Yiyi Yan, M.D., Ph.D.

Closed for Enrollment

• A Phase 2 Study Of INCMGA00012 In Participants With Metastatic Merkel Cell Carcinoma Rochester, MN

  The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with metastatic merkel cell carcinoma (MCC).

• 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 Rochester, MN

  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.

• A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study Of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab In Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010) Scottsdale/Phoenix, AZ Jacksonville, FL Rochester, MN

  The purpose of this study to compare MK-7684A to pembrolizumab with respect to RFS, and  to determine if MK-7684A is superior to pembrolizumab with respect to RFS as assessed by investigator.

• Immunotherapy And Ovarian Function Among Premenopausal Melanoma Survivors Rochester, MN

  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.

• Immunotherapy And Ovarian Function Among Premenopausal Melanoma Survivors Jacksonville, FL Rochester, MN

  The purposes of this study are to analyze the ovarian function of female premenopausal melanoma survivors who have undergone immunotherapy, and compare with data from age-matched controls, prospectively investigate ovarian function in premenopausal women with melanoma undergoing immunotherapy, and to identify the impact of ovarian function change on the frequency and function of CD8+ T cells during immunotherapy.

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

  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.