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Small Cell Lung CarcinomaPhase 1/2NCT04938817

Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)

A Phase 1/2 study testing coformulation pembrolizumab/quavonlimab, lenvatinib and MK-4830 in people with Small Cell Lung Carcinoma, run by Merck Sharp & Dohme LLC at 48 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is a rolling arm study of investigational agents as monotherapy or in combination with pembrolizumab in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
coformulation pembrolizumab/quavonlimab, lenvatinib and MK-4830
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
48 sitesin 12 countries
Study dates
19 Aug 2021to 10 Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • The main inclusion criteria include but are not limited to the following:
  • Arms A-E:
  • Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of second-line therapy
  • Has progressed on or after treatment with an anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered as part of first-line platinum-based systemic therapy for ES-SCLC
  • Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition
  • Has received 1 prior line of systemic therapy for small cell lung cancer (SCLC)
Show all 21Show fewer
  • If a woman of childbearing potential (WOCBP), participant must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study treatment
  • Has measurable disease per RECIST 1.1 as assessed by local site investigator/radiology and verified by BICR
  • Has submitted an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before allocation/randomization
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
  • Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • Has a predicted life expectancy of >3 months
  • Arms A-D:
  • Male participants must be abstinent from heterosexual intercourse or agree to use contraception during treatment for at least 7 days after the last dose of lenvatinib. No contraception is required if the participant is receiving pembrolizumab, pembrolizumab/quavonlimab, MK-4830, or favezelimab/pembrolizumab
  • Female participants are not pregnant or breastfeeding and are not a WOCBP or if are a WOCBP, are abstinent from heterosexual intercourse or are using contraception during the intervention period and for at least 120 days after the last dose of pembrolizumab, pembrolizumab/quavonlimab, MK-4830, or favezelimab/pembrolizumab or 30 days after the last dose of lenvatinib, whichever occurs last
  • Female participants must abstain from breastfeeding during the intervention period and for at least 120 days after the last dose of pembrolizumab, pembrolizumab/quavonlimab, MK-4830, or favezelimab/pembrolizumab or 7 days after the last dose of lenvatinib, whichever occurs last
  • Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week before allocation/randomization
  • Arm E:
  • If capable of producing sperm, the participant agrees to refrain from donating sperm and abstain from penile-vaginal intercourse or use a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant. The length of time required to continue contraception for the study intervention R-Dx-d is 150 days
  • If a person of childbearing potential (POCBP) must use a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or if they adhere to penile-vaginal intercourse abstinence 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 the study intervention after the last dose of study intervention. In addition, the participant agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of reproduction. The length of time required to continue contraception for the study intervention R-Dx-d is 210 days after the last dose

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Arms A-E:
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before start of study treatment
  • Has received prior radiotherapy within 2 weeks of start of study treatment
  • Has received lung radiation therapy >30 Gray (Gy) within 6 months before the first dose of study treatment
  • Has received a live or live attenuated vaccine within 30 days before the first dose of study treatment
Show all 39Show fewer
  • 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: completed treatment (e.g., whole brain radiation treatment, stereotactic radiosurgery, or equivalent) ≥14 days before the first dose of study intervention; have no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging (using the same modality) performed ≥4 weeks after pretreatment brain imaging; and are neurologically stable without the need for steroids for ≥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 millimeter (mm) or less in size and 3 or less in number.
  • Has a history of severe hypersensitivity reaction (≥Grade 3) to any study treatment and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
  • Has an active infection requiring systemic therapy
  • Arms A-D:
  • Has had major surgery within 3 weeks before first dose of study treatment
  • Has a preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
  • 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
  • Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks before the first dose of study treatment
  • 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 the start of study treatment
  • Has any major hemorrhage or venous thromboembolic events within 3 months before the start of study treatment
  • Has a history of inflammatory bowel disease
  • Has a history of a gastrointestinal perforation within 6 months before the start of study treatment
  • Has a known history of, or active, neurologic paraneoplastic syndrome
  • Has received prior therapy with a receptor tyrosine kinase (RTK) inhibitor or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), anti-immunoglobulin-like transcript (ILT)-4, or anti-lymphocyte-activation gene 3 (LAG-3) agents
  • Has received prior therapy with an anti-PD-1/L1 agent and was permanently discontinued from that treatment due to a treatment-related adverse event
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
  • Has symptomatic ascites, pleural effusion, or pericardial effusion
  • 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 treatment
  • Has a known history of Human Immunodeficiency Virus (HIV) infection
  • Has concurrent active HBV or HCV
  • Has progressive disease as initial response to first-line systemic chemotherapy in combination with PD-1/L1 inhibitor for ES-SCLC
  • Has had an allogenic tissue/solid organ transplant
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Arm E:
  • Received prior treatment with a CDH6-targeted agent or an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan, datopotamab deruxtecan)
  • Has received an investigational agent or has used an investigational device within 4 weeks (or 5 half-lives, whichever is shorter) prior to study intervention administration
  • Has Chronic steroid treatment (>10 mg/day prednisone [or equivalent] per day), except for inhaled steroids for asthma or COPD, mineralocorticoids (e.g., fludrocortisone) for participants with orthostatic hypotension, topical steroids for mild skin conditions, low-dose supplemental corticosteroids for adrenocortical insufficiency, Premedication for treatment groups and/or premedication in case of any hypersensitivity, or intra-articular steroid injections
  • Is an HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Any history of pneumonitis/interstitial lung disease (ILD) irrespective of prior steroid use, current ILD, or suspected ILD, or ILD that cannot be ruled out at screening

Trial locations and contacts

48 sites in 12 countries.

48 sites in 12 countries

United States12 sites

  • Northside Hospital-Northside Hospital Oncology Network ( Site 0156)

    Atlanta, Georgia, 30342

  • MFSMC-HJWCI-Oncology Research ( Site 0178)

    Baltimore, Maryland, 21237

  • Cleveland Clinic-Taussig Cancer Center ( Site 0166)

    Cleveland, Ohio, 44195

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0180)

    Fort Wayne, Indiana, 46845

  • Banner MD Anderson Cancer Center ( Site 0152)

    Gilbert, Arizona, 85234

  • St Francis Cancer Center-Research Office ( Site 0167)

    Greenville, South Carolina, 29607

  • Baptist Health Lexington-Research ( Site 0158)

    Lexington, Kentucky, 40503

  • University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0157)

    Lexington, Kentucky, 40536

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0172)

    Omaha, Nebraska, 68130

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0179)

    Omaha, Nebraska, 68130

  • UPMC Hillman Cancer Center ( Site 0177)

    Pittsburgh, Pennsylvania, 15232

  • Virginia Cancer Institute ( Site 0169)

    Richmond, Virginia, 23229

Other trials in United States

Russia6 sites

  • Krasnoyarsk Regional Oncology Dispensary, Named after Krizhanovsky ( Site 3708)

    Krasnoyarsk, Krasnoyarsk Krai, 660133

  • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 3702)

    Saint Petersburg, Leningradskaya Oblast', 198255

  • GBUZ LOKB-Oncology department #1 ( Site 3701)

    Saint Petersburg, Sankt-Peterburg, 194291

  • GBUZ "SPb CRPCstmc(o)" ( Site 3705)

    Saint Petersburg, Sankt-Peterburg, 197758

  • N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( Site 3703)

    Saint Petersburg, Sankt-Peterburg, 197758

  • Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 3704)

    Saint Petersburg, 197758

Other trials in Russia

Israel5 sites

  • Rambam Health Care Campus-Oncology ( Site 3600)

    Haifa, 3109601

  • Shaare Zedek Medical Center-Oncology ( Site 3602)

    Jerusalem, 9103102

  • Meir Medical Center. ( Site 3601)

    Kfar Saba, 4428164

  • Rabin Medical Center-Oncology ( Site 3604)

    Petah Tikva, 4941492

  • Sheba Medical Center-ONCOLOGY ( Site 3603)

    Ramat Gan, 5265601

Other trials in Israel

South Korea5 sites

  • Chungbuk National University Hospital ( Site 4106)

    Cheongju-si, North Chungcheong, 28644

  • Seoul National University Bundang Hospital-Medical Oncology ( Site 4104)

    Seongnam, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 4101)

    Seoul, 03080

  • Asan Medical Center-Lung Cancer Center ( Site 4103)

    Seoul, 05505

  • Samsung Medical Center ( Site 4100)

    Seoul, 06351

Other trials in South Korea

Australia4 sites

  • The Prince Charles Hospital-Oncology Clinical Trials ( Site 4003)

    Brisbane, Queensland, 4032

  • Monash Health-Oncology Research ( Site 4005)

    Clayton, Victoria, 3168

  • Hollywood Private Hospital-Medical Oncology ( Site 4001)

    Perth, Western Australia, 6009

  • Westmead Hospital-Department of Medical Oncology ( Site 4004)

    Westmead, New South Wales, 2145

Other trials in Australia

Italy4 sites

  • Ospedale San Raffaele-Oncologia Medica ( Site 3303)

    Milan, 20132

  • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 3304)

    Milan, 20141

  • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 3301)

    Rozzano, Milano, 20089

  • ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 3300)

    Siena, Tuscany, 53100

Other trials in Italy

Canada3 sites

  • Cross Cancer Institute ( Site 3004)

    Edmonton, Alberta, T6G 1Z2

  • St. Marys Hospital Center ( Site 3000)

    Montreal, Quebec, H3T 1M5

  • Princess Margaret Cancer Centre ( Site 3003)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Spain3 sites

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 3401)

    Barcelona, 08035

  • Hospital Clinic de Barcelona ( Site 3404)

    Barcelona, 08036

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals ( Site 3403)

    L'Hospitalet de Llobregat, Catalonia, 08908

Other trials in Spain

Austria2 sites

  • Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 3101)

    Vienna, 1140

  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 3100)

    Vienna, 1210

Other trials in Austria

Poland2 sites

  • Warminsko-Mazurskie Centrum Chorob Płuc w Olsztynie ( Site 3903)

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 3900)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Hungary1 site

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 3800)

    Szolnok, Jász-Nagykun-Szolnok, 5004

Other trials in Hungary

Switzerland1 site

  • Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 3502)

    Sankt Gallen, Canton of St. Gallen, 9000

Other trials in Switzerland

About this study

Official title: A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Investigational Agents as Monotherapy or in Combination With Pembrolizumab for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98)

This study is a rolling arm study of investigational agents as monotherapy or in combination with pembrolizumab in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation.

Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D.

There will be no hypothesis testing in this study.

Being tested
coformulation pembrolizumab/quavonlimab, lenvatinib, MK-4830, coformulation favezelimab/pembrolizumab, R-DXd
Keywords
Programmed Cell Death Receptor 1 (PD-1), Programmed Cell Death Receptor Ligand 1 (PD-L1), Programmed Cell Death Receptor Ligand 2 (PD-L2), PD-1, PDL1, PD-L1, PD-L2
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.

  • coformulation pembrolizumab/quavonlimabBiological

    Also called MK-1308A

    Intravenous (IV) infusion

  • lenvatinibDrug

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

    Oral administration

  • MK-4830Biological

    IV infusion

  • coformulation favezelimab/pembrolizumabBiological

    Also called MK-4280A

    IV infusion

  • R-DXdBiological

    IV Infusion

Study groups in NCT04938817
Study groupRoleWhat they receive
Coformulation Pembrolizumab/QuavonlimabExperimentalParticipants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation.
Receives: Biological: coformulation pembrolizumab/quavonlimab
Coformulation Pembrolizumab/Quavonlimab + LenvatinibExperimentalParticipants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation. Lenvatinib will be administered orally once-daily (QD) until progressive disease or discontinuation.
Receives: Biological: coformulation pembrolizumab/quavonlimab; Drug: lenvatinib
Coformulation Pembrolizumab/Quavonlimab + MK-4830ExperimentalParticipants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS MK-4830 800 mg. Pembrolizumab/quavonlimab will be administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation. MK-4830 will be administered by IV infusion once every 3 weeks (Q3W) for up to 36 infusions (up to approximately 2 years) or until progressive disease or discontinuation.
Receives: Biological: coformulation pembrolizumab/quavonlimab; Biological: MK-4830
Coformulation Favezelimab/PembrolizumabExperimentalParticipants receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg) administered by intravenous (IV) infusion once every 3 weeks (Q3W) for up to 36 infusions (up to approximately 2 years) or until progressive disease or discontinuation.
Receives: Biological: coformulation favezelimab/pembrolizumab
R-DXdExperimentalParticipants receive 5.6 mg/kg R-DXd via IV infusion every three weeks (Q3W) until progressive disease or discontinuation.
Receives: Biological: R-DXd

What is being measured

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

  1. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

    DLTs = ≥1 of the following treatment-related toxicities: Grade (G)4 nonhematologic toxicity; G4 hematologic toxicity lasting >7 days OR G4 platelet count decreased OR G3 platelet count decreased if associated with bleeding; G3 nonhematologic toxicity including G3 fatigue (lasting >3 days), G3 diarrhea, nausea, vomiting lasting ≥72 hours, G3 rash ≥7 days despite treatment, G3 uncontrolled hypertension; G3/4 nonhematologic laboratory abnormality if requires medical intervention, hospitalization, or persists for >1 week; G 3/4 febrile neutropenia, alanine aminotransferase, aspartate aminotransferase and/or bilirubin increase; drug-induced liver injury meeting the Hy's law; G4 creatinine increase; G4 electrolyte abnormalities; treatment related adverse event causing study intervention discontinuation during the first 21 days or administration delay >14 days during the first 21 days; G5 toxicity. The number of participants with ≥1 DLTs in the safety lead-in phase will be presented.

    Measured: Up to 21 days in Cycle 1 (Cycle 1 = 21 days)

  2. Number of Participants Who Experience at Least One 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. 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 at least one AE will be presented.

    Measured: Up to approximately 60 months

  3. Number of Participants Who Discontinue Study Treatment Due to 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. 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 will be presented.

    Measured: Up to approximately 60 months

  4. Objective Response Rate (ORR) 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 that has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 60 months

Secondary outcomes (2)

  1. Progression-free Survival (PFS) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

    PFS is defined as the time from randomization to the first radiographic disease progression (PD) or death due to any cause, whichever occurs first. PD is defined as at least a 20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review (BICR) will be presented.

    Measured: Up to approximately 60 months

  2. Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

    For participants who demonstrate 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), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 60 months

Timeline

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

  1. First posted24 Jun 2021
  2. Study start19 Aug 2021
  3. Primary completion10 Dec 2029 (estimated)
  4. Study completion10 Dec 2029 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04938817
Sponsor's protocol ID
3475-B98
Other IDs
MK-3475-B98, KEYNOTE-B98, 2023-507687-38-00, U1111-1296-5646, 2020-005628-12, 2023
Status last verified
May 2026
First submitted
21 Jun 2021
Last updated
1 Jun 2026
Results posted
No
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 1/2 study testing coformulation pembrolizumab/quavonlimab, lenvatinib and MK-4830 in people with Small Cell Lung Carcinoma, run by Merck Sharp & Dohme LLC at 48 sites in 12 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 21 inclusion and 39 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Russia, Israel, South Korea, Australia and 7 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

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?

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) (time frame: Up to 21 days in Cycle 1 (Cycle 1 = 21 days)). The study lists 4 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 NCT04938817.

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 1 Jun 2026.

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