Merkel Cell Carcinoma

Researchers are evaluating MDNA11, a long-acting beta-only recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 12 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11s effects alone and with pembrolizumab.

Researchers are evaluating ONM-501, a drug given as intratumoral injections, alone and in combination with cemiplimab, an immune checkpoint inhibitor, in patients with advanced solid tumors and lymphomas. This phase 1 study aims to find the maximum tolerated dose, minimum effective dose, and recommended dose for expansion of ONM-501. The study includes patients with various advanced cancers who have no alternative standard therapies available. The trial has three parts monotherapy dose escalation, combination therapy dose finding, and combination therapy dose expansion. ONM-501 is given once per week for three weeks followed by three weeks off, in 21-day cycles. Cemiplimab is given intravenously every three weeks during the combination phases. Dose escalation uses special methods to gradually increase doses, and after doses are established, patients will enroll in expansion cohorts for specific tumor types. Participants will have regular assessments including monitoring for side effects, blood tests to measure drug levels, and evaluation of tumor response over up to 24 months. Researchers will track treatment-emergent adverse events, dose-limiting toxicities, and serious adverse events. Outcomes such as objective response rate, duration of response, progression-free survival, and overall survival will also be recorded. The study involves close safety monitoring and follow-up throughout the treatment and observation periods.

Researchers are evaluating KUP-101A in patients with selected advanced solid tumors such as cutaneous melanoma, mucosal melanoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma of skin, and basal cell carcinoma of skin. The study aims to find the maximum tolerated dose and the recommended Phase 2 dose of KUP-101A. It also seeks to assess the drugs safety, tolerability, pharmacokinetics, and pharmacodynamics while gathering initial data on its efficacy in these patients. Participants receive intravenous infusions of KUP-101A at various dose levels, progressing sequentially to determine the best dose for further study. There are multiple experimental dose levels ranging from dose level 1 to dose level 7. The study follows a non-randomized design without blinding. Treatment continues while monitoring for dose-limiting toxicities and adverse events. During the trial, participants undergo evaluations for adverse events, laboratory tests including hematology and clinical chemistry, urinalysis, and vital signs, as well as 12-lead ECG monitoring. Pharmacokinetic parameters such as drug concentration and elimination half-life are measured up to three weeks, with safety assessments extending to three months after the last dose. The total participation timeline includes enrollment, treatment, and follow-up periods for safety and pharmacodynamic assessments.

Researchers are evaluating a mobile health intervention designed to promote sun protection behaviors and skin examinations among Hispanics at risk for skin cancer. This study aims to assess the feasibility, acceptability, and preliminary effects of a culturally guided WhatsApp-based program compared to general physical activity and nutrition information. The study will gather insights from Hispanic community members and key stakeholders to develop the intervention and refine it through a pilot randomized controlled trial RCT. Participants will first complete a baseline survey before being randomly assigned to either the intervention group receiving WhatsApp messages about skin cancer prevention for three months or a control group receiving information on physical activity and nutrition. After the intervention, participants will complete a post-intervention survey, followed by a six-month follow-up survey to assess longer-term behavior changes. The intervention uses a user-centered approach incorporating feedback from focus groups and interviews. Throughout the study, researchers will monitor skin cancer-related preventive behaviors such as the use of sunscreen, seeking shade, wearing protective clothing, hats, and sunglasses, as well as skin self-examination and professional skin examinations. Data will be collected at baseline, three months, and six months. The study also evaluates participant satisfaction and retention rates to inform further refinements. Total participation involves surveys and engagement via WhatsApp over a six-month period.

Researchers are studying the effects of injecting the seasonal influenza vaccine directly into cutaneous squamous cell carcinoma CSCC tumors before patients undergo standard Mohs excision surgery. This Phase 0, window-of-opportunity trial aims to understand if the influenza vaccine can boost the immune systems response against this type of skin cancer. The study involves adults diagnosed with CSCC who are preparing for curative surgery. Participants will receive the Fluzone influenza vaccine injected into their tumor on days 1 and 8. On day 15, they will have the standard Mohs micrographic surgery to remove the tumor, with tissue collected for analysis. Follow-up visits occur on day 21 for suture removal and day 38 to monitor recovery and any effects. During the study, participants will have blood tests, tumor measurements, and photographs taken to track changes. Researchers will assess immune cell changes, tumor size, and safety outcomes up to 38 days. The main measurement is the change in CD8 T-cell density within the tumor. Participants will be monitored closely throughout the trial, which is expected to include 25 people.

This research aims to evaluate whether a topical 5% niacinamide cream can help prevent skin cancer in organ transplant recipients. These individuals face a significantly higher risk of developing precancerous skin growths and skin cancers due to long-term use of immune-suppressing medications. The study focuses on whether daily topical niacinamide, combined with sunscreen, can reduce actinic keratoses and new keratinocyte cancers compared to sunscreen alone in this high-risk group. Participants will be randomly assigned to one of two groups one will apply topical 5% niacinamide cream once daily plus use SPF 30 sunscreen daily and every two hours when outdoors, while the control group will use sunscreen alone. The study lasts 12 months, with skin examinations at 6 and 12 months to assess changes in actinic keratosis counts and the development of new skin cancers. The safety, tolerability, and adherence to the niacinamide cream will also be evaluated. During the study, participants will undergo standardized skin mapping and clinical exams at 6 and 12 months. Researchers will collect data on treatment side effects, adherence, and patient experiences through structured surveys. Any suspicious lesions will be examined by a board-certified pathologist. The primary outcome is the change in actinic keratosis count, and secondary outcomes include the incidence of new non-melanoma skin cancers and product tolerability.

Researchers are evaluating the safety and effects of a study drug called CRD3874-SI in adults with advanced or metastatic malignant solid tumors, including types such as sarcoma, Merkel Cell Carcinoma, head and neck squamous cell carcinoma, adenoid cystic carcinoma, uveal melanoma, mucosal and acral melanoma, and non-small cell lung cancer. The study aims to find the highest dose of CRD3874-SI that causes only mild or manageable side effects and to learn more about how the drug is processed by the body and how the immune system responds to it. Participants receive weekly intravenous infusions of CRD3874-SI starting at a dose of 0.1 mgkg, with dose levels increasing in phases to find the recommended dose for further study. The treatment cycles vary, with the first two cycles consisting of four weekly infusions each over 28 days, and later cycles providing three weekly infusions if the treatment is well tolerated. The trial also includes a dose expansion phase where the recommended dose and one additional active dose are tested in selected tumor types. Blood tests and tumor biopsies are performed during the study to help assess the drugs effects. During the trial, participants undergo regular evaluations including tumor biopsies when feasible, blood tests for immune cells, and assessments of tumor response. Safety is closely monitored through side effect tracking and organ function tests. The studys main outcomes include determining the maximum tolerated dose over one year and measuring tumor response rates during dose expansion up to 48 weeks. Participation may last several months depending on treatment tolerance and disease progression, with ongoing monitoring to understand the drugs safety and activity.

Researchers are evaluating the safety and appropriate dosing of MQ710 in people with advanced solid tumor cancers that have returned, spread, or worsened after standard treatments, or for whom no standard treatments are available. This phase 1 study aims to find the highest dose of MQ710 that causes few or mild side effects. The trial includes various types of solid tumors such as cutaneous squamous cell carcinoma, basal cell carcinoma, melanoma, and others. Participants will receive MQ710 injected directly into their tumors, either alone or combined with pembrolizumab, which is administered intravenously every three weeks at a standard dose. The study involves a dose escalation group using a 33 scheme to find the safe dose range, followed by a dose expansion group to further evaluate the chosen doses of MQ710 alone or with pembrolizumab. Treatment schedules and doses are carefully monitored throughout the trial. During the study, participants will undergo tumor biopsies, assessments of tumor response, and safety monitoring for up to two years after treatment. Researchers will review side effects, laboratory tests, and overall health status to evaluate the safety of MQ710. Participants must comply with study procedures, including regular visits, tumor evaluations, and use of contraception if applicable. The study duration may vary depending on individual response and study phase completion.

Researchers are evaluating oral Alintegimod 7HP349 alone and in combination with ipilimumab, followed by nivolumab monotherapy, in patients with locally advanced or metastatic cancers who have received one or more prior therapies. This open-label Phase Ib dose escalation study is followed by a blinded, randomized multi-cohort Phase 2a comparison of combination versus reference regimens, aiming to assess safety, tolerability, and preliminary efficacy. Participants will receive Alintegimod monotherapy in escalating doses for one cycle, then Alintegimod combined with ipilimumab for four cycles, followed by nivolumab monotherapy for eleven cycles. Alintegimod is given orally as softgel capsules, while ipilimumab and nivolumab are administered intravenously. The treatment continues until the end of the study period, lasting 12 months, unless disease progression or toxicity requires early termination. Throughout the study, participants will undergo assessments including adverse event monitoring, pharmacokinetic testing, and tumor response evaluations using RECIST criteria. Researchers will measure treatment-related side effects, drug levels in the blood, progression-free survival, and overall response rates. Safety will be closely monitored over 18 months, with participants expected to attend regular visits for clinical evaluations and laboratory tests during the study duration.

Researchers are studying pembrolizumab to find new treatment options for people with solid tumors, lymphomas, and Merkel cell carcinoma, a type of skin cancer. The study aims to understand the safety and tolerability of pembrolizumab, how different doses behave in the body over time, and how the cancers respond to the treatment. This research includes both pediatric patients with specific tumors and adult patients with Merkel cell carcinoma. Participants are divided into two groups pediatric patients with solid tumors or lymphomas receive pembrolizumab at 2 mgkg through an intravenous infusion every three weeks for up to 17 or 35 cycles, while adult participants with Merkel cell carcinoma receive 400 mg pembrolizumab intravenously every six weeks for up to 18 cycles. Treatment schedules and doses are carefully monitored throughout the study. During the trial, participants undergo regular assessments including imaging to measure tumor response, blood tests to monitor drug levels and immune reactions, and tracking of any side effects or adverse events. The study measures outcomes such as tumor shrinkage, survival rates, and drug concentration in the body over periods up to approximately 46 months. Safety and tolerability are closely observed, with the study lasting up to the end of 2029.