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Found 44 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating new treatments for advanced renal cell carcinoma RCC, a type of kidney cancer. This study compares the effects of combining two targeted therapies, belzutifan and zanzalintinib, against belzutifan with a placebo. The goal is to see if the combination can help people live longer and prevent the cancer from getting worse after other treatments have failed. Participants will take 120 mg of belzutifan orally and either 60 mg of zanzalintinib or a matching placebo once daily for about 24 months. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active combination or placebo. Two groups are compared belzutifan plus zanzalintinib and belzutifan plus placebo. During the study, participants will be monitored for progression-free survival and overall survival, with assessments up to around 30 to 50 months. Researchers will also evaluate tumor response, duration of response, quality of life, and side effects. Safety and tolerability will be tracked throughout treatment and follow-up periods. The study is sponsored by Merck Sharp & Dohme LLC and aims to provide important information on treating advanced RCC.
Actively Recruiting
Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.
Actively Recruiting
Researchers are evaluating the effects of vipoglanstat on non-menstrual pelvic pain NMPP related to endometriosis in women aged 18 to 44 years. This Phase 2 trial aims to assess how well vipoglanstat works and its safety in treating moderate to severe pain caused by endometriosis. The study is sponsored by Gesynta Pharma AB and is designed as a randomized, double-blind, placebo-controlled trial.
Actively Recruiting
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.
Actively Recruiting
Researchers are studying pirtobrutinib, an oral drug, to understand how well it works and how safe it is for people with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study focuses on participants who have previously received 1 to 3 treatments, including a covalent Bruton tyrosine kinase BTK inhibitor, as well as those with treatment-nafve CLLSLL who have a specific genetic change called 17p deletion. This is a Phase 2 open-label trial sponsored by Loxo Oncology, Inc. The study has two parts. Part 1 tests three different dose levels of pirtobrutinib in participants with relapsed or refractory CLLSLL who have prior treatment experience, lasting about 3 years. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have the 17p deletion, with participation lasting up to 2 years. All doses are given orally. Participants will take the study drug orally and attend visits for up to 3 years in Part 1 or up to 2 years in Part 2. Researchers will monitor how well the disease responds to treatment using overall response rate and how long the response lasts. Safety will be tracked throughout. Participants ability to swallow oral medication and their overall health status will be assessed before and during the study to ensure suitability and safety.
Actively Recruiting
Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.
Actively Recruiting
Researchers are studying ARC-02 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and early signs of effectiveness in adults with B-cell Non-Hodgkin Lymphoma NHL. This phase 1 trial focuses on patients with various subtypes of B-cell NHL who have received at least two prior systemic therapies and are not eligible for standard treatments. Participants receive ARC-02 through intravenous infusion on Day 1 of each treatment cycle. Some participants receive ARC-02 alone, while others receive it combined with rituximab, also given by infusion. The treatment continues until the disease progresses or unacceptable side effects occur. The study has dose escalation and dose expansion parts to determine the appropriate dosing levels for both ARC-02 alone and in combination with rituximab. During the study, participants are monitored for dose-limiting toxicities, treatment-emergent adverse events, and serious adverse events for up to five years. Researchers also assess the tumor response and pharmacokinetic measures such as drug concentration in the blood. Participants undergo regular evaluations to track safety and treatment effects, with the overall participation lasting several years to capture long-term data.
Actively Recruiting
Multiple myeloma is a cancer of the plasma cells in the bone marrow. This phase 3 study is investigating how well Immune Globulin Infusion IGI, 10% helps prevent infections in adults with multiple myeloma who are receiving B-cell maturation antigen BCMA x cluster of differentiation 3 CD3 directed bispecific antibody therapy. The trial compares primary infection prevention using IGI, 10% with secondary prevention given only after a serious infection occurs. Participants are randomly assigned to one of two groups. The primary infection prevention group receives 400 mgkg IGI, 10% intravenously every 3 or 4 weeks for 12 months. The secondary infection prevention group receives the same dose and schedule only after they develop a serious infection during the 12-month study period. The dosing is given within 3 days after randomization and continues throughout the observation period. Participants will visit the study clinic 15 times if dosed every 4 weeks or 19 times if dosed every 3 weeks, for up to 14 months including an approximately 8-week screening. Assessments include monitoring time to first serious infection and rates of infections, antibiotic use, hospitalizations, and adverse events. Serum immunoglobulin levels and antibody responses are also measured. Safety and tolerability of IGI, 10% are evaluated during the 12-month treatment and follow-up.
Actively Recruiting
Researchers are evaluating the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a chemotherapy payload, compared to treatment chosen by physicians including paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine for patients with first-line metastatic triple-negative breast cancer TNBC or low estrogen receptor ER-low, HER2-negative breast cancer who cannot receive anti-PDL1 or endocrine therapies. This study includes adults with locally advanced, recurrent inoperable, or metastatic disease who meet specific eligibility criteria. Participants are randomly assigned to receive iza-bren or one of the physicians choice chemotherapy regimens. The treatments are given at specified doses on scheduled days. The study includes two phases Phase 2 to determine the recommended dose of iza-bren and Phase 3 to compare progression-free survival and other outcomes. The study will last several years, with follow-up extending up to approximately 47 months after randomization. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests, and monitoring for adverse events. Quality of life questionnaires will also be completed. Researchers will track progression-free survival, overall survival, treatment-related side effects, tumor size changes, and patient-reported outcomes to evaluate the treatments. The total participation duration may extend up to several years depending on treatment response and follow-up requirements.
Actively Recruiting
Researchers are studying LY4152199, a drug given by intravenous infusion, in adults with previously treated B-cell malignancies, including follicular lymphoma and diffuse large B-cell lymphoma. This Phase 1 study aims to find the best dose while evaluating the safety and early effectiveness of LY4152199 in participants who have relapsed or refractory disease. Participants may continue receiving the drug until the study ends. Participants receive escalating doses of LY4152199 administered intravenously during dose escalation and dose optimization phases. The study includes different cohorts focused on specific lymphoma types. LY4152199 is given repeatedly, with dose levels adjusted based on safety and response. Treatment continues until disease progression, unacceptable toxicity, or study completion. During the study, participants undergo regular clinical visits with laboratory monitoring and assessments to track safety, drug levels, and treatment response. Researchers measure dose-limiting toxicities, pharmacokinetics, overall response rate, duration and time to response, and progression-free survival. Participants must comply with ongoing evaluations and visits for the entire participation period, which may last up to several years depending on individual treatment duration and follow-up.
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