Clinical trials: sponsored by Merck Sharp & Dohme LLC
Hepatic Impairment
A Study to Investigate the Influence of Hepatic Impairment on Elpipodect (MK-8189) Treatment (MK-8189-012)
The purpose of this study is to compare the pharmacokinetics (PK) of elpipodect in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants.
- Trial name
- NCT04676425
- Testing
- Elpipodect
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Schizophrenia
A Study of Elpipodect (MK-8189) in Participants With Schizophrenia (MK-8189-014)
The primary purpose of this study is to assess the safety and tolerability of multiple ascending doses of elpipodect in participants with schizophrenia.
- Trial name
- NCT05406440
- Testing
- Elpipodect
- Where
- 3 sites in United States
- Volunteers
- 53 people
- Sponsor
- Merck Sharp & Dohme LLC
Schizophrenia, Acute Episode
An Active-Controlled Early Phase Study of Elpipodect (MK-8189) in Adults With Schizophrenia (MK-8189-005)
This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial of elpipodect compared with placebo, using Risperidone as an active control.
- Trial name
- NCT03055338
- Testing
- Elpipodect, Risperidone
- Where
- 28 sites in United States
- Volunteers
- 224 people
- Sponsor
- Merck Sharp & Dohme LLC
Schizophrenia
A Study To Evaluate The Effect Of A Supratherapeutic Dose Of Elpipodect (MK-8189) On The QTc Interval In Participants With Schizophrenia (MK-8189-019)
The primary purpose of this study to evaluate the effect of a supratherapeutic dose of 80 mg elpipodect on the QT interval corrected for heart rate (QTc interval) and to assess the safety and tolerability of multiple once-daily…
- Trial name
- TQT (NCT05893862)
- Testing
- Elpipodect, Moxifloxacin
- Where
- 4 sites in United States
- Volunteers
- 107 people
- Sponsor
- Merck Sharp & Dohme LLC
Alzheimer's Disease
Elpipodect (MK-8189) Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggression and/or Psychosis (MK-8189-017)
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of elpipodect in participants with Alzheimer's Disease (AD) with or without symptoms of agitation-aggression and/or psychosis.
- Trial name
- NCT05227118
- Testing
- Elpipodect
- Where
- 8 sites in United States
- Volunteers
- 29 people
- Sponsor
- Merck Sharp & Dohme LLC
Schizophrenia
Elpipodect (MK-8189) Multiple Dose Study in Healthy Volunteers and Schizophrenia Participants (MK-8189-003)
This 3-part dose titration study will assess elpipodect safety, tolerability, pharmacokinetics (PK), and central nervous system activity.
- Trial name
- NCT02181803
- Testing
- Elpipodect, Base Monotherapy
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Schizophrenia
Safety, Tolerability, and Pharmacokinetics Study of Elpipodect (MK-8189) in Participants With Schizophrenia and Healthy Participants (MK-8189-011)
This is a randomized, double-blind, 2-part clinical study of the safety, tolerability and pharmacokinetics of alternate elpipodect titration regimens.
- Trial name
- NCT04506905
- Testing
- Elpipodect
- Where
- 6 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Advanced/Metastatic Gastroesophageal Adenocarcinoma
Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic…
- Trial name
- NCT04662710
- Testing
- Pembrolizumab, Lenvatinib, Oxaliplatin
- Where
- 177 sites in United States, Argentina and 22 more
- Volunteers
- 895 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatocellular Carcinoma
Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)
This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or…
- Trial name
- NCT03867084
- Testing
- Pembrolizumab
- Where
- 249 sites in United States, Argentina and 29 more
- Volunteers
- 959 people
- Sponsor
- Merck Sharp & Dohme LLC
Biliary Tract Carcinoma
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study
In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma.
- Trial name
- NCT04924062
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 22 sites in China
- Volunteers
- 158 people
- Sponsor
- Merck Sharp & Dohme LLC
Narcolepsy
Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)
The purpose of this study was to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy Type 1 (NT1).
- Trial name
- NCT06179407
- Testing
- MK-6552
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-Small Cell Lung Cancer, Renal Cell Carcinoma
A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)
The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa [MK-3475A] administered subcutaneously (SC) over pembrolizumab [MK-3475]…
- Conditions
- Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma
- Trial name
- NCT06099782
- Testing
- Pembrolizumab (+) Berahyaluronidase alfa, Pembrolizumab
- Where
- 45 sites in United States, Argentina and 8 more
- Volunteers
- 147 people
- Sponsor
- Merck Sharp & Dohme LLC
Papillomavirus Infections
Immunobridging Study of 9- Valent Human Papillomavirus (9vHPV) Vaccine (V503) in Chinese Females 9 to 45 Years of Age (V503-024)
This study investigates the immunogenicity and safety of the 9vHPV vaccine in healthy Chinese females 9 to 45 years of age. The study consists of Stage I (Day 1 to Month 7) and Stage II (post Month 7 to Month 60).
- Trial name
- NCT03903562
- Testing
- V503
- Where
- 2 sites in China
- Volunteers
- 1,990 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)
The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with…
- Trial name
- NCT06450366
- Testing
- Enlicitide, Ezetimibe, Bempedoic Acid
- Where
- 35 sites in United States, Argentina and 6 more
- Volunteers
- 301 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infection
Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
This study will evaluate the safety and efficacy of a switch to Doravirine/Islatravir (DOR/ISL) (MK-8591A) (a fixed dose combination of doravirine 100 mg and islatravir 0.75 mg) in participants living with human immunodeficiency…
- Trial name
- NCT04223791
- Testing
- DOR/ISL, BIC/FTC/TAF
- Where
- 89 sites in United States, Australia and 9 more
- Volunteers
- 643 people
- Sponsor
- Merck Sharp & Dohme LLC
Biliary Tract Carcinoma
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)
This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma.
- Trial name
- KEYNOTE-966 (NCT04003636)
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 185 sites in United States, Argentina and 22 more
- Volunteers
- 1,069 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-small Cell Lung Cancer
Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091)
In this study, participants with Stage IB/II-IIIA non-small cell lung cancer (NSCLC) who have undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant chemotherapy will be treated with pembrolizumab or…
- Trial name
- PEARLS (NCT02504372)
- Testing
- Pembrolizumab
- Volunteers
- 1,177 people
- Sponsor
- Merck Sharp & Dohme LLC
Head and Neck Squamous Cell Carcinoma
A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell…
- Trial name
- NCT05523323
- Testing
- Lenvatinib, Pembrolizumab
- Where
- 28 sites in China
- Volunteers
- 112 people
- Sponsor
- Merck Sharp & Dohme LLC
Pneumococcal Infection
A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as…
- Trial name
- STRIDE-13 (NCT06177912)
- Testing
- V116, PPSV23
- Where
- 92 sites in United States, Canada and 11 more
- Volunteers
- 882 people
- Sponsor
- Merck Sharp & Dohme LLC
Renal Cell Carcinoma
Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no…
- Trial name
- NCT03142334
- Testing
- Pembrolizumab
- Where
- 251 sites in United States, Argentina and 19 more
- Volunteers
- 994 people
- Sponsor
- Merck Sharp & Dohme LLC
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