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Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information

A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors

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

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A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors

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:
1
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 the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information
Scottsdale/Phoenix, Ariz.	Closed for enrollment
Jacksonville, Fla.	Closed for enrollment

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Site IRB:
- Rochester, Minnesota: 18-007218
- Scottsdale/Phoenix, Arizona: 18-007218
- Jacksonville, Florida: 18-007218
NCT ID:
NCT04007744
Sponsor Protocol Number:
MC1718

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients with Stage IV Melanoma that Cannot be Removed by Surgery

Rochester, MN, Scottsdale/Phoenix, AZ
- See Details
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients with Stage IV Melanoma that Cannot be Removed by Surgery
- 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

This randomized phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab or ipilimumab works as first-line therapy in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab is more effective than ipilimumab in treating melanoma.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Closed for enrollment
View complete study & contact information

Scottsdale/Phoenix, Ariz.

Closed for enrollment

Print study details
Site IRB:
Rochester, Minnesota: 12-007265
Scottsdale/Phoenix, Arizona: 12-007265

NCT ID:
NCT01879306

Sponsor Protocol Number:
RU261206I

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Search Results 11-20 of 76 for

Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma

A Study to Evaluate Ipilimumab Administered Intra-lymphatically Using the Sofusa® DoseConnect™ DEVICE with IV-administered Nivolumab in Patients with Metastatic Melanoma

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A Study to Evaluate a Standard-dose and High- dose Regimen of Encorafenib + Binimetinib in Patients with BRAFV600-mutant Melanoma Brain Metastasis

Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma

A Study of CDX-1127 (Varlilumab) in Patients with Select Solid Tumor Types or Hematologic Cancers

MART-1 Antigen With or Without TLR4 Agonist GLA-SE in Treating Patients With Stage II-IV Melanoma That Has Been Removed by Surgery

A Study Comparing Temozolomide and Selumetinib for Treating Patients with Metastatic Melanoma of the Eye

A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients with Stage IV Melanoma that Cannot be Removed by Surgery

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