Skin Cancer

Researchers are evaluating 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in a Phase 0/1 study involving participants with advanced solid tumors that express PD-L1. The study aims to assess the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor effects of this treatment. The main goal is to find the maximum tolerated dose and recommended doses for future studies in participants with cancers such as NSCLC, SCLC, triple-negative breast cancer, melanoma, head and neck cancer, endometrial cancer, and others with specific genetic markers. The study includes a pre-screening period for PD-L1 testing if needed, followed by a screening period lasting up to four weeks. Participants undergo a Phase 0 Imaging Period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and dosimetry over two weeks. This may be followed by a Phase 1 Treatment Period with escalating doses of 177Lu-RAD204 administered in cycles lasting six weeks each. Participants may receive multiple treatment cycles based on clinical benefit and safety evaluations. Dose-limiting toxicity is monitored for six weeks after the first treatment dose, and dosing intervals may be adjusted as agreed by the study team. During the study, participants will have imaging scans, safety evaluations, and laboratory tests to track the distribution and effects of 177Lu-RAD204. Researchers will measure pharmacokinetics, radiation dosimetry, and tumor responses up to 30 weeks. Safety and tolerability are closely monitored throughout. Participants must meet specific health and tumor criteria to join and will be observed for any adverse reactions. The total duration of participation varies depending on treatment response and tolerability.

Researchers are studying the use of a 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) to treat advanced perioral lines and wrinkles. The goal is to assess the laser's effectiveness for skin rejuvenation by using both superficial epidermis ablation and deeper skin layers' ablative and coagulative effects. The study also aims to evaluate safety and participant satisfaction with this resurfacing treatment for photodamaged skin and wrinkles. Participants will receive up to two treatments with the UltraClear laser, spaced 6 to 8 weeks apart. These treatments focus on improving the appearance of perioral lines and wrinkles using the laser's combined superficial and deep skin effects. Following treatments, participants will have follow-up visits at 1 month and 3 months to evaluate the results and any side effects. Throughout the study, researchers will measure improvements using multiple scales, including the Fitzpatrick Wrinkling and Degree of Elastosis Scale, Physician Global Aesthetic Improvement Scale, and assessments by independent photographic reviewers. Participants will also report their own perceptions of aesthetic improvement and satisfaction. Safety and overall aesthetic outcomes will be monitored during follow-ups, with the total participation lasting through the 3 months after the final treatment.

Researchers are comparing two creams to treat low-risk skin cancers, specifically superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). The study evaluates whether a combination cream of 5-fluorouracil and calcipotriene applied for a shorter duration can clear these cancers effectively compared to the standard 5-fluorouracil cream used for 4 weeks. This pilot randomized single-blinded trial is sponsored by Boston University and includes follow-up for up to three years to monitor cancer clearance and recurrence. Participants will be randomly assigned to receive either the combination cream applied twice daily for 7 days, which may be extended to 14 days based on evaluation, or the standard 5-fluorouracil cream applied twice daily for 28 days. The creams are applied to the lesion and a surrounding 0.5 cm area of skin. The study treatments are compared by assessing the clearance of cancer lesions clinically. During the study, participants will have their lesions examined at 3 months and followed for up to 3 years with visits at 6 months and yearly intervals. If lesions are not clearly cleared, biopsies will be performed and standard care will be provided. Researchers will track clearance rates, recurrence, and side effects such as pain, redness, scaling, itching, and burning during treatment. Participant adherence and satisfaction with treatment will also be assessed over the study period.

Researchers are evaluating the use of the tracer [68Ga]Ga-FAPI-46 in PET/CT imaging to better assess how patients with advanced stage malignant melanoma respond to immune checkpoint inhibitor therapy (ICT). The study's main goal is to determine if this new imaging method can improve response evaluation compared to the standard [18F]FDG PET/CT and possibly act as a biomarker for treatment effectiveness. Participants with advanced malignant melanoma will undergo two PET/CT scans using the experimental tracer [68Ga]Ga-FAPI-46: one before starting ICT treatment and another after three months. These scans are additional to their standard imaging. Blood samples will also be collected twice, and patients will receive standard ICT treatment as prescribed by their medical team. During the study, participants will have their scans and blood samples analyzed to observe changes in tracer uptake in both cancerous lesions and healthy tissues. Researchers will follow up passively for six months after the last PET/CT scan to monitor outcomes. The primary outcome measured is the change in [68Ga]Ga-FAPI-46 uptake in malignant lesions over a three-month period, with further monitoring extending to nine months total from enrollment.

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 1/2 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 MDNA11's effects alone and with pembrolizumab.

Researchers are studying if combining intismeran autogene with pembrolizumab can prevent advanced melanoma, a type of skin cancer that has spread and cannot be removed by surgery, from growing or spreading further. This study compares this combination to pembrolizumab with a placebo to see if patients live longer without their cancer worsening. The trial is a phase 2 randomized study designed to evaluate these treatments in people with advanced melanoma. Participants will be randomly assigned to receive either intismeran autogene via muscle injection every three weeks for up to nine doses plus pembrolizumab through an intravenous infusion every six weeks for up to 17 doses, or a placebo injection with the same pembrolizumab schedule. Treatment may continue for up to approximately two years or until the cancer progresses or the participant stops treatment. During the study, participants will be monitored with scans to measure tumor response and blood tests to assess safety and side effects. Researchers will measure how long patients live without their cancer progressing as the main outcome, along with response rates, duration of response, overall survival, and treatment-related adverse events. Participants may be involved in the study for up to about six years to fully assess these outcomes and monitor safety.

Researchers are studying the safety and initial effects of T3011, given directly into tumors, alone and combined with the intravenous drug pembrolizumab. This Phase 1/2a open-label study focuses on adults with advanced or metastatic solid tumors, including melanoma, head and neck squamous cell carcinoma (HNSCC), sarcoma, cutaneous squamous cell carcinoma (cSCC), and non-small cell lung cancer (NSCLC). The study aims to find safe dose levels and assess how well these treatments are tolerated and work in these cancer types. The study involves several groups: Phase 1 tests increasing doses of T3011 alone to determine a recommended dose. Phase 2a Part 1 evaluates T3011 alone in participants with melanoma, HNSCC, sarcoma, and cSCC. Phase 2a Part 2 studies T3011 with pembrolizumab in NSCLC patients. A rollover arm allows participants whose cancer progresses on T3011 alone to receive the combination treatment. T3011 is given as an intratumoral injection every two weeks, and pembrolizumab is given intravenously every three weeks when combined. Participants will have tumor biopsies, imaging, and laboratory tests to monitor safety, drug levels, and cancer response. Researchers will track side effects and measure outcomes like tumor response and survival for up to two years after the first dose. Safety and tolerability are closely followed throughout, with additional monitoring for immune responses and drug presence in bodily fluids. Participants may be followed for up to one year after their last treatment dose to assess overall survival and long-term effects.

Researchers are evaluating the safety, tolerability, antitumor activity, and immune response of LM103 Injection in patients with advanced solid tumors, including melanoma, non-small cell lung cancer, and cervical cancer. This open-label, single-arm exploratory study aims to assess how well this treatment works and how safe it is for patients whose existing treatments are ineffective or unavailable. The treatment involves harvesting tumor-infiltrating lymphocytes (TILs) from the patients tumor sample, expanding them ex vivo, and then transferring them back to the patient intravenously after chemotherapy with cyclophosphamide and fludarabine. LM103 Injection is given as a single dose on day 1, combined with interleukin-2 (IL-2) therapy to support immune response. The study plans to enroll between 9 and 15 patients. Participants will undergo laboratory tests, imaging, and physical assessments to monitor response and safety for up to two years. Researchers will track adverse events for one year and evaluate tumor response, disease control, progression-free survival, and changes in immune activity. The total study duration includes treatment, follow-up, and monitoring to better understand the effects of LM103 Injection in advanced solid tumors.

Researchers are evaluating the safety and effectiveness of a modified herpes simplex virus called recombinant oncolytic herpes simplex virus type 1 (R130) in patients with advanced solid tumors. This early phase 1, open, single-arm clinical trial aims to study the treatment in people with various cancers such as sarcoma, carcinoma, digestive cancer, breast cancer, lung cancer, brain cancer, melanoma, gynecologic cancer, head and neck cancer, and kidney cancer. The study focuses on patients who have not responded to standard treatments or who choose not to receive other antitumor therapies. Participants will receive injections of 1 to 2 milliliters of R130 at a concentration of 1x10^8 plaque-forming units per milliliter into their tumors or abdominal cavity every 7 to 14 days. This approach allows the virus to be delivered directly to the cancer site. The study involves only one treatment group receiving the R130 virus, and no placebo or comparison group is used. During the trial, researchers will monitor participants for adverse events and laboratory abnormalities up to 6 months and assess their immune response. Disease control and response duration will be evaluated every 10 weeks for up to 12 months, while quality of life assessments will occur every 6 weeks for the same period. Participants will undergo regular laboratory tests and clinical evaluations to track safety and treatment impact. The total study duration for each participant may extend up to one year with ongoing monitoring.

Researchers are evaluating the safety and effectiveness of Alpha DaRT-224, a treatment involving the placement of radioactive seeds directly into tumors, for patients with recurrent cutaneous squamous cell carcinoma who have not responded to standard treatments. This prospective, multicenter, single-arm study aims to measure how well tumors respond to this therapy, the duration of response, progression-free survival, overall survival, local tumor control, and patient quality of life. The treatment involves inserting Alpha DaRT-224 seeds into the tumor using planned radiotherapy techniques. These radioactive seeds release alpha particles that target the tumor over a period of 14 to 21 days before being removed. Researchers use imaging to assess tumor response 2 to 3 weeks after placement. The study is open-label and does not include a comparison group. Participants will undergo regular assessments including imaging scans, blood tests, and quality of life questionnaires at specified intervals up to 12 months after treatment. Safety is closely monitored through reported adverse events related to the device. The main outcomes measured are tumor response and how long it lasts, with follow-up to document progression and survival. The total participation time varies with assessments scheduled from insertion through one year post-treatment.