Rankweil

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating the combination of BMS-986504, pembrolizumab, and chemotherapy compared to placebo plus pembrolizumab and chemotherapy in people with first-line metastatic non-small cell lung cancer who have a homozygous MTAP deletion. The study is a randomized phase 2/3 trial focused on assessing clinical benefits in this specific patient group. Participants will receive either BMS-986504 with pembrolizumab and chemotherapy or placebo with pembrolizumab and chemotherapy. The chemotherapy may include drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on specified days. This treatment is administered as part of the first-line therapy for metastatic disease. During the study, researchers will monitor progression-free survival up to 2 and 5 years using RECIST v1.1 criteria and overall survival up to 5 years. Participants will be assessed regularly for disease progression and survival outcomes. The study includes detailed monitoring to evaluate the effects and safety of the treatment combination over time.

Researchers are evaluating the safety and effectiveness of a new combination treatment using BMS-986489 (a fixed dose combination of BMS-986012 and Nivolumab) alongside Carboplatin and Etoposide compared to the current standard treatment with Atezolizumab plus Carboplatin and Etoposide. This study focuses on adults with extensive-stage small cell lung cancer and is conducted as a phase 3 randomized, double-blind, multicenter trial. The goal is to find out which combination works better as a first-line therapy for this advanced lung cancer. Participants will receive either BMS-986489 combined with Carboplatin and Etoposide or Atezolizumab combined with Carboplatin and Etoposide. Each drug will be given at specified doses on certain days according to the study protocol. The study compares these two treatment approaches to see their effects and safety when used as initial therapy for extensive-stage small cell lung cancer. During the study, participants will be closely monitored over a period of up to 5 years to assess overall survival. Researchers will use imaging techniques like CT scans or MRIs to measure tumor response and will evaluate participants' health and ability to perform normal activities. Safety and side effects will also be tracked throughout the study to ensure participant well-being.

Colorectal cancer (CRC) is a leading cause of cancer-related deaths in the United States and Europe. Most patients with metastatic colorectal cancer (mCRC) receive palliative care with a median overall survival of 9 to 38 months, depending on various factors. Promising treatment results have been seen in advanced stages, especially in patients receiving third-line therapy and beyond. This research aims to create a disease-specific registry to study treatment patterns and outcomes for mCRC patients who have undergone at least two prior systemic therapies. The registry collects retrospective and prospective data from multiple oncology centers in Austria. It includes patient medical records, testing, and treatment information, along with follow-up data on survival and tumor progression. Imaging studies at three or more lines of therapy are stored centrally in an "imaging-bank," and tumor tissue samples from deceased patients are preserved in a "bio-bank." Additional biomaterial, such as ctDNA or DNA from genotyping, may also be requested for specific research questions. No additional diagnostic or therapeutic interventions are required beyond routine care, and patient confidentiality is maintained through unique identifiers. Participants provide written consent before their data is included, except for deceased patients where no consent is needed. The registry does not interfere with usual treatment routines and only uses existing data from medical charts. Researchers will assess outcomes including overall survival, progression-free survival, response rates, and biomarker identification over a 10-year period. Data collection continues until patient death or loss to follow-up, with contributions from all willing sites.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are evaluating treatments for patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer that has a PIK3CA mutation. This Phase 3 study compares the effectiveness and safety of RLY-2608 combined with fulvestrant versus capivasertib combined with fulvestrant. The study focuses on patients whose cancer returned or worsened after treatment with a CDK4/6 inhibitor. Participants will receive either RLY-2608 taken orally twice daily every day in 28-day cycles or capivasertib taken orally twice daily on days 1 through 4 each week within a 28-day cycle. All participants will also receive fulvestrant by intramuscular injection on day 1 and day 15 of the first cycle, then on day 1 of each following 28-day cycle. Treatment continues until disease progression or other criteria are met. During the study, researchers will monitor participants regularly to assess progression-free survival, which is the time from starting treatment until cancer progression or death. Assessments include radiographic imaging based on RECIST v1.1 criteria and safety evaluations. The study duration may extend up to approximately 77 months, allowing for long-term monitoring of treatment effects and safety.

Researchers are evaluating the effectiveness and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that tests positive for TROP2 but does not have actionable genomic alterations. This phase III, randomized, open-label, multicenter study also assesses the performance of a new diagnostic device to identify suitable participants. Eligible patients have previously been treated for their cancer and meet specific genomic and disease progression criteria. Participants will receive either datopotamab deruxtecan or docetaxel, both given through intravenous (IV) infusions. The study has two arms comparing these treatments directly. Treatment and monitoring will continue according to the study protocol. The investigational drug, Dato-DXd, is being closely evaluated against the standard chemotherapy drug docetaxel for its impact on disease control. During the study, participants will undergo various assessments including imaging scans to measure tumor response and disease progression. Researchers will monitor progression-free survival over approximately 2.5 years and overall survival over about 3.5 years. Other evaluations include performance status, laboratory tests, and safety monitoring to track side effects and overall health throughout the study period.

Researchers are evaluating the use of venetoclax combined with induction and consolidation chemotherapy in adults newly diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB-2). This phase III, multicenter, double-blind, randomized, placebo-controlled study aims to establish the effectiveness and safety of adding venetoclax to standard chemotherapy compared to placebo. The study includes a feasibility run-in dose-escalation phase to determine the appropriate venetoclax dose for the main phase 3 trial. Eligible patients will first enter a dose-escalation phase if applicable, then be randomized to receive either venetoclax or placebo along with intensive chemotherapy. Treatment includes two induction chemotherapy cycles with cytarabine and daunorubicin, followed by consolidation chemotherapy based on age and response. Patients achieving complete remission or morphologic leukemia-free states may continue consolidation therapy. Some patients may also proceed to allogeneic stem cell transplantation based on institutional guidelines and individual factors. Participants will be closely monitored for events such as survival without leukemia relapse and treatment toxicities over 6 and 16 months. Safety assessments include tracking dose-limiting toxicities during the first treatment cycle. The study also involves molecular testing, kidney and liver function tests, and adherence to contraceptive measures for participants of childbearing potential. The total study participation duration varies based on treatment response and follow-up needs.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) combined with Rilvegostomig or Rilvegostomig alone compared to Pembrolizumab alone as first-line treatments for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Participants must have high PD-L1 expression (tumor cells 50% or greater) and no actionable genetic changes. This Phase III, randomized, open-label global study focuses on this specific group of lung cancer patients without known targetable mutations. The trial includes three treatment groups: one receiving Dato-DXd plus Rilvegostomig intravenously, one receiving Rilvegostomig alone intravenously, and one receiving Pembrolizumab alone intravenously. Treatments are given as first-line therapy, meaning participants have not received prior systemic treatment for advanced disease. The study compares these treatments to assess their effect on cancer progression and survival. Participants will be closely monitored throughout the study, which includes assessments of progression-free survival over about four years and overall survival over about six years. Researchers will collect tumor samples to confirm PD-L1 and TROP2 status, perform scans to measure tumor response, and evaluate organ function and performance status. Safety and side effects will be tracked to understand treatment tolerability. The entire participation duration may extend up to several years to capture long-term outcomes.

This research focuses on adult patients with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) and related myeloid neoplasms. It aims to register all patients treated at approximately 80-90 sites in Germany and Austria, capturing comprehensive data on patient characteristics, family history, biological disease features, and clinical outcomes. The study also seeks to analyze genetic markers related to the disease and evaluate treatment responses and survival outcomes over an extended period. Patients enrolled in the study will have their disease-related genetic markers analyzed rapidly to inform treatment recommendations. Biosamples such as bone marrow, blood, plasma, skin biopsy, fingernails, hair, sputum, or urine will be collected and stored for further analysis. The study intends to assess measurable residual disease using various methods and correlate biological markers with clinical outcomes. Participants will be observed for up to 10 years, during which researchers will monitor event-free survival, relapse-free survival, cumulative incidence of relapse and death, overall survival, and quality of life. Treatment decisions, response to therapy, and geographical representation will also be recorded. Data collection includes clinical assessments and storage of biosamples, with ongoing evaluation of disease progression and patient outcomes throughout the study period.