Clinical trials: High-risk
High-Risk Neuroblastoma
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
Neuroblastoma is the most common type of solid cancer found outside the brain in young children. Generally, it affects children younger than 5 years old, with the average age when it is found being just 2 years.
- Trial name
- SHINE (NCT07549321)
- Testing
- hu1418K322A + Temozolomide + Irinotecan
- Where
- 18 sites in United States, Canada and 5 more
- Volunteers
- 144 people
- Sponsor
- Renaissance Pharma Ltd.
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RYZ711 Diagnostic Platform Study
This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed…
- Conditions
- Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT07862582
- Testing
- RYZ711, PSMA PET/CT
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- RayzeBio, Inc.
High-risk Non-muscle Invasive Bladder Cancer
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the…
- Trial name
- NCT03711032
- Testing
- Pembrolizumab, BCG
- Where
- 209 sites in United States, Australia and 28 more
- Volunteers
- 1,397 people
- Sponsor
- Merck Sharp & Dohme LLC
High Risk Smoldering Multiple Myeloma (HR-SMM)
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of…
- Trial name
- LINKER-SMM2 (NCT07393282)
- Testing
- Linvoseltamab, Daratumumab
- Where
- 27 sites in United States, Japan and 3 more
- Volunteers
- 270 people
- Sponsor
- Regeneron Pharmaceuticals
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
The goal of this clinical study is to learn if DARE-HPV can treat persistent high-risk human papillomavirus (hrHPV). The primary outcome will be if the genital infection clears following treatment in 30, 60 or 90 days.
- Trial name
- NCT07601074
- Testing
- Lopinavir / ritonavir
- Where
- 8 sites in United States
- Volunteers
- 118 people
- Sponsor
- Daré Bioscience, Inc.
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Trial name
- SUPPORT II (NCT07296744)
- Testing
- The Supira System, Impella
- Where
- 25 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera
Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis
The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to…
- Conditions
- Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera, Myelofibrosis Transformation in Essential Thrombocythemia, Myelofibrosis With High Molecular Risk Mutations
- Trial name
- FM-MF-02 (NCT07750574)
- Testing
- Flonoltinib Maleate orally
- Volunteers
- 105 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
High Risk Cardiovascular Disease, Hypertension
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events.
- Conditions
- High Risk Cardiovascular Disease, Hypertension, High Cardiovascular Risk
- Trial name
- ZENITH (NCT07181109)
- Testing
- Zilebesiran
- Where
- 1,190 sites in United States, Argentina and 33 more
- Volunteers
- 11,000 people
- Sponsor
- Alnylam Pharmaceuticals
Acute Myeloid Leukaemia, High Risk Myelodysplastic Syndrome
Phase 1 Open-label Study of AMX-883 Alone in Participants With AML and High-risk MDS and in Combination in Participants With AML
The purpose of the study is to assess the safety, pharmacokinetics, and preliminary efficacy of AMX-883 monotherapy in participants with acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS) and in…
- Trial name
- BRAMLIE (NCT07723703)
- Testing
- AMX-883, Posaconazole
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Amphista Therapeutics Ltd
High Risk Biochemical Recurrence (BCR), Deutenzalutamide Soft Capsules
A Phase 3 Study of Deutenzalutamide in Patients With High-Risk BCR Prostate Cancer
This is a multicenter, randomized, double- blind, placebo-controlled Phase III trial to evaluate the efficacy and safety of Deutenzalutamide plus ADT versus placebo plus ADT in patients with high-risk biochemical recurrence (BCR)…
- Trial name
- NCT07875881
- Testing
- Deutenzalutamide Soft Capsules + ADT
- Where
- 3 sites in China
- Volunteers
- 1,044 people
- Sponsor
- Hinova Pharmaceuticals Inc.
NMIBC, High Risk NMIBC
A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
This is a first-in-human, multicenter, Phase 1/1b, 3-part, double-blind study of ZH9 in patients with recurrent NMIBC who are eligible for intravesical therapy.
- Conditions
- NMIBC, High Risk NMIBC, Non Muscle Invasive Bladder Cancer
- Trial name
- PARADIGM-1 (NCT06181266)
- Testing
- ZH9
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Prokarium Ltd
High-risk Localized Prostate Cancer
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make…
- Trial name
- CHINANEO (NCT07450599)
- Testing
- Darolutamide, ADT
- Where
- 23 sites in China
- Volunteers
- 250 people
- Sponsor
- Bayer
High-Risk Percutaneous Coronary Intervention (High-risk PCI)
ELEVATE High-Risk PCI Pivotal Study
The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group.
- Trial name
- ELEVATE III (NCT07001332)
- Testing
- Elevate, Impella
- Where
- 33 sites in United States
- Volunteers
- 290 people
- Sponsor
- Magenta Medical Ltd.
Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20).
- Conditions
- Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, Treatment-naïve High Risk Chronic Lymphocytic Leukemia
- Trial name
- EPCORE™ CLL-1 (NCT04623541)
- Testing
- Epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, Venetoclax
- Where
- 81 sites in United States, Australia and 10 more
- Volunteers
- 194 people
- Sponsor
- Genmab
High-risk PCI
SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
SAVE-PCI Ⅱ is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with ECMO in patients undergoing…
- Trial name
- NCT07860671
- Testing
- NyokAssist, ECMO
- Where
- 14 sites in China
- Volunteers
- 204 people
- Sponsor
- magAssist, Inc.
Coronary Artery Disease, Coronary Artery Disease Risk High
IVUS CHIP UPP Registry
The IVUS CHIP UPP Registry is a prospective, observational, multicenter, single-arm registry. A total of 1010 patients with complex coronary lesions will be enrolled in up to 2 years, with at least 500 men and women.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease Risk High, Complex Coronary Artery Disease
- Trial name
- NCT06625801
- Testing
- IVUS
- Where
- 18 sites in United States
- Volunteers
- 1,010 people
- Sponsor
- ECRI bv
High-risk Percutaneous Coronary Intervention
Impella ECP Early Feasibility Study
The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.
- Trial name
- ECP EFS (NCT04477603)
- Testing
- Impella ECP
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abiomed Inc.
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
This first-in-human study will evaluate RVU120 (SEL120), a novel small molecule CDK8/19 inhibitor, in patients with Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (HR-MDS), in terms of selection of the…
- Trial name
- NCT04021368
- Testing
- RVU120(SEL120)
- Where
- 10 sites in United States, Poland
- Volunteers
- 51 people
- Sponsor
- Ryvu Therapeutics SA
Advanced Solid Tumors, Acute Myeloid Leukaemia (AML)
RVU120 Rollover Study
This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when…
- Conditions
- Advanced Solid Tumors, Acute Myeloid Leukaemia (AML), High-risk Myelodysplastic Syndrome
- Trial name
- ROVER-01 (NCT06987058)
- Testing
- RVU120, Ruxolitinib
- Where
- 7 sites in France, Poland
- Volunteers
- 14 people
- Sponsor
- Ryvu Therapeutics SA
Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome
Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML
The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory…
- Trial name
- RIVER-52 (NCT06268574)
- Testing
- RVU120
- Where
- 41 sites in France, Italy and 2 more
- Volunteers
- 62 people
- Sponsor
- Ryvu Therapeutics SA