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RecruitingNCT02332668Updated Jul 6, 2026

A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)

A Phase 1/2 interventional study of Pembrolizumab in Melanoma, Lymphoma and Solid Tumor, sponsored by Merck Sharp & Dohme LLC. Recruiting at 16 sites in 10 countries. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2015; still recruiting 11 years 6 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
370
Allocation
Non-randomized
Ages
6 Months to 17 Years
Sex
All
01

Study summary

Researchers are looking for new ways to treat children with different types of melanoma (skin cancer), solid tumors, and lymphomas (blood cancers) that are any of these:

  • Advanced, which means cancer spread in the body or cannot be removed with surgery
  • Relapsed, which means cancer has come back after it had responded to previous treatment (responded means it stopped growing, gets smaller, or disappeared)
  • Refractory, which means cancer did not respond to previous treatment

Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Researchers want to learn if different doses of pembrolizumab can cause at least 1 of the types of cancer to get smaller or go away.

With Amendment 8, enrollment of participants with solid tumors and participants 6 months to under 12 years old with melanoma were closed.

With Amendment 13, enrollment was closed for participants with relapsed refractory classical Hodgkin lymphoma (rrCHL), microsatellite instabilty-high (MSI-H) solid tumors, tumor-mutational burden-high (TMB-H) solid tumors, and participants 12 years old to \<18 years old with advanced melanoma.

02

Conditions studied

  • Melanoma
  • Lymphoma
  • Solid Tumor
  • Classical Hodgkin Lymphoma
  • Microsatellite-instability-high Solid Tumor

Keywords

  • PD1
  • PD-1
  • PDL1
  • PD-L1
  • cHL
  • MSI-H
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.

This study's planned enrollment of 370 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Between 6 months and \<18 years of age on day of signing informed consent is documented.
  • Histologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate
  • Any number of prior treatment regimens
  • Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue sample or, if appropriate, a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
  • Measurable disease based on RECIST 1.1 (Or based on IWG [Cheson, 2007] [i.e., measurement must be >15 mm in longest diameter or >10 mm in short axis] for rrcHL participants)
  • Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
  • Lansky Play Scale ≥50 for participants from 6 months up to and including 16 years of age; or Karnofsky score ≥50 for participants >16 years of age
  • Adequate organ function
  • Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours before the first dose of study medication
  • Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who is abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the last dose of study intervention
  • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Demonstrate adequate organ function.

Exclusion criteria

Exclusion Criteria:

  • Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation/randomization
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the date of allocation/randomization
  • Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent
  • Prior radiotherapy within 2 weeks of start of study treatment
  • Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical carcinoma in situ) with potentially curative therapy, or in situ cervical cancer
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Tumor(s) involving the brain stem
  • Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
  • Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Active infection requiring systemic therapy
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of study medication
  • Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand 1 (anti-PD-L1), anti-PD-L2 agent, or any agent directed to another stimulatory or inhibitory T-cell receptor (eg, cytotoxic lymphocyte associated protein-4 [CTLA-4], OX-40, CD137)
  • Human immunodeficiency virus (HIV)
  • Hepatitis B or C
  • Known history of active tuberculosis (TB; Bacillus tuberculosis)
  • Received a live vaccine within 30 days of planned start of study medication
  • Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had an allogeneic hematopoietic transplant >5 years ago are eligible as long as there are no symptoms of Graft Versus Host Disease [GVHD].)
  • History or current evidence of any condition, therapy, or laboratory abnormality, or known severe hypersensitivity to any component or analog of the trial treatment, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study
  • Known psychiatric or substance abuse disorders that would interfere with the requirements of the study
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
370 participants (estimated)

Study arms

  • Experimental
    Melanoma

    Participants aged 6 months to \<18 years with melanoma receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), intravenously (IV) once every 3 weeks (Q3W). Enrollment of participants aged 6 months to \<12 years with melanoma was closed with Amendment 8. Enrollment of participants aged ≥12 years to ≤18 years with melanoma closed with Amendment 13.

    Biological: Pembrolizumab

  • Experimental
    Solid Tumors and Other Lymphomas

    Participants aged 6 months to \<18 years with solid tumors and other lymphomas receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W. Initial enrollment limited to programmed death-ligand 1 (PD-L1)-positive participants. PD-L1-negative participants may enroll if responses are observed. Enrollment of participants with solid tumors and other lymphomas was closed with Amendment 8.

    Biological: Pembrolizumab

  • Experimental
    Relapsed Refractory Classical Hodgkin Lymphoma (rrcHL)

    Participants aged 3 years to \<18 years with rrcHL receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W. Enrollment of participants with rrcHL was closed with Amendment 13.

    Biological: Pembrolizumab

  • Experimental
    Microsatellite Instability-High (MSI-H)

    Participants aged 6 months to \<18 years with MSI-H solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W. Enrollment of participants with MSI-H solid tumors was closed with Amendment 13.

    Biological: Pembrolizumab

  • Experimental
    Tumor Mutational Burden-High (TMB-H)

    Participants aged 6 months to \<18 years with TMB-H ≥10 mutation/Mb solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W. Enrollment of participants with TMB-H solid tumors was closed with Amendment 13.

    Biological: Pembrolizumab

  • Experimental
    Adjuvant Melanoma

    Participants aged 12 years to \<18 years with resected high-risk Stage IIB, IIC, III, or IV melanoma receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), intravenously (IV) once every 3 weeks (Q3W).

    Biological: Pembrolizumab

Interventions

  • BiologicalPembrolizumab

    IV infusion

    Also known as: MK-3475

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors and Other Lymphoma Version 1.1 (RECIST 1.1) per Site Assessment (Each Disease Indication Evaluated Separately)

    The ORR is assessed by RECIST 1.1 per site assessment. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Time frame: Up to 2 years

  2. ORR by RECIST 1.1 per Site Assessment for MSI-H or TMBH Solid Tumors (Each Cohort Evaluated Separately)

    The ORR is assessed by RECIST 1.1 per site assessment. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Time frame: Up to 2 years

  3. ORR by International Working Group (IWG) Response Criteria (Cheson, 2007) per Blinded Independent Central Review (BICR) Assessment for rrcHL Cohort

    The ORR is assessed by blinded independent central review utilizing the International Working Group \[IWG\] response assessment criteria per Cheson 2007 by BICR. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. Participants with missing data are considered non-responders.

    Time frame: Up to approximately 2 years

  4. Number of Participants with Dose-Limiting Toxicities (DLTs)

    Number of participants experiencing toxicities that are possibly, probably, or definitely related to study therapy; that meet pre-defined severity criteria; and result in a change in the given dose.

    Time frame: Cycle 1 (Up to 21 days)

  5. Number of Participants Experiencing Adverse Events (AEs)

    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Time frame: Up to 27 months

  6. Number of Participants Discontinuing Study Drug Due to AEs

    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Time frame: Up to 2 years

Secondary outcomes

  1. ORR by IWG Response Criteria (Cheson, 2007) per Site Assessment (rrcHL Cohort)

    The ORR is assessed by blinded independent central review utilizing the International Working Group \[IWG\] response assessment criteria per Cheson 2007 by site assessment. The ORR is defined as the percentage of participants who had a response (complete response, CR or partial response, PR) prior to disease progression. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. Participants with missing data are considered non-responders.

    Time frame: Up to 2 years

  2. DOR per RECIST 1.1 by Site Assessment (Advanced Melanoma, Solid Tumors and Other Lymphoma, Each Disease Indication Is Evaluated Separately)

    The duration of overall response is assessed by RECIST 1.1 by site evaluation. The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    Time frame: Up to approximately 2 years

  3. DOR per RECIST 1.1 by Site Assessment (MSI-H and TMB-H, Each Cohort Is Evaluated Separately)

    The duration of overall response is assessed by RECIST 1.1 by site evaluation. The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    Time frame: Up to approximately 2 years

  4. DOR per IWG 2007 (Cheson, 2007) Response by BICR Assessment (rrcHL Cohort)

    The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    Time frame: Up to approximately 2 years

  5. DOR per IWG 2007 (Cheson, 2007) Response by Site Assessment (rrcHL Cohort)

    The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    Time frame: Up to approximately 2 years

  6. DOR per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) by Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately)

    The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    Time frame: Up to approximately 2 years

  7. DOR per irRECIST by Site Assessment (MSI-H and TMB-H, Each Cohort Is Evaluated Separately)

    The duration of overall response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).

    Time frame: Up to approximately 2 years

  8. Progression-free Survival (PFS) Using RECIST 1.1 Criteria by Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately)

    Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using RECIST 1.1 criteria by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    Time frame: Up to approximately 2 years

  9. PFS using RECIST 1.1 Criteria by Site Assessment (MSI-H and TMB-H, Each Cohort Evaluated Separately)

    Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using RECIST 1.1 criteria by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    Time frame: Up to approximately 2 years

  10. PFS using IWG 2007 Criteria (Chesson 2007) by BICR Assessment (rrcHL Cohort)

    Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using IWG 2007 criteria (Chesson, 2007) by BICR assessment (rrcHL Cohort). Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    Time frame: Up to approximately 2 years

  11. PFS using IWG 2007 Criteria (Chesson, 2007) by Site Assessment (rrcHL Cohort)

    Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using IWG 2007 criteria (Chesson, 2007) by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    Time frame: Up to approximately 2 years

  12. PFS Using irRECIST Criteria by Site Assessment

    Progression free survival is defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS is assessed by using irRECIST criteria by site assessment. Median PFS will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    Time frame: Up to approximately 2 years

  13. Disease Control Rate by RECIST 1.1 Using Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately)

    Disease Control Rate is defined as the percentage of participants with a response of CR, PR, or SD. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease is least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Time frame: Up to approximately 2 years

  14. Disease Control Rate by RECIST 1.1 Using Site Assessment (MSI-H and TMB-H, Each Cohort Evaluated Separately)

    Disease Control Rate is defined as the percentage of participants with a response of CR, PR, or SD. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease is least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Time frame: Up to approximately 2 years

  15. Disease Control Rate by irRECIST Using Site Assessment (Solid Tumors and Other Lymphomas, Each Disease Indication Evaluated Separately)

    Disease Control Rate is defined as the percentage of participants with a response of CR, PR, or SD. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease is least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Time frame: Up to approximately 2 years

  16. Overall Survival

    Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up. Median overall survival will be calculated from the product-limit (Kaplan-Meier) method for censored data.

    Time frame: Up to approximately 2 years

  17. Objective irRECIST Response Rate by Site Assessment (Each Disease Indication Evaluated Separately)

    The ORR is assessed by irRECIST per site assessment.

    Time frame: Up to approximately 2 years

  18. Area Under the Concentration Curve (AUC) for Pembrolizumab

    The AUC of pembrolizumab when administered as monotherapy will be determined.

    Time frame: Predose Cycles 1, 2, 4, 8 and every 4 cycles thereafter, and within 30 minutes post infusion at Cycles 1 and 8. Additional single pharmacokinetic samples obtained in Cycle 1 between 72 to 168 hours post-dose, and Cycle 1 at 336 hours post-dose

07

Study locations

16 of 16 sites recruiting
  • Call for Information (Investigational Site 0019)
    Aurora, Colorado 80045, United States
    Recruiting
  • Call for Information (Investigational Site 0024)
    Chicago, Illinois 60637, United States
    Recruiting
  • Call for Information (Investigational Site 0026)
    Boston, Massachusetts 02445, United States
    Recruiting
  • Call for Information (Investigational Site 0031)
    New York, New York 10032, United States
    Recruiting
  • Call for Information (Investigational Site 0070)
    Fargo, North Dakota 58102, United States
    Recruiting
  • Call for Information (Investigational Site 0071)
    Sioux Falls, South Dakota 57117, United States
    Recruiting
  • Call for Information (Investigational Site 0054)
    Dallas, Texas 75235, United States
    Recruiting
  • MSD Brasil
    São Paulo, Brazil
    • MSD Online · Contact · 0800 012 22 32
    Recruiting
  • MSD France
    Paris, France
    • Dominique Blazy · Contact · 33 147548990
    Recruiting
  • MSD Sharp & Dohme GmbH
    München, Germany
    • German Medical Information Center · Contact · 49 800 673 673 673
    Recruiting
  • Merck Sharp & Dohme Co. Ltd.
    Hod HaSharon, Israel
    • Gally Teper · Contact · 972-9-9533310
    Recruiting
  • MSD Italia S.r.l.
    Rome, Italy
    • Barbara Capaccetti · Contact · 39 06361911
    Recruiting
  • Merck Sharp & Dohme Lda.
    Paço de Arcos, Portugal
    • Paula Martins de Jesus · Contact · 00351-214465803
    Recruiting
  • MSD Korea LTD
    Seoul, 4130, South Korea
    • Jongho Ahn · Contact · 82-2-331-2000 2015
    Recruiting
  • MSD Sweden
    Stockholm, Sweden
    • Tryggve Ljung · Contact · 46 (0)70 545 28 66
    Recruiting
  • Merck Sharp & Dohme Ltd.
    London, United Kingdom
    • Natalie White · Contact · 44 (0) 208 154 8000
    Recruiting
08

References and documents

Publications

  • Geoerger B, Kang HJ, Yalon-Oren M, Marshall LV, Vezina C, Pappo A, Laetsch TW, Petrilli AS, Ebinger M, Toporski J, Glade-Bender J, Nicholls W, Fox E, DuBois SG, Macy ME, Cohn SL, Pathiraja K, Diede SJ, Ebbinghaus S, Pinto N. Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020 Jan;21(1):121-133. doi: 10.1016/S1470-2045(19)30671-0. Epub 2019 Dec 4. PubMed 31812554 ↗

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02332668
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jan 7, 2015
Start date
Mar 19, 2015
Primary completion
Feb 2, 2028 (estimated)
Completion
Feb 2, 2028 (estimated)
Last update
Jul 6, 2026

Study contacts

Toll Free Number
Contact
Trialsites@msd.com
1-888-577-8839
Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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