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Researchers are studying an experimental drug called REGN10597, given alone or with another drug called cemiplimab, in adults with advanced solid tumors such as melanoma and clear-cell renal-cell carcinoma. This Phase 12a trial aims to evaluate how safe, tolerable, and effective these study drugs are in treating cancers that have spread in the body. The study also explores side effects, drug levels in the blood, and whether the body produces antibodies against the drugs that might affect their activity or cause side effects. Participants receive REGN10597 alone or combined with cemiplimab in different dose levels to find the best dose for future studies. The study includes dose escalation and dose expansion phases, with separate groups for melanoma and renal-cell carcinoma patients. Dosing and administration follow the study protocol, and participants may have biopsies at screening and other times for research purposes. During the study, participants will be monitored closely for side effects and treatment responses. Researchers assess tumor response using established criteria and track various safety outcomes over approximately six years. Blood samples are collected to measure drug concentrations and antibody development. Participants will have regular visits for evaluations, and their health status will be followed for a long-term period to understand treatment effects and safety.

Researchers are conducting a multicenter, open-label Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of YL211 in patients with advanced solid tumors. The study aims to determine the maximum tolerated dose MTD and recommended expansion doses RED of YL211, an antibody-drug conjugate, while assessing the nature and frequency of side effects and treatment responses in this patient group. The study includes three parts Part 1 involves dose escalation to assess safety and tolerability and establish MTD and RED. Part 2 is a backfill enrollment phase to further evaluate safety and efficacy at selected doses. Part 3 is a dose-expansion phase to continue evaluating safety and efficacy at the determined doses. YL211 is given to patients by intravenous infusion until treatment discontinuation criteria are met. Participants will undergo regular assessments including monitoring of adverse events, dose-limiting toxicities, and tumor response using RECIST version 1.1 criteria. Pharmacokinetic properties of YL211 and immune responses will also be measured. The study duration is approximately 36 months, with ongoing safety and efficacy evaluations throughout. Participants will be closely monitored for treatment effects and side effects during the study period and follow-up.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are studying nasal foralumab, a human anti-CD3 monoclonal antibody, for treating non-active secondary progressive multiple sclerosis SPMS, a form of multiple sclerosis affecting adults. This Phase 2a randomized, double-blind, placebo-controlled, multicenter trial aims to assess the safety and tolerability of two dosages of nasal foralumab and its effect on microglial activation in the brain, measured by PET scans after 12 weeks of treatment. Participants will be randomly assigned to one of three groups nasal foralumab 50 g, nasal foralumab 100 g, or nasal placebo. Each dose is given three days a week Monday, Wednesday, Friday for two weeks followed by a one-week rest, making a 3-week cycle. This cycle is repeated four times over three months. The nasal solution is administered via a nasal atomizer device, with each dose split evenly between nostrils. Throughout the study, participants undergo assessments including PET scans, MRI, disability scales, fatigue impact, and nasal symptom scoring at baseline and during treatment cycles. Safety is monitored by tracking adverse events and laboratory tests. The study lasts about 12 weeks, during which researchers will evaluate changes in microglial activity and disability, as well as the safety and tolerability of the nasal foralumab treatment.

Researchers are evaluating whether adding immunotherapy drugs, brentuximab vedotin and nivolumab, to the standard chemotherapy treatment with or without radiation improves survival in patients with early-stage stage I and II classical Hodgkin lymphoma. This phase III trial compares the standard treatment alone to the combination with immunotherapy. The study also aims to assess differences in side effects, quality of life, and long-term health outcomes among patients receiving these treatments. All patients start by receiving two cycles of ABVD chemotherapy every 28 days, followed by imaging to assess their early response. Based on their risk status and response, they are placed into groups receiving different treatments some continue with standard chemotherapy, while others receive the immunotherapy drugs with or without radiation. Treatments are given intravenously on specific days and cycles, and patients undergo various scans and blood tests throughout the trial. Participants are closely monitored with periodic imaging tests such as PET, CT, MRI scans, and blood sample collections. Follow-up visits occur every three months for the first year, then less frequently up to 12 years to track progression-free survival, overall survival, treatment side effects, fatigue, cognitive function, and quality of life. Researchers also study tumor metabolism, patient-reported outcomes, and the impact of social factors on treatment results.

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK46 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctors choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy treatment can improve outcomes for adults with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial compares standard chemotherapy alone to chemotherapy combined with durvalumab. Previous evidence suggests patients with this specific cancer profile may respond better to chemotherapy and immunotherapy, so this study aims to see if durvalumab helps prevent cancer from returning. Participants are first screened with MammaPrint testing on tumor tissue to confirm MP2 status. Those eligible are then randomly assigned to one of two treatment groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously during specific cycles. Mammography is done during screening, and optional tumor tissue and blood samples are collected throughout the study. During the trial, participants undergo regular assessments including mammograms, tissue biopsies, and blood tests to monitor response and safety. Researchers measure event-free survival, pathologic complete response, residual cancer burden, distant relapse-free survival, and overall survival for up to 10 years after treatment. Quality of life is also evaluated through questionnaires during and after treatment. Participants are followed long-term to track outcomes and side effects.

Researchers are studying advanced stomach or esophageal adenocarcinoma to see if adding the drug nivolumab to the usual treatment of paclitaxel and ramucirumab improves outcomes for patients. This phase IIIII trial compares the combination of nivolumab, paclitaxel, and ramucirumab with paclitaxel and ramucirumab alone. The study aims to assess progression-free survival and overall survival, while also evaluating response rates, disease control, safety, and quality of life. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, along with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives ramucirumab and paclitaxel on the same schedule without nivolumab. Treatments continue unless the disease progresses or unacceptable side effects occur. Patients may also have optional blood tests, CT scans, and MRIs during the study. Throughout the trial, participants undergo regular imaging scans and optional blood sample collection to monitor disease status. After treatment ends, follow-up visits occur at 30, 60, and 90 days, then every 6 months for up to 3 years to assess survival and health. Researchers also collect patient-reported outcomes related to symptoms and quality of life during the study period.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are evaluating how newly diagnosed Stage I HER2-positive invasive breast cancer responds to one of two different combinations of HER2-directed therapies after surgery. The study compares the effects and side effects of trastuzumab-emtansine T-DM1 followed by subcutaneous trastuzumab versus paclitaxel combined with subcutaneous trastuzumab. This phase II randomized trial also aims to understand the long-term benefits and disease-free survival for participants treated with these therapies. Participants are randomly assigned to one of two treatment groups. The first group receives intravenous T-DM1 every three weeks for six cycles, followed by subcutaneous trastuzumab every three weeks for eleven cycles. The second group receives weekly intravenous paclitaxel for twelve weeks alongside subcutaneous trastuzumab every three weeks for the first four doses, then continues with trastuzumab alone every three weeks for seventeen cycles. Treatment lasts about one year in total. During the study, participants undergo screening and regular evaluations including laboratory tests and follow-up visits. Researchers monitor the occurrence of clinically relevant toxicities during the first 18 weeks and track disease-free survival for up to 72 months. Additional assessments include quality of life, symptoms related to therapy, side effects, cardiac function, gene profiling, and overall survival. Participants will be followed for five years after completing treatment to assess long-term outcomes.