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Small Cell Lung CancerPhase 2NCT04924101

Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)

A Phase 2 study testing Pembrolizumab, MK-4830 and Boserolimab in people with Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 49 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Pembrolizumab, MK-4830 and Boserolimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
49 sitesin 11 countries
Study dates
15 Jul 2021to 23 Jun 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy
  • Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition
  • Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Lenvatinib (7 days); Etoposide, Cisplatin, or Carboplatin (180 days) and Pembrolizumab, MK-4830, or (no contraception measures); refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per protocol unless confirmed to be azoospermic
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman/women of childbearing potential (WOCBP) or is a WOCBP and uses a contraceptive method that is highly effective with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows: Lenvatinib (30 days), Etoposide, Cisplatin, or Carboplatin (180 days), and Pembrolizumab, MK-4830, or Boserolimab (120 days)
  • A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours (urine test) or 72 hours (serum test) before the first dose of study intervention
  • Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention
Show all 11Show fewer
  • Has measurable disease per RECIST 1.1 as assessed by local site investigator/radiology and verified by blinded independent central review (BICR)
  • Submits an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated where such sample exist
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
  • Has adequate organ function within 10 days before the first dose of study intervention
  • Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg with no changes in antihypertensive medications within 1 week before randomization

Who cannot join

  • Has had major surgery within 3 weeks before first dose of study interventions
  • Has a preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
  • Has urine protein ≥1 g/24 hours
  • Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multiple gated acquisition (MUGA) or echocardiogram (ECHO)
  • Prolongation of QT interval with Fridericia's correction (QTcF) interval to >480 ms
  • Has clinically significant cardiovascular disease or major arterial thromboembolic event within 12 months before first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
Show all 32Show fewer
  • Has active hemoptysis within 3 weeks before the first dose of study intervention
  • Has gastrointestinal malabsorption or any other condition that might affect oral study intervention absorption
  • Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention
  • Has any major hemorrhage or venous thromboembolic events within 3 months before the first dose of study intervention. Participants with venous thrombosis diagnosed more than 3 months before the first dose of study intervention must be on stable doses of anticoagulants
  • Has a history of inflammatory bowel disease
  • Has a history of a gastrointestinal perforation within 6 months before the first dose of study intervention
  • Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease
  • Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
  • Has received prior treatment (chemotherapy, radiotherapy, or surgical resection) including investigational agents for SCLC
  • Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study
  • 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 radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation. A participant that meets this exclusion criterion but is otherwise deemed eligible for the study may be randomized across the specific intervention groups.
  • Has symptomatic ascites, pleural effusion, or pericardial effusion. A participant who is clinically stable following treatment for these conditions is eligible
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with brain metastases may participate only if they satisfy all of the following: a) Completed treatment at least 14 days before the first dose of study intervention b) Have no evidence of new or enlarging brain metastases confirmed by posttreatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and c) Are neurologically stable without the need for steroids for at least 7 days before the first dose of study intervention as per local site assessment. Participants with untreated brain metastases will be allowed if they are asymptomatic, the investigator determines there is no immediate CNS-specific treatment required, there is no significant surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer in number
  • Has a history of severe hypersensitivity reaction to any study intervention and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has a known history of, or active, neurologic paraneoplastic syndrome
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection and/or Hepatitis B virus infection or an active Hepatitis C infection
  • Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • 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 had an allogenic tissue/solid organ transplant

Trial locations and contacts

49 sites in 11 countries.

49 sites in 11 countries

United States14 sites

  • Georgia Cancer Specialists ( Site 0106)

    Atlanta, Georgia, 30341

  • University of Colorado Anschutz Medical Campus ( Site 0104)

    Aurora, Colorado, 80045

  • MFSMC-HJWCI-Oncology Research ( Site 0128)

    Baltimore, Maryland, 21237

  • Cleveland Clinic-Taussig Cancer Center ( Site 0116)

    Cleveland, Ohio, 44195

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0130)

    Fort Wayne, Indiana, 46845

  • Banner MD Anderson Cancer Center ( Site 0102)

    Gilbert, Arizona, 85234

  • St Francis Cancer Center-Research Office ( Site 0117)

    Greenville, South Carolina, 29607

  • Baptist Health Lexington-Research ( Site 0108)

    Lexington, Kentucky, 40503

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0114)

    Mineola, New York, 11501

  • Memorial Sloan Kettering Cancer Center ( Site 0115)

    New York, New York, 10065

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0122)

    Omaha, Nebraska, 68130

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0129)

    Omaha, Nebraska, 68130

  • UPMC Hillman Cancer Center ( Site 0127)

    Pittsburgh, Pennsylvania, 15232

  • Virginia Cancer Institute ( Site 0119)

    Richmond, Virginia, 23229

Other trials in United States

South Korea7 sites

  • Chungbuk National University Hospital ( Site 1107)

    Cheongju-si, North Chungcheong, 28644

  • Seoul National University Bundang Hospital ( Site 1104)

    Seongnam, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 1101)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1105)

    Seoul, 03722

  • Asan Medical Center-Department of Oncology ( Site 1103)

    Seoul, 05505

  • Samsung Medical Center ( Site 1100)

    Seoul, 06351

  • The Catholic University Of Korea St. Vincent's Hospital ( Site 1106)

    Suwon, Kyonggi-do, 16247

Other trials in South Korea

Hungary5 sites

  • Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 2806)

    Budapest, Pest County, 1121

  • Semmelweis University-Pulmonológiai Klinika ( Site 2802)

    Budapest, 1083

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2800)

    Szolnok, Jász-Nagykun-Szolnok, 5004

  • Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 2801)

    Törökbálint, Pest County, 2045

  • Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 2805)

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Israel5 sites

  • Rambam Health Care Campus-Oncology ( Site 2600)

    Haifa, 3109601

  • Shaare Zedek Medical Center ( Site 2602)

    Jerusalem, 9103102

  • Meir Medical Center ( Site 2601)

    Kfar Saba, 4428164

  • Rabin Medical Center-Oncology ( Site 2604)

    Petah Tikva, 4941492

  • Sheba Medical Center-ONCOLOGY ( Site 2603)

    Ramat Gan, 5262100

Other trials in Israel

Russia4 sites

  • Krasnoyarsk Regional Oncology Dispensary, Named after Krizhanovsky ( Site 2708)

    Krasnoyarsk, Krasnoyarsk Krai, 660133

  • GBUZ "SPb CRPCstmc(o)" ( Site 2705)

    Saint Petersburg, Sankt-Peterburg, 197758

  • N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S

    Saint Petersburg, Sankt-Peterburg, 197758

  • Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 2704)

    Saint Petersburg, 197758

Other trials in Russia

Canada3 sites

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2003)

    Hamilton, Ontario, L8V 4X2

  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2005)

    Kingston, Ontario, K7L 2V7

  • St. Marys Hospital Center ( Site 2000)

    Montreal, Quebec, H3T 1M5

Other trials in Canada

Italy3 sites

  • Ospedale San Raffaele-Oncologia Medica ( Site 2303)

    Milan, Lombardy, 20132

  • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 2304)

    Milan, 20141

  • ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 2300)

    Siena, Tuscany, 53100

Other trials in Italy

Spain3 sites

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 2401)

    Barcelona, 08035

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals ( Site 2403)

    L'Hospitalet de Llobregat, Catalonia, 08908

  • Hospital Insular de Gran Canaria ( Site 2402)

    Las Palmas de Gran Canaria, Las Palmas, 35001

Other trials in Spain

Austria2 sites

  • Klinik Penzing-2. Lungenabteilung ( Site 2101)

    Vienna, State of Vienna, 1140

  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2100)

    Vienna, 1210

Other trials in Austria

Poland2 sites

  • Samodzielny Publiczny Zespó Grulicy i Chorób Puc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemi

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Switzerland1 site

  • Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 2502)

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

About this study

Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)

The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study.

Being tested
Pembrolizumab, MK-4830, Boserolimab, Lenvatinib, Etoposide
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Programmed Death-Ligand 2 (PDL2, PD-L2), Pembrolizumab (MK-3475)
Medical subject headings
Small Cell Lung Carcinoma, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called KEYTRUDA®, MK-3475, SCH 900475

    IV infusion

  • MK-4830Biological

    IV infusion

  • BoserolimabBiological

    Also called MK-5890

    IV infusion

  • LenvatinibDrug

    Also called LENVIMA®, KISPLYX®, MK-7902, E7080

    Oral capsule

  • EtoposideDrug

    Also called Etopophos®, Vepesid®, Toposar®, VP-16

    IV infusion

  • CisplatinDrug

    Also called Platinol-AQ, Platinol, CDDP

    IV infusion

  • CarboplatinDrug

    Also called Paraplatin, Paraplatin NovaPlus, Carboplatin N+ Novaplus, Carboplatin Novaplus

    IV infusion

Study groups in NCT04924101
Study groupRoleWhat they receive
Pembrolizumab + MK-4830 + ChemotherapyExperimentalParticipants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until disease progression (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
Receives: Biological: Pembrolizumab; Biological: MK-4830; Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin
Pembrolizumab + Boserolimab + ChemotherapyExperimentalParticipants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
Receives: Biological: Pembrolizumab; Biological: Boserolimab; Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin
Pembrolizumab + Lenvatinib + ChemotherapyExperimentalParticipants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally up to Cycles 1-4 cycles and up to 20 mg QD orally for Cycles 5-31 or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
Receives: Biological: Pembrolizumab; Drug: Lenvatinib; Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR is presented.

    Measured: Up to approximately 43 months

  2. Six-Month Progression-Free Survival (PFS) Rate as Assessed by BICR Per RECIST 1.1

    Six-month PFS rate is defined as the percentage of participants who have survival without documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first at 6 months after randomization. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS rate at 6 months as assessed by BICR is presented.

    Measured: At 6 months

Secondary outcomes (7)

  1. Duration of Response (DOR) as Assessed by BICR Per RECIST 1.1

    For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.

    Measured: Up to approximately 43 months

  2. Progression-Free Survival (PFS) as Assessed by BICR Per RECIST 1.1

    PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR is presented.

    Measured: Up to approximately 43 months

  3. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all participants is presented.

    Measured: Up to approximately 43 months

  4. Mean Percent Change From Baseline in Tumor Size as Assessed by BICR Per RECIST 1.1

    Tumor size change is defined as the best percent change from baseline in the sum of the diameters of the target lesions as assessed by BICR per RECIST 1.1. The mean best percent change from baseline in tumor size as assessed by BICR per RECIST 1.1 is presented.

    Measured: Baseline and up to 43 months

  5. Number of Participants Who Experienced an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE is presented.

    Measured: Up to approximately 43 months

  6. Number of Participants Who Discontinued Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE is presented.

    Measured: Up to approximately 22 months

  7. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized so that the total score ranges from 0 to 100 for the combined scores. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score is presented.

    Measured: Baseline, Week 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start15 Jul 2021
  3. Primary completion23 Jun 2025
  4. Study completion23 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04924101
Sponsor's protocol ID
3475-B99
Other IDs
MK-3475-B99, KEYNOTE-B99, 2023-506538-56-00, U1111-1293-9965, 2023-506538-56, 2023
Status last verified
Jul 2026
First submitted
9 Jun 2021
Last updated
13 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, MK-4830 and Boserolimab in people with Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 49 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, South Korea, Hungary, Israel, Russia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Up to approximately 43 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04924101.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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