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Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Rochester, MN	Closed for enrollment

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Empty Bladder Impact During Radiation Therapy For Prostate Cancer

Albert Lea, MN, Scottsdale/Phoenix, AZ, Eau Claire, WI, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

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Empty Bladder Impact During Radiation Therapy For Prostate Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to determine whether an empty bladder during radiation therapy delivery for prostate cancer affects patient-reported urinary symptoms related to treatment.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Albert Lea, MN	Closed for enrollment	View complete study & contact information
Scottsdale/Phoenix, AZ	Closed for enrollment
Eau Claire, WI	Closed for enrollment
Jacksonville, FL	Closed for enrollment
La Crosse, WI	Closed for enrollment
Mankato, MN	Closed for enrollment
Rochester, MN	Closed for enrollment

Print study details

Site IRB:
23-005799
NCT ID:
NCT06037863
Sponsor Protocol Number:
GMROR2352

Enfortumab Vedotin And Pembrolizumab With Cystectomy And/or Ureterectomy For Locally Advanced Or Metastatic Bladder And Upper Urothelial Tract Cancer, CAST-AI Trial

Rochester, MN
- See Details
Enfortumab Vedotin And Pembrolizumab With Cystectomy And/or Ureterectomy For Locally Advanced Or Metastatic Bladder And Upper Urothelial Tract Cancer, CAST-AI Trial
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  4
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

This phase IV trial tests the impact of standard of care enfortumab vedotin and pembrolizumab followed by removal of all or part of the bladder (cytoreductive cystectomy) and/or removal of all or part of the tube that carriers urine from the kidneys to the bladder (ureterectomy) on outcomes in patients with bladder and upper urothelial tract that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. Giving standard of care enfortumab vedotin and pembrolizumab followed by cytoreductive cystectomy and/or ureterectomy (CC/U) may improve outcomes in patients with locally advanced or metastatic bladder or upper urothelial tract cancer.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Open for enrollment
View complete study & contact information

Print study details
Site IRB:
24-006857

NCT ID:
NCT06764095

Sponsor Protocol Number:
MC240504

Mayo Clinic Location	Status	Contact
Rochester, MN	Open for enrollment	View complete study & contact information

An Open-label Multi-Cohort Phase 1b/2 Study To Evaluate The Safety, Efficacy, And Optimal Dose Of Telisotuzumab Adizutecan In Combination With A PD-1 Immune Checkpoint Inhibitor In Advanced Or Metastatic Non-Squamous NSCLC With No Prior Treatment For Advanced Disease And No Actionable Genomic Alterations (AndroMETa-Lung-536)

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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An Open-label Multi-Cohort Phase 1b/2 Study To Evaluate The Safety, Efficacy, And Optimal Dose Of Telisotuzumab Adizutecan In Combination With A PD-1 Immune Checkpoint Inhibitor In Advanced Or Metastatic Non-Squamous NSCLC With No Prior Treatment For Advanced Disease And No Actionable Genomic Alterations (AndroMETa-Lung-536)

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) inhibitor (budigalimab) to adult participants to treat NSCLC. ABBV-400 and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of ABBV-400 in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 4 treatment groups. Two groups will receive budigalimab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed. One group will receive the standard of care (SOC) pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 172 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with budigalimab or receive IV budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed, or IV SOC pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
26-001289
NCT ID:
NCT06772623
Sponsor Protocol Number:
M24-536

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Search Results 2551-2560 of 8962

A Study to Evaluate The Use of Intravenous Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery for Vestibular Schwannomas (VS)

Breast Education through Simulation Training (BEST): Post-Mastectomy Wound and Drain Care Patient Education

Z-Endoxifen Hydrochloride in Treating Patients with Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer

Exploring the Outcomes and Financial Impact of a CBT-I Group Program Provided by Registered Nurses for Adults with Insomnia

Pharmacogenomics and Post-Operative Nausea and Vomiting

Lenalidomide Or Observation In Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

Observation Or Radiation Therapy In Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed By Surgery

Empty Bladder Impact During Radiation Therapy For Prostate Cancer

Enfortumab Vedotin And Pembrolizumab With Cystectomy And/or Ureterectomy For Locally Advanced Or Metastatic Bladder And Upper Urothelial Tract Cancer, CAST-AI Trial

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