Brzozow

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

Researchers are evaluating the pharmacokinetics and safety of a subcutaneous injection of durvalumab combined with recombinant human hyaluronidase (rHu) in adults with different types of solid tumors. This Phase I multicenter study aims to find a subcutaneous durvalumab dose that provides drug levels similar to intravenous durvalumab. The study includes participants with non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), and limited-stage small cell lung cancer (LS-SCLC). The study is divided into two parts: Part 1 involves dose escalation with two planned dose levels of subcutaneous durvalumab in participants with NSCLC, HCC, or LS-SCLC. Part 2 focuses on dose expansion in participants with unresectable HCC, starting once the appropriate dose is identified. Durvalumab plus rHu is given under the skin, while intravenous durvalumab and tremelimumab are administered by infusion for some participants. Participants will be monitored from the first dose through approximately 17 months of durvalumab administration. Researchers will measure drug concentrations over time and the lowest concentration before the next dose. Participants will undergo assessments including safety evaluations, organ function tests, and disease measurements. The study also tracks side effects and overall drug exposure to evaluate safety and pharmacokinetics during treatment.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are comparing how long participants with KRAS/NRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer remain disease-free and their overall survival time when treated with two different regimens. This phase 3 study focuses on patients who have previously received chemotherapy. The study aims to evaluate progression-free survival and overall survival in participants receiving amivantamab plus FOLFIRI versus cetuximab or bevacizumab plus FOLFIRI. The study involves two treatment groups: one receiving amivantamab combined with chemotherapy drugs 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan (FOLFIRI), and the other receiving either cetuximab or bevacizumab with the same chemotherapy regimen. Participants will be randomly assigned to one of these treatment arms. The treatments will be administered according to protocol to assess their effects on the cancer. Participants will be monitored for up to 2 years and 1 month to measure progression-free survival through blinded independent central review and followed for overall survival for up to 4 years and 4 months. The study includes assessments of tumor response, safety, and other clinical evaluations. Tissue samples and detailed clinical data will also be collected. This comprehensive monitoring will help determine the comparative effectiveness of the treatment options over time.

This trial is focused on adults with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. It compares the length of time participants remain free from disease progression when treated with amivantamab combined with chemotherapy regimens (mFOLFOX6 or FOLFIRI) versus cetuximab combined with the same chemotherapy regimens. The study is a randomized, open-label Phase 3 clinical trial designed to evaluate progression-free survival over a period of up to 4 years and 2 months. Participants receive either amivantamab with chemotherapy drugs including 5-fluorouracil, leucovorin calcium or levoleucovorin, oxaliplatin, or irinotecan hydrochloride, or cetuximab with the same chemotherapy regimens (mFOLFOX6 or FOLFIRI). Treatments are administered as first-line therapy for their colorectal cancer. The trial assesses how these treatments affect disease progression and survival. During the study, participants will be monitored regularly through assessments and evaluations to measure progression-free survival. Researchers will gather data via blinded independent central review to ensure unbiased assessment of disease status. Participants are followed up for safety and treatment efficacy over the study duration, which may last over four years.

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are types of blood cancers that can cause symptoms like enlarged lymph nodes, spleen, or liver, night sweats, weight loss, and fever. People with these conditions have shorter life expectancy, creating an urgent need for new treatments to extend life and control symptoms. This research evaluates the safety and effectiveness of a drug called BGB-16673 compared to other treatments chosen by doctors in participants previously treated with both Bruton tyrosine kinase inhibitors (BTKi) and B-cell leukemia/lymphoma 2 protein inhibitors (BCL2i). Participants with relapsed or refractory CLL or SLL will be randomly assigned to receive either BGB-16673 taken orally or one of the investigator's chosen treatments, which include idelalisib plus rituximab (for CLL only), bendamustine plus rituximab, or venetoclax plus rituximab retreatment. The study plans to include approximately 250 participants worldwide. Treatments are given according to the assigned group to compare how well each controls disease progression. During the study, researchers will monitor participants for about 36 months to measure progression-free survival, which is the length of time patients live without their disease worsening. Participants will undergo assessments including imaging and laboratory tests to evaluate their health and treatment response. Safety and effectiveness will be closely followed throughout the study period to better understand the potential benefits and risks of BGB-16673 compared to other treatment options.

Researchers are evaluating a new treatment approach for patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC) in this Phase 3, randomized, double-blind, placebo-controlled study. The study compares the combination of the drug pazopanib with abexinostat against pazopanib with a placebo. The goal is to assess the effectiveness of adding abexinostat to pazopanib in treating this type of kidney cancer. Participants will be randomly assigned in a 2:1 ratio to receive either pazopanib plus abexinostat or pazopanib plus a placebo. Pazopanib is taken orally once daily at 800 mg each morning with water, timed around meals. Abexinostat or its placebo is taken twice daily at 80 mg on specific days within a 28-day treatment cycle, with doses spaced four hours apart and taken around meal times. Treatment will continue until disease progression, unacceptable side effects, withdrawal of consent, or study closure. Patients on placebo who experience disease progression may switch to the combination treatment. Before starting treatment, patients undergo screening within 28 days and receive their first dose within 7 days after randomization. Throughout the study, researchers monitor patients for progression-free survival, which is the time from randomization until disease progression or death, for up to about four years. Regular assessments include imaging scans evaluated by specific criteria, clinical evaluations, and safety monitoring. There is no set maximum treatment duration, allowing patients to continue therapy as long as it remains beneficial and safe.

This research aims to evaluate the long-term safety of pirtobrutinib in adults who have previously been treated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It focuses on participants who completed a prior study (J2N-MC-JZNN/LOXO-BTK-20020) and offers them continued access to the study drug or follow-up visits. The study is in Phase 4 and targets assessing safety outcomes over an extended period. Participants will receive pirtobrutinib orally every four weeks. The study includes treatment administration and ongoing follow-up for about five years, allowing researchers to monitor the long-term effects of the drug. Idelalisib is also listed as an intervention but the study primarily assesses pirtobrutinib. Throughout the study, researchers will monitor participants for any treatment-emergent adverse events of grade 3 or higher from the first dose until 30 days after the last dose or start of new anticancer therapy, whichever occurs first. Participants will be regularly assessed during their visits to ensure safety and collect necessary data over the duration of the study.

Researchers are evaluating treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.