Portimao

Researchers are evaluating petosemtamab compared with investigators choice monotherapy in patients with incurable, metastatic or recurrent head and neck squamous cell carcinoma HNSCC who have previously received treatment. This phase 3 open-label, randomized, controlled, multicenter study focuses on patients whose disease progressed after anti-PD-1 and platinum-containing therapies. The study aims to assess treatment options for second- and third-line therapy in this challenging condition. Participants will be randomly assigned to receive either petosemtamab or one of several investigator-chosen monotherapies, including cetuximab, methotrexate, or docetaxel. The study compares these treatment approaches without masking, allowing patients and researchers to know the assigned therapies. Treatments will be provided according to the study protocol, with follow-up to monitor effects and safety. During the study, participants will undergo assessments including radiologic evaluations to measure tumor response, laboratory tests to monitor organ function, and quality of life questionnaires. The main outcome is overall survival tracked for up to about three years, with additional measures such as response rate, progression-free survival, and treatment-related side effects observed for up to two years. Safety will be closely monitored, including adverse events and antibody responses, ensuring comprehensive evaluation throughout the study period.

Researchers are investigating the effectiveness and safety of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as first-line treatment for recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma HNSCC. This Phase 3 randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease and aims to improve treatment outcomes in this population. Participants will be randomly assigned to receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone. The study excludes patients previously treated with anti PD-L1 or anti-EGFR therapies, with some exceptions for local treatments like cetuximab under specific conditions. The treatments will be administered as part of the trial, with researchers comparing the two approaches over the treatment period. During the study, participants will undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, health-related quality of life questionnaires, and safety monitoring for adverse events. The main outcomes measured include overall survival and objective response rate up to approximately three years. Additional assessments include progression-free survival, duration of response, and pharmacokinetics. These activities aim to provide comprehensive data on how well the treatments work and their safety profiles throughout the study period.

Researchers are evaluating the anti-tumor activity of adding amivantamab to pembrolizumab and carboplatin compared to pembrolizumab combined with 5-fluorouracil and platinum therapy carboplatin or cisplatin in participants with recurrent or metastatic head and neck squamous cell carcinoma HNSCC who have not received prior systemic treatment in this setting. HNSCC is a cancer affecting areas such as the mouth and throat. This phase 3, randomized, open-label study aims to better understand treatment options for this condition. Participants are assigned randomly to one of two treatment groups. One group receives pembrolizumab, amivantamab, and carboplatin, while the other group receives pembrolizumab, 5-fluorouracil administered via a 4-day infusion, and either carboplatin or cisplatin. The treatments are given as part of standard care agents, and the study compares these combinations to assess their effects and safety over time. Throughout the study, participants will be monitored for overall survival and tumor response using established criteria over approximately three years and seven months. Additional assessments include progression-free survival, duration of response, quality of life questionnaires focusing on symptoms and functioning, and safety evaluations such as adverse event tracking and laboratory testing. Blood samples will also be collected to measure amivantamab concentration and antibodies. The study involves multiple visits and evaluations to thoroughly assess the treatments impact and participant well-being.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart RO7790121 compared to placebo in people with moderately to severely active ulcerative colitis UC. This Phase III, multicenter, double-blind, placebo-controlled study aims to understand how well Afimkibart works and its safety profile in this population. Participants will be randomly assigned to receive either Afimkibart or a placebo. Those in the Afimkibart group will receive the drug first through an intravenous IV infusion followed by a subcutaneous SC injection. The placebo group will receive matching placebo treatments by IV and SC as well. The study treatment period includes these induction therapies, with monitoring continuing up to 30 weeks for safety. During the study, participants will be assessed for clinical remission at 12 weeks, which is the primary outcome. Other evaluations include changes in partial Modified Mayo Score, endoscopic improvement and remission, histologic improvements, bowel urgency, abdominal pain, fatigue, and health-related quality of life. Safety will be monitored by recording adverse events throughout the study. Participants will have visits for these assessments and monitoring over the course of the study duration.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This Phase 3 program includes two separate studies with different treatment goals. Study 1 includes both induction and maintenance treatment and aims to see if tulisokibart doses are better than placebo in achieving clinical remission and endoscopic response at 12 and 52 weeks. Study 2 focuses only on induction treatment with similar goals measured at 12 weeks. Participants receive different dosing regimens of tulisokibart administered either intravenously IV or subcutaneously SC. Study 1 has groups receiving high or low dose IV tulisokibart followed by high or low dose SC tulisokibart maintenance, as well as placebo groups matching these routes. Study 2 includes induction treatment with high or low dose IV tulisokibart or placebo. Some participants may continue in extension arms with SC dosing after completing their initial study phase if they meet specific requirements. During the study, participants will be assessed regularly for clinical remission using Crohns Disease Activity Index scores or stool frequency and abdominal pain scores, and for endoscopic response by examination. These assessments occur at weeks 12 and 52 for Study 1 and at week 12 for Study 2. Researchers will monitor safety by tracking adverse events and treatment discontinuations. The total participation duration varies, with Study 1 lasting up to 52 weeks and Study 2 up to 12 weeks.

Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab in adults with first-line PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma HNSCC. This study focuses on targeting two cancer drivers, EGFR and TGF-, which promote tumor growth and spread. The research is conducted in two phases to identify the best dose and compare treatment outcomes. In Phase 2, participants are randomly assigned to one of three groups high-dose ficerafusp alfa with pembrolizumab, lower-dose ficerafusp alfa with pembrolizumab, or placebo with pembrolizumab. Phase 3 compares the chosen optimal dose of ficerafusp alfa plus pembrolizumab against placebo plus pembrolizumab with a 21 randomization ratio. Treatments are given weekly or every three weeks according to the study arm. Participants will undergo regular evaluations including scans to measure tumor response, safety monitoring for side effects, and quality of life assessments. The study measures outcomes such as tumor response rate, overall survival, progression-free survival, and treatment safety over periods ranging from one to three years. Researchers will also monitor treatment-related adverse events and the impact on symptoms and pain throughout the study.