- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02332668
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)
This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of the following types of cancer:
- advanced melanoma (6 months to <18 years of age),
- advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumor or other lymphoma (6 months to <18 years of age),
- relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age), or
- advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age), or
- advanced relapsed or refractory tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors (6 months to <18 years of age), or
- with adjuvant treatment of resected high-risk Stage IIB, IIC, III, or IV melanoma in children 12 years to <18 years of age
Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D.
The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer. The 10% assessment does not apply to the MSI-H and TMB-H cohorts.
With Amendment 8, enrollment of participants with solid tumors and of participants aged 6 months to <12 years with melanoma were closed. Enrollment of participants aged ≥12 years to ≤18 years with melanoma continues. Enrollment of participants with MSI-H and TMB-H solid tumors also continues.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Toll Free Number
- Phone Number: 1-888-577-8839
Study Locations
-
-
-
Sao Paulo, Brazil
- Recruiting
- MSD Brasil
-
Contact:
- MSD Online
- Phone Number: 0800 012 22 32
-
-
-
-
-
Paris, France
- Recruiting
- MSD France
-
Contact:
- Dominique Blazy
- Phone Number: 33 147548990
-
-
-
-
-
Haar, Germany
- Recruiting
- MSD Sharp & Dohme GmbH
-
Contact:
- German Medical Information Center
- Phone Number: 49 800 673 673 673
-
-
-
-
-
Hod Hasharon, Israel
- Recruiting
- Merck Sharp & Dohme Co. Ltd.
-
Contact:
- Gally Teper
- Phone Number: 972-9-9533310
-
-
-
-
-
Rome, Italy
- Recruiting
- MSD Italia S.r.l.
-
Contact:
- Barbara Capaccetti
- Phone Number: 39 06361911
-
-
-
-
-
Seoul, Korea, Republic of, 4130
- Recruiting
- MSD Korea LTD
-
Contact:
- Jongho Ahn
- Phone Number: 82-2-331-2000 2015
-
-
-
-
-
Haarlem, Netherlands
- Recruiting
- Merck Sharp & Dohme BV
-
Contact:
- Caroline Doornebos
- Phone Number: 31 23 515 3362
-
-
-
-
-
Stockholm, Sweden
- Recruiting
- MSD Sweden
-
Contact:
- Tryggve Ljung
- Phone Number: 46 (0)70 545 28 66
-
-
-
-
-
Hoddesdon, United Kingdom
- Recruiting
- Merck Sharp & Dohme Ltd.
-
Contact:
- Natalie White
- Phone Number: +44 (7795) 828757
-
-
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Call for Information (Investigational Site 0019)
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Call for Information (Investigational Site 0025)
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02445
- Recruiting
- Call for Information (Investigational Site 0026)
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Call for Information (Investigational Site 0031)
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- Recruiting
- Call for Information (Investigational Site 0012)
-
-
Texas
-
Dallas, Texas, United States, 75235
- Recruiting
- Call for Information (Investigational Site 0054)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 continues.
|
IV infusion
Other Names:
|
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.
|
IV infusion
Other Names:
|
Experimental: rrcHL
Participants aged 3 years to <18 years with rrcHL receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.
|
IV infusion
Other Names:
|
Experimental: MSI-H
Participants aged 6 months to <18 years with microsatellite-instability-high (MSI-H) solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.
|
IV infusion
Other Names:
|
Experimental: TMB-H
Participants aged 6 months to <18 years with tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.
|
IV infusion
Other Names:
|
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).
|
IV infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: Up to 2 years
|
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.
|
Up to 2 years
|
ORR by RECIST 1.1 per Site Assessment for MSI-H or TMBH Solid Tumors (Each Cohort Evaluated Separately)
Time Frame: Up to 2 years
|
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.
|
Up to 2 years
|
ORR by International Working Group (IWG) Response Criteria (Cheson, 2007) per BICR Assessment for rrcHL Cohort
Time Frame: Up to approximately 2 years
|
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.
|
Up to approximately 2 years
|
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame: Cycle 1 (Up to 21 days)
|
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.
|
Cycle 1 (Up to 21 days)
|
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to 27 months
|
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.
|
Up to 27 months
|
Number of Participants Discontinuing Study Drug Due to AEs
Time Frame: Up to 2 years
|
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.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR by IWG Response Criteria (Cheson, 2007) per Site Assessment (rrcHL Cohort)
Time Frame: Up to 2 years
|
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.
|
Up to 2 years
|
DOR per RECIST 1.1 by Site Assessment (Advanced Melanoma, Solid Tumors and Other Lymphoma, Each Disease Indication Is Evaluated Separately)
Time Frame: Up to approximately 2 years
|
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).
|
Up to approximately 2 years
|
DOR per RECIST 1.1 by Site Assessment (MSI-H and TMBH, Each Cohort Is Evaluated Separately)
Time Frame: Up to approximately 2 years
|
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).
|
Up to approximately 2 years
|
DOR per IWG 2007 (Cheson, 2007) Response by BICR Assessment (rrcHL Cohort)
Time Frame: Up to approximately 2 years
|
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).
|
Up to approximately 2 years
|
DOR per IWG 2007 (Cheson, 2007) Response by Site Assessment (rrcHL Cohort)
Time Frame: Up to approximately 2 years
|
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).
|
Up to approximately 2 years
|
DOR per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) by Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately)
Time Frame: Up to approximately 2 years
|
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).
|
Up to approximately 2 years
|
DOR per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) by Site Assessment (MSI-H and TMB-H, Each Cohort Is Evaluated Separately)
Time Frame: Up to approximately 2 years
|
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).
|
Up to approximately 2 years
|
Progression-free Survival (PFS) Using RECIST 1.1 Criteria by Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately)
Time Frame: Up to approximately 2 years
|
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.
|
Up to approximately 2 years
|
PFS using RECIST 1.1 Criteria by Site Assessment (MSI-H and TMB-H, Each Cohort Evaluated Separately)
Time Frame: Up to approximately 2 years
|
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.
|
Up to approximately 2 years
|
PFS using IWG 2007 Criteria (Chesson 2007) by BICR Assessment (rrcHL Cohort)
Time Frame: Up to approximately 2 years
|
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.
|
Up to approximately 2 years
|
PFS using IWG 2007 Criteria (Chesson, 2007) by Site Assessment (rrcHL Cohort)
Time Frame: Up to approximately 2 years
|
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.
|
Up to approximately 2 years
|
PFS Using irRECIST Criteria by Site Assessment
Time Frame: Up to approximately 2 years
|
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.
|
Up to approximately 2 years
|
Disease Control Rate by RECIST 1.1 Using Site Assessment (Solid Tumors and Other Lymphoma, Each Disease Indication Evaluated Separately)
Time Frame: Up to approximately 2 years
|
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).
|
Up to approximately 2 years
|
Disease Control Rate by RECIST 1.1 Using Site Assessment (MSIH and TMB-H, Each Cohort Evaluated Separately)
Time Frame: Up to approximately 2 years
|
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).
|
Up to approximately 2 years
|
Disease Control Rate by irRECIST Using Site Assessment (Solid Tumors and Other Lymphomas, Each Disease Indication Evaluated Separately)
Time Frame: Up to approximately 2 years
|
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).
|
Up to approximately 2 years
|
Overall Survival
Time Frame: Up to approximately 2 years
|
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.
|
Up to approximately 2 years
|
Objective irRECIST Response Rate by Site Assessment (Each Disease Indication Evaluated Separately)
Time Frame: Up to approximately 2 years
|
The ORR is assessed by irRECIST per site assessment.
|
Up to approximately 2 years
|
Area Under the Concentration Curve (AUC) for Pembrolizumab
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
|
The AUC of pembrolizumab when administered as monotherapy will be determined.
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Genomic Instability
- Skin Neoplasms
- Neoplasms
- Lymphoma
- Melanoma
- Microsatellite Instability
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Pembrolizumab
Other Study ID Numbers
- 3475-051
- MK-3475-051 (Other Identifier: Merck Protocol Number)
- 2022-501257-36-00 (Registry Identifier: EU CT Number)
- 2014-002950-38 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma
-
H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
-
National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
-
BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
-
Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
Clinical Trials on Pembrolizumab
-
University Medical Center GroningenCompleted
-
Incyte CorporationMerck Sharp & Dohme LLCCompletedMelanomaUnited States, France, Italy, United Kingdom, Spain, Belgium, Israel, Mexico, Japan, Canada, Netherlands, Sweden, Korea, Republic of, Australia, Russian Federation, Chile, Germany, Poland, Ireland, New Zealand, Denmark, Switzerland, South Africa
-
Merck Sharp & Dohme LLCCompletedMelanomaAustralia, South Africa, Spain, Sweden
-
Acerta Pharma BVMerck Sharp & Dohme LLCCompletedMetastatic Urothelial CarcinomaUnited States
-
HUYABIO International, LLC.Active, not recruitingNon Small Cell Lung CancerUnited States
-
Prof. Dr. Matthias PreusserUnknownPrimary Central Nervous System LymphomaAustria
-
Yonsei UniversityNot yet recruitingMucosal Melanoma | Acral MelanomaKorea, Republic of
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Merck Sharp & Dohme LLC; PTC TherapeuticsRecruitingColorectal Cancer | Endometrium CancerNetherlands
-
Michael BoyiadzisMerck Sharp & Dohme LLCCompletedAcute Myeloid LeukemiaUnited States