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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03615326
Other study ID # 3475-811
Secondary ID MK-3475-81118414
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 5, 2018
Est. completion date December 30, 2024

Study information

Verified date March 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).


Description:

Pembrolizumab (200 mg) or placebo will be administered intravenously [IV] on day 1 of each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be administered IV on day 1 of each 3-week cycle. SOC chemotherapy for the global cohort will either be FP (80 mg/m^2 cisplatin administered IV on Day 1 of each 3-week cycle and 800 mg/m^2 5-fluorouracil [5-FU] administered IV on Days 1-5 of each 3-week cycle) or CAPOX (1000 mg/m^2 capecitabine administered orally twice daily [BID] on days 1-14 of each 3-week cycle and 130 mg/m^2 oxaliplatin administered IV on Day 1 of each 3-week cycle). A Japan cohort will receive SOX chemotherapy consisting of S-1 (tegafur, 5-chloro-2,4-dihydroxypyridine [CDHP], and potassium oxonate [Oxo]) administered orally BID according to Body Surface Area (BSA) on Days 1-14 of each 3-week cycle and oxaliplatin (130 mg/m^2) administered IV on Day 1 each 3-week cycle.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 738
Est. completion date December 30, 2024
Est. primary completion date March 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma - HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor - Has measurable disease as defined by RECIST 1.1 as determined by the site investigator - Male participants must agree to use approved contraception - Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception - Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of trial treatment - Has a life expectancy of greater than 6 months - Has adequate organ function Exclusion Criteria: - Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer - Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment - Has had radiotherapy within 14 days of randomization - Has a known additional malignancy that is progressing or has required active treatment within the past 5 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has an active autoimmune disease that has required systemic treatment in past 2 years - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis - Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis) - Has an active infection requiring systemic therapy - Has poorly controlled diarrhea - Accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. If the participant is receiving diuretic drugs for other reasons, it is acceptable - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator - Has peripheral neuropathy > Grade 1 - Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial - A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation - Has active or clinically significant cardiac disease - Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) - Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection - Has severe hypersensitivity (=Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum-containing products - Has had an allogeneic tissue/solid organ transplant - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, Cluster of Differentiation 137 [CD137])

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Pembrolizumab
200 mg on Day 1 of each 3-week cycle as an IV infusion.
Placebo
Solution for IV infusion on Day 1 of each 3-week cycle.
Drug:
Cisplatin
80 mg/m^2 on Day 1 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen.
5-FU
800 mg/m^2/day continuous on Days 1-5 of each 3-week cycle (120 hours or per local standard), administered as part of FP chemotherapy regimen.
Oxaliplatin
130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen and as part of SOX chemotherapy regimen.
Capecitabine
1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.
S-1
Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): <1.25 m^2 BSA =40 mg, 1.25 to <1.5 m^2 BSA=50 mg, =1.5 m^2 BSA=60 mg. Administered as part of SOX chemotherapy regimen.
Biological:
Trastuzumab
8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.

Locations

Country Name City State
Australia Monash Health ( Site 2202) Clayton Victoria
Australia Liverpool Hospital ( Site 2206) Liverpool New South Wales
Australia Westmead Hospital ( Site 2200) Westmead New South Wales
Australia Southern Medical Day Care Centre ( Site 2207) Wollongong New South Wales
Brazil CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205) Curitiba Parana
Brazil CEPON - Centro de Pesquisas Oncologicas ( Site 0200) Florianopolis Santa Catarina
Brazil Instituto do Cancer do Ceara ( Site 0208) Fortaleza Ceara
Brazil Hospital de Caridade de Ijui ( Site 0202) Ijui Rio Grande Do Sul
Brazil Hospital Nossa Senhora da Conceicao ( Site 0203) Porto Alegre Rio Grande Do Sul
Brazil Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201) Rio de Janeiro
Brazil Hospital Sao Rafael ( Site 0209) Salvador Bahia
Brazil IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204) Sao Paulo
Chile Fundacion Arturo Lopez Perez FALP ( Site 0302) Santiago Region M. De Santiago
Chile Instituto Nacional del Cancer ( Site 0303) Santiago Region M. De Santiago
Chile Pontificia Universidad Catolica de Chile ( Site 0301) Santiago Region M. De Santiago
Chile Clinica Universidad Catolica del Maule ( Site 0305) Talca Maule
Chile Centro Investigación del Cáncer James Lind ( Site 0300) Temuco Araucania
China Beijing Cancer Hospital ( Site 2413) Beijing Beijing
China Fifth Medical Center of CPLA General Hospital ( Site 2415) Beijing Beijing
China Peking Union Medical College Hospital ( Site 2419) Beijing Beijing
China The First Hospital Of Jilin University ( Site 2402) Chang chun Jilin
China Xiangya Hospital Central-South University ( Site 2426) Changsha Hunan
China 900 Hospital of the Joint ( Site 2420) Fuzhou Fujian
China Fujian Provincial Cancer Hospital ( Site 2418) Fuzhou Fujian
China Guangdong General Hospital ( Site 2433) Guangzhou Guangdong
China Sir Run Run Shaw Hospital ( Site 2412) Hangzhou Zhejiang
China The First Affiliated Hospital.Zhejiang University ( Site 2408) Hangzhou Zhejiang
China Zhejiang Cancer Hospital ( Site 2409) Hangzhou Zhejiang
China Harbin Medical University Cancer Hospital ( Site 2407) Harbin Heilongjiang
China Jiangsu Cancer Hospital ( Site 2432) Nanjing Jiangsu
China Fudan University Shanghai Cancer Center ( Site 2424) Shanghai Shanghai
China Shanghai General Hospital ( Site 2404) Shanghai Anhui
China Zhongshan Hospital affiliated to Fudan University ( Site 2401) Shanghai Shanghai
China Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430) Urumqi Xinjiang
China The First Affiliated Hospital of Xiamen University ( Site 2431) Xiamen Fujian
China Henan Cancer Hospital ( Site 2400) Zhengzhou Henan
France Hopital Jean Minjoz Besancon ( Site 0901) Besancon Doubs
France C.H.R.U. de Brest - Hopital Morvan ( Site 0913) Brest Finistere
France Centre Oscar Lambret ( Site 0911) Lille Nord
France Centre Leon Berard ( Site 0904) Lyon Rhone
France CHU Hopital Saint Antoine ( Site 0905) Paris
France CHU de Rouen ( Site 0912) Rouen Ain
France Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902) Saint-Herblain Val-de-Marne
France HUS Hopital Hautepierre ( Site 0910) Strasbourg Bas-Rhin
France Institut Gustave Roussy ( Site 0900) Villejuif Val-de-Marne
Germany Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026) Berlin
Germany Klinikum Bremen Nord ( Site 1017) Bremen
Germany Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001) Dresden Sachsen
Germany Asklepios Klinik Altona ( Site 1000) Hamburg
Germany Facharztzentrum Eppendorf ( Site 1025) Hamburg
Germany Medizinische Hochschule Hannover ( Site 1019) Hannover Niedersachsen
Germany SLK-Kliniken Heilbronn ( Site 1015) Heilbronn Baden-Wurttemberg
Germany Universitaetsklinikum Leipzig AOeR ( Site 1007) Leipzig Sachsen
Germany Klinikum Ludwigsburg ( Site 1014) Ludwigsburg Baden-Wurttemberg
Germany Klinikum rechts der Isar der Technischen Universitaet ( Site 1027) Muenchen Bayern
Germany Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020) Tuebingen Baden-Wurttemberg
Guatemala Celan SA ( Site 0504) Guatemala
Guatemala Grupo Angeles SA ( Site 0501) Guatemala
Guatemala Medi-K Cayala ( Site 0505) Guatemala
Guatemala Nucare Center ( Site 0506) Guatemala
Guatemala Oncomedica ( Site 0500) Guatemala
Guatemala Centro Regional de Sub Especialidades Medicas SA ( Site 0502) Quetzaltenango
Ireland Beaumont Hospital ( Site 1506) Dublin
Ireland Saint James's Hospital ( Site 1505) Dublin
Ireland Tallaght University Hospital ( Site 1513) Dublin
Israel Soroka University Medical Center ( Site 1603) Beer Sheva
Israel Rambam Health Care Campus ( Site 1606) Haifa
Israel Edith Wolfson Medical Center ( Site 1605) Holon
Israel Hadassah Ein Kerem Medical Center ( Site 1604) Jerusalem
Israel Meir Medical Center ( Site 1609) Kfar-Saba
Israel Rabin Medical Center ( Site 1602) Petah Tikva
Israel Chaim Sheba Medical Center. ( Site 1607) Ramat Gan
Israel Sourasky Medical Center ( Site 1601) Tel Aviv
Italy Humanitas Gavazzeni ( Site 1106) Bergamo
Italy Universita Magna Graecia di Catanzaro ( Site 1107) Catanzaro
Italy IEO Istituto Europeo di Oncologia ( Site 1105) Milano
Italy Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1102) Modena
Italy A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103) Napoli
Italy Istituto Oncologico Veneto ( Site 1101) Padova
Italy Ospedale Civile Spirito Santo ( Site 1104) Pescara
Italy AUOP Ospedale Santa Chiara ( Site 1100) Pisa Toscana
Japan Hyogo Cancer Center ( Site 2619) Akashi Hyogo
Japan Chiba Cancer Center ( Site 2623) Chiba
Japan National Hospital Organization Kyushu Cancer Center ( Site 2609) Fukuoka
Japan Gifu University Hospital ( Site 2621) Gifu
Japan Kansai Medical University Hospital ( Site 2618) Hirakata Osaka
Japan Hiroshima City Hiroshima Citizens Hospital ( Site 2625) Hiroshima
Japan Ibaraki Prefectural Central Hospital ( Site 2611) Kasama Ibaraki
Japan National Cancer Center Hospital East ( Site 2605) Kashiwa Chiba
Japan Kagawa University Hospital ( Site 2604) Kita-gun Kagawa
Japan Saitama Cancer Center ( Site 2620) Kitaadachi-gun Saitama
Japan Kobe City Medical Center General Hospital ( Site 2614) Kobe Hyogo
Japan Kumamoto University Hospital ( Site 2601) Kumamoto
Japan National Hospital Organization Shikoku Cancer Center ( Site 2615) Matsuyama Ehime
Japan Kyorin University Hospital ( Site 2608) Mitaka Tokyo
Japan Aichi Cancer Center Hospital ( Site 2617) Nagoya Aichi
Japan Niigata Cancer Center Hospital ( Site 2622) Niigata
Japan Gunma Prefectural Cancer Center ( Site 2602) Ohta Gunma
Japan National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26 Osaka
Japan Osaka General Medical Center ( Site 2624) Osaka
Japan Osaka International Cancer Institute ( Site 2613) Osaka
Japan Kindai University Hospital ( Site 2616) Osakasayama Osaka
Japan Osaki Citizen Hospital ( Site 2626) Osaki Miyagi
Japan Osaka University Hospital ( Site 2600) Suita Osaka
Japan Shizuoka Cancer Center Hospital and Research Institute ( Site 2607) Sunto-gun Shizuoka
Japan National Cancer Center Hospital ( Site 2612) Tokyo
Japan The Cancer Institute Hospital of JFCR ( Site 2610) Tokyo
Japan Tokyo Metropolitan Komagome Hospital ( Site 2606) Tokyo
Japan Toranomon Hospital ( Site 2628) Tokyo
Japan Tochigi Cancer Center ( Site 2627) Utsunomiya Tochigi
Japan Kanagawa Cancer Center ( Site 2603) Yokohama Kanagawa
Korea, Republic of Asan Medical Center ( Site 2702) Seoul
Korea, Republic of Samsung Medical Center ( Site 2701) Seoul
Korea, Republic of Seoul National University Hospital ( Site 2703) Seoul
Korea, Republic of Severance Hospital Yonsei University Health System ( Site 2700) Seoul
New Zealand Auckland City Hospital ( Site 2300) Auckland
Poland Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710) Bielsko-Biala Slaskie
Poland Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715) Gdynia Pomorskie
Poland Przychodnia Lekarska Komed ( Site 1716) Konin Wielkopolskie
Poland Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708) Koscierzyna Pomorskie
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709) Lublin Lubelskie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Warszawa Mazowieckie
Poland Dolnoslaskie Centrum Onkologii. ( Site 1712) Wroclaw Dolnoslaskie
Poland Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705) Wroclaw Dolnoslaskie
Russian Federation Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815) Chelyabinsk Chelyabinskaya Oblast
Russian Federation Blokhin National Medical Oncology ( Site 1805) Moscow Moskva
Russian Federation Podolsky City Clinical Hospital ( Site 1817) Podolsk Moskovskaya Oblast
Russian Federation Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801) Saint Petersburg Sankt-Peterburg
Russian Federation St Petersburg City Clinical Oncology Dispensary ( Site 1812) Saint Petersburg Sankt-Peterburg
Russian Federation Leningrad Regional Oncology Center ( Site 1800) Saint-Petersburg Sankt-Peterburg
Russian Federation Medical University REAVIZ ( Site 1816) Samara Samarskaya Oblast
Russian Federation Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1807) Ufa Baskortostan, Respublika
Spain Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410) Badalona Barcelona
Spain Hospital General Universitari Vall d Hebron ( Site 1401) Barcelona
Spain Hospital General Universitario de Elche ( Site 1404) Elche Alicante
Spain Hospital Universitario Ramon y Cajal ( Site 1400) Madrid
Spain Hospital Universitario Central de Asturias ( Site 1402) Oviedo Asturias
Spain Hospital Universitario Quiron Madrid ( Site 1407) Pozuelo de Alarcon Madrid
Spain Hospital Universitario Marques de Valdecilla ( Site 1405) Santander Cantabria
Turkey Adana Sehir Hastanesi ( Site 2002) Adana
Turkey Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006) Ankara
Turkey Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2017) Ankara
Turkey Trakya Universitesi Tip Fakultesi ( Site 2015) Edirne
Turkey Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000) Erzurum
Turkey Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001) Istanbul
Turkey Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011) Izmir
Turkey Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009) Malatya
Turkey Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012) Sakarya
Ukraine City Clinical Hosp.4 of DCC ( Site 2102) Dnipro Dnipropetrovska Oblast
Ukraine MI Precarpathian Clinical Oncology Center ( Site 2105) Ivano-Frankivsk Ivano-Frankivska Oblast
Ukraine Communal non profit enterprise Regional Clinical Oncology Center ( Site 2112) Kharkiv Kharkivska Oblast
Ukraine Medical Center Asklepion LLC ( Site 2115) Khodosivka Kyivska Oblast
Ukraine MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101) Kryviy Rih Dnipropetrovska Oblast
Ukraine Clinic of National Cancer Institute ( Site 2104) Kyiv Kyivska Oblast
Ukraine Kyiv City Clinical Oncology Centre ( Site 2110) Kyiv
Ukraine Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2114) Kyiv Kyivska Oblast
Ukraine Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106) Lviv Lvivska Oblast
Ukraine MI Odessa Regional Oncological Centre ( Site 2108) Odesa Odeska Oblast
Ukraine Medical Centre LLC Oncolife ( Site 2103) Zaporizhzhya Zaporizka Oblast
United Kingdom Castle Hill Hospital ( Site 1501) Cottingham East Riding Of Yorkshire
United Kingdom Royal Hospital in Derby ( Site 1514) Derby Derbyshire
United Kingdom Ninewells Hospital and Medical School ( Site 1504) Dundee Dundee City
United Kingdom Royal Marsden NHS Foundation Trust ( Site 1512) London
United Kingdom St Georges University Hospitals NHS Foundation Trust. ( Site 1500) London London, City Of
United Kingdom University College London Hospital NHS Foundation Trust ( Site 1508) London London, City Of
United Kingdom The Christie Hospital NHS Foundation Trust ( Site 1503) Manchester
United Kingdom Mount Vernon Cancer Centre ( Site 1507) Northwood
United Kingdom Royal Marsden Hospital ( Site 1510) Sutton Surrey
United Kingdom Manor Hospital Walsall England ( Site 1515) Walsall
United States Beth Israel Deaconess Medical Center ( Site 0070) Boston Massachusetts
United States Dana-Farber Cancer Institute [Boston, MA] ( Site 0010) Boston Massachusetts
United States Levine Cancer Institute ( Site 0015) Charlotte North Carolina
United States Duke Cancer Institute ( Site 0042) Durham North Carolina
United States Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065) Harrison New York
United States University of Texas MD Anderson Cancer Center ( Site 0001) Houston Texas
United States UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045) Los Angeles California
United States University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026) Miami Florida
United States Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071) Middletown New Jersey
United States Minnesota Oncology Hematology, PA ( Site 8001) Minneapolis Minnesota
United States Pacific Cancer Care ( Site 0063) Monterey California
United States Memorial Sloan-Kettering Cancer Center ( Site 0017) New York New York
United States Southeastern Regional Medical Center, Inc. ( Site 0058) Newnan Georgia
United States UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050) Orange California
United States Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025) Philadelphia Pennsylvania
United States Allegheny General Hospital ( Site 0053) Pittsburgh Pennsylvania
United States Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000) Roanoke Virginia
United States University of Rochester ( Site 0041) Rochester New York
United States Washington University School of Medicine ( Site 0040) Saint Louis Missouri
United States Seattle Cancer Care Alliance ( Site 0038) Seattle Washington
United States Sanford Hematology Oncology-Sioux Falls SD ( Site 0004) Sioux Falls South Dakota
United States CTCA Southwestern ( Site 0060) Tulsa Oklahoma
United States Midwestern Regional Medical Center, Inc. ( Site 0059) Zion Illinois

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Chile,  China,  France,  Germany,  Guatemala,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  New Zealand,  Poland,  Russian Federation,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study 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 progression. PFS will be determined for each treatment arm. Up to approximately 4 years
Primary Overall Survival (OS) OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm. Up to approximately 5 years
Secondary Objective Response Rate (ORR) per RECIST 1.1 assessed by BICR ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by BICR. ORR will be determined for each treatment arm. Up to approximately 5 years
Secondary Duration of Response (DOR) per RECIST 1.1 assessed by BICR For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR will be determined for each treatment arm. Up to approximately 5 years
Secondary Adverse Events (AE) An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. 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 treatment. The number of participants who experience an AE will be reported for each treatment arm. Up to approximately 5 years
Secondary Treatment Discontinuations Due to AEs An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. 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 treatment. The number of participants who discontinue study treatment due to an AE will be reported for each treatment arm. Up to approximately 5 years
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