Tomaszow Mazowiecki

Researchers are investigating a combination therapy of BNT326 and pumitamig also called BNT327 or PM8002 in adults with advanced or metastatic non-small cell lung cancer NSCLC who may have relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study aims to find the best dose levels for this combination, assess how well participants tolerate the therapy, including side effects, and evaluate its ability to shrink tumors in this population. The study has three parts Part 1 focuses on finding safe dose levels for the combination Part 2a expands the dose evaluation to assess preliminary effectiveness and safety Part 2b is a randomized phase to optimize doses and understand the contribution of each drug component. Participants will receive intravenous infusions of BNT326 and pumitamig or pumitamig alone in some arms. Treatment continues until disease progression, unacceptable side effects, withdrawal, study end, or up to 24 months. Dose levels for later parts are chosen based on earlier safety and efficacy data. Participants will go through screening, treatment, safety follow-up, efficacy follow-up, and long-term survival follow-up phases, with total involvement expected to last about 36 months unless treatment benefit continues. Assessments include monitoring for dose-limiting toxicities, adverse events, tumor response, progression-free survival, overall survival, and pharmacokinetics of the drugs. Safety evaluations continue up to 90 days after treatment ends, and antibody responses to the drugs are also measured for up to one year post-treatment.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are evaluating how well brentuximab vedotin BV works for treating adults with Hodgkin lymphoma HL who have undergone or are candidates for autologous stem cell transplant ASCT. This observational study focuses on assessing BVs safety and effectiveness in real-world clinical settings before and after ASCT treatment. Approximately 70 participants will take part in this multi-center trial conducted in Poland over about 4.5 years. Participants will receive standard treatment with BV according to clinic practice and be assigned to one of two groups those receiving BV before ASCT as salvage therapy and those receiving BV after ASCT as consolidation therapy. Each participant will be observed prospectively for 24 months following the end of their BV treatment. No experimental interventions are administered as part of this study. Participants will visit the study clinic five times, spaced every 12 weeks during treatment. After treatment ends, follow-up visits will occur every three months during the first year and every four to six months during the second year. Researchers will collect data electronically and monitor progression-free survival and overall survival for up to 36 months to evaluate treatment outcomes and safety.

Researchers are evaluating the effectiveness and safety of Ifinatamab Deruxtecan I-DXd compared to the treatment chosen by a physician for people with relapsed small cell lung cancer SCLC. This Phase 3 study aims to see if I-DXd can help participants live longer than current treatments, while also examining other effects such as patient-reported outcomes, immune response, and the drugs behavior in the body. Participants will be randomly assigned to one of two groups. One group will receive I-DXd as an intravenous infusion at a dose of 12 mgkg every 21 days until the disease worsens, unacceptable side effects occur, or other stopping reasons arise. The other group will receive one of the standard treatments chosen by their doctortopotecan, lurbinectedin, or amrubicinaccording to local approved dosing guidelines and until treatment discontinuation criteria are met. During the study, participants will be closely monitored with regular imaging and assessments to track tumor response, disease progression, and quality of life using questionnaires. Safety events and immune responses will also be recorded. Pharmacokinetic samples will be collected at specified times to understand how I-DXd behaves in the body. Participants may remain in the study for up to approximately 3.7 years, allowing for long-term evaluation of outcomes and safety.

Researchers are conducting an observational study to assess patient satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in people with certain types of lung cancer and hepatocellular carcinoma. The study focuses on participants treated for approved indications in routine clinical practice across multiple countries and centers. It collects primary data on patient-reported outcomes and clinical effectiveness in real-world settings. Participants receive Atezolizumab as prescribed by their doctors for conditions including early-stage non-small cell lung cancer NSCLC after surgery and chemotherapy, metastatic NSCLC, extensive-stage small cell lung cancer ES-SCLC, and advanced or unresectable hepatocellular carcinoma HCC. Atezolizumab administration is at the physicians discretion and is independent of study participation. The study includes several cohorts based on cancer type and stage. During the study, participants report treatment satisfaction using the Therapy Administration Satisfaction Questionnaire Subcutaneous TASQ-SC at cycles 2 and 3, each lasting 3 weeks. Researchers also evaluate overall survival up to about 3.5 years, quality of life with the EORTC QLQ-C30 questionnaire, and record adverse events during the same period. The study aims to monitor patient experience, clinical outcomes, and safety over the long term, with participation lasting several years.

Researchers are evaluating the efficacy, safety, and tolerability of adding ponsegromab to systemic chemotherapy compared to chemotherapy plus placebo for adults with metastatic pancreatic ductal adenocarcinoma mPDAC who have cachexia, a condition causing significant weight loss and fatigue. This Phase 2b3 randomized, double-blind, multinational study focuses on first-line treatment for this advanced cancer and associated cachexia. Participants will receive standard first-line chemotherapy regimens, either nab-paclitaxel plus gemcitabine or FOLFIRINOX, combined with either ponsegromab at one of two doses or a matching placebo. Study intervention is given subcutaneously every four weeks starting on the same day as the chemotherapy cycle and prior to chemotherapy administration. After Phase 2b, one ponsegromab dose will be selected for Phase 3, and participants will either continue or switch to that dose while remaining blinded. An optional open-label extension allows participants to receive ponsegromab for up to 12 months after the double-blind phase. During the study, participants will have tumor assessments approximately every 6 to 8 weeks by independent radiologists. Researchers will measure changes in body weight, anorexia symptoms, physical activity, muscle and fat tissue quality, overall survival, and treatment safety through laboratory tests, adverse event monitoring, and patient questionnaires. The study duration extends through Phase 3 with ongoing monitoring until key survival events occur, with an additional optional sub-study assessing caregiver quality of life.

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 studying the safety, tolerability, how the body processes, immune response, and early anti-tumor effects of trastuzumab deruxtecan T-DXd alone or combined with chemotherapy andor immunotherapy. This study focuses on adults with HER2-expressing advanced or metastatic gastric, gastroesophageal junction GEJ, and esophageal adenocarcinoma who have either not been treated before for advanced disease or have progressed after prior trastuzumab treatment. The trial aims to find manageable safety profiles and preliminary evidence of anti-tumor activity to support further testing.

Researchers are evaluating the safety and tolerability of trastuzumab deruxtecan T-DXd combined with immunotherapy agents, with or without chemotherapy, in patients who have HER2 over-expressing non-small cell lung cancer NSCLC. This phase Ib study focuses on advanced or metastatic non-squamous NSCLC patients, aiming to understand optimal dosing and safety profiles. The study is sponsored by AstraZeneca and includes multiple study parts to explore different drug combinations and regimens. The trial includes several parts Part 1 involved dose escalation of T-DXd with durvalumab plus cisplatin, carboplatin, or pemetrexed Parts 3, 4, and 5 assess combinations of T-DXd with volrustomig or rilvegostomig, with or without carboplatin, in various dosing schedules. Patients receive the study drugs as intravenous infusions. Some parts involve randomization between arms with or without carboplatin, focusing on dose optimization in first-line treatment settings. Enrollment in some parts is closed, while others continue to explore safety and efficacy. Participants undergo regular assessments including tumor measurements by RECIST 1.1, organ and bone marrow function tests, and monitoring of adverse events for about 20 months. The study measures safety outcomes like frequency of adverse events and serious adverse events, and secondary outcomes such as response rate, duration of response, disease control, progression-free survival, overall survival, and pharmacokinetics of the drugs. Immunogenicity of the treatments is also evaluated. Participants must have measurable disease and meet performance status criteria, with follow-up to assess treatment effects and safety.

Researchers are evaluating the effectiveness and safety of the drug RO7771950 combined with trastuzumab and capecitabine compared to tucatinib combined with trastuzumab and capecitabine in people with locally advanced or metastatic HER2-positive breast cancer. This study includes patients with or without central nervous system metastases and focuses on those who have previously received anti-HER2 therapies. The trial is a randomized, open-label study sponsored by Hoffmann-La Roche, designed to assess treatment outcomes in this patient population. Participants will be assigned to one of three groups two experimental arms receiving different doses of RO7771950 orally twice daily, or a comparator arm receiving tucatinib orally twice daily. All participants will also receive trastuzumab, administered either intravenously or subcutaneously according to local guidelines, and capecitabine taken orally twice daily. The study evaluates these treatments over an extended period to monitor their effects on disease progression and safety. During the trial, participants will undergo regular assessments including imaging scans to measure disease progression, evaluations of heart function, and monitoring of symptoms and quality of life. Researchers will track progression-free survival as the primary outcome, along with secondary measures such as overall survival, response rates, treatment-related side effects, and patient-reported outcomes. The total study duration may extend up to several years to capture long-term results and safety data.