Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-7902-017 | Other Identifier | MSD | |
| LEAP-017 | Other Identifier | MSD | |
| E7080-G000-325 | Other Identifier | Eisai | |
| jRCT2031200453 | Registry Identifier | jRCT | |
| 2020-004289-20 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride).
The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.
The Global portion, or Global Cohort, will include all participants who are enrolled during the Global enrollment period and will be the primary analysis population for the study. After enrollment of the global portion of the study is complete, the study will remain open to enrollment in China alone until the target number of participants from China have been enrolled to meet local regulatory requirements.
The China Cohort will include both participants enrolled in China for the Global Cohort plus those participants enrolled in China as part of the China extension enrollment period.
Per the supplemental Statistical Analysis Plan (sSAP), China participants randomized after the enrollment of the global portion is closed as part of the China extension enrollment period will not be included in the global analysis populations.
As pre-specified in the protocol, safety and efficacy outcome measures for the China Cohort will be analyzed separately from the Global Cohort.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lenvatinib+pembrolizumab | Experimental | Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week (Q6W) Cycle for up to 18 cycles (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily until progressive disease. |
|
| standard of care treatment (regorafenib OR TAS-102) | Active Comparator | Participants receive regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pembrolizumab | Drug | IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Cohort: Overall Survival (OS) | OS was defined as the time from randomization to the date of death from any cause. Per the supplemental Statistical Analysis Plan (sSAP), Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
| China Cohort: Overall Survival (OS) | OS was defined as the time from randomization to the date of death from any cause. Per the sSAP, the China Cohort was evaluated for efficacy separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| Measure | Description | Time Frame |
|---|---|---|
| Global Cohort: 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 date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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 demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per modified RECIST 1.1 is presented. Per the sSAP, Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. |
Not provided
Inclusion Criteria:
Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma (Stage IV A, B and C as defined by American Joint Committee on Cancer [AJCC] 8th edition). Note: Tumor must be determined to be NOT microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) by local testing
Has been previously treated for their disease and has shown disease progression as defined by RECIST 1.1 on or after or could not tolerate standard treatment, which must include ALL of the following agents if approved and locally available in the country where the participant is randomized:
Has measurable disease per RECIST 1.1 assessed by the investigator
Has provided to a designated central laboratory an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion which has not been previously irradiated
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days prior to randomization
Has a life expectancy of at least 3 months, based on the investigator assessment
Has the ability to swallow capsules or ingest a suspension orally or by a feeding tube
Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 millimeter of mercury (mmHg) with no change in antihypertensive medications within 1 week prior to randomization
Male participants must agree to the following during the treatment period and for at least 90 days after the last dose of regorafenib or TAS-102 and at least 7 days after the last dose of lenvatinib: refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle or use contraception. The male contraception period should continue for at least 7 days after discontinuation of lenvatinib
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a highly-effective contraceptive method during the treatment period and for at least 30 days after the last dose of lenvatinib, 120 days after the last dose of pembrolizumab, and 180 days after the last dose of regorafenib or TAS-102 (whichever is last) AND agrees not to donate eggs (ova, oocytes)
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study treatment
Exclusion Criteria:
Participants with cardiac failure NYHA Class II, III and IV are not allowed to be assigned to the regorafenib in Arm B
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Cancer Care ( Site 0031) | Monterey | California | 93940 | United States | ||
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0021) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38833658 | Result | Kawazoe A, Xu RH, Garcia-Alfonso P, Passhak M, Teng HW, Shergill A, Gumus M, Qvortrup C, Stintzing S, Towns K, Kim TW, Shiu KK, Cundom J, Ananda S, Lebedinets A, Fu R, Jain R, Adelberg D, Heinemann V, Yoshino T, Elez E; LEAP-017 Investigators. Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study. J Clin Oncol. 2024 Aug 20;42(24):2918-2927. doi: 10.1200/JCO.23.02736. Epub 2024 Jun 4. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Primary Completion for the study is being updated to 27-Sep-2024 to reflect that the protocol specified non-alpha controlled final analyses for the China Cohort was conducted with a 27-Sep 2024 data cutoff, after the protocol-specified final analyses of the Global Cohort was completed on 20-Feb-2023. Final Analysis of all outcome measures for the Global Cohort was conducted with a data cut-off of 20-Feb-2023.
A total of 480 participants were enrolled in the Global Cohort, including 17 participants from China. An additional 83 participants were subsequently enrolled in the China extension, bringing the total number of participants in the China Cohort to 100 and the overall study population to 563. These results have been updated to include data from the China Cohort.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lenvatinib+Pembrolizumab | Participants received pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week (Q6W) Cycle for up to 18 cycles (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily until progressive disease. |
| FG001 | Standard of Care (SOC) Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2022 | Sep 29, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| lenvatinib | Drug | oral capsule |
|
|
| regorafenib | Drug | oral tablet |
|
|
| TAS-102 (trifluridine and tipiracil) | Drug | oral tablet |
|
|
| Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
| China Cohort: 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 date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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 demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per modified RECIST 1.1 is presented. Per the sSAP, the China Cohort was evaluated for efficacy separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| Global Cohort: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR per modified RECIST 1.1 assessed by BICR is presented. Per the sSAP, Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
| China Cohort: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR per modified RECIST 1.1 assessed by BICR is presented. Per the sSAP, the China Cohort was evaluated for efficacy separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| Global Cohort: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR per modified RECIST 1.1 is presented. Per the sSAP, Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
| China Cohort: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR per modified RECIST 1.1 is presented. Per the sSAP, the China Cohort was evaluated for efficacy separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| Global Cohort: Number of Participants Who Experience an Adverse Event (AE) | An adverse event is defined as 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. 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 intervention. Per the sSAP, Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
| China Cohort: Number of Participants Who Experience an Adverse Event (AE) | An adverse event is defined as 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. 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 intervention. Per the sSAP, the China Cohort was evaluated for safety separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| Global Cohort: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | An adverse event is defined as 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. 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 intervention. The number of participants who discontinued any study treatment due to an adverse event is presented. Per the sSAP, Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
| China Cohort: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | An adverse event is defined as 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. 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 intervention. The number of participants who discontinued any study treatment due to an adverse event is presented. Per the sSAP, the China Cohort was evaluated for safety separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | Up to approximately 28 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| Global Cohort: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score is presented. A higher score indicates a better outcome. | Baseline and 8 weeks |
| Global Cohort: 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function. The change from baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) scale score is presented. | Baseline and 8 weeks |
| Global Cohort: 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 is presented. | Baseline and 8 weeks |
| Global Cohort: 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 is presented. | Baseline and 8 weeks |
| Global Cohort: Time to Deterioration (TTD) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (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 Global Health Status (GHS; EORTC QLQ-C30 Item 29) & Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. 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 GHS and QoL combined score, is presented. A longer TTD indicates a better outcome. | Up to approximately 21 months |
| Global Cohort: TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) 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 (QLQ-C30 Items 1-5). 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, is presented. A longer TTD indicates a better outcome. | Up to approximately 21 months |
| Global Cohort: TTD 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 (increase) from baseline in appetite loss (QLQ-C30 Item 13) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point change (increase) from baseline in appetite loss score, is presented. A longer TTD indicates a better outcome. | Up to approximately 21 months |
| Global Cohort: 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 (increase) from baseline in bloating (QLQ-CR29 Item 37) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point change (increase) from baseline in bloating score, is presented. A longer TTD indicates a better outcome. | Up to approximately 21 months |
| Marietta |
| Georgia |
| 30060 |
| United States |
| University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P | Chicago | Illinois | 60637 | United States |
| MFSMC-HJWCI-Oncology Research ( Site 0012) | Baltimore | Maryland | 21237 | United States |
| MedStar Good Samaritan Hospital-Oncology Research ( Site 0038) | Baltimore | Maryland | 21239 | United States |
| Henry Ford Hospital ( Site 0024) | Detroit | Michigan | 48202 | United States |
| St. Vincent Frontier Cancer Center ( Site 0005) | Billings | Montana | 59102 | United States |
| Providence Portland Medical Center ( Site 0019) | Portland | Oregon | 97213 | United States |
| Thomas Jefferson University - Clinical Trials Office ( Site 0027) | Philadelphia | Pennsylvania | 19107 | United States |
| Inova Schar Cancer Institute ( Site 0022) | Fairfax | Virginia | 22031 | United States |
| Blue Ridge Cancer Care ( Site 0036) | Roanoke | Virginia | 24014 | United States |
| Northwest Medical Specialties, PLLC ( Site 0033) | Tacoma | Washington | 98405 | United States |
| Hospital Británico de Buenos Aires-Oncology ( Site 0308) | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1280AEB | Argentina |
| Fundación favaloro para la Docencia e Investigación Médica-Oncología ( Site 0301) | Buenos Aires | Buenos Aires F.D. | C1096AAS | Argentina |
| Instituto de Oncología de Rosario ( Site 0305) | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0303) | Buenos Aires | 1431 | Argentina |
| IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0300) | Buenos Aires | C1012AAR | Argentina |
| Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si | Brisbane | Queensland | 4029 | Australia |
| Gallipoli Medical Research Foundation-GMRF CTU ( Site 1500) | Greenslopes | Queensland | 4120 | Australia |
| The Queen Elizabeth Hospital-Cancer Clinical Trials ( Site 1503) | Woodville | South Australia | 5011 | Australia |
| Epworth Freemasons ( Site 1506) | Melbourne | Victoria | 3002 | Australia |
| Western Health-Sunshine & Footscray Hospitals ( Site 1501) | St Albans | Victoria | 3021 | Australia |
| Hollywood Private Hospital-Medical Oncology ( Site 1507) | Perth | Western Australia | 6009 | Australia |
| Cross Cancer Institute-Department of Medical Oncology ( Site 0207) | Edmonton | Alberta | T6G 1Z2 | Canada |
| NSHA-QEII Health Sciences Centre-Dickson Bldg-Dept. of Medical Oncology ( Site 0200) | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205) | Hamilton | Ontario | L8V 4X2 | Canada |
| North York General Hospital ( Site 0206) | Toronto | Ontario | M2K1E1 | Canada |
| CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0211) | Montreal | Quebec | H1T 2M4 | Canada |
| CHU de Quebec - Université Laval - Hotel Dieu de Quebec-Hemato-Dermato-Gyneco-Oncology ( Site 0203) | Québec | Quebec | G1R 3S1 | Canada |
| The First People's Hospital of Foshan-Gastrointestinal oncology ( Site 1604) | Foshan | Guangdong | 528041 | China |
| SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1600) | Guangzhou | Guangdong | 510060 | China |
| Sir Run Run Shaw Hospital-Medical Oncology ( Site 1606) | Hangzhou | Zhejiang | 310016 | China |
| Rigshospitalet ( Site 0702) | Copenhagen | Capital Region | 2100 | Denmark |
| Herlev and Gentofte Hospital-Department of Oncology ( Site 0704) | Copenhagen | Capital Region | 2730 | Denmark |
| Odense Universitetshospital ( Site 0700) | Odense | Region Syddanmark | 5000 | Denmark |
| Vejle Sygehus-Department of Oncology ( Site 0701) | Vejle | Region Syddanmark | DK-7100 | Denmark |
| Klinikum am Steinenberg-Kreiskliniken Reutlingen GmbH ( Site 0908) | Reutlingen | Baden-Wurttemberg | 72764 | Germany |
| klinikum rechts der isar der technischen universität münchen-Klinik und Poliklinik für Innere Mediz | Munich | Bavaria | 81675 | Germany |
| Onkodok GmbH ( Site 0907) | Gütersloh | North Rhine-Westphalia | 33332 | Germany |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901) | Berlin | 10117 | Germany |
| Asklepios Altona-Oncology ( Site 0903) | Hamburg | 22763 | Germany |
| Rambam Health Care Campus-Oncology ( Site 0800) | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center-Oncology ( Site 0804) | Jerusalem | 9013102 | Israel |
| Hadassah Medical Center-Oncology ( Site 0802) | Jerusalem | 9112001 | Israel |
| Sheba Medical Center ( Site 0803) | Ramat Gan | 5262100 | Israel |
| Sourasky Medical Center-Oncology ( Site 0801) | Tel Aviv | 6423906 | Israel |
| Aichi Cancer Center Hospital ( Site 1701) | Nagoya | Aichi-ken | 4648681 | Japan |
| National Cancer Center Hospital East ( Site 1700) | Kashiwa | Chiba | 277-8577 | Japan |
| Kobe City Medical Center General Hospital ( Site 1707) | Kobe | Hyōgo | 650-0047 | Japan |
| Kagawa University Hospital ( Site 1708) | Kita | Kagawa-ken | 761-0701 | Japan |
| Kanagawa cancer center ( Site 1705) | Yokohama | Kanagawa | 2418515 | Japan |
| Kindai University Hospital- Osakasayama Campus-Medical Oncology ( Site 1704) | Sayama | Osaka | 589-8511 | Japan |
| Saitama Prefectural Cancer Center ( Site 1703) | Ina-machi | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center ( Site 1706) | Nakatogari | Shizuoka | 411-8777 | Japan |
| National Hospital Organization Kyushu Cancer Center ( Site 1709) | Fukuoka | 811-1395 | Japan |
| National Cancer Center Hospital ( Site 1702) | Tokyo | 104-0045 | Japan |
| Japanese Foundation for Cancer Research-GI Oncology ( Site 1710) | Tokyo | 135-8550 | Japan |
| GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1109) | Ufa | Baskortostan, Respublika | 450054 | Russia |
| Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1100) | Saint Petersburg | Leningradskaya Oblast' | 198255 | Russia |
| The National Medico-Surgical Center N.I. Pirogov ( Site 1102) | Moscow | Moscow | 105203 | Russia |
| Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1107) | Moscow | Moscow | 115478 | Russia |
| First Moscow State Medical University I.M. Sechenov-Interhospital Institution ""Health Management ( | Moscow | Moscow | 119991 | Russia |
| SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY ( Site 1108) | Yekaterinburg | Sverdlovsk Oblast | 620905 | Russia |
| SHBI Leningrad Regional Clinical Oncology Dispensary-Clinical Trials Department ( Site 1111) | Saint Petersburg | 188663 | Russia |
| Korea University Anam Hospital ( Site 1806) | Seoul | 02841 | South Korea |
| Seoul National University Hospital-Internal Medicine ( Site 1800) | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1801) | Seoul | 03722 | South Korea |
| Asan Medical Center ( Site 1803) | Seoul | 05505 | South Korea |
| Samsung Medical Center-Division of Hematology/Oncology ( Site 1804) | Seoul | 06351 | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1802) | Seoul | 06591 | South Korea |
| Hospital Universitario Marqués de Valdecilla ( Site 1201) | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Central de Asturias-Digestive ( Site 1200) | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitari Vall d'Hebron-Oncology ( Site 1204) | Barcelona | 08035 | Spain |
| HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1205) | Madrid | 28007 | Spain |
| Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1207) | Seville | 41014 | Spain |
| China Medical University Hospital-Surgical Department ( Site 1903) | Taichung | 40447 | Taiwan |
| NATIONAL CHENG-KUNG UNI. HOSP. ( Site 1904) | Tainan | 704 | Taiwan |
| National Taiwan University Hospital ( Site 1900) | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital-Oncology ( Site 1901) | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation.Linkou Branch ( Site 1902) | Taoyuan | 333 | Taiwan |
| Hacettepe Universitesi-oncology hospital ( Site 1302) | Ankara | 06230 | Turkey (Türkiye) |
| Memorial Ankara Hastanesi-Medical Oncology ( Site 1304) | Ankara | 06520 | Turkey (Türkiye) |
| Trakya University-Oncology ( Site 1303) | Edirne | 22030 | Turkey (Türkiye) |
| Acıbadem Maslak Hastanesi ( Site 1307) | Istanbul | 34457 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1300) | Istanbul | 34668 | Turkey (Türkiye) |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1301) | Istanbul | 34722 | Turkey (Türkiye) |
| Ege University Medicine of Faculty-Medical Oncology ( Site 1305) | Izmir | 35100 | Turkey (Türkiye) |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1306) | Malatya | 44280 | Turkey (Türkiye) |
| Addenbrooke's Hospital ( Site 1407) | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| UCLH-Cancer Clinical Trials Unit ( Site 1400) | London | Essex | NW1 2PG | United Kingdom |
| Guy's & St Thomas' NHS Foundation Trust ( Site 1404) | London | London, City of | SE1 9RT | United Kingdom |
| ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1403) | London | London, City of | SW3 6JJ | United Kingdom |
| Western General Hospital ( Site 1401) | Edinburgh | Midlothian | EH4 2XU | United Kingdom |
| Royal Marsden Hospital (Sutton) ( Site 1409) | London | Surrey | SM3 5PT | United Kingdom |
| The Christie-Medical Oncology ( Site 1411) | Manchester | M20 4BX | United Kingdom |
| Plain Language Summary | View source |
Participants received regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease. |
| Treated |
|
| Global Cohort Efficacy |
|
| China Cohort Efficacy |
|
| Global Cohort Safety |
|
| China Cohort Safety |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics include data from 480 participants in the Global Cohort and 83 participants from the China extension (Total Study N=563)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lenvatinib+Pembrolizumab | Participants received pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week (Q6W) Cycle for up to 18 cycles (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily until progressive disease. |
| BG001 | Standard of Care (SOC) Treatment | Participants received regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Presence of Liver Metastasis | Number of participants with liver metastasis at baseline (Yes/No) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Global Cohort: 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 date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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 demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per modified RECIST 1.1 is presented. Per the sSAP, Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | All randomized participants in the Global Cohort included in the treatment arm to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | China Cohort: 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 date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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 demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per modified RECIST 1.1 is presented. Per the sSAP, the China Cohort was evaluated for efficacy separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | All randomized participants in the China Cohort (17 participants enrolled in the Global Cohort and 83 participants enrolled in the China extension) included in the treatment arm to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR per modified RECIST 1.1 assessed by BICR is presented. Per the sSAP, Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | All randomized participants in the Global Cohort included in the treatment arm to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | China Cohort: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR per modified RECIST 1.1 assessed by BICR is presented. Per the sSAP, the China Cohort was evaluated for efficacy separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | All randomized participants in the China Cohort (17 participants enrolled in the Global Cohort and 83 participants enrolled in the China extension) included in the treatment arm to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR per modified RECIST 1.1 is presented. Per the sSAP, Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | Randomized participants in the Global Cohort who had a confirmed complete or partial response, included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | China Cohort: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR per modified RECIST 1.1 is presented. Per the sSAP, the China Cohort was evaluated for efficacy separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | Randomized participants in the China Cohort (17 participants enrolled in the Global Cohort and 83 participants enrolled in the China extension) who had a confirmed complete or partial response, included in the treatment arm to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: Number of Participants Who Experience an Adverse Event (AE) | An adverse event is defined as 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. 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 intervention. Per the sSAP, Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | All randomized participants in the Global Cohort who received at least one dose of study treatment. Two participants randomized to pembrolizumab plus lenvatinib group were incorrectly treated with SOC; these participants were included in the SOC group for safety analyses. | Posted | Count of Participants | Participants | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | China Cohort: Number of Participants Who Experience an Adverse Event (AE) | An adverse event is defined as 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. 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 intervention. Per the sSAP, the China Cohort was evaluated for safety separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | All randomized participants in the China Cohort (17 participants enrolled in the Global Cohort and 83 participants enrolled in the China extension) who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | An adverse event is defined as 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. 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 intervention. The number of participants who discontinued any study treatment due to an adverse event is presented. Per the sSAP, Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | All randomized participants in the Global Cohort who received at least one dose of study treatment. Two participants randomized to pembrolizumab plus lenvatinib group were incorrectly treated with SOC; these participants were included in the SOC group for safety analyses. | Posted | Count of Participants | Participants | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | China Cohort: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | An adverse event is defined as 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. 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 intervention. The number of participants who discontinued any study treatment due to an adverse event is presented. Per the sSAP, the China Cohort was evaluated for safety separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | All randomized participants in the China Cohort (17 participants enrolled in the Global Cohort and 83 participants enrolled in the China extension) who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 28 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score is presented. A higher score indicates a better outcome. | All participants in the Global Cohort who have at least one assessment available for EORTC QLQ-C30 and have received at least one dose of the study intervention. Per the sSAP, this Patient Reported Outcome (PRO) was not pre-specified for the China Cohort and was thus not analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function. The change from baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) scale score is presented. | All participants in the Global Cohort who have at least one assessment available for EORTC QLQ-C30 and have received at least one dose of the study intervention. Per the sSAP, this PRO was not pre-specified for the China Cohort and was thus not analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: 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 is presented. | All participants in the Global Cohort who have at least one assessment available for EORTC QLQ-C30 appetite loss and have received at least one dose of the study intervention. Per the sSAP, this PRO was not pre-specified for the China Cohort and was thus not analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: 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 is presented. | All participants in the Global Cohort who have at least one assessment available for EORTC QLQ-CR29 and have received at least one dose of the study intervention. Per the sSAP, this PRO was not pre-specified for the China Cohort and was thus not analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: Time to Deterioration (TTD) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (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 Global Health Status (GHS; EORTC QLQ-C30 Item 29) & Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. 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 GHS and QoL combined score, is presented. A longer TTD indicates a better outcome. | All participants in the Global Cohort who have at least one assessment available for EORTC QLQ-C30 GHS/QoL TTD and have received at least one dose of the study intervention. Per the sSAP, this PRO was not pre-specified for the China Cohort and was thus not analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 21 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) 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 (QLQ-C30 Items 1-5). 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, is presented. A longer TTD indicates a better outcome. | All participants in the Global Cohort who have at least one assessment available for EORTC QLQ-C30 Physical Functioning TTD and have received at least one dose of the study intervention. Per the sSAP, this PRO was not pre-specified for the China Cohort and was thus not analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 21 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: TTD 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 (increase) from baseline in appetite loss (QLQ-C30 Item 13) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point change (increase) from baseline in appetite loss score, is presented. A longer TTD indicates a better outcome. | All participants in the Global Cohort who have at least one assessment available for EORTC QLQ-C30 Appetite Loss TTD and have received at least one dose of the study intervention. Per the sSAP, this PRO was not pre-specified for the China Cohort and was thus not analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 21 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Cohort: 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 (increase) from baseline in bloating (QLQ-CR29 Item 37) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point change (increase) from baseline in bloating score, is presented. A longer TTD indicates a better outcome. | All participants in the Global Cohort who have at least one assessment available for EORTC QLQ-CR29 Bloating TTD and have received at least one dose of the study intervention. Per the sSAP, this PRO was not pre-specified for the China Cohort and was thus not analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 21 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Global Cohort: Overall Survival (OS) | OS was defined as the time from randomization to the date of death from any cause. Per the supplemental Statistical Analysis Plan (sSAP), Final Analysis for the Global Cohort was performed with a data cut-off date of 20-Feb-2023. | All randomized participants in the Global Cohort included in the treatment arm to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 22 months (through sSAP pre-specified Final Analysis database cut-off date of 20-Feb-2023) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | China Cohort: Overall Survival (OS) | OS was defined as the time from randomization to the date of death from any cause. Per the sSAP, the China Cohort was evaluated for efficacy separately from the Global Cohort, with Final Analysis performed using a data cut-off of 27-Sep-2024. | All randomized participants in the China Cohort (17 participants enrolled in the Global Cohort and 83 participants enrolled in the China extension) included in the treatment arm to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 35 months (through sSAP pre-specified Final Analysis database cut-off date of 27-Sep-2024) |
|
Up to approximately 41 months (through End of Trial database cut-off date of 27-Sep-2024)
The population for all-cause mortality includes all participants (N=563) in the treatment arm to which they were randomized. Serious and other AEs include all treated participants according to treatment received. 2 participants randomized to lenvatinib plus pembrolizumab were incorrectly treated with SOC and were included in SOC arm. Per protocol, MedDRA V27.0 terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
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 | Lenvatinib + Pembrolizumab | Participants received pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week (Q6W) Cycle for up to 18 cycles (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily until progressive disease. | 251 | 282 | 117 | 279 | 273 | 279 |
| EG001 | Standard Of Care Treatment | Participants received regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease. | 264 | 281 | 66 | 277 | 263 | 277 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant biliary obstruction | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fournier's gangrene | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Spontaneous bacterial peritonitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Stoma prolapse | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Clostridium test positive | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Granulocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Sinonasal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 27.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
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 |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2025 | Sep 29, 2025 | SAP_002.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 |
| C531958 | lenvatinib |
| C559147 | regorafenib |
| C000613803 | trifluridine tipiracil drug combination |
| D014271 | Trifluridine |
| C000613754 | tipiracil |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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 |
|
| No |
|
| Standard of Care (SOC) Treatment |
Participants enrolled in China received regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease. |
|
|
|
|
|
|
|
|
|
Participants received regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease. |
|
|
| OG001 | Standard of Care (SOC) Treatment | Participants enrolled in China received regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease. |
|
|
|
|
|
|
Participants received regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease.
|
|
Participants enrolled in China received regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease.
|
|
Participants received regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|