A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Colorectal Cancer Clinical Trial

Official title:

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (KEYFORM-007)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05064059
• Other study ID #: 4280A-007
• Secondary ID: MK-4280A-007jRCT
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 10, 2021
• Est. completion date: November 11, 2025

Study information

• Verified date: April 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 432
• Est. completion date: November 11, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable.
• Has measurable disease per RECIST 1.1 as assessed by the local site investigator.
• Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
• Submits an archival (= 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
• Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention.
• Has a life expectancy of at least 3 months, based on the investigator assessment.
• Has the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption.
• Has adequate organ function.

Exclusion Criteria:

• Has previously been found to have deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
• Has a history of acute or chronic pancreatitis.
• Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
• Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
• Has urine protein greater than or equal to 1g/24h.
• A woman of childbearing potential who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention.
• Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).
• Has previously received regorafenib or TAS-102.
• Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization.
• Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or bacterial infections, etc.).
• Has a known history of human immunodeficiency virus (HIV) infection.
• Has known history of Hepatitis B or known active Hepatitis C virus infection.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
• Has had an allogenic tissue/solid organ transplant.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• favezelimab/pembrolizumab
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion

Drug:
• regorafenib
Oral
• TAS-102
Oral

Locations

Country	Name	City	State
Australia	Frankston Hospital ( Site 0056)	Frankston	Victoria
Australia	Royal Brisbane and Women s Hospital ( Site 0058)	Herston	Queensland
Australia	St John of God Subiaco Hospital ( Site 0051)	Perth	Western Australia
Australia	Western Health-Sunshine & Footscray Hospitals ( Site 0052)	St Albans	Victoria
Australia	Westmead Hospital ( Site 0057)	Westmead	New South Wales
Australia	Queen Elizabeth Hospital ( Site 0050)	Woodville South	South Australia
Canada	London Regional Cancer Program - London HSC ( Site 0154)	London	Ontario
Canada	The Ottawa Hospital ( Site 0151)	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0155)	Toronto	Ontario
Chile	IC La Serena Research ( Site 0202)	La Serena	Coquimbo
Chile	Clinica Puerto Montt ( Site 0211)	Puerto Montt	Los Lagos
Chile	Bradfordhill ( Site 0200)	Santiago	Region M. De Santiago
Chile	Clínica Vespucio ( Site 0205)	Santiago	Region M. De Santiago
Chile	Fundacion Arturo Lopez Perez FALP ( Site 0208)	Santiago	Region M. De Santiago
Chile	Oncovida ( Site 0209)	Santiago	Region M. De Santiago
Chile	Pontificia Universidad Catolica de Chile ( Site 0206)	Santiago	Region M. De Santiago
Chile	Centro Investigacion Cancer James Lind ( Site 0204)	Temuco	Araucania
China	Jilin Cancer Hospital ( Site 1163)	Changchun	Jilin
China	Hunan Cancer Hospital ( Site 1174)	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University ( Site 1175)	Changsha	Hunan
China	Xiangya Hospital Central South University ( Site 1171)	Changsha	Hunan
China	Changzhou Cancer Hospital-Department of Oncology ( Site 1183)	Changzhou	Jiangsu
China	West China Hospital Sichuan University ( Site 1172)	Chengdu	Sichuan
China	Chongqing Cancer Hospital ( Site 1151)	Chongqing	Chongqing
China	Fujian Province Cancer Hospital ( Site 1178)	Fuzhou	Fujian
China	Southern Medical University Nanfang Hospital ( Site 1154)	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Center ( Site 1150)	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)	Guangzhou	Guangdong
China	Hainan General Hospital ( Site 1177)	Haikou	Hainan
China	Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital ( Site 1180)	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Anhui Medical University ( Site 1179)	Hefei	Anhui
China	Jinan Central Hospital ( Site 1167)	Jinan	Shandong
China	Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)	Kunming	Yunnan
China	Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center ( Site 1176)	Shangai	Shanghai
China	Shanghai Tenth People's Hospital ( Site 1170)	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute and Hospital ( Site 1161)	Tianjin	Tianjin
China	Hubei Cancer Hospital ( Site 1152)	Wuhan	Hubei
China	Wuhan Union Hospital Cancer Center ( Site 1162)	Wuhan	Hubei
China	Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)	Wuxi City	Jiangsu
Czechia	Masarykuv onkologicky ustav ( Site 1203)	Brno	Brno-mesto
Czechia	Fakultni nemocnice Hradec Kralove ( Site 1207)	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc ( Site 1204)	Olomouc
Czechia	Fakultni nemocnice v Motole ( Site 1201)	Praha	Praha, Hlavni Mesto
Czechia	Fakultni nemocnice Kralovske Vinohrady ( Site 1208)	Praha 10
Czechia	Fakultni Thomayerova nemocnice ( Site 1205)	Praha 4
Czechia	Fakultni nemocnice Na Bulovce ( Site 1202)	Praha 8
France	Institut du Cancer Avignon-Provence ( Site 0306)	Avignon	Vaucluse
France	CHU Hotel Dieu Nantes ( Site 0303)	Nantes	Pays-de-la-Loire
France	Hopital Europeen Georges Pompidou ( Site 0300)	Paris
France	CHU Bordeaux Haut-Leveque ( Site 0305)	Pessac	Gironde
France	CHU Poitiers ( Site 0304)	Poitiers	Vienne
Germany	Johanniter Krankenhaus Bonn ( Site 1254)	Bonn	Nordrhein-Westfalen
Germany	Universitätsklinikum Halle ( Site 1251)	Halle (Saale)	Sachsen-Anhalt
Germany	Katholisches Marienkrankenhaus gGmbH ( Site 1257)	Hamburg
Germany	Philipps-Universitaet Marburg. ( Site 1252)	Marburg	Hessen
Germany	Kliniken Maria Hilf GmbH ( Site 1255)	Moenchengladbach	Nordrhein-Westfalen
Germany	LMU Klinikum Grosshadern der Universitaet Muenchen ( Site 1253)	Muenchen	Bayern
Germany	Klinikum Wolfsburg ( Site 1256)	Wolfsburg	Niedersachsen
Israel	Assuta Ashdod Public ( Site 0507)	Ashdod
Israel	Bnei Zion Medical Center ( Site 0506)	Haifa
Israel	Rambam Health Care Campus-Oncology Division ( Site 0500)	Haifa
Israel	Hadassa Ein Karem Medical Center ( Site 0504)	Jerusalem
Israel	Rabin Medical Center ( Site 0503)	Petah Tikva
Israel	Chaim Sheba Medical Center ( Site 0501)	Ramat Gan
Israel	Sourasky Medical Center ( Site 0502)	Tel Aviv
Italy	A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0553)	Catania
Italy	ASST Grande Ospedale Metropolitano Niguarda ( Site 0550)	Milano
Italy	Universita degli Studi della Campania Luigi Vanvitelli-UOC Oncoematologia ( Site 0556)	Napoli
Italy	Policlinico Gemelli di Roma ( Site 0552)	Roma	Abruzzo
Italy	Istituto Clinico Humanitas - Cancer Center ( Site 0555)	Rozzano	Milano
Italy	IRCCS Casa Sollievo della Sofferenza ( Site 0554)	San Giovanni Rotondo	Foggia
Japan	National Hospital Organization Kyushu Cancer Center ( Site 0609)	Fukuoka
Japan	National Cancer Center Hospital East ( Site 0600)	Kashiwa	Chiba
Japan	Kagawa University Hospital ( Site 0608)	Kita-gun	Kagawa
Japan	Saitama Prefectural Cancer Center ( Site 0603)	Kitaadachi-gun	Saitama
Japan	Kindai University Hospital ( Site 0607)	Osakasayama	Osaka
Japan	Shizuoka Cancer Center ( Site 0605)	Sunto-gun,	Shizuoka
Japan	Japanese Foundation for Cancer Research ( Site 0602)	Tokyo
Japan	National Cancer Center Hospital ( Site 0601)	Tokyo
Korea, Republic of	Samsung Medical Center ( Site 0651)	Seoul
Korea, Republic of	Seoul National University Hospital ( Site 0653)	Seoul
Korea, Republic of	Severance Hospital ( Site 0652)	Seoul
Korea, Republic of	Asan Medical Center ( Site 0650)	Songpagu	Seoul
Malaysia	Pantai Hospital Kuala Lumpur ( Site 1303)	Bangsar	Kuala Lumpur
Malaysia	University Malaya Medical Centre ( Site 1301)	Kuala Lumpur
Malaysia	Beacon Hospital Sdn Bhd ( Site 1305)	Petaling Jaya	Selangor
Malaysia	Institut Kanser Negara - National Cancer Institute ( Site 1302)	Putrajaya	Wilayah Persekutuan Putrajaya
Norway	Helse Bergen HF - Haukeland univeritetssykehus ( Site 1353)	Bergen	Vestfold
Norway	Akershus universitetssykehus ( Site 1352)	Loerenskog	Akershus
Norway	Oslo Universitetssykehus HF. Ulleval ( Site 1351)	Oslo
Norway	Universitetssykehuset i Nord Norge. ( Site 1355)	Tromsoe	Troms
Norway	St Olavs Hospital ( Site 1354)	Trondheim	Sor-Trondelag
Russian Federation	SRBHI of Kirov Region Center of Oncology and medical radiology ( Site 0854)	Kirov	Kirovskaya Oblast
Russian Federation	FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 0851)	Moscow	Moskva
Russian Federation	Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0870)	Moscow	Moskva
Russian Federation	City Hospital #40 ( Site 0853)	Saint Petersburg	Sankt-Peterburg
Russian Federation	Clinical Research Center of specialized types medical care-Oncology ( Site 0860)	Saint-Petersburg	Sankt-Peterburg
Russian Federation	SHBI "Leningrad Regional Clinical Oncology Dispensary n.a. L.D. Roman"-Clinical Trials Department (	Sankt-Peterburg
Russian Federation	Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0872)	Tomsk	Tomskaya Oblast
Russian Federation	Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0871)	Ufa	Baskortostan, Respublika
Russian Federation	Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0850)	Yaroslavl	Yaroslavskaya Oblast
South Africa	Cape Town Oncology Trials Pty Ltd ( Site 1506)	Kraaifontein	Western Cape
South Africa	Cancer Care Langenhoven Drive Oncology Centre ( Site 1504)	Port Elizabeth	Eastern Cape
South Africa	Cancercare Rondebosch Oncology ( Site 1509)	Rondebosch	Western Cape
South Africa	Sandton Oncology Medical Group PTY LTD ( Site 1501)	Sandton	Gauteng
Spain	Hospital Sant Pau i la Santa Creu ( Site 0905)	Barcelona
Spain	Hospital Universitari Vall d Hebron ( Site 0900)	Barcelona
Spain	Hospital Clinico San Carlos ( Site 0902)	Madrid
Spain	Hospital Universitario 12 de Octubre ( Site 0901)	Madrid
Spain	Hospital Universitario Virgen Macarena ( Site 0906)	Sevilla
Taiwan	Chang Gung Medical Foundation - Kaohsiung ( Site 0956)	Kaohsiung	Changhua
Taiwan	China Medical University Hospital ( Site 0953)	Taichung
Taiwan	National Cheng Kung University Hospital ( Site 0955)	Tainan
Taiwan	National Taiwan University Hospital ( Site 0950)	Taipei
Taiwan	Taipei Veterans General Hospital ( Site 0951)	Taipei
Taiwan	Chang Gung Medical Foundation. Linkou ( Site 0952)	Taoyuan
Turkey	Acibadem Adana Hastanesi ( Site 1008)	Adana
Turkey	Baskent Universitesi Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1007)	Adana
Turkey	Ankara Sehir Hastanesi ( Site 1005)	Ankara
Turkey	Gulhane Egitim ve Arastirma Hastanesi ( Site 1009)	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi ( Site 1003)	Ankara
Turkey	Antalya Egitim ve Arastirma Hastanesi ( Site 1010)	Antalya
Turkey	Goztepe Prof.Dr. Suleyman Yalcin Sehir Hastanesi ( Site 1002)	Istanbul
Turkey	Ege Universitesi Tip Fakultesi Hastanesi ( Site 1006)	Izmir
Ukraine	Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1657)	Dnipro	Dnipropetrovska Oblast
Ukraine	MI Precarpathian Clinical Oncology Center ( Site 1654)	Ivano-Frankivsk	Ivano-Frankivska Oblast
Ukraine	Ukrainian Center of Tomotherapy ( Site 1658)	Kropyvnytskyi	Kirovohradska Oblast
Ukraine	Odessa Regional Clinical Hospital ( Site 1664)	Odesa	Odeska Oblast
United Kingdom	Velindre Cancer Centre ( Site 1058)	Cardiff
United Kingdom	University Hospital Coventry & Warwickshire ( Site 1062)	Coventry	Warwickshire
United Kingdom	Leeds Teaching Hospitals NHS Trust ( Site 1050)	Leeds
United Kingdom	Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 1052)	London	London, City Of
United Kingdom	Royal Marsden NHS Foundation Trust ( Site 1064)	London	London, City Of
United Kingdom	University College London Hospitals NHS Foundation Trust ( Site 1056)	London	Camden
United Kingdom	Royal Marsden NHS Trust ( Site 1063)	Sutton	London, City Of
United States	MUSC Hollings Cancer Center ( Site 1715)	Charleston	South Carolina
United States	UT Southwestern Medical Center ( Site 1709)	Dallas	Texas
United States	Inova Schar Cancer Institute ( Site 1130)	Fairfax	Virginia
United States	The West Clinic, PLLC dba West Cancer Center ( Site 1149)	Germantown	Tennessee
United States	Norton Cancer Institute ( Site 1139)	Louisville	Kentucky
United States	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118)	Marietta	Georgia
United States	Intermountain Medical Center ( Site 1707)	Murray	Utah
United States	Rutgers Cancer Institute of New Jersey ( Site 1105)	New Brunswick	New Jersey
United States	Memorial Sloan Kettering Cancer Center ( Site 1703)	New York	New York
United States	Oregon Health & Science University ( Site 1141)	Portland	Oregon
United States	VCU Health Adult Outpatient Pavillion ( Site 1712)	Richmond	Virginia
United States	Blue Ridge Cancer Care ( Site 1718)	Roanoke	Virginia
United States	Seattle Cancer Care Alliance ( Site 1107)	Seattle	Washington
United States	Georgetown University Hospital ( Site 1148)	Washington	District of Columbia
United States	Sibley Memorial Hospital ( Site 1143)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  China,  Czechia,  France,  Germany,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Norway,  Russian Federation,  South Africa,  Spain,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 26 months
Secondary	Progression-Free Survival (PFS) according per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)	PFS is 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 occurs first.	Up to approximately 19 months
Secondary	Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR	The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR.	Up to approximately 19 months
Secondary	Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR	For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.	Up to approximately 19 months
Secondary	Number of Participants Who Experience at least One Adverse Event (AE)	An AE is 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 27 months
Secondary	Number of Participants Who Discontinue Study Treatment Due to an AE	An AE is 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 discontinue study treatment due to an AE will be reported.	Up to approximately 24 months
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). 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 will be presented. A higher score indicates a better outcome.	Baseline and up to approximately 25 months
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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function.	Baseline and up to approximately 25 months
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.	Baseline and up to approximately 25 months
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.	Baseline and up to approximately 25 months
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). 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, will be presented. A longer TTD indicates a better outcome.	Baseline and up to approximately 25 months
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). 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, will be presented. A longer TTD indicates a better outcome.	Baseline and up to approximately 25 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.	Baseline and up to approximately 25 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.	Baseline and up to approximately 25 months

External Links

•   Merck Clinical Trials Information