Recoleta

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 been treated. This phase 3 open-label, randomized controlled study focuses on patients whose disease has progressed after anti-PD-1 and platinum-containing therapies. It aims to assess effectiveness and safety for second- and third-line treatments in this population. Participants will be randomly assigned to receive either petosemtamab or one of several investigators choice monotherapies, including cetuximab, methotrexate, or docetaxel. The treatments are given as part of a controlled multicenter trial. The study includes follow-up periods to evaluate responses and safety outcomes over time. During the study, participants will undergo regular assessments including radiologic evaluations to measure tumor response according to RECIST criteria, physical performance status checks, and laboratory tests to monitor organ function and adverse events. Researchers will track overall survival for up to approximately three years and evaluate other outcomes such as progression-free survival, response rates, quality of life measures, and treatment safety. The total duration of participation is aligned with treatment and outcome measurement timelines as specified.

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 combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating the clinical benefit of combining Navlimetostat BMS-986504, a selective MTA-cooperative inhibitor of PRMT5, with pembrolizumab and chemotherapy compared to placebo plus pembrolizumab and chemotherapy. This study focuses on participants with first-line metastatic non-small cell lung cancer NSCLC who have a homozygous MTAP deletion. The trial is a randomized Phase 23 study aimed at advancing treatment options for this specific lung cancer group. Participants will receive one of several combinations Navlimetostat plus pembrolizumab and chemotherapy, or placebo plus pembrolizumab and chemotherapy. Chemotherapy drugs involved may include cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on certain days. The study uses a quadruple-masked, parallel design with multiple treatment arms to compare these regimens. During the study, participants will be monitored for progression-free survival and overall survival up to five years. Researchers will assess tumor response, disease control, duration and time to response, and safety through adverse event reporting and laboratory tests. The study includes detailed follow-up to evaluate efficacy and safety outcomes over the long term, with a primary completion date in 2031.

This trial studies participants with previously untreated, unresectable, or metastatic colorectal cancer. It evaluates the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy. The study includes participants who do not have specific genetic markers like dMMR, MSI-H, or BRAF V600E mutations, which may affect treatment response. Participants receive treatment with study drugs such as pumitamig, bevacizumab, and chemotherapy regimens including FOLFOX, FOLFIRI, and CAPOX. The treatments are given at specified doses on specific days. The study uses a randomized, double-blind design with multiple experimental and comparator arms to assess these combinations. Throughout the study, participants undergo regular assessments to measure tumor response and survival outcomes. Key evaluations include imaging tests using RECIST v1.1 criteria, monitored by both investigators and independent reviewers, over a period of up to 5 years. Researchers track objective response, progression-free survival, and overall survival to determine treatment outcomes and safety.

Researchers are evaluating a medicine called nerandomilast for adults with systemic sclerosis, a condition affecting the skin and internal organs. The study focuses on people with limited or diffuse cutaneous systemic sclerosis who have had symptoms for less than 7 years. The goal is to see if nerandomilast helps improve symptoms and slows disease progression while assessing how well the medicine is tolerated. Participants are randomly assigned to one of two groups one takes nerandomilast tablets, and the other takes placebo tablets that look identical but do not contain medicine. Tablets are taken twice daily. The study lasts from 1 to about 4 years, with regular visits to the study site and phone check-ins. During visits, participants have blood tests and assessments of skin thickening, lung function, and organ health to monitor changes and treatment effects. Throughout the study, doctors monitor participants overall health and any side effects. They regularly assess safety and tolerability of the treatment. The main outcome measured is the time to disease progression or death over up to 4 years. Other outcomes include changes in skin scores, lung capacity, physical function, and disease impact questionnaires. Participants health is closely followed during the study period.

Researchers are evaluating zongertinib, an oral drug targeting HER2 mutations, to see if it can improve outcomes compared with standard adjuvant treatments in adults who have had complete surgical removal of Stage II-IIIB non-small cell lung cancer NSCLC with activating HER2 tyrosine kinase domain mutations. This Phase 3, global, randomized, open-label study involves participants who have already received appropriate perioperative systemic therapy, including neoadjuvant or adjuvant platinum-based chemotherapy, with or without immunotherapy. Participants are randomly assigned in equal numbers to receive either zongertinib once daily by mouth for up to 3 years or standard treatment, which may include approved adjuvant immunotherapy or observation depending on local guidelines and patient status. The study compares disease-free survival between these groups and also monitors safety and patient-reported outcomes. Tumor samples are collected centrally to confirm HER2 status. During the study, participants undergo regular assessments to monitor disease status, safety, and quality of life. The primary outcome is disease-free survival, tracked for up to 8 years and 5 months. Secondary outcomes include overall survival and occurrence of significant adverse events over up to 3 years. Participant involvement may last several years, with follow-up continuing after treatment to assess long-term outcomes and safety.

Researchers are investigating advanced small cell lung cancer SCLC in adults to determine if adding a medicine called obrixtamig to the standard treatment of atezolizumab, carboplatin, and etoposide improves survival compared to the standard treatment alone. Obrixtamig is a molecule designed to help the immune system fight cancer. The study also tests a new medical device that measures levels of the tumour marker DLL3. This is a phase III clinical trial sponsored by Boehringer Ingelheim, using a randomized design to compare treatments. Participants are randomly assigned to one of two groups. One group receives obrixtamig together with the standard treatment, while the other group receives only the standard treatment. All treatments are given through infusions into a vein. Participants receiving obrixtamig will stay overnight at the study site after their first two treatments. The study lasts up to three years, during which tumour size and health status are regularly checked. Throughout the study, participants visit the study site regularly for assessments. Doctors monitor tumour response and check for any side effects or unwanted reactions. The main outcome is overall survival measured up to 36 months. Additional outcomes include progression-free survival, symptom changes, response rates, and monitoring of treatment-related side effects. The study team closely tracks participant health and evaluates quality of life using questionnaires during the first year.

Researchers are studying adults with advanced extrapulmonary neuroendocrine cancer to find out if adding a study medicine called obrixtamig to standard chemotherapy carboplatin and etoposide improves survival compared to standard chemotherapy alone. This phase III trial also evaluates a medical device designed to measure levels of the tumor marker DLL3, which helps identify suitable patients for treatment. Participants are randomly assigned to one of two groups. One group receives obrixtamig combined with standard chemotherapy followed by obrixtamig alone for up to three years. The other group receives just the standard chemotherapy for about four months. All treatments are given through intravenous infusions. Participants in the obrixtamig group stay overnight at the study site after the first two treatments. During the trial, participants visit the study site regularly for health checks, monitoring of any side effects, and tumor size assessments. Researchers compare outcomes such as overall survival and disease progression between the two groups. The study measures physical functioning and tracks adverse events throughout treatment, with monitoring continuing for up to 38 months.

Researchers are evaluating lunsekimig, a subcutaneous injection, compared with placebo in adults aged 40 to 80 years with inadequately controlled Chronic Obstructive Pulmonary Disease COPD characterized by an eosinophilic phenotype. This Phase 2bPhase 3 parallel study aims to assess the efficacy, safety, and tolerability of lunsekimig in reducing COPD exacerbations and improving lung function and symptoms. Participants are randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. They will receive subcutaneous injections during a 48-week treatment period. The study also includes a screening period of up to 4 weeks before treatment and an approximately 8-week follow-up period after treatment, totaling up to 60 weeks of participation. During the study, participants will undergo regular assessments including lung function tests such as post- and pre-bronchodilator Forced Expiratory Volume in 1 second FEV1, questionnaires measuring respiratory health and symptoms, and monitoring of COPD exacerbations. Safety will be evaluated through reported adverse events and laboratory tests. Researchers will also monitor blood levels of lunsekimig and the presence of antidrug antibodies. Participants will be followed closely throughout the study duration to assess treatment impact and safety.