Lung Cancer Clinical Trial

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

Summary

This study is a rolling arm study of pembrolizumab in combination with investigational agents 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)
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 woman of childbearing potential (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
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours 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 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
Has a predicted life expectancy of >3 months

Exclusion Criteria:

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 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
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 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 a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT04938817

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 44 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center ( Site 0152)
Gilbert Arizona, 85234, United States More Info
Study Coordinator
Contact
480-256-6444
Georgia Cancer Specialists ( Site 0156)
Atlanta Georgia, 30341, United States More Info
Study Coordinator
Contact
770-496-9400
Parkview Research Center at Parkview Regional Medical Center ( Site 0180)
Fort Wayne Indiana, 46845, United States More Info
Study Coordinator
Contact
833-724-8326
Baptist Health Lexington-Research ( Site 0158)
Lexington Kentucky, 40503, United States More Info
Study Coordinator
Contact
270-575-2100
University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0157)
Lexington Kentucky, 40536, United States More Info
Study Coordinator
Contact
859-323-6720
MFSMC-HJWCI-Oncology Research ( Site 0178)
Baltimore Maryland, 21237, United States More Info
Study Coordinator
Contact
443-777-8876
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0172)
Omaha Nebraska, 68130, United States More Info
Study Coordinator
Contact
402-334-4733
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0179)
Omaha Nebraska, 68130, United States More Info
Study Coordinator
Contact
402-334-4773
Cleveland Clinic-Taussig Cancer Center ( Site 0166)
Cleveland Ohio, 44195, United States More Info
Study Coordinator
Contact
216-636-7563
UPMC Hillman Cancer Center ( Site 0177)
Pittsburgh Pennsylvania, 15232, United States More Info
Study Coordinator
Contact
412-623-5898
St Francis Cancer Center-Research Office ( Site 0167)
Greenville South Carolina, 29607, United States More Info
Study Coordinator
Contact
864-255-1901
Virginia Cancer Institute ( Site 0169)
Richmond Virginia, 23229, United States More Info
Study Coordinator
Contact
804-287-3000
Westmead Hospital-Department of Medical Oncology ( Site 4004)
Westmead New South Wales, 2145, Australia More Info
Study Coordinator
Contact
+61 2 8890 5555
The Prince Charles Hospital-Oncology Clinical Trials ( Site 4003)
Brisbane Queensland, 4032, Australia More Info
Study Coordinator
Contact
+61 7 3139 4000
Monash Health-Oncology Research ( Site 4005)
Clayton Victoria, 3168, Australia More Info
Study Coordinator
Contact
03 9594 6666
Hollywood Private Hospital-Medical Oncology ( Site 4001)
Perth Western Australia, 6009, Australia More Info
Study Coordinator
Contact
+61 8 9346 6000
Klinik Penzing-2. Lungenabteilung ( Site 3101)
Vienna Wien, 1140, Austria More Info
Study Coordinator
Contact
+4319106042003
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 3100)
Wien , 1210, Austria More Info
Study Coordinator
Contact
0043 1 27700 5634
Cross Cancer Institute ( Site 3004)
Edmonton Alberta, T6G 1, Canada More Info
Study Coordinator
Contact
7804328248
Princess Margaret Cancer Centre ( Site 3003)
Toronto Ontario, M5G 2, Canada More Info
Study Coordinator
Contact
4169464645
St. Marys Hospital Center ( Site 3000)
Montreal Quebec, H3T 1, Canada More Info
Study Coordinator
Contact
514-345-3511
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 3800)
Szolnok Jasz-Nagykun-Szolnok, 5004, Hungary More Info
Study Coordinator
Contact
+36209323256
Rambam Health Care Campus-Oncology ( Site 3600)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+97247776700
Shaare Zedek Medical Center-Oncology ( Site 3602)
Jerusalem , 91031, Israel More Info
Study Coordinator
Contact
+972587040620
Meir Medical Center ( Site 3601)
Kfar Saba , 44281, Israel More Info
Study Coordinator
Contact
+97297472414
Rabin Medical Center-Oncology ( Site 3604)
Petah Tikva , 49414, Israel More Info
Study Coordinator
Contact
+9729378101
Sheba Medical Center-ONCOLOGY ( Site 3603)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
+97235307096
Ospedale San Raffaele-Oncologia Medica ( Site 3303)
Milano Lombardia, 20132, Italy More Info
Study Coordinator
Contact
390226436627
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 3301)
Rozzano Milano, 20089, Italy More Info
Study Coordinator
Contact
390282244080
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 3300)
Siena Toscana, 53100, Italy More Info
Study Coordinator
Contact
390577586335
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 3304)
Milano , 20141, Italy More Info
Study Coordinator
Contact
390257489440
Chungbuk National University Hospital ( Site 4106)
Cheongju-si Chungbuk, 28644, Korea, Republic of More Info
Study Coordinator
Contact
82432696015
Seoul National University Bundang Hospital-Medical Oncology ( Site 4104)
Seongnam Kyonggi-do, 13620, Korea, Republic of More Info
Study Coordinator
Contact
82317877003
Seoul National University Hospital ( Site 4101)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
82-2-2072-2995
Asan Medical Center-Lung Cancer Center ( Site 4103)
Seoul , 05505, Korea, Republic of More Info
Study Coordinator
Contact
+82230103214
Samsung Medical Center ( Site 4100)
Seoul , 06351, Korea, Republic of More Info
Study Coordinator
Contact
+82234103438
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Warszawa Mazowieckie, 02-78, Poland More Info
Study Coordinator
Contact
+48225463066
Samodzielny Publiczny Zespó Grulicy i Chorób Puc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemi
Olsztyn Warminsko-mazurskie, 10-35, Poland More Info
Study Coordinator
Contact
48895322935
Krasnoyarsk Regional Oncology Dispensary, Named after Krizhanovsky ( Site 3708)
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 3702)
Saint Petersburg Leningradskaya Oblast, 19825, Russian Federation
N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
GBUZ LOKB-Oncology department #1 ( Site 3701)
Saint-Petersburg Sankt-Peterburg, 19429, Russian Federation
GBUZ "SPb CRPCstmc(o)" ( Site 3705)
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 3704)
Sankt-Peterburg , 19775, Russian Federation
Instituto Catalan de Oncologia - Hospital Duran i Reynals ( Site 3403)
L'Hospitalet de Llobregat Cataluna, 08908, Spain More Info
Study Coordinator
Contact
34932607744
Hospital Universitari Vall d'Hebron-Oncology ( Site 3401)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
+34934894375
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 3502)
st.Gallen Sankt Gallen, 9007, Switzerland More Info
Study Coordinator
Contact
+41714941111

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT04938817

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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