A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)

A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] With MK-3475 [Pembrolizumab] Coformulation) in Participants With Relapsed or Refractory Hematological Malignancies

The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684).

Study Overview

• Status: Completed
• Conditions: Hematological Malignancies
• Intervention / Treatment: Biological: Pembrolizumab/vibostolimab coformulation

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 80510130
      • Instituto do Câncer e Transplante de Curitiba ( Site 0611)
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59075-740
      • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0601)
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer Vancouver ( Site 0034)
  • Ontario
    • Toronto, Ontario, Canada, m5g2m9
      • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0031)
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital ( Site 0032)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre ( Site 0037)
• Chile
  • Region M. de Santiago
    • Chile, Region M. de Santiago, Chile, 8380455
      • Instituto Nacional del Cancer ( Site 0626)
    • Santiago, Region M. de Santiago, Chile, 6900941
      • FALP-UIDO ( Site 0623)
• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2100
      • Rigshospitalet-Hematology - CTU ( Site 0361)
  • Central Jutland
    • Aarhus, Central Jutland, Denmark, 8200
      • Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0362)
• France
  • Paris, France, 75013
    • Pitie Salpetriere University Hospital-Clinical haematology ( Site 0304)
  • Paris
    • Villejuif, Paris, France, 94800
      • Gustave Roussy-DITEP ( Site 0301)
  • Rhone
    • Pierre-Bénite, Rhone, France, 69310
      • centre hospitalier lyon sud-Service Hématologie ( Site 0300)
• Germany
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf-II. medical clinic ( Site 0332)
  • Hesse
    • Marburg, Hesse, Germany, 35033
      • Universitätsklinikum Marburg ( Site 0333)
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0321)
    • Essen, North Rhine-Westphalia, Germany, 45122
      • Universitaetsklinikum Essen ( Site 0327)
  • Rhineland-Palatinate
    • Trier, Rhineland-Palatinate, Germany, 54290
      • Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 0325)
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Universitätsklinikum Leipzig ( Site 0328)
• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 0403)
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
  • Baranya
    • Pécs, Baranya, Hungary, 7624
      • Pécsi Tudományegyetem Klinikai Központ-I.sz. Belgyógyászati Klinika Hematológia ( Site 0401)
  • Pest County
    • Budapest, Pest County, Hungary, 1122
      • Országos Onkológiai Intézet-HEMATOLÓGIA ÉS LYMPHOMA OSZTÁLY KEMOTERÁPIA A ( Site 0405)
• Israel
  • Beersheba, Israel, 8410101
    • Soroka Medical Center-Hematology Department ( Site 0523)
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus ( Site 0526)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center ( Site 0522)
  • Ramat Gan, Israel, 5262100
    • Sheba Medical Center-Hemato Oncology ( Site 0524)
  • Tel Aviv, Israel, 64239
    • Sourasky Medical Center ( Site 0525)
• Italy
  • Bologna, Italy, 40138
    • Policlinico S. Orsola- Malpighi-Istituto di Ematologia "L. e A. Seragnoli" ( Site 0381)
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0383)
  • Lombardy
    • Brescia, Lombardy, Italy, 25123
      • Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 0400)
    • Milan, Lombardy, Italy, 20132
      • Ospedale San Raffaele-Unità Linfomi ( Site 0382)
• Poland
  • Lower Silesian Voivodeship
    • Wrocaw, Lower Silesian Voivodeship, Poland, 50-556
      • Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-214
      • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0424)
  • Silesian Voivodeship
    • Gliwice, Silesian Voivodeship, Poland, 44-101
      • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0427)
• Russia
  • Baskortostan, Respublika
    • Ufa, Baskortostan, Respublika, Russia, 450054
      • GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0548)
  • Leningradskaya Oblast'
    • Saint Petersburg, Leningradskaya Oblast', Russia, 197341
      • Almazov National Medical Research Centre-Intensive care unit No. 10 for oncohematological patients (
  • Moscow
    • Moscow, Moscow, Russia, 125284
      • Moscow City Clinical Hospital S.P. Botkin ( Site 0547)
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 191024
      • Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 0542)
• Spain
  • Madrid, Spain, 28040
    • Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0446)
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca-Hematology ( Site 0441)
  • Barcelona
    • L'Hospitalet Del Llobregat, Barcelona, Spain, 08908
      • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0442)
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra ( Site 0444)
• Taiwan
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch ( Site 0262)
  • Kaohsiung
    • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
      • Chang Gung Memorial Hospital at Kaohsiung ( Site 0263)
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Ankara University Hospital Cebeci ( Site 0561)
  • Istanbul, Turkey (Türkiye), 34214
    • Mega Medipol-Hematology ( Site 0567)
  • Istanbul, Turkey (Türkiye), 34365
    • Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 0562)
  • Izmir, Turkey (Türkiye), 35340
    • Dokuz Eylül Üniversitesi-Hematology ( Site 0563)
  • Samsun, Turkey (Türkiye), 55139
    • Ondokuz Mayıs Universitesi ( Site 0564)
  • İzmir
    • Bornova, İzmir, Turkey (Türkiye), 35100
      • Ege University Medicine of Faculty ( Site 0565)
• Ukraine
  • Kyiv, Ukraine
    • National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (
  • Cherkasy Oblast
    • Cherkassy, Cherkasy Oblast, Ukraine, 18009
      • Cherkasy Regional Oncology Dispensary ( Site 0593)
  • Kyivska Oblast
    • Kyiv, Kyivska Oblast, Ukraine, 03022
      • National Cancer Institute ( Site 0585)
  • Lviv Oblast
    • Lviv, Lviv Oblast, Ukraine, 79044
      • Institute of Transfusion Medicine and Blood of the National Academy of Medical Sciences of Ukraine (
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Comprehensive Cancer Center-Hematology ( Site 0024)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0021
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center ( Site 0005)
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital ( Site 0003)
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey ( Site 0023)
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center ( Site 0014)
  • Washington
    • Spokane, Washington, United States, 99208
      • Medical Oncology Associates, PS ( Site 0001)
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • MEDICAL COLLEGE OF WISCONSIN ( Site 0016)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

- Have confirmed relapsed/refractory classic Hodgkins Lymphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM).

For PMBCL, DLBCL, FL, and MM:

- Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it.

For DLBCL and NHL:

- Must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease.

For NHL:

- Participants with Mantle cell lymphoma (MCL) must have received prior Bruton's tyrosine kinase inhibitor therapy.

All participants:

• Have measurable disease.
• Have adequate organ function.
• Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation.
• Must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment.
• Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of non child-bearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.

Exclusion Criteria

For DLBCL and NHL:

- Has lymphoplasmacytic lymphomas, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), Burkitt (-like) lymphoma, mature T cell and NK cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms.

For MM:

• Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance.
• Has a history of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
• Has known prior or current central nervous system (CNS) involvement.

For Epstein Barr virus (EBV) positive DLBCL:

- Associated with a solid organ transplant.

For all participants:

• A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation.
• Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
• Has a history of a second malignancy.
• Any PMBCL participants that require the use of urgent cytoreductive therapy.
• If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention.
• Has received prior radiotherapy within 2 weeks of start of study intervention.
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
• Has a known severe hypersensitivity to MK-7684A, vibostolimab or pembrolizumab and/or any of its excipients.
• Has a known history of Human Immunodeficiency Virus (HIV) infection.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Has an active infection requiring systemic therapy.
• Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
• Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment.
• Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and Hepatitis C (HCV) infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry..
• Has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab/vibostolimab coformulation; Participants will receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Biological: Pembrolizumab/vibostolimab coformulation; Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.; Other Names: MK7684A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Dose-Limiting Toxicity (DLT)	A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Percentage of participants who experience a DLT per CTCAE 5.0 are reported.	Up to approximately 6 weeks
Percentage of Participants Who Experienced an Adverse Event (AE)	An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experience an AE are reported.	Up to approximately 27 months
Percentage of Participants Who Discontinued Study Treatment Due to an AE	An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants discontinued from the study treatment due to an AE are reported.	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)	ORR for Cohorts A-D and F was assessed based on the Lugano 2014 Classification. ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). ORR for Cohorts A-D and F is presented. Cohort E is presented separately.	Up to approximately 37 months
ORR as Assessed by the 2016 International Myeloma Working Group (IMWG) Response Criteria (Cohort E)	ORR for Cohort E was measured by 2016 IMWG Response Criteria. ORR is defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The ORR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.	Up to approximately 37 months
Duration of Response (DOR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)	For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)- CT and response was evaluated based on the Lugano 2014 Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR for Cohorts A-D and F are presented. Cohort E is presented separately.	Up to approximately 37 months
DOR as Assessed by 2016 IMWG Response Criteria (Cohort E)	DOR is defined as the time from CR or PR to documented disease progression or death. DOR for Cohort E was measured by the 2016 IMWG Response Criteria with response criteria defined as participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The DOR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.	Up to approximately 37 months
Disease Control Rate (DCR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)	DCR is % of participants who had tumor response per response criteria or have stable disease (SD) for ≥ 12 weeks before any evidence of progressive disease (PD). CR or PR were evaluated with CT and PET-CT. CR: complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. DCR for Cohorts A-D & F are presented. Cohort E is presented in a separate outcome measure.	Up to approximately 37 months
DCR as Assessed by 2016 IMWG Response Criteria (Cohort E)	DCR: percentage of participants who have achieved tumor response or have shown SD for at least 12 weeks before any evidence of PD per IMWG response criteria 2016. Response criteria are defined as participants with either a sCR, CR, VGPR, or PR. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. SD = Not meeting criteria for CR, VGPR, PR, or PD. PD as defined by prespecified 2016 IMWG response criteria. DCR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.	Up to approximately 37 months
Lowest Plasma Concentration (Ctrough) of Vibostolimab	Ctrough is the lowest concentration reached by a drug before the next dose is administered. Blood samples collected predose were used to determine Ctrough of Vibostolimab.	Predose at Cycles 1, 3, 7, 11, 15, 19, 23, 27 and 31. Cycle = 3 weeks
Maximum Concentration (Cmax) of Vibostolimab	Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected post dose were used to determine Cmax of Vibostolimab.	Postdose: after end of infusion (up to ~10 minutes) at Cycles 1 and 8. Cycle = 3 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; pembrolizumab
• Other Study ID Numbers: 7684A-004; MK-7684A-004 (Other Identifier: MSD); KEYVIBE-004 (Other Identifier: MSD); 2021-001700-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No