Filter Results
Clinical Studies
Results filtered:Study status:
Contact Us for the Latest Status
Closed for Enrollment
Contact Us for the Latest Status
Closed for Enrollment
-
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma
Rochester, Minn.
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with metastatic merkel cell carcinoma (MCC).
-
ARRAY 818-201, A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis (POLARIS)
Rochester, Minn.
The purpose of this study is to assess the safety, effectiveness and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis.
-
Immunotherapy and Ovarian Function Among Premenopausal Melanoma Survivors
Rochester, Minn.
The purpose of this study is to analyze the ovary function of female premenopausal melanoma survivors who have undergone immunotherapy, and to compare with data from age-matched controls.
-
Phase I Study of Single Agent Pembrolizumab (MK-3475) in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma (KEYNOTE 001) (KEYNOTE-001)
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
This study will be done in 6 parts. In Part A the dose of intravenous (IV) pembrolizumab (MK-3475) will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of any type of carcinoma or melanoma (MEL). Part B of the study will explore the safety, tolerability, and efficacy of the drug in participants with advanced or metastatic MEL and compare every 2 week to every 3 week dosing. Part C of the study will explore the safety, tolerability, and efficacy of the drug in participants with non-small cell lung carcinoma (NSCLC) that is locally advanced or metastatic. Part D of the study will explore the low and high doses of study drug identified in Parts A and B in participants with advanced or metastatic MEL. Part E (closed with Amendment 7) will explore low, medium, and high doses of study drug in combination with standard chemotherapy in participants with locally advanced or metastatic NSCLC. Part F will explore low and high doses of study drug in treatment-naive and previously-treated participants with NSCLC with programmed cell death 1 ligand (PD-L1) gene expression. In Parts D and F and some of Part B participants will be randomized to one dose level. The primary hypotheses are the following: that pembrolizumab has acceptable safety and tolerability; and that pembrolizumab shows a clinically meaningful response rate (RR) or disease-control rate (DCR) in participants with melanoma (ipilimumab-refractory or not), and a clinically meaningful RR in participants with NSCLC, especially a clinically meaningful RR in those participants with either cancer, whose tumors express PD-L1.
.