Merck Sharp & Dohme LLC

Address: 126 East Lincoln Avenue, P. O. Box 2000

Sponsor Overview

assignment

298

Specializations

Oncology and Immuno-Oncology

Merck Sharp & Dohme LLC funds a broad oncology portfolio centered on immune checkpoint inhibition and combination regimens across solid tumors and hematologic malignancies. Its studies include disease areas such as non-small cell lung cancer, melanoma, bladder cancer, breast cancer, colorectal cancer, gastric and gastroesophageal junction adenocarcinoma, and head and neck squamous cell carcinoma.

Pembrolizumab in advanced and resectable cancers
Triple-negative breast cancer and hormone receptor-low breast cancer
Urothelial carcinoma and muscle-invasive bladder cancer
Classical Hodgkin lymphoma and diffuse large B-cell lymphoma
Biomarker-defined solid tumors including MSI-H and TMB-H disease

Research also extends to perioperative, adjuvant, and metastatic cancer settings, with interest in KRAS-mutant, PD-L1–expressing, and DNA repair–deficient tumors.

Viral Prevention and Infectious Diseases

The sponsor maintains active programs in vaccine development and infectious disease prevention, including studies in human papillomavirus, respiratory syncytial virus, COVID-19, HIV-1, and pneumococcal disease. Its work includes prevention of infection-related cancers and respiratory illness in children and adults.

9-valent HPV vaccine and prevention of HPV-related disease
RSV prophylaxis in infants and young children
COVID-19 antiviral research
HIV-1 treatment and HIV prevention
Antibacterial therapy for nosocomial pneumonia

Additional infectious disease interest includes fungal infection and pneumococcal infection.

Cardiovascular and Pulmonary Vascular Disease

Merck Sharp & Dohme LLC supports trials in cardiovascular disease and pulmonary vascular disorders, with emphasis on heart failure, atherosclerotic cardiovascular disease, hypercholesterolemia, and pulmonary arterial hypertension. The portfolio also includes studies in related hemodynamic and functional outcomes.

Heart failure with reduced ejection fraction
Heart failure with preserved ejection fraction
Pulmonary arterial hypertension
Hyperlipidemia and heterozygous familial hypercholesterolemia
ASCVD and vascular thrombosis prevention

Research in this area also touches on pulmonary hypertension associated with chronic obstructive pulmonary disease and exercise capacity in pulmonary vascular disease.

Neurology, Autoimmune Disease, and Inflammatory Disorders

The sponsor funds research in neurodegenerative disease and immune-mediated inflammatory conditions, including Alzheimer’s disease, amyotrophic lateral sclerosis, rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It also studies hidradenitis suppurativa and vitiligo.

Alzheimer’s disease dementia
Rheumatoid arthritis and systemic lupus erythematosus
Inflammatory bowel disease
Psoriatic arthritis and axial spondyloarthritis
Non-segmental vitiligo and hidradenitis suppurativa

Other neurological interests include narcolepsy and broader central nervous system disease research.

Metabolic, Renal, and Rare Disease Research

Its non-oncology portfolio also includes metabolic disease, renal disease, and selected rare genetic disorders. Areas of interest include type 2 diabetes mellitus, weight management, non-alcoholic steatohepatitis, metabolic dysfunction-associated steatohepatitis, chronic kidney disease–related conditions, and prostate cancer-adjacent endocrine and metabolic settings.

Type 2 diabetes mellitus
Non-alcoholic steatohepatitis and metabolic dysfunction-associated steatohepatitis
Renal cell carcinoma and von Hippel-Lindau disease–associated tumors
Myeloproliferative neoplasms
PIK3CA-related overgrowth spectrum and Proteus syndrome

Trials also address familial hypercholesterolemia, essential thrombocythemia, and other rare oncologic and non-oncologic syndromes.

Sponsored Trials

Trial Name	Country	Status
A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE-158)	Denmark France Germany Italy Norway Poland Portugal Spain The Netherlands	Not Recruiting
A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination with R-CHP in Participants with DLBCL (waveLINE)	Italy Poland Spain	Not Recruiting
A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants who are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab	Austria Belgium Czechia Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Norway Poland Portugal Romania Spain Sweden The Netherlands	Recruiting
A Multiple Ascending Dose Study of MK-7480 in Healthy Participants for the Treatment of Non-Alcoholic Steatohepatitis	Belgium	Not Recruiting
A Multiple-Ascending-Dose Study of MK-1708 in Healthy Participants for Amyotrophic Lateral Sclerosis and Alzheimer’s Disease	Belgium	Not Recruiting
A Multiple-Ascending-Dose Study of MK-4318 for the Management of Pain in Healthy Participants	Belgium	Not Recruiting
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MK-4605 in Healthy Participants	Belgium	Not Recruiting
A Phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia	Estonia Greece Spain	Not Recruiting
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04–Substudy 04D	France Spain The Netherlands	Recruiting
A Phase 1/Phase 2 Study to Evaluate the Safety and Tolerability of MK-1088 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors	Denmark	Not Recruiting