Type Condition

Norwalk, CT

183 Clinical Trials near Norwalk, CT

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

Stem Cells + Light Therapy for Alzheimer's Disease and Autism

Westport, Connecticut
The purpose of the study is to evaluate the use of autologous Bone Marrow Derived Stem Cells (BMSC) as a means to improve cognitive impairment as occurs in Alzheimer's Disease and other dementias and to improve behavior and socialization issues which occur in adult Autism Spectrum Disorder. The use of Near Infrared Light, in conjunction with the use of BMSC, will also be assessed.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased

100 Participants Needed

Stem Cell Therapy for Retinal and Optic Nerve Disorders

Westport, Connecticut
This trial will use stem cells from patients' own bone marrow to treat severe vision loss caused by retinal or optic nerve damage. The stem cells will be injected into the eye to help repair the damaged tissues. SCOTS is the largest ophthalmology stem cell study registered at the National Institutes of Health, using autologous bone marrow-derived stem cells for retinal and optic nerve diseases.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

500 Participants Needed

GP0116 for Facial Wrinkles and Folds

Westport, Connecticut
This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22+

186 Participants Needed

Bare Temporary Spur Stent System for Peripheral Arterial Disease

Darien, Connecticut
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

130 Participants Needed

Endovascular Stent Graft for Venous Obstruction

Darien, Connecticut
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

357 Participants Needed

VenaSeal for Venous Reflux Disease

Darien, Connecticut
This trial tests the VenaSeal™ Closure System, which uses a special glue to close off problematic veins. It targets patients with superficial venous disease and those with active venous leg ulcers. The glue seals the vein, redirecting blood flow to healthier veins. The VenaSeal™ Closure System uses cyanoacrylate glue, which has been studied for its effectiveness in treating venous leg ulcers.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

506 Participants Needed

MRI + Mammography for Breast Cancer Screening

Norwalk, Connecticut
This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense breasts. Abbreviated breast MRI is a low cost procedure in which radio waves and a powerful magnet linked to a computer and used to create detailed pictures of the breast in less than 10 minutes. These pictures can show the difference between normal and diseased tissue. Digital tomosynthesis mammography is a procedure that uses multiple x-rays pictures of each breast to produce a 3-dimensional rendering of the entire breast. Combined screening with abbreviated breast MRI and digital tomosynthesis mammography may be a better method to screen women with dense breasts.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:40 - 75
Sex:Female

1516 Participants Needed

Ellansé S for Nasolabial Folds

Westport, Connecticut
The study will be a prospective, randomized, multi-center, split-face, controlled, double-blind clinical trial to evaluate the safety and effectiveness of ELLANSÉ®-S for the treatment of NLFs. Subjects will be randomized to receive treatment (ELLANSÉ®-S) in one NLF and control (Radiesse®) in the contralateral NLF. A total of 126 subjects will be treated. The control and test articles will be supplied in sterile ready-to-use, pre-filled syringes. Initial treatment and any 4-week touch-up will be done consistent with initial randomization. Any retreatment(s) in either NLF will be with ELLANSÉ®-S. Subjects who meet Inclusion/Exclusion criteria will receive an initial treatment, an optional touch up at the 4-week visit, and may be eligible to receive retreatment at either 12 or 18 months after treatment (determined by when the fold has returned to baseline score, or the fold has lost at least 1 point on the Wrinkle Severity Rating Scale (WSRS) from optimal improvement). Retreatment to one side is allowed if only one side qualifies, but the other side may not be retreated at a later visit. If retreatment occurs, the subject may also be eligible to receive an optional touch up at the 4-week follow up visit. If a touch up occurs after the initial or retreatment injection, the subject will return for an additional safety visit 2 weeks after each injection. A week 4 safety visit will occur after retreatment touch-up. Primary effectiveness will be assessed at 6 months. All subjects will be followed for a minimum of 24 months after the initial treatment phase. After each injection, subjects will be contacted by telephone call/email after 72 hours and will return for a safety visit 2 weeks after treatment. At the week 4 visit, subjects will be assessed for a touch up. If a touch up is indicated as determined by the investigator, the investigator will use the same material as that used for initial treatment for the respective side. In addition, subjects will be seen at 6 weeks 3, 6, 9, 12, 18, and 24 months (from the end of the initial treatment phase). Subjects receiving a retreatment (at 12 or 18 months after treatment) will return for additional safety visits at 2 weeks and 3 and 6 months after this retreatment (the 6 month coincides with regularly scheduled visit). Subjects will have the option of a retreatment touch up injection at 4 weeks after retreatment, and if they do will have another call at 72hrs and a week 2 safety visit. The validated Wrinkle Severity Rating Scale will be used for assessment of the primary effectiveness endpoint (1). Assessment of the secondary effectiveness endpoints will include use of WSRS, the Global Aesthetic Improvement Scale (GAIS), VAS pain assessment, the validated FACE-Q Appraisal of Nasolabial Folds Questionnaire, the FACE-Q Satisfaction with Treatment Outcome Scale and the FACE-Q Age Appraisal VAS. The study will last approximately 30 months. All subjects will be recruited within approximately 6 months after the recruitment of the first subject and followed for a minimum of 24 months after the initial treatment visit. Subjects receiving a retreatment (at 12 or 18 months) will receive a telephone call/email 72 hours after retreatment and they will return for an additional safety visit 2 weeks after retreatment. Subjects may receive a retreatment touch up at 4 weeks after retreatment, and if touched up, will have safety visits at 2 and 4 weeks. All retreated subjects will also be asked to attend month 3 and month 6 safety visits. The 6-month safety visit will correspond with the next study visit (e.g., 18 month or 24-month visit depending on when they are reinjected) 126 male and female subjects will be enrolled. This enrollment number accounts for a 20% attrition rate, to ensure an adequate safety population for long-term follow-up, and a Per Protocol Set (PPS) of at least 101 NLFs per treatment arm. At least 20% of treated subjects will have Fitzpatrick Skin Types IV, V, and VI. Of these, at least, 10% will be Type IV, 5% Type V and 5% Type VI. The investigative sites will be encouraged to enroll both male and female subjects. In addition, up to 2 non-randomized, non-split-face run-in subjects will be treated with ELLANSÉ®-S by each investigator to allow the investigator to become familiar with injection characteristics. This run-in cohort will be required to meet all study inclusion/exclusion criteria and will be followed in the same manner as the non-run-in cohort. Up to seven US sites will participate.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:22+

126 Participants Needed

Letrozole for Hormone Receptor-Positive Breast Cancer

Norwalk, Connecticut
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Sex:Female

3966 Participants Needed

Ovarian Suppression + Tamoxifen/Exemestane for Breast Cancer

Norwalk, Connecticut
RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Age:18 - 65
Sex:Female

3066 Participants Needed

GAL1906 for Wrinkles

Westport, Connecticut
This trial is testing a new treatment called GAL1906 to see if it can safely and effectively reduce wrinkles in the upper chest area. It focuses on people who want to improve the appearance of their skin in that region.
No Placebo Group

Trial Details

Trial Status:Recruiting
Age:22+
Sex:Female

192 Participants Needed

AVP-786 for Agitation in Alzheimer's Disease

Norwalk, Connecticut
This trial is testing a medication called AVP-786 on individuals who have taken part in previous studies. The goal is to see if this medication can help with their conditions over time.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Age:50 - 90

1197 Participants Needed

Chemotherapy + Bevacizumab for Non-Small Cell Lung Cancer

Norwalk, Connecticut
This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting

1501 Participants Needed

Ketogenic Diet for Pancreatic Cancer

Norwalk, Connecticut
This study will evaluate the effects of the ketogenic diet in patients with metastatic pancreatic cancer while receiving chemotherapy.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting

32 Participants Needed

Serplulimab + Chemotherapy for Small Cell Lung Cancer

Stamford, Connecticut
This trial is testing two different treatment combinations for patients with extensive-stage small cell lung cancer who have not received any prior treatment. One group will receive a new drug called Serplulimab along with standard chemotherapy, while the other group will receive an existing drug called Atezolizumab with the same chemotherapy. Both immunotherapy drugs aim to help the immune system fight cancer, and the chemotherapy drugs work by killing cancer cells. Atezolizumab has been shown to improve survival in small-cell lung cancer when combined with chemotherapy, changing the standard first-line therapy.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting

200 Participants Needed

Active on Power

Frexalimab for Multiple Sclerosis

Stamford, Connecticut
The study is evaluating the efficacy and safety of Frexalimab in patients with non-relapsing, secondary progressive MS. The primary objective is to determine whether Frexalimab can delay disability progression compared to placebo.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 60

858 Participants Needed

Active on Power

Frexalimab for Multiple Sclerosis

Stamford, Connecticut
The study is evaluating whether Frexalimab performs better than the existing MS medication, Teriflunomide, at reducing the number of relapses in patients with relapsing forms of multiple sclerosis.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 55

1400 Participants Needed

Rimegepant for Pediatric Migraine

Stamford, Connecticut
This trial aims to test the safety of rimegepant, a medication for treating migraines. The study focuses on children and adolescents aged 6 to 17 years who experience moderate to severe migraines. Rimegepant works by blocking a protein that triggers migraine pain, helping to alleviate symptoms.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17

600 Participants Needed

Rimegepant for Pediatric Migraine

Stamford, Connecticut
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17

2100 Participants Needed

CD388 for Flu Prevention

Bridgeport, Connecticut
The purpose of this study is to evaluate how well CD388 works in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, when given as a single dose via 3 subcutaneous (SQ) injections to adult and adolescent participants who are at higher risk of developing influenza complications, and to evaluate the safety and tolerability of CD388, as compared to placebo.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+

6000 Participants Needed

Why Other Patients Applied

"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

"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

"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

"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

"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."

WR
Obesity PatientAge: 58

Retatrutide vs Tirzepatide for Obesity

Bridgeport, Connecticut
The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 3

800 Participants Needed

Tivozanib + Pembrolizumab for Kidney Cancer

Fairfield, Connecticut
This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

1040 Participants Needed

Remternetug for Alzheimer's Disease

Stamford, Connecticut
The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo. Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:65 - 80

1200 Participants Needed

Targeted Therapy vs. Chemotherapy for Thyroid Cancer

Stamford, Connecticut
This phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment (refractory) and which expresses a BRAF V600E mutation. Cabozantinib is in a class of medications called receptor tyrosine kinase inhibitors. It binds to and blocks the action of several enzymes which are often over-expressed in a variety of tumor cell types. This may help stop or slow the growth of tumor cells and blood vessels the tumor needs to survive. Dabrafenib is an enzyme inhibitor that binds to and inhibits the activity of a protein called B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. Trametinib is also an enzyme inhibitor. It binds to and inhibits the activity of proteins called MEK 1 and 2, which play a key role in activating pathways that regulate cell growth. This may inhibit the growth of tumor cells mediated by these pathways. The usual approach for patients with thyroid cancer is targeted therapy with dabrafenib and trametinib. This trial may help researchers decide which treatment option (cabozantinib alone or dabrafenib in combination with trametinib) is safer and/or more effective in treating patients with refractory BRAF V600E-mutated differentiated thyroid cancer.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

264 Participants Needed

Immunotherapy + Chemotherapy for Sarcoma

Stamford, Connecticut
This phase III trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable DDLPS, UPS or a related poorly differentiated sarcoma live longer without having disease progression.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

365 Participants Needed

CDK4/6 Inhibitors for Metastatic Breast Cancer

Fairfield, Connecticut
The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs. The primary objective of the CDK Study is to compare time to treatment discontinuation (TTD) on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (aromatase inhibitor (AI) or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors. Together with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing). Note: Telehealth visits are allowed at any time per institutional guidelines. In addition, the study allows for remote consenting per institutional guidelines.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:65+

500 Participants Needed

Nivolumab + Standard Treatment for Stomach and Esophageal Cancer

Stamford, Connecticut
This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). 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. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2, 3

224 Participants Needed

Durvalumab + Chemotherapy for Breast Cancer

Stamford, Connecticut
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide 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. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3

3680 Participants Needed

Blood Test and Immunotherapy for Bladder Cancer

Fairfield, Connecticut
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2, 3

992 Participants Needed

Zanubrutinib for Mantle Cell Lymphoma

Stamford, Connecticut
This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:60+

421 Participants Needed

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