Clovis

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.

Researchers are evaluating BMS-986340 alone and combined with nivolumab, docetaxel, or pumitamig in people with advanced solid tumors. This first-in-human study aims to assess the safety, tolerability, and recommended doses of BMS-986340 in participants with various advanced cancers who have progressed after standard treatments. This study includes different phases and treatment parts to explore dosing and effects. Participants receive BMS-986340 either as monotherapy or combined with nivolumab, docetaxel, or pumitamig at specified doses on scheduled days. The study includes dose escalation and expansion phases for each treatment combination. The treatments are given sequentially, with participants assigned randomly to different parts of the study to evaluate safety and dosing. During the trial, participants undergo tumor biopsies for biomarker analysis and have measurable disease per standard criteria. Researchers monitor adverse events, serious side effects, and dose-limiting toxicities up to 120 weeks. Pharmacokinetics, immune responses, and tumor responses are regularly assessed. Participants are followed for safety, disease control, and progression-free survival for up to 120 weeks.

Researchers are evaluating the combination of Surovatamig AZD0486, a fully human bispecific monoclonal IgG4 antibody, plus rituximab versus standard immunochemotherapy regimens in adults with untreated follicular lymphoma FL. This global, randomized, open-label Phase III study aims to assess the efficacy, safety, and added benefit of this combination compared to investigator-chosen standard treatments. The study includes a safety run-in and a Phase III portion with three treatment arms. The study has two parts first, a Safety Run-in to determine the recommended Phase III dose RP3D of Surovatamig combined with rituximab second, a Phase III comparison of Surovatamig plus rituximab two dosing schedules against one of three standard chemoimmunotherapy regimens chosen by the investigator R-CVP, R-CHOP, or B-R, all followed by rituximab maintenance. Participants are assigned to one of these three arms to evaluate treatment effects. Participants will be monitored for up to 10 years, with assessments including adverse event tracking, dose adjustments, and efficacy measures such as response rates, progression-free survival, and overall survival. Evaluations involve physical exams, laboratory tests, and imaging to measure disease activity and safety. The study aims to gather long-term data on treatment impact and safety in this patient population.

This trial studies newly diagnosed multiple myeloma in participants who are not candidates for stem cell transplant. It compares the effects of two drug combinations 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. The goal is to assess how these combinations affect disease progression and treatment response. Participants are randomly assigned to one of three groups receiving either Tec-DR, Tal-DR, or DRd. Teclistamab and talquetamab are given as subcutaneous injections, daratumumab is given subcutaneously, lenalidomide is taken orally, and dexamethasone can be given orally or intravenously. Treatments are administered according to the study protocol over an extended period, with follow-up lasting up to nine years to monitor outcomes. During the study, participants undergo regular evaluations including disease progression monitoring, minimal residual disease status at 12 months, and assessments of response levels. Researchers also track survival, adverse events, laboratory and vital sign changes, quality of life, and drug concentrations. The study involves multiple visits for treatment and assessment to carefully evaluate the long-term impact of these drug combinations on patient health and disease control.

Researchers are evaluating the addition of Tersolisib LY4064809STX-478 to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- breast cancer that has a PIK3CA mutation. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand the efficacy and safety of this combination compared to placebo, focusing on improving outcomes for patients with this specific genetic change. Participants receive LY4064809 orally in one of two doses combined with a CDK46 inhibitor such as Ribociclib, Palbociclib, or Abemaciclib and endocrine therapy ET administered orally or via intramuscular injection. The comparison group receives a placebo combined with the same CDK46 inhibitor and ET. The study includes two parts Part 1 explores dose optimization, and Part 2 evaluates the treatment combinations effectiveness and safety as a first-line therapy. During the study, participants will have regular assessments to monitor cancer response, progression, and safety over an estimated period of up to 5 years or more. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and quality of life. Treatment continues as long as the cancer benefits without intolerable side effects. Safety monitoring, laboratory tests, and quality of life questionnaires are part of the participant involvement throughout the trial.

Researchers are evaluating the effectiveness of divarasib compared with investigators choice of immunotherapy pembrolizumab or nivolumab or observation in participants with resected Stage II-IIIB non-small cell lung cancer NSCLC that has a KRAS G12C mutation. This study focuses on patients who have not achieved a complete pathological response after neoadjuvant chemoimmunotherapy, regardless of their tumors PD-L1 status. The purpose is to understand which treatment approach may better prevent disease recurrence or death. Participants will be randomly assigned to one of two groups. One group will receive divarasib, taken orally once daily for up to 52 cycles, with each cycle lasting 21 days. The other group will receive either pembrolizumab or nivolumab, depending on prior treatment, or undergo observation without additional study treatment. Pembrolizumab is given as an intravenous infusion or subcutaneous injection every three weeks for up to 13 cycles. Nivolumab is administered intravenously or subcutaneously every four weeks for up to 13 cycles. During the study, participants will be monitored regularly to assess disease-free survival, which measures the time from randomization to disease recurrence or death for up to approximately five years. Other outcomes include overall survival and adverse event tracking for up to eight years. Participants will undergo evaluations including clinical assessments and safety monitoring throughout the treatment and follow-up period, which may last several years in total.

Researchers are studying an optimized treatment approach for participants with relapsed or refractory aggressive B-cell Non-Hodgkins lymphoma. This Phase II trial focuses on improving the cytokine release syndrome CRS profile when using glofitamab combined with gemcitabine and oxaliplatin. The study aims to enable this treatment to be given safely in an outpatient setting through a special steroid premedication regimen and monitoring schedule. Participants receive intravenous obinutuzumab as a pre-treatment seven days before starting the main therapy. Then, they receive a combination of intravenous glofitamab, gemcitabine, and oxaliplatin for up to eight 21-day cycles, followed by glofitamab alone for up to twelve 21-day cycles. The treatment is given in a single group without placebo or comparison arms. During the study, participants are closely monitored for cytokine release syndrome and other responses to treatment. The main outcome measured is the incidence of CRS up to approximately five years. Researchers also assess response rates, duration of response, progression-free survival, and overall survival. Safety and effectiveness are tracked through regular assessments and follow-up visits throughout the study period.

Chronic lymphocytic leukemia CLL is the most common type of leukemia affecting blood cells. Researchers are evaluating the safety of combining oral venetoclax with either intravenously infused obinutuzumab or oral acalabrutinib for treating previously untreated CLL. The study focuses on assessing adverse events and changes in disease activity in adult participants. Participants are randomly assigned to one of four treatment groups. Arm A receives oral venetoclax with IV obinutuzumab, including a 5-week venetoclax ramp-up period. Arms B, C, and D receive oral venetoclax combined with oral acalabrutinib, with different venetoclax ramp-up schedules varying between 5 weeks and modified ramp-up periods. The total study duration is approximately 28 months. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect checks, and questionnaires to monitor treatment effects. Researchers will measure the percentage of participants experiencing laboratory tumor lysis syndrome and hyperkalemia during treatment. Safety monitoring and evaluations of tumor burden changes will continue for up to 28 months throughout the study.

Researchers are studying multiple myeloma, a type of blood cancer, to see if the drug elranatamab, alone or combined with daratumumab, can offer more benefits compared to a combination therapy of daratumumab, pomalidomide, and dexamethasone. This Phase 3 clinical trial focuses on people who have already been treated for multiple myeloma, including with lenalidomide. The study also evaluates the safety and activity of elranatamab with daratumumab and assesses infection protection measures for participants. The trial has three parts. Part 1 tests different doses of elranatamab combined with daratumumab to check safety and activity. In Part 2, participants are randomly assigned to one of three groups elranatamab alone, elranatamab plus daratumumab, or the combination of daratumumab, pomalidomide, and dexamethasone. Part 3 examines how increased infection prevention affects those treated with elranatamab alone or with daratumumab. Treatments are given until the disease worsens, side effects become unacceptable, or participants choose to stop. Participants will be monitored for side effects, disease progression, and overall response using standardized criteria from the International Myeloma Working Group. Safety is closely watched, especially in early treatment phases, and quality of life is assessed with questionnaires. Outcome measures include progression-free survival, response rates, adverse events, and lab results. Participant involvement may last up to 51 months with regular evaluations during the study.