Clinical trials: sponsored by Merck Sharp & Dohme LLC
Melanoma
A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS).
- Trial name
- NCT05665595
- Testing
- Pembrolizumab/Vibostolimab, Pembrolizumab
- Where
- 205 sites in United States, Argentina and 24 more
- Volunteers
- 1,594 people
- Sponsor
- Merck Sharp & Dohme LLC
Warts, Genital, Neoplasms, Anal
Efficacy, Immunogenicity, and Safety Study of V503 (9-valent Human Papillomavirus [9vHPV] Vaccine) in Japanese Males (V503-064)
The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the…
- Trial name
- NCT04635423
- Testing
- V503
- Where
- 22 sites in Japan
- Volunteers
- 1,059 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
RSV Infection
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
- Trial name
- SMART (NCT04938830)
- Testing
- Clesrovimab, Palivizumab
- Where
- 146 sites in United States, Australia and 25 more
- Volunteers
- 1,003 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Preexposure Prophylaxis
Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who…
- Trial name
- Impower-024 (NCT04652700)
- Testing
- ISL, FTC/TDF, FTC/TAF
- Where
- 25 sites in United States, Brazil and 5 more
- Volunteers
- 494 people, healthy volunteers welcome
- 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
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
Respiratory Syncytial Virus Infection
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants.
- Trial name
- CLEVER (NCT04767373)
- Testing
- Clesrovimab
- Where
- 217 sites in United States, Argentina and 22 more
- Volunteers
- 3,632 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Papillomavirus Infections, Coronavirus Disease (COVID-19)
Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)
The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of 9vHPV vaccine, where the first dose is administered concomitantly with a first dose of a 2-dose regimen of mRNA-1273 vaccine versus…
- Trial name
- NCT05119855
- Testing
- 9vHPV Vaccine, mRNA-1273 Vaccine
- Where
- 38 sites in United States
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Suspected or Documented Gram-negative Bacterial Infection
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial…
- Trial name
- NCT03969901
- Testing
- IMI/REL, Active Control, Oral Switch
- Where
- 67 sites in United States, Bulgaria and 16 more
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-I, Human Immunodeficiency Virus Type 1
Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection.
- Conditions
- HIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis
- Trial name
- Impower-022 (NCT04644029)
- Testing
- Islatravir, FTC/TDF
- Where
- 24 sites in United States, South Africa and 1 more
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Type 2 Diabetes Mellitus
Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
This study evaluated the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin.
- Trial name
- NCT04029480
- Testing
- Ertugliflozin 5 mg, Ertugliflozin 15 mg, Insulin
- Where
- 104 sites in United States, Belgium and 20 more
- Volunteers
- 166 people
- Sponsor
- Merck Sharp & Dohme LLC
Relapsed or Refractory Solid Tumors
A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)
The main purpose of this study is to evaluate the antitumor activity and safety of lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration.
- Trial name
- E7080-G000-231 (NCT04447755)
- Testing
- Lenvatinib
- Where
- 49 sites in United States, Argentina and 18 more
- Volunteers
- 127 people
- Sponsor
- Merck Sharp & Dohme LLC
Nosocomial Pneumonia
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
This is 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 (NP).
- Trial name
- NCT04223752
- Testing
- Ceftolozane/Tazobactam
- Where
- 24 sites in United States, Chile and 7 more
- Volunteers
- 41 people
- Sponsor
- Merck Sharp & Dohme LLC
Cervical Cancer, Genital Warts
Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)
The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.
- Trial name
- FUTURE II (NCT00092534)
- Testing
- Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
- Volunteers
- 12,167 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Acute Bacterial Skin and Skin Structure Infections
A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)
This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and…
- Trial name
- NCT03176134
- Testing
- Tedizolid phosphate, Comparator
- Where
- 58 sites in United States, Brazil and 12 more
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Blockade
Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)
This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to <2 years.
- Trial name
- NCT03909165
- Testing
- Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, Neostigmine + Glycopyrrolate
- Where
- 39 sites in United States, Australia and 12 more
- Volunteers
- 145 people
- Sponsor
- Merck Sharp & Dohme LLC
Papillomavirus Infections
Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)
The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9-valent human…
- Trial name
- NCT04772534
- Testing
- 9vHPV vaccine
- Where
- 12 sites in Japan
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Merkel Cell Carcinoma
Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)
This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC).
- Trial name
- NCT03783078
- Testing
- Pembrolizumab (MK-3475)
- Where
- 22 sites in United States, Australia and 6 more
- Volunteers
- 55 people
- Sponsor
- Merck Sharp & Dohme LLC
Gram-Positive Infections
A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)
The primary objectives of this study are to describe the single-dose, and multiple dose pharmacokinetics (PK) of intravenous (IV) tedizolid phosphate, or a single dose oral suspension of tedizolid phosphate, when administered to…
- Trial name
- NCT03217565
- Testing
- IV Tedizolid Phosphate, Oral Suspension Tedizolid Phosphate
- Where
- 30 sites in United States, Bulgaria and 3 more
- Volunteers
- 47 people
- Sponsor
- Merck Sharp & Dohme LLC
Chemotherapy-induced Nausea and Vomiting
Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)
The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic…
- Trial name
- NCT04054193
- Testing
- Fosaprepitant Dimeglumine, 5-HT3 antagonist, Dexamethasone
- Where
- 26 sites in United States, Greece and 7 more
- Volunteers
- 103 people
- Sponsor
- Merck Sharp & Dohme LLC