Ipatinga

Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after 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 the safety and efficacy of JNJ-90301900 NBTXR3 activated by radiotherapy, with or without cetuximab, compared to radiotherapy with or without cetuximab alone. This Phase 3 study focuses on elderly participants aged 60 years and older who have locally advanced head and neck squamous cell carcinoma LA-HNSCC and are ineligible for platinum chemotherapy. The study is randomized and open-label, aiming to provide insights for this specific patient group. Participants will be assigned to one of two groups. One group receives an intratumoral or intranodal injection of JNJ-90301900 NBTXR3 at a dose of 33% of the gross tumor volume, followed by radiotherapy alone or combined with cetuximab, based on the investigators choice. The other group receives radiotherapy alone or combined with cetuximab. Radiotherapy is intensity-modulated, delivering 70 Gray over 35 fractions across 7 weeks. During the study, participants will be monitored for up to 48 months following the first randomized participant. Researchers will assess progression-free survival as the primary outcome, measured at 30 months, along with secondary outcomes such as overall survival, local-regional control, distant control, quality of life, safety, response rates, and head and neck cancer-specific survival. Regular assessments include clinical evaluations and quality of life questionnaires to track treatment effects and safety over time.

This research aims to assess the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd combined with rilvegostomig or rilvegostomig alone compared to pembrolizumab alone as initial treatment in participants with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has high PD-L1 expression tumor cells 50% and no actionable genetic alterations. This Phase III, randomized, open-label global study focuses on patients who have not received previous systemic therapy for advanced disease. Participants are randomly assigned to one of three groups one group receives Dato-DXd plus rilvegostomig, another receives rilvegostomig alone, and the third receives pembrolizumab alone. All treatments are given as intravenous infusions every three weeks on the first day of each 21-day cycle. The study evaluates these treatments as first-line therapy for eligible participants. During the study, participants will have regular assessments including tumor evaluations and biomarker testing to monitor disease progression, overall survival, and response rates. Patient-reported symptoms and quality of life will also be measured. The study may last up to approximately six years to capture long-term outcomes. Safety monitoring and pharmacokinetics assessments are included throughout the trial to understand treatment effects and immune responses.

Researchers are examining the use of extreme hypofractionation radiotherapy in selected Brazilian patients with breast cancer. This study aims to evaluate cancer control outcomes and side effects related to this treatment approach using data collected retrospectively. It focuses on patients treated with this specific radiotherapy method in clinical practice since December 2019. Data will be collected from medical records of up to 500 women diagnosed with any subtype of breast cancer who received five sessions of 5.2 Gy radiotherapy after surgery. There is no intervention in this study patients continue their usual care as determined by their medical teams. The study gathers clinical, demographic, socioeconomic, treatment, and outcome information from participating centers across Brazil. Participants medical records will be reviewed to assess locoregional cancer recurrence over an 18-month period. Since this is observational, no changes to treatment are made, and patients maintain regular evaluations and care. The study collects detailed clinical data without altering standard treatment or requiring additional procedures, with data collection ongoing until June 2025.