Brzozow

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are evaluating subcutaneous under the skin durvalumab combined with recombinant human hyaluronidase rHu in adult participants with various solid tumors, including non-small cell lung cancer NSCLC, hepatocellular carcinoma HCC, and limited-stage small cell lung cancer LS-SCLC. The study aims to find a dose of subcutaneous durvalumab that provides similar drug exposure as the intravenous form and to assess its safety and pharmacokinetics in these patients. The study has two parts Part 1 focuses on dose escalation with two planned dose levels of subcutaneous durvalumab plus rHu, followed by intravenous durvalumab at scheduled intervals for participants with NSCLC, LS-SCLC, or unresectable HCC. Part 2 will expand the study to include participants with unresectable HCC using the dose level identified in Part 1. Some participants with unresectable HCC may also receive tremelimumab intravenously. Participants will be monitored over approximately 17 months, with regular assessments of drug levels and safety. The study will measure how much drug is in the body over time and track any adverse events or dose-limiting toxicities. Participants will have evaluations including laboratory tests and clinical assessments to monitor organ function and treatment effects throughout the study duration.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating treatments for participants with KRASNRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer who have previously received chemotherapy. The study compares how long participants remain free of disease progression and the overall survival time when treated with amivantamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy. This Phase 3 trial focuses on patients who have already undergone prior chemotherapy for their cancer. Participants are randomly assigned to one of two groups. One group receives amivantamab combined with the chemotherapy regimen FOLFIRI, which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan. The other group receives either cetuximab or bevacizumab combined with the same chemotherapy regimen FOLFIRI. Treatments are given in 28-day cycles and continue until the cancer progresses or other criteria require stopping treatment. During the study, participants undergo regular assessments to monitor disease status, including imaging scans reviewed by independent experts. Researchers measure progression-free survival and overall survival over periods up to several years. Additional outcomes include response rates, duration of response, quality of life assessments, and side effects. Safety and laboratory evaluations are conducted throughout the study, which spans up to four years and four months in total duration.

Researchers are evaluating how long adult participants with KRASNRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer remain disease-free when treated with different combinations of drugs. The study compares amivantamab combined with chemotherapy regimens mFOLFOX6 or FOLFIRI versus cetuximab combined with the same chemotherapy regimens. This phase 3 trial aims to understand which treatment approach may better delay cancer progression. Participants will be randomly assigned to one of two treatment groups. One group receives amivantamab along with chemotherapy cycles consisting of 5-fluorouracil, leucovorin calcium or levoleucovorin, and oxaliplatin or irinotecan hydrochloride, repeated every 28 days. The other group receives cetuximab combined with the same chemotherapy regimens, also in 28-day cycles. Treatments continue until imaging shows disease progression or other criteria require stopping. During the study, participants will undergo regular assessments including radiographic imaging to monitor disease status and treatment effects. Researchers will measure progression-free survival for up to over 4 years, along with other outcomes such as overall survival, response rates, duration and time to response, and quality of life using validated questionnaires. Safety will be monitored through adverse event reporting and laboratory tests, with follow-up continuing for several years to capture long-term results.

Researchers are evaluating the efficacy and safety of BGB-16673 compared with the investigators choice of treatments in participants with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with both Bruton Tyrosine Kinase inhibitors BTKi and B-cell leukemialymphoma 2 protein inhibitors BCL2i. This study addresses the urgent need for new treatments to extend life and control symptoms such as enlarged lymph nodes, spleen, or liver, night sweats, weight loss, and fever in these patients. Participants will be randomly assigned to receive either BGB-16673 once daily or the investigators choice of treatment, which includes idelalisib plus rituximab for CLL only, bendamustine plus rituximab, or venetoclax plus rituximab retreatment. Treatments will continue until criteria for stopping treatment are met. This is a Phase 3, open-label, randomized study conducted globally with about 250 participants. During the study, participants will undergo regular assessments to monitor disease progression and response to treatment. Researchers will evaluate progression-free survival, overall survival, response rates, duration of response, and quality of life measures over approximately 24 to 36 months. Safety will be closely monitored by tracking treatment-emergent adverse events. Participants involvement includes receiving study medication, regular visits, and various evaluations to assess treatment effects and side effects.

Researchers are evaluating the effectiveness of JNJ-79635322 in adults with Relapsed or Refractory Multiple Myeloma RRMM, a type of cancer affecting plasma cells. This study focuses on participants who have already undergone at least three previous treatments, including specific therapies such as proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies. The study is conducted in a Phase 2, open-label format to assess how well this treatment works in this patient group. Participants will receive JNJ-79635322 through injections under the skin. The study involves a single group where all participants receive this investigational drug. The treatment period lasts up to two years and nine months, during which the medications effects and participants responses are closely monitored. Throughout the study, participants will undergo regular assessments to measure various outcomes, including overall response rate, survival times, symptom changes, and quality of life using specialized questionnaires. Researchers will also monitor safety by tracking adverse events and checking for antibodies against the drug. The total participation duration may last up to nearly three years, allowing comprehensive evaluation of both effectiveness and safety over time.

Researchers are evaluating the combination of pazopanib with or without abexinostat in patients who have locally advanced unresectable or metastatic renal cell carcinoma RCC. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare the effects of pazopanib plus abexinostat versus pazopanib plus placebo. The study focuses on progression-free survival and other outcomes to understand the potential benefits and risks of adding abexinostat to pazopanib treatment for this condition. Participants will be randomly assigned in a 21 ratio to receive either pazopanib plus abexinostat or pazopanib plus a placebo. Pazopanib is taken daily by mouth throughout each 28-day treatment cycle, while abexinostat or its matching placebo is taken twice daily on specific days within each cycle. If disease progression occurs, patients initially receiving placebo may switch to the combination of pazopanib plus abexinostat. Treatment continues until disease progression, unacceptable side effects, withdrawal, or study closure. Participants will undergo screening within 28 days before starting treatment to confirm eligibility. They will be monitored regularly during treatment cycles with assessments including imaging scans and evaluations of side effects using standard criteria. Outcome measures include progression-free survival, overall survival, response rates, duration of response, and changes in quality of life scores. Follow-up will continue for up to approximately four years, with ongoing safety and efficacy evaluations throughout the study period.

This research aims to evaluate the long-term safety of pirtobrutinib in people who have previously been treated for chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. It offers continued access to the study drug or follow-up for participants who completed a prior related study LOXO-BTK-20020. The study is designed to observe and monitor safety outcomes over an extended period. Participants receive either pirtobrutinib or idelalisib orally as part of the study treatments. These medications are taken every four weeks. The study is expected to last about five years, allowing researchers to collect long-term safety data on these treatments in a parallel group setup. Throughout the study, participants will have regular visits to monitor their health and any treatment-related effects. Researchers will track the percentage of participants experiencing serious treatment-emergent adverse events. They will also observe overall survival from the original study enrollment. Safety monitoring will continue up to 30 days after the last dose or until new anticancer therapy begins, ensuring careful follow-up for each participant.