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106 Parkinson's Disease Trials near California
Power is an online platform that helps thousands of Parkinson's Disease patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerVibrotactile Stimulation for Parkinson's Disease
Stanford, California
This trial is testing a new treatment called Vibrotactile Coordinated Reset stimulation (vCR) for people with early stage Parkinson's disease. The treatment uses a device called the Stanford Glove to send vibrations to the nervous system. It aims to provide a non-invasive alternative to common treatments like medication or surgery by helping the brain's nerve cells work better.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Neuro-psychiatric Problems, Drug Abuse, Others
20 Participants Needed
Non-Invasive Vibration Therapy for Parkinson's Disease
Stanford, California
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on advanced stage Parkinson's symptoms. VCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. Patients will be followed for two years.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Neuro-psychiatric Problems, Drug Abuse, Others
Must Not Be Taking:Antidepressants, Others
35 Participants Needed
Adaptive DBS for Parkinson's Disease
Stanford, California
The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Depression, Metallic Implants, Under 18, Others
85 Participants Needed
PKG Monitoring for Parkinson's Disease
San Diego, California
The primary objective is to understand the utility of Personal KinetiGraph movement recording system data in the clinical management of Parkinson's disease (PD) in routine clinical care at a movement disorders clinic. Specifically:
1. Measure medication use and clinical management plan changes in a large, multicenter cohort among participants undergoing a clinical assessment with an MDS in which the MDS reviews the participant's PKG during the clinical assessment in half of the enrolled participants (PKG + Group) and in half of the enrolled participants the MDS completes the clinical assessment without the PKG (PKG- Group).
2. Determine the association between frequency of medication changes, the PKG information, and other clinical assessments among participants with and without a PKG report of their PD motor status available to the clinician at the time of evaluation.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:46 - 83
Key Eligibility Criteria
Disqualifiers:Not Listed
231 Participants Needed
Cortical Stimulation for Parkinson's Disease
San Francisco, California
This study will investigate cortical stimulation to treat mood and behavioral symptoms in Parkinson's disease patients.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:30 - 75
Key Eligibility Criteria
Disqualifiers:Pregnancy, Severe Hypertension, Severe Diabetes, Others
Must Be Taking:Anti-Parkinsonian
10 Participants Needed
UCB0022 for Parkinson's Disease
Las Vegas, Nevada
This trial is testing UCB0022, a new medication, to see if it can help people with advanced Parkinson's Disease. It is added to their regular treatments to see if it reduces the time they spend with bad symptoms. The goal is to make their usual treatments work better.
Stay on current meds
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:35 - 85
Key Eligibility Criteria
Disqualifiers:Not Listed
207 Participants Needed
Minzasolmin for Parkinson's Disease
Los Angeles, California
The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:40 - 78
Key Eligibility Criteria
Disqualifiers:Not Listed
428 Participants Needed
Genetic Testing for Parkinson's Disease
La Jolla, California
To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Not Listed
1982 Participants Needed
CVN424 Monotherapy for Early Parkinson's Disease
Palo Alto, California
This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150 milligrams (mg) tablets in early, untreated Parkinson's Disease (PD). Participants will be randomized in a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The purpose of this study is to measure effect on motor features with CVN424 tablets compared to placebo in early, untreated PD and to evaluate the potential of CVN424 to improve motor and non-motor functions in participants with early PD who are not taking dopaminergic or anti-PD therapies.
Trial Details
Trial Status:Active Not Recruiting
Age:30+
Key Eligibility Criteria
Disqualifiers:Not Listed
62 Participants Needed
Long-Term Treatment for Parkinson's Disease
Los Angeles, California
This study seeks to establish the safety and efficacy of extended twice daily treatments for treating symptoms associated with PD. Only participants who completed the STEM-PD RCT trial are eligible for the OLE.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Key Eligibility Criteria
Disqualifiers:Not Listed
220 Participants Needed
18F-OP-801 for ALS
Stanford, California
This trial tests a new brain scan substance called 18F-OP-801 on patients with ALS, AD, MS, PD, and healthy volunteers. It helps doctors see brain inflammation by highlighting active immune cells. This could improve early detection and treatment of these diseases.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Obesity, Alcoholism, Drug Abuse, Others
Must Not Be Taking:Corticosteroids, NSAIDs
65 Participants Needed
Psilocybin Therapy for Depression in Parkinson's Disease
San Francisco, California
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:40 - 80
Key Eligibility Criteria
Disqualifiers:Psychosis, Cognitive Impairment, Others
Must Not Be Taking:Psilocybin Interactions
60 Participants Needed
Deep Brain Stimulation for Parkinson's Disease
San Francisco, California
This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson's disease (PD) and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Parkinson's disease and isolated dystonia patients will be implanted unilaterally or bilaterally with a totally internalized bidirectional neural interface, Medtronic Summit RC+S.
This study includes three populations: ten PD patients undergoing deep brain stimulation in the subthalamic nucleus (STN), ten PD patients with a globus pallidus (GPi) target and five dystonia patients. All groups will test a variety of strategies for feedback-controlled deep brain stimulation, and all patients will undergo a blinded, small pilot clinical trial of closed-loop stimulation for thirty days.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21 - 75
Key Eligibility Criteria
Disqualifiers:Coagulopathy, Uncontrolled Hypertension, Seizures, Heart Disease, Others
Must Be Taking:Antiparkinsonian, Anti-dystonia
25 Participants Needed
Neurostimulation for Parkinson's Disease
Stanford, California
Parkinson's disease (PD) is a neurodegenerative disorder that leads to both motor and non-motor symptoms. Therapies have been developed that effectively target the motor symptoms. Non-motor symptoms are far more disabling for patients, precede the onset of motor symptoms by a decade, are more insidious in onset, have been less apparent to clinicians, and are less effectively treated. Sleep dysfunction is oftentimes the most burdensome of the non-motor symptoms. There are limited options for treating sleep dysfunction in PD, and the mainstay of therapy is the use of sedative-hypnotic drugs without addressing the underlying mechanisms. Patients with PD who demonstrate significant motor fluctuations and dyskinesia are considered for subthalamic nucleus (STN) deep brain stimulation (DBS) surgery. Several studies have reported that STN-DBS also provides benefit for sleep dysregulation. Additionally, local field potentials recorded from STN DBS electrodes implanted for the treatment of PD, have led to the identification of unique patterns in STN oscillatory activity that correlate with distinct sleep cycles, offering insight into sleep dysregulation. This proposal will leverage novel investigational DBS battery technology (RC+S Summit System; Medtronic) that allows the exploration of sleep biomarkers and prototyping of closed-loop stimulation algorithms, to test the hypothesis that STN contributes to the regulation and disruption of human sleep behavior and can be manipulated for therapeutic advantage. Specifically, in PD patients undergoing STN-DBS, the investigators will determine whether STN oscillations correlate with sleep stage transitions, then construct and evaluate sensing and adaptive stimulation paradigms that allow ongoing sleep-stage identification, and induce through adaptive stimulation an increase in duration of sleep stages associated with restorative sleep.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21 - 80
Key Eligibility Criteria
Disqualifiers:Hypertension, Heart Disease, Seizures, Others
20 Participants Needed
Neurostimulation for Sleep Problems in Parkinson's Disease
Stanford, California
Parkinson's Disease (PD) is the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye movement (REM or dream sleep) Sleep Behavior Disorder (RBD), Restless legs syndrome (RLS), periodic limb movement, excessive daytime sleepiness, and sleep apnea. Sleep is vital to homeostasis, cognition, and nervous system repair. The dysfunctional sleep accompanying PD adversely affects both motor and non-motor symptoms, resulting in diminished quality of life for both patients and caregivers, including impairments in mood and behavior, and increased morbidity and mortality. Knowledge of sleep phenomenology and pathology in humans has largely been informed by analysis of non-invasive scalp electroencephalogram (EEG), and despite the profound importance of sleep, the underlying neural circuits important for controlling sleep and wakefulness in humans remain poorly understood.
This study assesses whether adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Participants are adults with PD who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Prior to surgery, participant sleep patterns will be assessed with questionnaires and monitored with a non-invasive watch-like device. Approximately four months after implantation surgery, participants will each receive 2 1-week deep brain stimulation (DBS) treatments and 1 1-week control session with no DBS in random order. Sleep patterns will again be monitored during the treatments and compared to the patterns before surgery.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Seizures, Heart Disease, Alcohol Abuse, Others
Must Not Be Taking:Anticoagulants
20 Participants Needed
Focused Ultrasound Pallidotomy for Parkinson's Disease
Stanford, California
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Trial Details
Trial Status:Active Not Recruiting
Age:30+
Key Eligibility Criteria
Disqualifiers:Not Listed
92 Participants Needed
Carvedilol for Early Parkinson's Disease
Los Angeles, California
REM Behavior Sleep Disorder (RBD) is a sleep disorder causing people to 'act out' their dreams. A high percentage of individuals with idiopathic RBD (iRBD) are known to develop conditions affecting the neurons in the brain such as Parkinson's disease (PD). Based on the increased risk to develop PD, individuals with iRBD are currently considered ideal candidates for therapies that can possibly protects brain cells, due to the critical window of opportunity to intervene early before brain cell loss progresses significantly.
Early changes of PD are associated with a number of symptoms including loss of smell, constipation, anxiety and depression. In addition, early heart and brain abnormalities can be visualized using specialized imaging techniques called 123I-MIBG myocardial scintigraphy (MIBG) and dopamine transporter (DAT) single photon emission computerized tomography (SPECT) respectively. The combined presence of certain symptoms and the use of these imaging techniques are considered early markers of PD in individuals with iRBD.
In other conditions, like heart failure, MIBG abnormalities are reversed by drugs able to block excessive adrenergic stimulation, known as beta-blockers. In this study the investigators want to learn about the effect of treatment with the beta-blocker carvedilol on MIBG abnormalities found in iRBD patients at risk to develop PD. The investigators believe that reversing the MIBG abnormality might prelude to a slowing of the neurodegenerative process. This drug is approved by the U.S. Food and Drug Administration (FDA) for congestive heart failure, hypertension and left ventricular dysfunction after myocardial infarction. However, carvedilol is not approved by the FDA in patients with iRBD at risk for PD. The available doses for this drug oral formulations are 3.125mg, 6.25mg, 12.5mg and 25mg.
Changes visualized with the MIBG imaging technique will be correlated to the presence and severity of neurological (i.e. tremors, stiffness, slow movements, walking difficulties) and other symptoms associated with PD (i.e. abnormal smell, constipation, depression, color vision abnormalities), as measured by specific clinical scales and exams.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:50 - 85
Key Eligibility Criteria
Disqualifiers:Dementia, Heart Failure, Diabetes, COPD, Others
Must Not Be Taking:Antidepressants
15 Participants Needed
Carvedilol for Parkinson's Disease
Los Angeles, California
The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, a dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging technique in a population of subjects with defined pre-motor Parkinson's disease risks (i.e., REM sleep Behavior Disorder (RBD) and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal 123I-Metaiodobenzylguanidine (MIBG) scintigraphy.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Dementia, Severe Depression, Heart Failure, Hypertension, Diabetes, Others
Must Not Be Taking:Beta-blockers
15 Participants Needed
Virtual Reality for Freezing of Gait in Parkinson's Disease
Los Angeles, California
Freezing of gait - the inability to start or continue walking - is a particularly disabling problem in Parkinson's disease that has few treatment options. This project records human brain activity from deep brain stimulation (DBS) devices during walking and freezing of gait episodes to understand the pathophysiology of freezing of gait. Findings will lay the foundation for the development of new treatment strategies that address this disabling symptom.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Dementia, Stroke, Severe Gait Impairments, Others
36 Participants Needed
Gene Transfer for Pompe Disease
Orange, California
This trial is testing a new treatment called SPK-3006 for adults with late-onset Pompe disease who are already on enzyme replacement therapy. The treatment involves an infusion that delivers a gene to help produce a missing enzyme. The goal is to see if this new approach is safe and effective.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Hepatitis, HIV, Liver Disease, Others
Must Be Taking:Enzyme Replacement
4 Participants Needed
Why Other Patients Applied
"I wasn’t diagnosed until February, but I showed symptoms over ten years before. I want to help find a cure. I have lost family members to Parkinson’s and want to contribute to the search for better treatments before my children possibly come down with it."
YX
Parkinson's PatientAge: 61
"I have 5 kids. I'll do anything I can to slow this disease down in hopes that I can stay active with them into their adulthood. I also feel I am serving the greater good for all those who suffer from Parkinson's. Since I'm self employed, my schedule is flexible. "
UR
Parkinson's PatientAge: 53
"My dad was in a research group for Parkinson's for about 6 years, which was very interesting. I was just diagnosed 1.5 years ago, and started on low dose Sinemet. Doing well on Sinemet, but I'd like to get ahead of the condition. I'm excited about participating in research. "
LN
Parkinson's PatientAge: 74
"It seems my Parkinson’s is progressing more rapidly now. And my meds are lagging behind. My off time is more frequent and the episodes are longer. Trying to figure out what my options are."
TM
Parkinson's PatientAge: 58
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
Suvecaltamide for Tremors in Parkinson's Disease
Los Angeles, California
This trial tests suvecaltamide, a medication aimed at reducing severe tremors in adults with Parkinson's disease whose current treatments are not effective. The medication likely helps by calming the overactive nerves or muscles responsible for the tremors.
Trial Details
Trial Status:Recruiting
Age:40 - 85
Key Eligibility Criteria
Disqualifiers:Not Listed
160 Participants Needed
Transcranial Ultrasound Stimulation for Alzheimer's Disease
Santa Monica, California
The purpose of this study is to evaluate the safety and efficacy of transcranial focused ultrasound neuromodulation in improving neural function, cognitive and behavioral performance, and quality of life for patients with neurodegenerative diseases.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Cardiac Conditions, Psychiatric Conditions, Others
Must Not Be Taking:Seizure-inducing Drugs
20 Participants Needed
Transcranial Focused Ultrasound for Dementia
Santa Monica, California
This trial is testing a treatment that uses sound waves aimed at specific brain areas to help patients with memory and cognitive issues. The goal is to see if this method is safe and effective for people with mild cognitive impairment or dementia. The therapy has been shown to be effective and safe in animal models of Alzheimer's disease and vascular dementia, with previous trials indicating a tendency to suppress cognitive impairment.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Age:45 - 93
Key Eligibility Criteria
Disqualifiers:Not Listed
100 Participants Needed
Sacituzumab Tirumotecan for Breast Cancer
Fullerton, California
Researchers are looking for new ways to treat types of breast cancer that are both:
* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment
* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.
Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.
The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:
* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy
* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Cancer, Prior Treatment, Others
Must Not Be Taking:Anti-PD-1, Anti-PD-L1
2400 Participants Needed
Sacituzumab Tirumotecan + Pembrolizumab for Endometrial Cancer
Orange, California
Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent.
* EC is a type of cancer that starts in the tissues inside the uterus (womb)
* pMMR indicates that certain normal proteins are present in the cancer cells
* Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery
* Recurrent means the cancer came back after surgery
Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.
The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Sarcomas, DMMR, Cardiovascular, Others
Must Not Be Taking:Immunosuppressants, T-cell Inhibitors
1123 Participants Needed
Sacituzumab Tirumotecan + Pembrolizumab for Breast Cancer
Los Angeles, California
Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Cardiovascular Disease, Others
Must Not Be Taking:Immunosuppressants, Steroids
1000 Participants Needed
V940 + Pembrolizumab for Non-Small Cell Lung Cancer
Long Beach, California
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:SCLC, ALK Rearrangements, Others
Must Be Taking:Pembrolizumab
680 Participants Needed
MK-1084 + Pembrolizumab for Lung Cancer
Bakersfield, California
This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:
Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Small Cell Lung Cancer, Cardiovascular Disease, Autoimmune Disease, Others
Must Not Be Taking:Immunosuppressants, Steroids
600 Participants Needed
Sacituzumab Tirumotecan + Pembrolizumab for Breast Cancer
Los Alamitos, California
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.
The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Curative Cancer, Autoimmune Disease, Others
Must Not Be Taking:Steroids
1200 Participants Needed
Sacituzumab Tirumotecan + Pembrolizumab for Lung Cancer
Burbank, California
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.
All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Small Cell Lung Cancer, Cardiovascular Disease, CNS Metastases, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
614 Participants Needed
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