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Found 10 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating new treatments for advanced ovarian cancer, specifically in patients who do not have homologous recombination deficiency (non-HRD positive). This Phase 3 study aims to assess whether maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, can improve progression-free survival compared to the current standard care after initial platinum-based chemotherapy and surgery. Participants receive sacituzumab tirumotecan through intravenous infusion at a dose of 4 mg/kg. Some also receive bevacizumab intravenously at 15 mg/kg as part of their maintenance treatment. Before sac-TMT infusion, participants are given prophylactic steroid mouthwash and recommended rescue medications including histamine-1 and histamine-2 receptor antagonists, acetaminophen or equivalent, and dexamethasone or equivalent. The study compares these treatments to standard care or observation following first-line chemotherapy. During the study, participants are monitored for progression-free survival for up to approximately 49 months. Researchers will assess how long participants live without their cancer getting worse. Throughout the trial, safety and response to treatment are evaluated. The study includes women aged 18 years and older who have completed surgery and first-line chemotherapy with specific responses and meet certain health criteria.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of calderasib combined with pembrolizumab as a first treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. This Phase 3 trial aims to test if the combination of calderasib and pembrolizumab improves progression-free survival and overall survival compared to pembrolizumab with a placebo. Participants receive oral calderasib tablets or placebo along with pembrolizumab given by intravenous infusion. The study compares these two treatment groups to see which provides better outcomes. Treatments continue during the study, and there are no additional interventions described beyond these drugs. During the trial, participants undergo regular assessments including scans and tests to monitor their cancer's progression and overall health. The main outcomes measured are progression-free survival for up to about 42 months and overall survival for up to about 56 months. Safety is monitored throughout, and participants are followed for several years to evaluate long-term effects of the treatments.
Actively Recruiting
Researchers are evaluating new treatment options for people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or has come back after prior treatment. This type of cancer starts in the lining of the uterus and is considered advanced when it has spread locally or to other body parts and cannot be removed by surgery. The study aims to compare the effectiveness of sacituzumab tirumotecan (sac-TMT), an antibody drug conjugate, combined with pembrolizumab versus pembrolizumab alone, to see which approach helps people live longer without the cancer worsening. Participants first receive an induction phase of six cycles, each lasting three weeks, of pembrolizumab combined with carboplatin and either paclitaxel or docetaxel through intravenous infusions. Those whose cancer does not progress after this phase enter the maintenance treatment phase, where they are randomly assigned to receive either pembrolizumab plus sac-TMT or pembrolizumab alone. If the cancer does progress, participants may enter a subsequent treatment phase and be randomly assigned to pembrolizumab plus sac-TMT or sac-TMT alone. During the study, researchers monitor participants for progression-free survival and overall survival for up to approximately 44 and 54 months, respectively. Participants undergo regular imaging, assessments, and laboratory tests to evaluate cancer status and treatment effects. The study also tracks safety and tolerability throughout all phases, providing a comprehensive follow-up to understand treatment impact over time.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of sacituzumab tirumotecan with or without bevacizumab compared to standard care in women with platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer. This phase 3 study aims to learn how well patients tolerate these treatments and whether they live longer without their cancer worsening. The study focuses on those who have already undergone second-line platinum-based chemotherapy and have specific cancer stages and types. Participants receive sacituzumab tirumotecan and may also receive bevacizumab through intravenous infusion. Before sacituzumab tirumotecan, rescue medications such as H1 and H2 receptor antagonists, acetaminophen, dexamethasone, and steroid mouthwash are given to help manage side effects. The study includes multiple treatment phases and compares these interventions to standard care. These treatments are administered under close medical supervision throughout the study. During the study, participants are monitored for adverse events and treatment tolerability over approximately six weeks in the first part, followed by progression-free survival tracking for up to about four years. Assessments include physical exams, performance status evaluations, and safety monitoring. Researchers also collect tumor tissue samples and conduct laboratory tests to evaluate treatment effects. The total participation time involves ongoing observation to measure safety and effectiveness outcomes.
Actively Recruiting
Researchers are evaluating a phase 3 study of pembrolizumab combined with carboplatin and a taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT) in adults with metastatic squamous non-small cell lung cancer. The study aims to determine if adding sac-TMT maintenance to pembrolizumab improves overall survival compared to pembrolizumab alone. Participants have confirmed stage IV squamous NSCLC and measurable disease. All participants first receive an induction phase of four cycles lasting 21 days each. During induction, they receive pembrolizumab every 3 weeks plus carboplatin every 3 weeks, along with either paclitaxel every 3 weeks or weekly nab-paclitaxel. After induction, participants are randomly assigned to continue pembrolizumab maintenance alone or pembrolizumab combined with sac-TMT maintenance. Treatments are given by intravenous infusion. Participants undergo scans to measure tumor response and are monitored for side effects and overall health. Researchers assess overall survival up to about 50 months. Organ function, adverse events, and performance status are regularly evaluated before and during the study. The study includes safety monitoring and follows participants through their treatment and maintenance phases.
Actively Recruiting
Researchers are evaluating the overall survival of women with stage I epithelial ovarian cancer following comprehensive staging surgery. This phase III trial compares the effects of adjuvant chemotherapy versus observation without chemotherapy in this patient group. Patients are randomly assigned based on histologic type, enrollment facility, and clinical staging according to the FIGO system. Participants are divided into two groups. Group A receives adjuvant chemotherapy, which includes either Paclitaxel plus Carboplatin or Docetaxel plus Carboplatin, administered every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. Group B undergoes observation only, with no chemotherapy given. The study treatment starts within eight weeks after comprehensive staging surgery. During the study, participants undergo regular assessments to monitor survival status up to 60 months from randomization. Researchers collect data including clinical evaluations, imaging, and laboratory tests as needed. Safety is closely monitored, and participants provide informed consent before enrollment. The trial aims to determine whether adjuvant chemotherapy improves survival compared to observation alone in this patient population.
Actively Recruiting
Researchers are evaluating the safety, tolerability, and characteristics of a drug called Rina-S in people with various advanced solid tumors that have spread or cannot be removed by surgery. This includes cancers such as ovarian, endometrial, breast, non-small cell lung cancer, and mesothelioma. The study is a Phase 1/2 trial designed to assess how the drug works and its effects on these cancers. Participants will receive intravenous infusions of Rina-S alone or in combination with other drugs like Carboplatin, Bevacizumab, or Pembrolizumab. The study is divided into multiple parts focusing on different tumor types and treatment combinations, including monotherapy and combination therapy cohorts. Treatments continue until disease progression, unacceptable side effects, or other reasons for stopping treatment. During the study, participants will undergo various assessments including safety monitoring for side effects and dose-limiting toxicities, tumor response evaluations using imaging criteria, and heart monitoring with electrocardiograms for some participants. Researchers will track treatment-emergent adverse events for up to about one year. Participants remain involved through treatment cycles and follow-up evaluations to understand the drug's effects and safety profile.
Actively Recruiting
Researchers are evaluating the use of sacituzumab tirumotecan combined with pembrolizumab compared to pembrolizumab alone in treating adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death ligand 1 (PD-L1) expression of 50% or higher. This phase 3 study aims to determine if the combination therapy can improve overall survival. Participants must have confirmed NSCLC without certain gene mutations and meet other health criteria, including good performance status. Participants are randomly assigned to receive either sacituzumab tirumotecan plus pembrolizumab or pembrolizumab alone, both given by intravenous infusion. Supportive care measures, such as anti-nausea or blood growth factor treatments, may be provided as needed. Those who complete the first course of pembrolizumab may be eligible for up to nine additional cycles of pembrolizumab if disease progression is confirmed by central review. During the study, participants will be monitored for overall survival up to about 49 months. Researchers will assess responses to treatment using standard criteria and monitor side effects and safety. Various evaluations, including tumor tissue analysis and health status assessments, will be conducted to understand the impact of the treatments. The study also tracks supportive care use and any adverse events throughout participation.
Actively Recruiting
Researchers are evaluating sacituzumab tirumotecan compared to a combination of pemetrexed and carboplatin for treating advanced nonsquamous non-small cell lung cancer (NSCLC) with a specific EGFR mutation. This trial focuses on participants whose cancer progressed despite prior treatment with EGFR tyrosine kinase inhibitors. The main goal is to determine if sacituzumab tirumotecan improves overall survival compared to standard platinum-based chemotherapy. Participants are randomly assigned to one of two groups: one receiving sacituzumab tirumotecan at 4 mg/kg through an intravenous infusion, and the other receiving pemetrexed at 500 mg/m² plus carboplatin dosed by area under the curve (AUC 5 mg/mL*min) via intravenous infusion. Treatment continues until certain criteria for stopping are met. Rescue medications such as H1 and H2 receptor antagonists, acetaminophen, dexamethasone, or steroid mouthwash may be given as needed according to approved guidelines. During the study, participants will be closely monitored for overall survival for up to approximately 51 months. Researchers will assess health status, side effects, and treatment response throughout the trial. Eligibility includes confirmed advanced nonsquamous NSCLC and stable health conditions, with regular evaluations to ensure safety and effectiveness over the course of participation.
Actively Recruiting
Researchers are evaluating the effectiveness of Rina-S (GEN1184) compared to standard chemotherapy treatments chosen by physicians for women with recurrent or progressive endometrial cancer after prior therapy. This Phase 3, global, open-label study involves about 660 participants who have previously been treated with platinum-based chemotherapy and PD(L)-1 inhibitors. The study aims to assess how well these treatments control cancer progression and improve survival over approximately three years. Participants will be randomly assigned to receive either Rina-S through intravenous infusion or one of two chemotherapy options: paclitaxel given by IV infusion or doxorubicin administered as an IV bolus injection or infusion. Each participant's treatment will be decided before randomization if assigned to the investigator's choice arm. Treatment duration varies but is expected to average between four to six months. Throughout the study, participants will visit study sites for treatment and monitoring. Researchers will evaluate progression-free survival and overall survival up to about three years, using blinded independent central review according to established cancer response criteria. Safety and treatment effects will be carefully monitored during this time. No placebo treatments will be given, and all participants will receive an active drug.