising results in treating advanced cancers like non-small cell lung cancer and melanoma. However, there is no specific data provided about the effectiveness of BAY2965501 combined with Pembrolizumab for advanced cancer. The studies mainly focus on Pembrolizumab's effectiveness as a standalone treatment for other conditions, not in combination with BAY2965501.238911
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that previous therapy with a DGK inhibitor other than BAY 2965501 or BAY 2862789 is prohibited, and certain conditions related to brain metastases and gastrointestinal issues may affect eligibility. It's best to discuss your current medications with the study team to get a clear answer.
Eligibility Criteria
This trial is for adults with advanced solid tumors, including specific types of skin, kidney, stomach, and lung cancers. Participants must have a confirmed diagnosis, measurable disease per RECIST 1.1 criteria, adequate organ function, and an ECOG status of 0 to 1. They cannot have had certain recent treatments or severe infusion reactions to similar drugs in the past.Treatment Details
The study tests BAY2965501 alone or combined with pembrolizumab on different tumor types. It aims to find safe doses and understand how the drug affects the body and cancer cells. The trial has two parts: dose escalation to determine appropriate dosing levels and dose expansion where those doses are given more broadly.
6Treatment groups
Experimental Treatment
Group I: Dose expansion of BAY2965501 +pembrolizumabExperimental Treatment1 Intervention
For expansion part, specific tumor types are recruited (non-small cell lung cancer (NSCLC) and gastric/gastroesophageal junction (GEJ) adenocarcinoma). BAY2965501 will be taken in combination with 200mg pembrolizumab every 3 weeks.
Group II: Dose expansion of BAY2965501Experimental Treatment1 Intervention
For expansion part, specific tumor types are recruited (non-small cell lung cancer (NSCLC) and gastric/gastroesophageal junction (GEJ) adenocarcinoma).
Group III: Dose expansion of BAY 2965501 + pembrolizumab + platinum-based regimenExperimental Treatment1 Intervention
Participants with selected (to be decided by the sponsor) advanced solid tumors will be recruited in a dose expansion cohort of BAY 2965501 with pembrolizumab and platinum-based regimen.
Group IV: Dose escalation of BAY2965501+pembrolizumabExperimental Treatment1 Intervention
For escalation part different dose levels of BAY2965501 are planned in combination with 200mg pembrolizumab. BAY2965501 will be taken in combination with 200mg pembrolizumab every 3 weeks.
Group V: Dose escalation of BAY2965501Experimental Treatment1 Intervention
For escalation part, different dose levels of BAY2965501 are planned.
Group VI: Dose escalation of BAY 2965501 + pembrolizumab + platinum-based regimenExperimental Treatment1 Intervention
The starting dose of BAY 2965501 with pembrolizumab for this combination will be no higher than one dose level below that shown to be safe in BAY 2965501 and pembrolizumab dose escalation. The doses of platinum-based regimen will be as per standard of care and given for a maximum of 6 cycles, in line with the current labeled dose. The dose of pembrolizumab will be 200 mg every 3 weeks, in line with the current labeled dose.
Find a clinic near you
Research locations nearbySelect from list below to view details:
START | San AntonioSan Antonio, TX
UF Health Cancer CenterGainesville, FL
Tranquil Clinical ResearchWebster, TX
South Texas Accelerated Research Therapeutics, LLCSan Antonio, TX
More Trial Locations
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Who is running the clinical trial?
BayerLead Sponsor
References
Phase I Study of Pembrolizumab (MK-3475; Anti-PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors. [2022]This phase I study evaluated the safety, maximum tolerated dose, antitumor activity, and pharmacokinetics and pharmacodynamics of pembrolizumab in patients with advanced solid tumors.
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. [2017]Pembrolizumab, a humanized monoclonal antibody IgG4 anti-PD-1, having offered promising results in patients suffering from non-small cell lung cancer metastatic and heavily pretreated.
Evaluation of efficacy and safety of different pembrolizumab dose/schedules in treatment of non-small-cell lung cancer and melanoma: a systematic review. [2018]Pembrolizumab is a fully humanized anti-PD-1 agent currently approved for the treatment of advanced melanoma and pretreated non-small-cell lung cancer (NSCLC).
Could knee inflammatory synovitis be induced by pembrolizumab? [2018]Pembrolizumab, a selective anti-PD-1 humanized monoclonal antibody, reactivates T cells to fight cancer. Immune-related adverse events such as autoimmune colitis, pneumonitis, hepatitis, nephritis, hypophysitis, and thyroiditis may occur during, or weeks to months after therapy. Pemprolizumab-induced synovitis is rarely reported. With the wide use of immunotherapy to treat cancers, physicians need to be aware of this rare immune-related adverse event and provide immediate treatment to avoid permanent joint damage.
Pembrolizumab in the management of metastatic melanoma. [2020]Pembrolizumab is a humanized IgG4 anti-PD-1 antibody that plays a major role in the treatment of advanced melanoma. Through blockade of PD-1, it leads to an increase in effector T-cell activity in the tumor microenvironment. Clinical trial outcomes for pembrolizumab in addition to pharmacokinetics, pharmacodynamics and safety of the compound are discussed in this article. Phase I trials have demonstrated safety and efficacy of pembrolizumab in advanced, pretreated melanoma patients. When compared with chemotherapy in a Phase II trial of ipilimumab-refractory patients, those treated with pembrolizumab showed superior progression-free survival. In addition, in the pivotal Phase III trial pembrolizumab improved overall survival compared with ipilimumab in patients naive to immune checkpoint inhibition. Pembrolizumab is well tolerated and has a favorable safety profile. Common adverse events are fatigue, rash, itching and diarrhea. Less frequent immune-related adverse events include hypothyroidism, colitis, hepatitis and pneumonitis.
Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. [2022]We aimed to characterize the safety profile of pembrolizumab in advanced melanoma patients at our center to better reflect 'real-world' data on anti-PD-1 inhibitors.
Multiple autoimmune side effects of immune checkpoint inhibitors in a patient with metastatic melanoma receiving pembrolizumab. [2021]Immune agents including anti-programmed death receptor-1 and anti-cytotoxic T-lymphocyte antigen-4 have been associated with numerous immune-related complications. Pembrolizumab, a programmed death-1 inhibitor, has been associated with a number of immune-related adverse events such as pneumonitis, colitis, hepatitis, hypophysitis, hyperthyroidism, hypothyroidism, nephritis, and type 1 diabetes.
Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer. [2022]Pembrolizumab is a programmed death receptor-1 masking antibody approved for metastatic non-small cell lung cancer. This Phase 2 study (NCT02818920) of neoadjuvant pembrolizumab in non-small cell lung cancer had a primary end point of safety and secondary end points of efficacy and correlative science.
Clinical application effect of Pembrolizumab in the treatment of advanced cutaneous malignant melanoma. [2021]To investigate the clinical application value of Pembrolizumab (PEM) in the treatment of advanced cutaneous malignant melanoma (ACMM).
An unusual case of checkpoint-inhibitor-induced pleuropericarditis. [2023]Pembrolizumab is an immune checkpoint inhibitor that promotes effector T-cell functions on malignant cells by binding to programmed cell death protein 1 (PD-1). Pembrolizumab is well tolerated in most cases with an adverse event profile consisting mainly of pruritus, fatigue, and anorexia. Cardiotoxicity comprises 1% of the total adverse events.
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.