Lebanon

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Migraine is a common neurological disorder that causes moderate to severe headache attacks, often with nausea, vomiting, and sensitivity to light and sound. This study is evaluating the safety and effectiveness of ubrogepant, a drug approved for adults, for the acute treatment of migraine in children and adolescents aged 6 to 17 years. The trial includes two participant groups a pharmacokinetic PK cohort for dose analysis in younger children and a main study cohort involving randomized treatment with different ubrogepant doses or placebo. Participants aged 6 to 11 years in the PK cohort will receive one of two doses of ubrogepant to determine dosing for the main study. In the main study, children aged 6 to 11 and adolescents aged 12 to 17 will be randomly assigned to low or high doses of ubrogepant or placebo, with a one in three chance of receiving placebo. For qualifying migraine attacks, participants will take oral tablets of the assigned study treatment, with the option of a second dose or rescue medication at least two hours later if headaches remain moderate or severe. Participants will be involved for up to six months and will attend regular hospital or clinic visits. Researchers will monitor treatment effects using medical assessments, blood tests, side effect checks, and questionnaires. The primary outcome measured is the percentage of participants achieving pain freedom two hours after the initial dose. Safety, tolerability, and pharmacokinetic data will also be collected to understand ubrogepants effects in this younger population.

Researchers are evaluating a new medicine called PF-08634404 for adults with locally advanced or metastatic urothelial cancer, a type of bladder cancer that has spread to nearby tissues or other parts of the body. The study aims to assess the safety, effectiveness, how the medicine moves through the body, and its impact on cancer-related markers. This is a Phase 1B2 treatment study sponsored by Pfizer. Participants are divided into two groups Cohort A includes those who have already received treatment and will receive PF-08634404 alone, while Cohort B includes untreated participants who will receive PF-08634404 combined with another cancer medicine called enfortumab vedotin. Both study medicines are given through an intravenous infusion. Treatment continues as long as it is beneficial and side effects are manageable. Before starting treatment, participants undergo a screening period to confirm eligibility. During the study, they have regular visits for treatment, health assessments, and tests to monitor cancer response, including scans. If the cancer worsens but treatment still helps and side effects are manageable, participants may continue treatment with approval. The study tracks outcomes such as tumor response, adverse events, survival, and drug levels over up to three years.

Researchers are evaluating a new medicine called PF-08634404 in adults with advanced Renal Cell Carcinoma RCC, a type of kidney cancer that has spread locally or to other parts of the body. This study aims to understand how the medicine works alone or combined with other anticancer treatments, focusing on safety and cancer response. Participants must be adults with advanced RCC who have not yet received treatment for their advanced kidney cancer. Participants will receive PF-08634404 through intravenous infusions either alone or combined with other anticancer medicines such as ipilimumab or axitinib. The study includes different groups receiving these treatments sequentially, with all infusions delivered at clinical sites by medical staff. Treatment and evaluation will continue for up to approximately three years. During the trial, participants will have regular assessments including scans and lab tests to monitor cancer response and safety. Researchers will measure outcomes such as the confirmed objective response rate, adverse events, dose-limiting toxicities, and survival. Pharmacokinetics and immune responses to the study drug will also be tracked. Participants may be followed for up to three years to evaluate treatment effects and safety.

Researchers are evaluating whether a new medicine called PF-08634404, given with chemotherapy, works better than the current standard treatment of pembrolizumab combined with chemotherapy for adults with a type of lung cancer known as non-small cell lung cancer NSCLC. This study focuses on participants with locally advanced or metastatic NSCLC who are not candidates for surgery or curative chemoradiotherapy and have no known actionable genomic alterations. The study is a Phase 3 randomized trial with double-blind masking to compare these treatments. Participants are assigned to one of two parts based on their tumor type those with squamous NSCLC are in Part 1, and those with non-squamous NSCLC are in Part 2. Each participant is randomly placed into one of two treatment groups the experimental group receives PF-08634404 plus chemotherapy, while the control group receives pembrolizumab plus chemotherapy. Treatments are given through intravenous infusions in cycles, followed by maintenance therapy with either PF-08634404 or pembrolizumab, depending on the part of the study. Participants continue treatment as long as it helps and side effects are manageable. During the study, participants attend regular visits for treatment and health assessments. Cancer response is checked every 6 weeks for the first 48 weeks and then every 12 weeks after that. Researchers monitor overall survival, progression-free survival, objective response rates, duration of response, adverse events, lab abnormalities, and quality of life measures. The study includes detailed tracking of drug levels and immune responses. Participation may last up to approximately 39 months, with continuous safety and effectiveness monitoring.

Researchers are investigating whether combining the investigational drug mevrometostat PF-06821497 with enzalutamide works better than enzalutamide alone for men with metastatic castration-sensitive prostate cancer mCSPC who have not previously received androgen receptor pathway inhibitors ARPI or chemotherapy in this setting. This Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study aims to compare these treatments to understand if the combination improves outcomes for participants. Participants will be randomly assigned to one of two groups one group will receive mevrometostat 875 mg twice daily plus enzalutamide 160 mg once daily, while the other group will receive a placebo plus enzalutamide 160 mg once daily. The study includes several phases Screening, Randomization, Treatment, Safety Follow-up, and Long-Term Follow-up. Prior short-term androgen-deprivation therapy ADT of up to 3 months is allowed if there is no disease progression before starting the study. During the study, participants will have regular assessments including radiographic scans to monitor disease progression, laboratory tests, patient-reported questionnaires on pain and quality of life, and blood samples to evaluate tumor DNA and drug levels. The main measure is radiographic progression-free survival tracked for up to about 4 years. Safety outcomes and overall survival will also be monitored for several years. The total participation may last up to nearly 9 years, including long-term follow-up to understand treatment effects and safety over time.

Researchers are evaluating the therapeutic cancer vaccine OSE2101 in patients with metastatic non-small cell lung cancer NSCLC who have developed secondary resistance to immune checkpoint inhibitors ICI. This phase 3, multicenter, randomized, open-label study focuses on HLA-A2 positive patients with either squamous or non-squamous NSCLC. The study aims to compare the efficacy and safety of OSE2101 with the standard treatment docetaxel, considering factors like cancer histology and performance status. Participants will be randomized in a 21 ratio to receive either OSE2101 monotherapy or docetaxel monotherapy. OSE2101 is administered as a subcutaneous injection of 5 mg peptides every three weeks for six cycles, then every eight weeks during the first year, and every twelve weeks until the end of the second year. Docetaxel is given as a 75 mgm2 intravenous infusion over one hour every three weeks. Additionally, a companion diagnostic device system is used to assess patient eligibility based on HLA-A2 phenotype. During the study, participants will have regular evaluations including clinical assessments and monitoring of survival time from randomization to death, which is the primary outcome measured over an average of three years. The study involves ongoing monitoring of treatment effects and safety. Participants can expect scheduled visits aligned with treatment cycles and assessments throughout the trial duration, which extends up to nearly five years from start to completion.