Esophageal Cancer Clinical Trial

Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)

Summary

The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of one of the following advanced (unresectable and/or metastatic) solid tumors, documented by histopathology or cytopathology:

Hepatocellular carcinoma (HCC)
Colorectal cancer (CRC) (non-microsatellite instability-high [non-MSI-H]/deficient mismatch repair [dMMR])
Pancreatic ductal adenocarcinoma (PDAC).
Biliary tract cancer (BTC) (includes intrahepatic, extrahepatic cholangiocarcinoma [CCA] and gall bladder cancer)
Endometrial cancer (EC)
Esophageal squamous cell carcinoma (ESCC)
Disease progression on or since the most recent treatment (does not apply to newly diagnosed unresectable or metastatic HCC or EC).
Measurable disease per RECIST v1.1 as assessed locally (by investigator) and verified by BICR
Submission of an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Male participants are abstinent from heterosexual intercourse or agree to follow contraceptive guidance during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib
Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and and for at least 120 days after the last dose of pembrolizumab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
Adequate organ function
Adequately controlled blood pressure with or without antihypertensive medications
HCC Specific Inclusion Criteria: No prior systemic chemotherapy, including anti-VEGF therapy, anti-programmed cell-death (PD-1)/immunotherapy-drugs-are-boosting-survival/" >PD-L1 or any systemic investigational anticancer agents for advanced/unresectable HCC (1L)
CRC ([non-MSI-H/dMMR) Specific Inclusion Criteria: Received at least 2 prior lines of systemic therapy for unresectable or metastatic disease which includes fluoropyrimidine, irinotecan and oxaliplatin
PDAC Specific Inclusion Criteria: Prior therapy with at least 1 (platinum or gemcitabine containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer
BTC Specific Inclusion Criteria: Received at least 1 prior line of systemic therapy (containing gemcitabine or fluoropyrimidine) for unresectable or metastatic disease
EC Specific Inclusion Criteria: Study treatment is for 1L therapy of EC and participants should not have received prior systemic chemotherapy. Exception: May have received 1 prior line of line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of a curative-intent resection, if the recurrence occurred ≥6 months after the last dose of chemotherapy or may have received prior radiation with or without chemotherapy
ESCC Specific Inclusion Criteria: Have experienced radiographic or clinical progression on one prior line of standard systemic therapy (immune oncology (IO) naïve participants) or an anti-PD-1/PD-L1 (IO resistant participants)

Exclusion Criteria:

Unable to swallow orally administered medication or presence of a gastrointestinal (GI) disorder that may affect study intervention absorption
History of a second malignancy that is progressing or has required active treatment within 3 years
A pulse oximeter reading <92% at rest, or requirement of intermittent supplemental oxygen/ chronic supplemental oxygen
Presence of central nervous system (CNS) metastases and/or carcinomatous meningitis
Clinically significant cardiovascular disease within 6 months of first dose of study intervention
Symptomatic pleural effusion, unless clinically stable after treatment
Preexisting ≥ Grade 3 gastrointestinal (GI) or non-GI fistula
Moderate to severe hepatic impairment
Clinically significant history of bleeding within 3 months before screening
Presence of serious active nonhealing wound/ulcer/bone fracture
Requirement for hemodialysis or peritoneal dialysis
History of human immunodeficiency virus (HIV) infection
History of Hepatitis B or active Hepatis C virus infections. with exceptions for HCC and BTC
Prior therapy with a PD-1, anti-PD-L1, anti-PD-L2 agent, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) or hypoxia-inducible factor 2α (HIF-2α)
Radiographic evidence of intratumoral cavitation, or invasion/infiltration of a major blood vessel
EC specific exclusion criteria: History of carcinosarcoma, endometrial leiomyosarcoma or other high-grade sarcomas, or endometrial stromal sarcomas
ESCC specific exclusion criteria: Has clinically apparent ascites or pleural effusion or experienced weight loss >20% over approximately 3 months before first dose of study therapy

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

730

Study ID:

NCT04976634

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 45 Locations for this study

See Locations Near You

University of Arizona Cancer Center-University of Arizona Cancer Center - North Campus ( Site 5047)
Tucson Arizona, 85724, United States More Info
Study Coordinator
Contact
520-626-8551
City of Hope Comprehensive Cancer Center ( Site 5002)
Duarte California, 91010, United States More Info
Study Coordinator
Contact
626-256-4673
Cedars-Sinai Medical Center ( Site 5045)
Los Angeles California, 90048, United States More Info
Study Coordinator
Contact
310-423-5776
UCSF Medical Center at Mission Bay ( Site 5021)
San Francisco California, 94158, United States More Info
Study Coordinator
Contact
415-353-9888
Yale-New Haven Hospital-Yale Cancer Center ( Site 5013)
New Haven Connecticut, 06520, United States More Info
Study Coordinator
Contact
203-737-3472
Sibley Memorial Hospital ( Site 5051)
Washington District of Columbia, 20016, United States More Info
Study Coordinator
Contact
410-955-6832
University of Florida College of Medicine ( Site 5015)
Gainesville Florida, 32610, United States More Info
Study Coordinator
Contact
352-273-7990
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 5048)
Baltimore Maryland, 21287, United States More Info
Study Coordinator
Contact
410-955-6832
Memorial Sloan Kettering Cancer Center ( Site 5050)
New York New York, 10065, United States More Info
Study Coordinator
Contact
646-888-4308
Duke Cancer Institute ( Site 5026)
Durham North Carolina, 27710, United States More Info
Study Coordinator
Contact
919-684-8111
University of Texas MD Anderson Cancer Center-Gastrointestinal Medical Oncology ( Site 5049)
Houston Texas, 77030, United States More Info
Study Coordinator
Contact
713-563-4799
Inova Schar Cancer Institute ( Site 5039)
Fairfax Virginia, 22031, United States More Info
Study Coordinator
Contact
571-645-8222
Northwest Medical Specialties, PLLC ( Site 5025)
Tacoma Washington, 98405, United States More Info
Study Coordinator
Contact
253-381-0674
University of Wisconsin Hospitals and Clinics ( Site 5037)
Madison Wisconsin, 53792, United States More Info
Study Coordinator
Contact
608-265-9966
Gosford Hospital-Oncology Trials ( Site 4004)
Gosford New South Wales, 2250, Australia More Info
Study Coordinator
Contact
+61243209890
Westmead Hospital-Department of Medical Oncology ( Site 4001)
Westmead New South Wales, 2145, Australia More Info
Study Coordinator
Contact
+61288908935
Northern Hospital-Department of Medical Oncology ( Site 4003)
Epping Victoria, 3076, Australia More Info
Study Coordinator
Contact
6138405 8303
Cabrini Hospital - Malvern-Cabrini Institute ( Site 4000)
Malvern Victoria, 3144, Australia More Info
Study Coordinator
Contact
61395083434
Antwerp University Hospital-Oncology ( Site 1002)
Edegem Antwerpen, 2650, Belgium More Info
Study Coordinator
Contact
+32 3 821 55 80
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1003)
Yvoir Namur, 5530, Belgium More Info
Study Coordinator
Contact
3281423849
UZ Leuven ( Site 1000)
Leuven Vlaams-Brabant, 3000, Belgium More Info
Study Coordinator
Contact
3216344218
Centro Investigación del Cáncer James Lind ( Site 3107)
Temuco Araucania, 48008, Chile More Info
Study Coordinator
Contact
+56995579412
Clínica Puerto Montt ( Site 3110)
Puerto Montt Los Lagos, 55002, Chile More Info
Study Coordinator
Contact
+56998634501
FALP-UIDO ( Site 3102)
Santiago Region M. De Santiago, 69009, Chile More Info
Study Coordinator
Contact
+56981369487
Oncovida ( Site 3108)
Santiago Region M. De Santiago, 75100, Chile More Info
Study Coordinator
Contact
+56323320850
Bradfordhill-Clinical Area ( Site 3100)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56229490970
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1103)
Rennes Bretagne, 35042, France More Info
Study Coordinator
Contact
+33299253196
CHU Besançon-Medical oncology ( Site 1101)
Besançon Doubs, 25000, France More Info
Study Coordinator
Contact
+33370632237
Institut Régional du Cancer Montpellier ( Site 1106)
Montpellier Herault, 34298, France More Info
Study Coordinator
Contact
33467612304
Hôpital Beaujon-Oncologie Digestive ( Site 1104)
Clichy Ile-de-France, 92110, France More Info
Study Coordinator
Contact
+33140875614
Centre Hospitalier Universitaire de Grenoble-Medical Oncology ( Site 1105)
La Tronche Isere, 38700, France More Info
Study Coordinator
Contact
33476765450
Rambam Health Care Campus-Oncology ( Site 1300)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+97247776700
Hadassah Medical Center-Oncology ( Site 1303)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
97226777957
Sheba Medical Center-ONCOLOGY ( Site 1302)
Ramat Gan , 52621, Israel More Info
Study Coordinator
Contact
97235307776
Sourasky Medical Center-Oncology ( Site 1301)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
97236973082
Seoul National University Hospital-Internal Medicine ( Site 4103)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
82220723943
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4100)
Seoul , 03722, Korea, Republic of More Info
Study Coordinator
Contact
82222288050
Asan Medical Center-Department of Oncology ( Site 4101)
Seoul , 05505, Korea, Republic of More Info
Study Coordinator
Contact
82230101720
Samsung Medical Center-Division of Hematology/Oncology ( Site 4102)
Seoul , 06351, Korea, Republic of More Info
Study Coordinator
Contact
82234103459
Maastricht UMC+-Medical Oncology ( Site 1501)
Maastricht Limburg, 6229 , Netherlands More Info
Study Coordinator
Contact
+31433872001
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1504)
Leiden Zuid-Holland, 2333 , Netherlands More Info
Study Coordinator
Contact
+31715298849
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1503)
Utrecht , 3584 , Netherlands More Info
Study Coordinator
Contact
+31887556308
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1802)
Oviedo Asturias, 33011, Spain More Info
Study Coordinator
Contact
+34646662756
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1801)
Madrid Madrid, Comunidad De, 28007, Spain More Info
Study Coordinator
Contact
+34914269519
Hospital Universitari Vall d'Hebron-Oncology ( Site 1800)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
+34934894158

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

730

Study ID:

NCT04976634

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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