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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4280A-007 | Other Identifier | MSD | |
| jRCT2031210482 | Registry Identifier | jRCT(Japan Registry of Clinical Trials) | |
| 2024-511043-25-00 | Registry Identifier | EU CT | |
| U1111-1302-9933 | Registry Identifier | UTN |
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The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil).
The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favezelimab/Pembrolizumab | Experimental | Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions. |
|
| Standard of Care (Regorafenib or TAS-102) | Active Comparator | At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| favezelimab/pembrolizumab | Biological | Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. | Up to approximately 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital ( Site 1148) | Washington D.C. | District of Columbia | 20007 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41811823 | Derived | Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Favezelimab/Pembrolizumab | Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions. |
| FG001 | Standard of Care (Regorafenib or TAS-102) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2023 |
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None (Open-label)
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| regorafenib | Drug | Oral |
|
|
| TAS-102 | Drug | Oral |
|
|
| Up to approximately 21 months |
| Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | ORR was defined as the percentage of participants who achieved 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 lesion) per RECIST 1.1 as assessed by BICR. | Up to approximately 21 months |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | For participants who demonstrate confirmed CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions), duration of response was defined as the time from the first documented evidence of CR or PR until progressive disease (PD) or death due to any cause. 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. | Up to approximately 21 months |
| Number of Participants Who Experienced at Least One Adverse Event (AE) | An AE was 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. | Up to approximately 31 months |
| Number of Participants Who Discontinued Study Treatment Due to an AE | An AE was 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. The number of participants who discontinued study treatment due to an AE is presented. | Up to approximately 28 months |
| Change From Baseline in European Organisation 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 cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "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). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. | Baseline and up to approximately 8 weeks |
| Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome | Baseline and up to approximately 8 weeks |
| Change From Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for appetite loss (QLQ-C30 Item 13). For this item, individual responses to the question "Have you lacked appetite?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 appetite loss (Item 13) scale score will be presented. | Baseline and up to approximately 8 weeks |
| Change From Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score | The EORTC QLQ-CR29 is a health-related quality-of life (QoL) questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). For this item, individual responses to the question "Did you have a bloated feeling in your abdomen?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-CR29 bloating (Item 37) scale score will be presented. | Baseline and up to approximately 8 weeks |
| Time to Deterioration (TTD) in EORTC QLQ-C30 GHS (Item 29) and QoL (Item 30) Combined Score | TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in GHS (EORTC QLQ-C30 Item 29) & QoL combined score (EORTC QLQ-C30 Item 30). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome. | Baseline and up to approximately 38 months |
| TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score | TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome. | Baseline and up to approximately 38 months |
| TTD in in EORTC QLQ-C30 Appetite Loss (Item 13) Score | TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in appetite loss score (EORTC QLQ-C30 Item 13). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome. | Baseline and up to approximately 38 months |
| TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score | TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in bloating score (QLQ-CR29 Item 37). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in appetite loss score, will be presented. A longer TTD indicates a better outcome. | Baseline and up to approximately 38 months |
| Sibley Memorial Hospital ( Site 1143) |
| Washington D.C. |
| District of Columbia |
| 20016 |
| United States |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118) | Marietta | Georgia | 30060 | United States |
| Norton Cancer Institute ( Site 1139) | Louisville | Kentucky | 40217 | United States |
| Rutgers Cancer Institute of New Jersey ( Site 1105) | New Brunswick | New Jersey | 08903 | United States |
| Memorial Sloan Kettering Cancer Center ( Site 1703) | New York | New York | 10065 | United States |
| Oregon Health & Science University ( Site 1141) | Portland | Oregon | 97239 | United States |
| MUSC Hollings Cancer Center ( Site 1715) | Charleston | South Carolina | 29425 | United States |
| The West Clinic, PLLC dba West Cancer Center ( Site 1149) | Germantown | Tennessee | 38138 | United States |
| UT Southwestern Medical Center ( Site 1709) | Dallas | Texas | 75390-9063 | United States |
| Intermountain Medical Center ( Site 1707) | Murray | Utah | 84107 | United States |
| Inova Schar Cancer Institute ( Site 1130) | Fairfax | Virginia | 22031 | United States |
| VCU Health Adult Outpatient Pavillion ( Site 1712) | Richmond | Virginia | 23219 | United States |
| Blue Ridge Cancer Care ( Site 1718) | Roanoke | Virginia | 24014 | United States |
| Seattle Cancer Care Alliance ( Site 1107) | Seattle | Washington | 98109 | United States |
| Westmead Hospital ( Site 0057) | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women s Hospital ( Site 0058) | Herston | Queensland | 4029 | Australia |
| Queen Elizabeth Hospital ( Site 0050) | Woodville South | South Australia | 5011 | Australia |
| Frankston Hospital ( Site 0056) | Frankston | Victoria | 3199 | Australia |
| Western Health-Sunshine & Footscray Hospitals ( Site 0052) | St Albans | Victoria | 3021 | Australia |
| St John of God Subiaco Hospital ( Site 0051) | Perth | Western Australia | 6008 | Australia |
| London Regional Cancer Program - London HSC ( Site 0154) | London | Ontario | N6A 5W9 | Canada |
| The Ottawa Hospital ( Site 0151) | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0155) | Toronto | Ontario | M5G 2M9 | Canada |
| Centro Investigacion Cancer James Lind ( Site 0204) | Temuco | Araucania | 4800827 | Chile |
| IC La Serena Research ( Site 0202) | La Serena | Coquimbo Region | 1720430 | Chile |
| Clinica Puerto Montt ( Site 0211) | Port Montt | Los Lagos Region | 5500656 | Chile |
| Fundacion Arturo Lopez Perez FALP ( Site 0208) | Santiago | Region M. de Santiago | 7500921 | Chile |
| Oncovida ( Site 0209) | Santiago | Region M. de Santiago | 7510032 | Chile |
| ClÃnica Vespucio ( Site 0205) | Santiago | Region M. de Santiago | 8241479 | Chile |
| Pontificia Universidad Catolica de Chile ( Site 0206) | Santiago | Region M. de Santiago | 8330032 | Chile |
| Bradfordhill ( Site 0200) | Santiago | Region M. de Santiago | 8420383 | Chile |
| The Second Affiliated Hospital of Anhui Medical University ( Site 1179) | Hefei | Anhui | 230601 | China |
| Chongqing Cancer Hospital ( Site 1151) | Chongqing | Chongqing Municipality | 400030 | China |
| Fujian Province Cancer Hospital ( Site 1178) | Fuzhou | Fujian | 350014 | China |
| Sun Yat-Sen University Cancer Center ( Site 1150) | Guangzhou | Guangdong | 510060 | China |
| Southern Medical University Nanfang Hospital ( Site 1154) | Guangzhou | Guangdong | 510515 | China |
| The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159) | Guangzhou | Guangdong | 510655 | China |
| Guangxi Medical University Affiliated Tumor Hospital ( Site 1158) | Nanning | Guangxi | 531021 | China |
| Hainan General Hospital ( Site 1177) | Haikou | Hainan | 570311 | China |
| Wuhan Union Hospital Cancer Center ( Site 1162) | Wuhan | Hubei | 430022 | China |
| Hubei Cancer Hospital ( Site 1152) | Wuhan | Hubei | 430079 | China |
| Xiangya Hospital Central South University ( Site 1171) | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital ( Site 1174) | Changsha | Hunan | 410013 | China |
| The Third Xiangya Hospital of Central South University ( Site 1175) | Changsha | Hunan | 410013 | China |
| Changzhou Cancer Hospital-Department of Oncology ( Site 1183) | Changzhou | Jiangsu | 213000 | China |
| Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185) | Wuxi | Jiangsu | 214122 | China |
| Jilin Cancer Hospital ( Site 1163) | Changchun | Jilin | 130012 | China |
| Jinan Central Hospital ( Site 1167) | Jinan | Shandong | 250000 | China |
| Shanghai Tenth People's Hospital ( Site 1170) | Shanghai | Shanghai Municipality | 200072 | China |
| Fudan University Shanghai Cancer Center ( Site 1176) | Shanghai | Shanghai Municipality | 201321 | China |
| West China Hospital Sichuan University ( Site 1172) | Chengdu | Sichuan | 332001 | China |
| Tianjin Medical University Cancer Institute and Hospital ( Site 1161) | Tianjin | Tianjin Municipality | 300060 | China |
| Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169) | Kunming | Yunnan | 650106 | China |
| Zhejiang Cancer Hospital ( Site 1180) | Hangzhou | Zhejiang | 310005 | China |
| Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173) | Hangzhou | Zhejiang | 310018 | China |
| Masarykuv onkologicky ustav ( Site 1203) | Brno | Brno-mesto | 656 53 | Czechia |
| Fakultni nemocnice v Motole ( Site 1201) | Prague | Praha, Hlavni Mesto | 150 06 | Czechia |
| Fakultni nemocnice Hradec Kralove ( Site 1207) | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc ( Site 1204) | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady ( Site 1208) | Prague | 100 34 | Czechia |
| Fakultni Thomayerova nemocnice ( Site 1205) | Prague | 140 59 | Czechia |
| Fakultni nemocnice Na Bulovce ( Site 1202) | Prague | 180 81 | Czechia |
| CHU Bordeaux Haut-Leveque ( Site 0305) | Pessac | Gironde | 33604 | France |
| CHU Hotel Dieu Nantes ( Site 0303) | Nantes | Pays de la Loire Region | 44093 | France |
| Institut du Cancer Avignon-Provence ( Site 0306) | Avignon | Vaucluse | 84000 | France |
| CHU Poitiers ( Site 0304) | Poitiers | Vienne | 86021 | France |
| Hopital Europeen Georges Pompidou ( Site 0300) | Paris | 75015 | France |
| LMU Klinikum Grosshadern der Universitaet Muenchen ( Site 1253) | Munich | Bavaria | 81377 | Germany |
| Philipps-Universitaet Marburg. ( Site 1252) | Marburg | Hesse | 35043 | Germany |
| Klinikum Wolfsburg ( Site 1256) | Wolfsburg | Lower Saxony | 38440 | Germany |
| Johanniter Krankenhaus Bonn ( Site 1254) | Bonn | North Rhine-Westphalia | 53113 | Germany |
| Kliniken Maria Hilf GmbH ( Site 1255) | Mönchengladbach | North Rhine-Westphalia | 41063 | Germany |
| Universitätsklinikum Halle ( Site 1251) | Halle | Saxony-Anhalt | 06120 | Germany |
| Katholisches Marienkrankenhaus gGmbH ( Site 1257) | Hamburg | 22087 | Germany |
| Assuta Ashdod Public ( Site 0507) | Ashdod | 7747629 | Israel |
| Rambam Health Care Campus-Oncology Division ( Site 0500) | Haifa | 3109601 | Israel |
| Bnei Zion Medical Center ( Site 0506) | Haifa | 3339419 | Israel |
| Hadassa Ein Karem Medical Center ( Site 0504) | Jerusalem | 9112001 | Israel |
| Rabin Medical Center ( Site 0503) | Petah Tikva | 4941492 | Israel |
| Chaim Sheba Medical Center ( Site 0501) | Ramat Gan | 5262000 | Israel |
| Sourasky Medical Center ( Site 0502) | Tel Aviv | 6423906 | Israel |
| Policlinico Gemelli di Roma ( Site 0552) | Roma | Abruzzo | 00168 | Italy |
| IRCCS Casa Sollievo della Sofferenza ( Site 0554) | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Istituto Clinico Humanitas - Cancer Center ( Site 0555) | Rozzano | Milano | 20089 | Italy |
| A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0553) | Catania | 95122 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda ( Site 0550) | Milan | 20162 | Italy |
| Universita degli Studi della Campania Luigi Vanvitelli-UOC Oncoematologia ( Site 0556) | Naples | 80131 | Italy |
| National Cancer Center Hospital East ( Site 0600) | Kashiwa | Chiba | 277-8577 | Japan |
| Kagawa University Hospital ( Site 0608) | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Kindai University Hospital ( Site 0607) | Sayama | Osaka | 5898511 | Japan |
| Saitama Prefectural Cancer Center ( Site 0603) | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center ( Site 0605) | Sunto-gun, | Shizuoka | 411-8777 | Japan |
| National Hospital Organization Kyushu Cancer Center ( Site 0609) | Fukuoka | 811-1395 | Japan |
| National Cancer Center Hospital ( Site 0601) | Tokyo | 104-0045 | Japan |
| Japanese Foundation for Cancer Research ( Site 0602) | Tokyo | 135-8550 | Japan |
| Pantai Hospital Kuala Lumpur ( Site 1303) | Bangsar | Kuala Lumpur | 59100 | Malaysia |
| Institut Kanser Negara - National Cancer Institute ( Site 1302) | Putrajaya | Putrajaya | 62250 | Malaysia |
| Beacon Hospital Sdn Bhd ( Site 1305) | Petaling Jaya | Selangor | 46050 | Malaysia |
| University Malaya Medical Centre ( Site 1301) | Kuala Lumpur | 59100 | Malaysia |
| Akershus universitetssykehus ( Site 1352) | Loerenskog | Akershus | 1478 | Norway |
| St Olavs Hospital ( Site 1354) | Trondheim | Sor-Trondelag | 7030 | Norway |
| Universitetssykehuset i Nord Norge. ( Site 1355) | Tromsø | Troms | 9019 | Norway |
| Helse Bergen HF - Haukeland univeritetssykehus ( Site 1353) | Bergen | Vestfold | 5053 | Norway |
| Oslo Universitetssykehus HF. Ulleval ( Site 1351) | Oslo | 0450 | Norway |
| Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0871) | Ufa | Baskortostan, Respublika | 450054 | Russia |
| SRBHI of Kirov Region Center of Oncology and medical radiology ( Site 0854) | Kirov | Kirov Oblast | 105094 | Russia |
| Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0870) | Moscow | Moscow | 105094 | Russia |
| FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 0851) | Moscow | Moscow | 115682 | Russia |
| City Hospital #40 ( Site 0853) | Saint Petersburg | Sankt-Peterburg | 197706 | Russia |
| Clinical Research Center of specialized types medical care-Oncology ( Site 0860) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0872) | Tomsk | Tomsk Oblast | 634045 | Russia |
| Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0850) | Yaroslavl | Yaroslavl Oblast | 150054 | Russia |
| SHBI "Leningrad Regional Clinical Oncology Dispensary n.a. L.D. Roman"-Clinical Trials Department ( | Saint Petersburg | 188663 | Russia |
| Cancer Care Langenhoven Drive Oncology Centre ( Site 1504) | Port Elizabeth | Eastern Cape | 6045 | South Africa |
| Sandton Oncology Medical Group PTY LTD ( Site 1501) | Sandton | Gauteng | 2196 | South Africa |
| Cape Town Oncology Trials Pty Ltd ( Site 1506) | Kraaifontein | Western Cape | 7570 | South Africa |
| Cancercare Rondebosch Oncology ( Site 1509) | Rondebosch | Western Cape | 7700 | South Africa |
| Asan Medical Center ( Site 0650) | Songpagu | Seoul | 05505 | South Korea |
| Seoul National University Hospital ( Site 0653) | Seoul | 03080 | South Korea |
| Severance Hospital ( Site 0652) | Seoul | 03722 | South Korea |
| Samsung Medical Center ( Site 0651) | Seoul | 06351 | South Korea |
| Hospital Universitari Vall d Hebron ( Site 0900) | Barcelona | 08035 | Spain |
| Hospital Sant Pau i la Santa Creu ( Site 0905) | Barcelona | 08041 | Spain |
| Hospital Clinico San Carlos ( Site 0902) | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre ( Site 0901) | Madrid | 28041 | Spain |
| Hospital Universitario Virgen Macarena ( Site 0906) | Seville | 41009 | Spain |
| Chang Gung Medical Foundation - Kaohsiung ( Site 0956) | Kaohsiung City | Changhua | 833 | Taiwan |
| China Medical University Hospital ( Site 0953) | Taichung | 40447 | Taiwan |
| National Cheng Kung University Hospital ( Site 0955) | Tainan | 704 | Taiwan |
| National Taiwan University Hospital ( Site 0950) | Taipei | 10048 | Taiwan |
| Taipei Veterans General Hospital ( Site 0951) | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation. Linkou ( Site 0952) | Taoyuan | 333 | Taiwan |
| Baskent Universitesi Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1007) | Adana | 01120 | Turkey (Türkiye) |
| Acibadem Adana Hastanesi ( Site 1008) | Adana | 01130 | Turkey (Türkiye) |
| Gulhane Egitim ve Arastirma Hastanesi ( Site 1009) | Ankara | 06010 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi ( Site 1003) | Ankara | 06230 | Turkey (Türkiye) |
| Ankara Sehir Hastanesi ( Site 1005) | Ankara | 06800 | Turkey (Türkiye) |
| Antalya Egitim ve Arastirma Hastanesi ( Site 1010) | Antalya | 07100 | Turkey (Türkiye) |
| Goztepe Prof.Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1002) | Istanbul | 34722 | Turkey (Türkiye) |
| Ege Universitesi Tip Fakultesi Hastanesi ( Site 1006) | Izmir | 35100 | Turkey (Türkiye) |
| Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1657) | Dnipro | Dnipropetrovsk Oblast | 49102 | Ukraine |
| MI Precarpathian Clinical Oncology Center ( Site 1654) | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| Ukrainian Center of Tomotherapy ( Site 1658) | Kropyvnytskyi | Kirovohrad Oblast | 25011 | Ukraine |
| Odessa Regional Clinical Hospital ( Site 1664) | Odesa | Odesa Oblast | 65025 | Ukraine |
| University College London Hospitals NHS Foundation Trust ( Site 1056) | London | Camden | WC1E 6AG | United Kingdom |
| Royal Marsden NHS Foundation Trust ( Site 1064) | London | London, City of | SW3 6JJ | United Kingdom |
| Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 1052) | London | London, City of | W12 0HS | United Kingdom |
| Royal Marsden NHS Trust ( Site 1063) | Sutton | London, City of | SM25PT | United Kingdom |
| University Hospital Coventry & Warwickshire ( Site 1062) | Coventry | Warwickshire | CV2 2DX | United Kingdom |
| Velindre Cancer Centre ( Site 1058) | Cardiff | United Kingdom |
| Leeds Teaching Hospitals NHS Trust ( Site 1050) | Leeds | LS9 7TF | United Kingdom |
| Plain Language Summary | View source |
At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Favezelimab/Pembrolizumab | Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions. |
| BG001 | Standard of Care (Regorafenib or TAS-102) | At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Geographic Region | Randomization of participants was stratified by the geographic region of the participants (Asia Pacific or Europe, the Middle East and Africa [EMEA]/Americas). | Count of Participants | Participants |
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| Presence of Liver Metastasis | Randomization of participants was stratified by the presence of liver metastasis (Yes or No). | Count of Participants | Participants |
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| Time from Initial Diagnosis of Metastatic Disease to Randomization | Randomization of participants was stratified by the time from initial diagnosis of metastatic disease to randomization (≥18 months or <18 months). | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. | All randomized participants were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 33 months |
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| Secondary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. | All randomized participants were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 21 months |
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| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | ORR was defined as the percentage of participants who achieved 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 lesion) per RECIST 1.1 as assessed by BICR. | All randomized participants were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 21 months |
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| Secondary | Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | For participants who demonstrate confirmed CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions), duration of response was defined as the time from the first documented evidence of CR or PR until progressive disease (PD) or death due to any cause. 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. | All randomized participants who experienced a confirmed CR or PR were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 21 months |
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| Secondary | Number of Participants Who Experienced at Least One Adverse Event (AE) | An AE was 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. | All randomized participants who received at least one dose of study intervention were analyzed. | Posted | Count of Participants | Participants | Up to approximately 31 months |
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| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | An AE was 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. The number of participants who discontinued study treatment due to an AE is presented. | All randomized participants who received at least one dose of study intervention were analyzed. | Posted | Count of Participants | Participants | Up to approximately 28 months |
|
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| Secondary | Change From Baseline in European Organisation 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 cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "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). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. | All randomized participants who have received at least one dose of the study intervention and had at least one EORTC QLQ-C30 assessment data available for this outcome measure were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and up to approximately 8 weeks |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome | All randomized participants who have received at least one dose of the study intervention and had at least one EORTC QLQ-C30 assessment data available for this outcome measure were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and up to approximately 8 weeks |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for appetite loss (QLQ-C30 Item 13). For this item, individual responses to the question "Have you lacked appetite?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 appetite loss (Item 13) scale score will be presented. | All randomized participants who have received at least one dose of the study intervention and had at least one EORTC QLQ-C30 assessment data available for this outcome measure were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and up to approximately 8 weeks |
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| Secondary | Change From Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score | The EORTC QLQ-CR29 is a health-related quality-of life (QoL) questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). For this item, individual responses to the question "Did you have a bloated feeling in your abdomen?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-CR29 bloating (Item 37) scale score will be presented. | All randomized participants who have received at least one dose of the study intervention and had at least one EORTC QLQ-CR29 assessment data available for this outcome measure were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and up to approximately 8 weeks |
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| Secondary | Time to Deterioration (TTD) in EORTC QLQ-C30 GHS (Item 29) and QoL (Item 30) Combined Score | TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in GHS (EORTC QLQ-C30 Item 29) & QoL combined score (EORTC QLQ-C30 Item 30). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome. | All randomized participants who have received at least one dose of the study intervention and had EORTC QLQ-C30 assessment data available at baseline for this outcome measure were analyzed. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 38 months |
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| Secondary | TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score | TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome. | All randomized participants who have received at least one dose of the study intervention and had EORTC QLQ-C30 assessment data available at baseline for this outcome measure were analyzed. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 38 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in in EORTC QLQ-C30 Appetite Loss (Item 13) Score | TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in appetite loss score (EORTC QLQ-C30 Item 13). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome. | All randomized participants who have received at least one dose of the study intervention and had EORTC QLQ-C30 assessment data available at baseline for this outcome measure were analyzed. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 38 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score | TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in bloating score (QLQ-CR29 Item 37). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in appetite loss score, will be presented. A longer TTD indicates a better outcome. | All randomized participants who have received at least one dose of the study intervention and had EORTC QLQ-CR29 assessment data available at baseline for this outcome measure were analyzed. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 38 months |
|
Up to approximately 38 months
Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Favezelimab/Pembrolizumab | Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions. | 202 | 221 | 75 | 221 | 193 | 221 |
| EG001 | Standard of Care (Regorafenib or TAS-102) | At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle. | 203 | 220 | 56 | 210 | 187 | 210 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Addison's disease | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rectal stenosis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatorenal failure | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Anal fistula infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour perforation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary cavitation | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated dermatitis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Jul 31, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C559147 | regorafenib |
| C000613803 | trifluridine tipiracil drug combination |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| EMEA/Americas |
|
| No |
|
| <18 months |
|
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