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200 Clinical Trials near Easton, PA
Power is an online platform that helps thousands of 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 PowerBION-1301 for IgA Nephropathy
Bethlehem, Pennsylvania
This trial is testing BION-1301, a new medication, in adults with IgA nephropathy. The goal is to see if it can help reduce the amount of protein leaking into their urine by improving kidney function.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Nephrotic Syndrome, HIV, Others
Must Be Taking:ACEi, ARB, SGLT2i, ERAs
383 Participants Needed
Pegcetacoplan for Complement 3 Glomerulopathy
Bethlehem, Pennsylvania
This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Drug Abuse, Others
Must Be Taking:Pegcetacoplan
100 Participants Needed
Milvexian for Acute Coronary Syndrome
Bethlehem, Pennsylvania
This trial is testing a new medication called milvexian to see if it can better prevent serious heart problems like heart attacks and strokes in patients who are at high risk. The medication works by preventing blood clots, which helps keep blood flowing smoothly.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 2 MI, Planned CABG, Others
Must Not Be Taking:Anticoagulants
16000 Participants Needed
Inavolisib + Fulvestrant vs Alpelisib + Fulvestrant for Breast Cancer
Bethlehem, Pennsylvania
This trial is testing two drug combinations to find out which one is better for treating a specific type of advanced breast cancer that hasn't responded to previous treatments. The drugs work by stopping cancer cells from growing and spreading.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, CNS Metastases, Others
Must Be Taking:LHRH Agonists
420 Participants Needed
Sacituzumab Govitecan + Pembrolizumab for Triple Negative Breast Cancer
Bethlehem, Pennsylvania
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage IV Breast Cancer, BRCA Mutations, Others
Must Not Be Taking:Endocrine Therapy, HER2-directed Agents
1514 Participants Needed
Imlunestrant for Early Breast Cancer
Bethlehem, Pennsylvania
This trial is testing a new medication called imlunestrant to see if it works better than standard hormone treatments for certain breast cancer patients. The study focuses on patients with early-stage breast cancer that is estrogen receptor positive and HER2 negative, who have already been on hormone therapy for a period of time and are at high risk of their cancer returning. Imlunestrant works by blocking estrogen from helping cancer cells grow.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Other Cancer, Others
Must Be Taking:Endocrine Therapy
8000 Participants Needed
CSL300 for Kidney Failure
Bethlehem, Pennsylvania
This trial is testing CSL300, a new treatment, to see if it helps people with heart disease or diabetes who are on dialysis. The study aims to find the right dose and check if it improves heart health by reducing inflammation.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Abnormal LFTs, Life-threatening Disease, Others
Must Not Be Taking:Immunosuppressants
2310 Participants Needed
Abatacept for Myocarditis
Bethlehem, Pennsylvania
This Trial tests if abatacept can reduce serious heart problems in patients with heart inflammation caused by cancer treatments. Abatacept calms the immune system by preventing certain immune cells from becoming fully active, reducing inflammation and damage. Abatacept has been approved by the US Food and Drug Administration for the treatment of rheumatoid arthritis, with or without methotrexate.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Infections, Pregnancy, Recent Cardiac Events, Others
Must Be Taking:Solumedrol
390 Participants Needed
Relacorilant + Nab-Paclitaxel for Ovarian Cancer
Bethlehem, Pennsylvania
This trial tests a new combination of two drugs for ovarian cancer patients who have no other treatment options left. The combination includes a drug that may make chemotherapy more effective and a chemotherapy drug that has been used in various cancer treatments. The goal is to see if this combination can help patients live longer without their disease getting worse.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis, CNS Metastases, Others
Must Not Be Taking:Corticosteroids, Mifepristone, CYP3A Modulators
381 Participants Needed
PC945 + Antifungal Therapy for Invasive Pulmonary Aspergillosis
La Jolla, California
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Allergy, Hypersensitivity, Others
Must Be Taking:Antifungal Therapy
123 Participants Needed
Bemarituzumab + Chemotherapy + Nivolumab for Stomach Cancer
Bethlehem, Pennsylvania
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.
The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HER2 Positive, CNS Metastases, Cardiac Disease, Others
Must Not Be Taking:FGF-FGFR Inhibitors
515 Participants Needed
Finerenone for Chronic Kidney Disease
Bethlehem, Pennsylvania
This trial is testing finerenone, a daily pill, to help people with non-diabetic chronic kidney disease. Finerenone works by blocking a hormone called aldosterone that can cause damage and swelling in the heart and kidneys. The goal is to see if finerenone can slow down the worsening of kidney disease. Finerenone has shown promise in reducing kidney disease progression in patients with chronic kidney disease and type 2 diabetes.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Polycystic Kidney, Lupus, Others
Must Be Taking:ACEI, ARB
1584 Participants Needed
Pembrolizumab + Lenvatinib + Chemo for Esophageal Cancer
Bethlehem, Pennsylvania
This trial tests a new combination of drugs and chemotherapy for advanced esophageal cancer. It targets patients whose cancer has spread and who need effective first-line treatment. The treatment works by enhancing the immune system, blocking cancer growth, and killing cancer cells.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Previous Therapy, Adenocarcinoma, CNS Metastases, Others
Must Not Be Taking:Steroids, Immunosuppressants
863 Participants Needed
Pegcetacoplan for Age-Related Macular Degeneration
Bethlehem, Pennsylvania
This trial is testing a medication called pegcetacoplan to see if it is safe and effective for people with a severe eye condition called geographic atrophy, which is related to age-related macular degeneration. The medication aims to protect the eye by blocking harmful immune responses. Pegcetacoplan has shown an acceptable safety profile in previous studies for geographic atrophy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Eye Diseases, Eye Inflammation, Allergies, Pregnancy, Others
1200 Participants Needed
Itepekimab for COPD
Bethlehem, Pennsylvania
Primary Objective:
Primary population (former smokers cohort):
* Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD
Secondary Objectives:
Primary population (former smokers cohort):
* Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
* Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
* Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
* Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
Secondary population (current smokers cohort)
* Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD
* Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD
* Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD
* Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD
* Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40 - 85
Key Eligibility Criteria
Disqualifiers:Asthma, Pulmonary Disease, Hypertension, Others
Must Be Taking:Inhaled Corticosteroids, Long-acting Beta-agonists
1239 Participants Needed
Fenebrutinib for Relapsing Multiple Sclerosis
Bethlehem, Pennsylvania
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. At the end of the DBT phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension phase of the study.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Primary Progressive MS, Active Infection, Cancer, Neurological Disorders, Others
Must Not Be Taking:Systemic Corticosteroids, Immunosuppressants
746 Participants Needed
Atrasentan for IgA Nephropathy
Bethlehem, Pennsylvania
This trial is testing a medication called atrasentan to help people with a kidney disease called IgA nephropathy. It aims to protect their kidneys by reducing protein in their urine. The study will compare atrasentan to another treatment over a few years. Atrasentan has been studied for its effects on reducing protein in urine and protecting kidney function in patients with diabetic nephropathy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetic Kidney Disease, Nephrotic Syndrome, Others
Must Be Taking:RAS Inhibitors
404 Participants Needed
Benralizumab for Nasal Polyps
Bethlehem, Pennsylvania
This trial tests benralizumab injections in patients with severe nasal polyps who haven't responded to other treatments. The medication reduces specific cells that cause inflammation, aiming to improve symptoms. Benralizumab has been studied for its effects on severe asthma and nasal polyps.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Recent Nasal Surgery, Allergic Fungal Sinusitis, Others
Must Be Taking:Intranasal Corticosteroids
296 Participants Needed
Acalabrutinib for Chronic Lymphocytic Leukemia
Bethlehem, Pennsylvania
This is a global, Phase IIIb, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL). Participants will be enrolled into 3 following cohorts: treatment-naive (TN), relapsed/refractory (R/R), and prior ibrutinib therapy. For this study, participants in the UK will be enrolled ONLY into the R/R cohort or the prior ibrutinib cohort. Participants in the US will be enrolled ONLY into the TN or R/R cohort. Participants will remain on study intervention until completion of 48 cycles (28 days per cycle), or until study intervention discontinuation due to, for example disease progression, or toxicity, withdrawal of consent, loss to follow-up, death, or study termination by the sponsor whichever occurs first. The duration of the study will be approximately 72 months from the first participant enrolled. This duration includes an estimated 24-month recruitment time and an assumed 48 cycles of study intervention (28 days per cycle); additional study time will be accrued during the Disease Follow up period for those participants remaining on study intervention after completion of 48 cycles prior to the final data cutoff (DCO) (the amount of time will vary by participant).
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior Malignancy, Cardiovascular Disease, Hepatitis, Others
Must Not Be Taking:Proton-pump Inhibitors, Warfarin
552 Participants Needed
Venetoclax + Chemotherapy for B-Cell Lymphoma
Bethlehem, Pennsylvania
This phase II/III trial tests whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, CNS Involvement, Active Hepatitis, Others
Must Not Be Taking:Strong CYP3A4 Inhibitors, Inducers
363 Participants Needed
Why Other Patients Applied
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"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
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
Atezolizumab Continuation for Cancer
Bethlehem, Pennsylvania
This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Serious Adverse Events, Others
Must Be Taking:Atezolizumab
1000 Participants Needed
Durvalumab + Chemotherapy for Bladder Cancer
Bethlehem, Pennsylvania
A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Prior Radiotherapy, Others
Must Not Be Taking:Immunosuppressants, Live Vaccines
1063 Participants Needed
Mavacamten for Hypertrophic Cardiomyopathy
Bethlehem, Pennsylvania
Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study.
Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study.
Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:ECG Abnormalities, Syncope, Cardiac Arrest, Others
Must Not Be Taking:Disopyramide, Ranolazine
282 Participants Needed
Combination Therapy for Chronic Lymphocytic Leukemia
Bethlehem, Pennsylvania
This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Obinutuzumab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib, obinutuzumab, and venetoclax may work better than giving ibrutinib and obinutuzumab in treating patients with chronic lymphocytic leukemia.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Congestive Heart Failure, Hepatitis C, Others
Must Not Be Taking:CYP3A Inhibitors, CYP3A Inducers
720 Participants Needed
Sparsentan for Focal Segmental Glomerulosclerosis
Bethlehem, Pennsylvania
To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:8 - 75
Key Eligibility Criteria
Disqualifiers:Diabetes, Heart Disease, Liver Disease, Others
Must Not Be Taking:Rituximab, Cyclophosphamide, Abatacept
371 Participants Needed
Hypofractionated Radiation Therapy for Breast Cancer
Bethlehem, Pennsylvania
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metaplastic Breast Cancer, T4, N3, Others
897 Participants Needed
Seladelpar for Primary Biliary Cholangitis
Bethlehem, Pennsylvania
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cancer, Hepatitis, HIV, Others
Must Not Be Taking:Fibrates, Obeticholic Acid
500 Participants Needed
Pembrolizumab for Bladder Cancer
Bethlehem, Pennsylvania
This phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal antibodies recognizing and blocking checkpoint molecules can enhance the patient's immune response and therefore help fight cancer. Pembrolizumab is one of the monoclonal antibodies that block the PD-1 axis and can interfere with the ability of tumor cells to grow.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Diseases, Hepatitis, Pneumonitis, Others
Must Not Be Taking:Corticosteroids, Immunosuppressants
739 Participants Needed
Nivolumab for Anal Cancer
Bethlehem, Pennsylvania
This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Transplant, Autoimmune Disease, Others
Must Not Be Taking:Immune Checkpoint Inhibitors, Immunosuppressants
344 Participants Needed
Atezolizumab + Standard Therapy for HER2-Positive Breast Cancer
Bethlehem, Pennsylvania
This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.
\*NOTE: This study has a central confirmation step. The purpose of this step is to confirm by central testing that the patient's tumor has specific receptors. If the patient meets all the study requirements, the patient will join the study and begin therapy for breast cancer while the tumor is being tested.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Hypertension, Cardiac Disease, Autoimmune Disease, Others
Must Be Taking:Trastuzumab, Pertuzumab, Taxane
190 Participants Needed
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