Clovis

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 evaluating the safety, tolerability, and recommended dosing of BMS-986340, both alone and combined with nivolumab or docetaxel, in adults with advanced solid tumors. This first-in-human phase 1/2 study focuses on various advanced cancers including cervical, gastric/gastroesophageal, colorectal, lung, head and neck, renal, urothelial, pancreatic, melanoma, ovarian, and triple-negative breast cancers. Participants must have progressive disease after prior therapies and measurable tumors accessible for biopsy. Participants receive specified doses of BMS-986340 alone or combined with nivolumab (BMS-936558-01) or docetaxel on scheduled days. The study includes initial treatment phases with these drugs administered in specified protocols. Biopsies before and during treatment are collected for biomarker analysis. Treatment groups assess the safety and proper dosing of these combinations in the advanced cancer setting. During the study, participants undergo tumor biopsies, imaging scans, and regular health assessments to monitor disease progression and treatment effects. Researchers track adverse events, including serious and dose-limiting toxicities, over up to 120 weeks. Safety monitoring includes evaluating events leading to treatment discontinuation or death. The study documents tolerability and gathers data to guide future dosing and combination strategies for these advanced cancers.

Researchers are evaluating the safety, effectiveness, and tolerability of subcutaneous blinatumomab for treating Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL in participants aged 12 years and older. This Phase 1/2 study aims to find the maximum tolerated dose and recommended dose for Phase 2, as well as to assess clinical pharmacokinetics of two blinatumomab formulations (SC1 and SC2). Blinatumomab will be given as a subcutaneous injection. The study includes several parts: a dose escalation phase to determine safety and dosage, followed by dose expansion and Phase 2 cohorts to further evaluate efficacy and drug concentrations. Different participant groups will receive treatments based on their disease status, with monitoring periods ranging from up to 29 days for early toxicities to approximately 28 weeks for adverse events and up to 10 weeks for remission outcomes. Participants will undergo regular assessments including safety evaluations, response to treatment, and pharmacokinetic measurements. Researchers will monitor for treatment-related side effects, remission status, and drug levels in the blood. The study involves ongoing follow-up to capture complete remission rates, disease response, and safety for up to several months after treatment begins.

Researchers are evaluating the safety and effectiveness of a new combination treatment using Surovatamig (AZD0486), a fully human bispecific monoclonal IgG4 antibody, together with rituximab. This Phase III, global, randomized, open-label study focuses on participants with untreated follicular lymphoma (FL) to see if this combination offers added benefits compared to three standard chemoimmunotherapy regimens chosen by the investigator. The study has two parts: a safety run-in and the main Phase III comparison. The first part, the Safety Run-in, compares different dose levels of Surovatamig plus rituximab to find the recommended Phase III dose (RP3D). The second part, Phase III, involves three groups: two groups receiving different schedules of Surovatamig plus rituximab, and one group receiving one of three standard regimens (R-CVP with rituximab maintenance, R-CHOP with rituximab maintenance, or Bendamustine plus rituximab maintenance) as chosen by the investigator. Treatment schedules and doses are monitored closely through the study. Participants will be followed for up to 10 years to monitor the occurrence and severity of side effects, treatment discontinuations, dose changes, and overall safety. The main goal is to assess whether the new combination is superior to standard treatments. Regular evaluations include safety assessments and monitoring treatment effects over time, with attention to both short-term and long-term outcomes.

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.

Researchers are evaluating the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.

Researchers are evaluating a treatment combination for people with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. This Phase II trial focuses on improving the profile of cytokine release syndrome (CRS), a potential side effect, when using glofitamab together with gemcitabine and oxaliplatin. The study uses a specially designed steroid premedication and monitoring plan to allow this treatment to be given safely in an outpatient setting. Participants receive intravenous obinutuzumab one week before starting glofitamab. Glofitamab is given intravenously both with gemcitabine and oxaliplatin and alone, for up to 12 cycles, each lasting 21 days. Gemcitabine and oxaliplatin are also given intravenously in combination with glofitamab for up to 8 cycles, with each cycle lasting 21 days. During the study, participants are closely monitored for signs of cytokine release syndrome for up to about 5 years. Researchers will assess treatment effects and safety through exams, scans, and lab tests. The study tracks how well participants tolerate the treatment and follows their progress over time, including long-term monitoring of side effects and disease status.

Chronic lymphocytic leukemia (CLL) is the most common type of leukemia affecting blood cells. This research aims to evaluate the safety of the drug venetoclax when combined with either obinutuzumab or acalabrutinib for treating adults with previously untreated CLL. The study focuses on monitoring side effects and changes in disease activity to better understand treatment risks, including the risk of tumor lysis syndrome (TLS). Participants will be assigned to one of four treatment groups. All will receive oral venetoclax with different ramp-up schedules combined with either intravenous obinutuzumab or oral acalabrutinib. Treatment arms vary in their dosing schedules and combination therapies. The total study period lasts about 28 months, during which participants receive their assigned treatments and monitoring. Throughout the study, participants will have regular visits at hospitals or clinics for medical exams, blood tests, and side effect checks. Questionnaires will also be completed to assess their condition. Researchers will track the occurrence of TLS and other laboratory indicators related to safety. This ongoing monitoring will help understand treatment effects and ensure participant safety over the study duration.

Researchers are evaluating the safety and tolerability of loncastuximab tesirine combined with polatuzumab vedotin, glofitamab, or mosunetuzumab in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This Phase 1b, multi-center, open-label study aims to find the maximum tolerated dose and recommended dose for expansion of these drug combinations. The trial includes approximately 200 participants and focuses on various lymphoma types, including diffuse large B-cell lymphoma and high-grade B-cell lymphoma. Participants receive treatments through intravenous infusions or subcutaneous injections, depending on the drug. The study has multiple arms with a Dose Escalation part (Part 1) to establish safe dosing and a Dose Expansion part (Part 2) to treat participants at selected dose levels. The treatments are given in cycles of 21 days. The study excludes previous treatments with the study drugs for corresponding arms and has removed arms involving gemcitabine, lenalidomide, and umbralisib. The study involves a screening period of up to 28 days, followed by treatment cycles and a follow-up period with visits every 12 weeks for up to two or three years depending on the arm. Researchers will monitor dose-limiting toxicities, treatment-emergent adverse events, dose delays or interruptions due to adverse events, and changes in lab tests, vital signs, performance status, and ECG measurements. Participants may continue treatment for up to one year or until disease progression or unacceptable side effects occur.

Researchers are evaluating the study medicine elranatamab alone and in combination with daratumumab for people with relapsed or refractory multiple myeloma who have received prior treatments including lenalidomide and a proteasome inhibitor. The study aims to compare elranatamab to a combination therapy of daratumumab, pomalidomide, and dexamethasone, while also assessing the safety and activity of elranatamab with daratumumab. This is an open-label, phase 3 randomized trial involving multiple centers. The study includes three parts. Part 1 evaluates the safety and activity of different doses of elranatamab combined with daratumumab. In Part 2, participants are randomly assigned to receive either elranatamab alone, elranatamab with daratumumab, or the combination of daratumumab, pomalidomide, and dexamethasone. Part 3 investigates the effect of increased infection protection measures in participants treated with elranatamab alone or with daratumumab. All drugs are given by either subcutaneous injection or orally depending on the medication. Participants will receive study treatment until their disease worsens, unacceptable side effects occur, or they decide to stop. Researchers will monitor safety by tracking dose limiting toxicities during the first 42 days after starting elranatamab and treatment-emergent adverse events during the first 84 days. Progression-free survival will be assessed up to 51 months after randomization. Throughout the study, participants will undergo regular assessments to evaluate treatment safety and effectiveness.