Mayo Clinic AZ

This registry is a sponsor-initiated, multi-center, observational study that collects data on liver transplant recipients. It focuses on patients who receive donor livers preserved using the TransMedics4 Organ Care System OCS Liver, a portable device approved by the FDA. The study also includes patients transplanted using other preservation methods to compare outcomes. Participants will be grouped into those who receive OCS Liver-perfused donor livers and those who undergo liver transplantation with other preservation techniques. Data is gathered from the United Network for Organ Sharing UNOS via the Organ Procurement and Transplantation Network OPTN and additional information is collected by participating centers using the OCS Liver perfusion system. Throughout the study, researchers will review survival rates up to five years after transplant. Data collection involves routine transplant outcome information and specific data related to OCS Liver use. The registry aims to follow all enrolled liver transplant recipients over time to assess long-term outcomes and safety. Participation duration spans several years, reflecting post-transplant monitoring.

This trial focuses on participants with relapsed andor refractory multiple myeloma RRMM. It aims to find a safe and tolerable dose of arlocabtagene autoleucel BMS-986393 when combined with other investigational drugs including alnuctamab, mezigdomide, iberdomide, and elranatamab. The study is a Phase 1, open-label, multicenter trial designed to evaluate safety and preliminary efficacy while determining the recommended dose for each combination. Participants receive arlocabtagene autoleucel along with one or more of the investigational drugs alnuctamab, mezigdomide, iberdomide, elranatamab, or mezigdomide with dexamethasone. Each drug is administered at specified doses on specified days. The study follows a sequential model and includes multiple experimental arms, each testing a different combination of these drugs. During the study, participants are closely monitored for adverse events and safety outcomes over two years, including serious events and events of special interest. Researchers will also assess the overall response rate and other measures of treatment effectiveness. Blood samples will be collected to measure drug concentration over time. The study will establish the recommended Phase 2 dose and track participant health for up to two years after treatment.

Researchers are evaluating the combination of abemaciclib and olaparib in treating women with recurrent platinum-resistant ovarian cancer, a type of ovarian cancer that initially responds to platinum-based chemotherapy but returns within six months. This phase IIb trial aims to identify the side effects and best dose of abemaciclib when given together with olaparib. The study also explores the anti-tumor activity of this combination and collects genetic and biomarker data to understand treatment responses better. Participants receive olaparib orally twice daily for 28-day cycles, with abemaciclib added from day 8 to day 28 in the first cycle and throughout subsequent cycles, continuing until disease progression or unacceptable side effects occur. The study includes procedures like blood collection and tumor biopsies. After completing treatment, participants are followed up for 30 days to monitor outcomes and safety. During the study, participants undergo regular assessments including blood tests and tumor biopsies to measure response and side effects. Researchers track the maximum tolerated dose and recommended phase 2 dose after the first 28-day cycle. They also observe overall response rates and duration of response following treatment completion. Genetic and biomarker analyses are performed on collected samples, and safety is monitored throughout participation, which may last several treatment cycles plus follow-up.

Researchers are investigating targeted therapies directed by genetic testing for patients with locally advanced or advanced solid tumors that have spread or progressed after standard treatments. This Phase 2 screening trial, called ComboMATCH, aims to match patients to specific combination treatments based on genetic mutations found in their tumor cells. The study seeks to improve treatment planning by using genetic information to guide therapy choices. Patients undergo tumor genetic screening using previously collected samples or a new biopsy if eligible and aged 18 or older. Based on their tumors genetic profile, patients are assigned to one of multiple treatment subprotocols involving different drug combinations. Treatments include oral, intravenous, and intramuscular drugs such as selumetinib, olaparib, fulvestrant, binimetinib, and others. Treatment cycles generally repeat every 28 days until disease progression or unacceptable toxicity. Patients may also undergo biopsies, blood collection, imaging scans CT, MRI, PET, echocardiograms, and bone marrow procedures as part of the study. Throughout the trial, participants have regular assessments including tumor biopsies, blood draws, imaging tests, and heart function monitoring. These evaluations occur during screening, treatment, and follow-up periods. Researchers measure patient enrollment, assignment to treatment arms, and treatment outcomes over up to 8 years. Safety is monitored via clinical evaluations and diagnostic tests. This comprehensive approach aims to evaluate responses to targeted therapies guided by tumor genetics for advanced solid tumors.

Researchers are evaluating whether adding chemotherapy before surgery can improve outcomes for patients with high-risk dedifferentiated liposarcoma DDLPS and leiomyosarcoma LMS in the retroperitoneal area. This phase III trial compares standard surgery alone to surgery combined with chemotherapy, aiming to improve disease-free survival for these patients. The study is randomized and open-label, involving multiple centers. Participants are randomly assigned to one of two groups. The standard group undergoes large curative surgery within four weeks after randomization. The experimental group receives three cycles of chemotherapy tailored to their sarcoma typedoxorubicin and ifosfamide for high-grade liposarcoma, or doxorubicin and dacarbazine for leiomyosarcomastarting within two weeks of randomization, followed by a reassessment and surgery within three to six weeks after the last chemotherapy cycle. During the study, patients are closely monitored through imaging and pathology reviews to confirm tumor characteristics and treatment effects. Researchers measure disease-free survival over seven years, along with overall survival, recurrence rates, response to chemotherapy, side effects, complications, and quality of life for up to eight years. Participants provide tumor tissue and blood samples for research, and their health and safety are carefully tracked throughout the study period.

Researchers are evaluating the safety, side effects, and optimal dose of cabozantinib combined with standard chemotherapy in patients newly diagnosed with osteosarcoma. This phase IIIII trial aims to compare the effects of adding cabozantinib, a kinase inhibitor that may slow tumor growth, to the usual chemotherapy drugs methotrexate, doxorubicin, and cisplatin. The study focuses on patients under 40 years old with high-grade osteosarcoma, including both localized and metastatic cases. Participants receive treatment in two main phases. The feasibility phase now closed tested cabozantinib with chemotherapy in metastatic patients with resectable tumors, using cycles of oral cabozantinib and intravenous chemotherapy drugs over several months. The ongoing efficacy phase randomly assigns patients to either standard chemotherapy alone or chemotherapy combined with cabozantinib, with treatment divided into induction, consolidation, and maintenance cycles lasting 35 or 28 days each. Imaging scans, blood samples, and surgery are part of the treatment and evaluation process. During the study, participants undergo regular assessments including X-rays, CT scans, MRI, PET or bone scans, and blood sample collection at diagnosis and throughout treatment. Researchers monitor event-free survival, overall survival, symptom burden, and side effects reported by patients. The trial lasts up to 5 years after treatment to assess long-term outcomes, gather tumor and blood samples for further biological studies, and evaluate the impact of cabozantinib addition on patient health and response.

This research investigates the prevention of recurrent pericarditis in patients who have a history of this condition and have been treated with an IL-1 blocker for at least 12 months. The study is a multi-center, randomized, double-blind, placebo-controlled Phase-3 trial aiming to evaluate whether patients remain free of pericarditis recurrence while receiving the study drug CardiolRx. Participants will be randomly assigned to receive either CardiolRx or a matching placebo. The treatment begins 10 to 16 days before the last scheduled dose of the IL-1 blocker and continues for 24 weeks. CardiolRx or placebo is administered orally twice daily with food, starting at 5 mgkg twice daily for the first few doses, increasing to 7.5 mgkg, and then to 10 mgkg twice daily through Week 24. Throughout the study, participants will undergo various assessments including physical exams, vital signs, ECGs, blood tests for inflammation markers, and pain evaluations using a numerical rating scale. Safety monitoring includes recording adverse events and concomitant medications at all visits. After 24 weeks of treatment, a final efficacy assessment occurs, followed by a virtual safety follow-up visit four weeks after the last dose. The primary outcome is the recurrence of pericarditis during the 24 weeks of treatment.

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 safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are studying the combination of trastuzumab deruxtecan DS-8201a and olaparib in patients with HER2-expressing cancers that have spread or cannot be removed by surgery, including platinum-resistant ovarian cancer. This phase I trial aims to find the best dose and identify side effects of this drug combination. Olaparib blocks an enzyme involved in DNA repair, potentially preventing tumor cells from repairing damage, while DS-8201a targets HER2-positive tumor cells to deliver chemotherapy directly to them. Participants receive trastuzumab deruxtecan through an intravenous infusion lasting 30 to 90 minutes on day 1 of each 21-day cycle. Olaparib is taken orally twice daily on specific days within each cycle, with cycles repeating every 21 days unless the disease progresses or unacceptable side effects occur. The study includes a dose-escalation phase followed by a dose-expansion phase for patients with platinum-resistant ovarian cancer. Throughout the trial, patients undergo various procedures including blood sample collection, heart function tests echocardiography or MUGA scan, CT scans, and biopsies. During the study, participants are closely monitored for safety and response to treatment. Researchers assess the maximum tolerated dose and record adverse events up to 30 days after treatment ends. They also measure tumor response, progression-free survival, and duration of response. Additional analyses include HER2 expression testing, pharmacokinetics, DNA damage markers, and exploratory biomarker studies using tumor and blood samples. After completing treatment, participants are followed for 30 days to monitor safety.