Karsiyaka

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 combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.

Researchers are evaluating the clinical benefit of combining Navlimetostat BMS-986504, a selective MTA-cooperative inhibitor of PRMT5, with pembrolizumab and chemotherapy compared to placebo plus pembrolizumab and chemotherapy. This study focuses on participants with first-line metastatic non-small cell lung cancer NSCLC who have a homozygous MTAP deletion. The trial is a randomized Phase 23 study aimed at advancing treatment options for this specific lung cancer group. Participants will receive one of several combinations Navlimetostat plus pembrolizumab and chemotherapy, or placebo plus pembrolizumab and chemotherapy. Chemotherapy drugs involved may include cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on certain days. The study uses a quadruple-masked, parallel design with multiple treatment arms to compare these regimens. During the study, participants will be monitored for progression-free survival and overall survival up to five years. Researchers will assess tumor response, disease control, duration and time to response, and safety through adverse event reporting and laboratory tests. The study includes detailed follow-up to evaluate efficacy and safety outcomes over the long term, with a primary completion date in 2031.

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with previously untreated advanced Non-Small Cell Lung Cancer NSCLC who have a PD-L1 expression level of 50% or higher. This Phase 3 randomized, double-blind study focuses on patients with locally advanced or metastatic NSCLC to better understand first-line treatment options. Participants receive either Pumitamig or Pembrolizumab as the study drug, given at specified doses on certain days. The study uses a parallel design with two treatment groups to compare these therapies as first-line options. The study is planned to continue until October 2031, with treatment and follow-up periods extending up to approximately 5 years for overall survival assessments. During the study, participants will have regular assessments to monitor disease progression and response to treatment using criteria like RECIST v1.1. Researchers will evaluate progression-free survival, overall survival, objective response rates, duration of response, disease control rate, and symptom changes related to lung cancer over time. Safety and treatment effects will be closely monitored throughout the study duration.

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

Researchers are evaluating the combination of brenetafusp IMC-F106C plus nivolumab compared to standard nivolumab regimens in people with previously untreated advanced melanoma who are HLA-A*0201-positive. This phase 3, randomized, controlled study aims to understand how these treatments perform in this specific group. The study focuses on improving progression-free survival and overall outcomes for participants with advanced melanoma. Participants are assigned to one of three groups one group receives a low dose of brenetafusp once weekly for 13 weeks, then every two weeks until Week 51, and every four weeks thereafter, along with nivolumab every four weeks another group receives a high dose of brenetafusp on the same schedule plus nivolumab the third group receives nivolumab alone or nivolumab combined with relatlimab every four weeks. The study includes a dose recommendation phase with changes made in November 2025 based on safety and efficacy data. During the study, participants undergo assessments including tumor measurements per RECIST 1.1, BRAF V600 mutation status evaluation, and performance status scoring. Researchers will monitor progression-free survival up to approximately 45 months, overall survival up to 57 months, and record adverse events, immune responses, and quality of life. The study involves regular dosing and long-term follow-up to evaluate treatment effects and safety.

Researchers are evaluating the safety, tolerability, and anti-tumor activity of Datopotamab Deruxtecan Dato-DXd alone and combined with other anticancer agents in patients with advanced or metastatic solid tumors. This Phase II, open-label, multicenter study uses a master protocol with independent substudies focused on different tumor types including endometrial, gastric, prostate, ovarian, colorectal, urothelial, and biliary tract cancers. The study aims to find the recommended Phase II dose and assess efficacy and safety across these varied cancers. Participants receive Dato-DXd as monotherapy or in combination with approved or novel anticancer drugs depending on their specific cancer type and substudy assignment. Treatments include intravenous Dato-DXd alone or combined with agents such as capecitabine, 5-Fluorouracil, prednisoneprednisolone, carboplatin, bevacizumab, volrustomig, rilvegostomig, or cisplatin. The study allows evaluation of various combinations across substudies to understand the drugs role in different cancer settings. During the study, participants undergo regular assessments including tumor measurements, safety evaluations, blood tests for pharmacokinetics and immune response, and specific cancer marker tests like PSA or CA-125 depending on cancer type. Researchers measure outcomes such as objective response rate, progression-free survival, duration of response, and adverse events over approximately one year. Safety follow-up occurs after treatment ends, and participants are monitored closely throughout their involvement, which lasts about one year from treatment start.

Researchers are evaluating the safety and effectiveness of volrustomig in women with high-risk locally advanced cervical cancer FIGO 2018 stage IIIA to IVA who have not experienced disease progression following platinum-based concurrent chemoradiation therapy CCRT. This phase III, randomized, double-blind, placebo-controlled global study aims to compare volrustomig with a placebo to gain insights into treatment outcomes for this patient group. Participants will be randomly assigned in a 11 ratio to receive either volrustomig or a placebo by intravenous infusion. The study compares these two groups over time to assess progression-free survival and other important outcomes. Treatment is given after patients complete platinum-based CCRT and have no disease progression. The study includes long-term follow-up for up to approximately seven years to monitor various measures such as survival, response rates, and side effects. Throughout the study, participants will undergo regular assessments including tumor sample analysis, physical exams, and evaluations of organ function and overall health. Researchers will track progression-free survival, overall survival, response rates, and patient-reported symptoms and quality of life. Safety and adverse events related to volrustomig will also be monitored closely during the study and follow-up period. Participation involves a long-term commitment with ongoing monitoring for up to seven years.