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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05064059




Registration number
NCT05064059
Ethics application status
Date submitted
29/09/2021
Date registered
1/10/2021

Titles & IDs
Public title
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)
Scientific 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)
Secondary ID [1] 0 0
MK-4280A-007
Secondary ID [2] 0 0
4280A-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - favezelimab/pembrolizumab
Treatment: Drugs - regorafenib
Treatment: Drugs - TAS-102

Experimental: Favezelimab/Pembrolizumab - Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.

Active comparator: Standard of Care (Regorafenib or TAS-102) - At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.


Treatment: Other: favezelimab/pembrolizumab
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion

Treatment: Drugs: regorafenib
Oral

Treatment: Drugs: TAS-102
Oral
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 26 months
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to approximately 19 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
Timepoint [2] 0 0
Up to approximately 19 months
Secondary outcome [3] 0 0
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Timepoint [3] 0 0
Up to approximately 19 months
Secondary outcome [4] 0 0
Number of Participants Who Experience at least One Adverse Event (AE)
Timepoint [4] 0 0
Up to approximately 27 months
Secondary outcome [5] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [5] 0 0
Up to approximately 24 months
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline and up to approximately 25 months
Secondary outcome [7] 0 0
Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
Timepoint [7] 0 0
Baseline and up to approximately 25 months
Secondary outcome [8] 0 0
Change from Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score
Timepoint [8] 0 0
Baseline and up to approximately 25 months
Secondary outcome [9] 0 0
Change from Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
Timepoint [9] 0 0
Baseline and up to approximately 25 months
Secondary outcome [10] 0 0
Time to Deterioration (TTD) in EORTC QLQ-C30 GHS (Item 29) and QoL (Item 30) Combined Score
Timepoint [10] 0 0
Baseline and up to approximately 25 months
Secondary outcome [11] 0 0
TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Timepoint [11] 0 0
Baseline and up to approximately 25 months
Secondary outcome [12] 0 0
TTD in in EORTC QLQ-C30 Appetite Loss (Item 13) Score
Timepoint [12] 0 0
Baseline and up to approximately 25 months
Secondary outcome [13] 0 0
TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
Timepoint [13] 0 0
Baseline and up to approximately 25 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/11/2025
Actual
Sample size
Target
Accrual to date
Final
505
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital ( Site 0057) - Westmead
Recruitment hospital [2] 0 0
Royal Brisbane and Women s Hospital ( Site 0058) - Herston
Recruitment hospital [3] 0 0
Queen Elizabeth Hospital ( Site 0050) - Woodville South
Recruitment hospital [4] 0 0
Frankston Hospital ( Site 0056) - Frankston
Recruitment hospital [5] 0 0
Western Health-Sunshine & Footscray Hospitals ( Site 0052) - St Albans
Recruitment hospital [6] 0 0
St John of God Subiaco Hospital ( Site 0051) - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment postcode(s) [6] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Chile
State/province [14] 0 0
Araucania
Country [15] 0 0
Chile
State/province [15] 0 0
Coquimbo
Country [16] 0 0
Chile
State/province [16] 0 0
Los Lagos
Country [17] 0 0
Chile
State/province [17] 0 0
Region M. De Santiago
Country [18] 0 0
China
State/province [18] 0 0
Anhui
Country [19] 0 0
China
State/province [19] 0 0
Chongqing
Country [20] 0 0
China
State/province [20] 0 0
Fujian
Country [21] 0 0
China
State/province [21] 0 0
Guangdong
Country [22] 0 0
China
State/province [22] 0 0
Guangxi
Country [23] 0 0
China
State/province [23] 0 0
Hainan
Country [24] 0 0
China
State/province [24] 0 0
Hubei
Country [25] 0 0
China
State/province [25] 0 0
Hunan
Country [26] 0 0
China
State/province [26] 0 0
Jiangsu
Country [27] 0 0
China
State/province [27] 0 0
Jilin
Country [28] 0 0
China
State/province [28] 0 0
Shandong
Country [29] 0 0
China
State/province [29] 0 0
Shanghai
Country [30] 0 0
China
State/province [30] 0 0
Sichuan
Country [31] 0 0
China
State/province [31] 0 0
Tianjin
Country [32] 0 0
China
State/province [32] 0 0
Yunnan
Country [33] 0 0
China
State/province [33] 0 0
Zhejiang
Country [34] 0 0
Czechia
State/province [34] 0 0
Brno-mesto
Country [35] 0 0
Czechia
State/province [35] 0 0
Praha, Hlavni Mesto
Country [36] 0 0
Czechia
State/province [36] 0 0
Hradec Kralove
Country [37] 0 0
Czechia
State/province [37] 0 0
Olomouc
Country [38] 0 0
Czechia
State/province [38] 0 0
Praha 10
Country [39] 0 0
Czechia
State/province [39] 0 0
Praha 4
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha 8
Country [41] 0 0
France
State/province [41] 0 0
Gironde
Country [42] 0 0
France
State/province [42] 0 0
Pays-de-la-Loire
Country [43] 0 0
France
State/province [43] 0 0
Vaucluse
Country [44] 0 0
France
State/province [44] 0 0
Vienne
Country [45] 0 0
France
State/province [45] 0 0
Paris
Country [46] 0 0
Germany
State/province [46] 0 0
Bayern
Country [47] 0 0
Germany
State/province [47] 0 0
Hessen
Country [48] 0 0
Germany
State/province [48] 0 0
Niedersachsen
Country [49] 0 0
Germany
State/province [49] 0 0
Nordrhein-Westfalen
Country [50] 0 0
Germany
State/province [50] 0 0
Sachsen-Anhalt
Country [51] 0 0
Germany
State/province [51] 0 0
Hamburg
Country [52] 0 0
Israel
State/province [52] 0 0
Ashdod
Country [53] 0 0
Israel
State/province [53] 0 0
Haifa
Country [54] 0 0
Israel
State/province [54] 0 0
Jerusalem
Country [55] 0 0
Israel
State/province [55] 0 0
Petah Tikva
Country [56] 0 0
Israel
State/province [56] 0 0
Ramat Gan
Country [57] 0 0
Israel
State/province [57] 0 0
Tel Aviv
Country [58] 0 0
Italy
State/province [58] 0 0
Abruzzo
Country [59] 0 0
Italy
State/province [59] 0 0
Foggia
Country [60] 0 0
Italy
State/province [60] 0 0
Milano
Country [61] 0 0
Italy
State/province [61] 0 0
Catania
Country [62] 0 0
Italy
State/province [62] 0 0
Napoli
Country [63] 0 0
Japan
State/province [63] 0 0
Chiba
Country [64] 0 0
Japan
State/province [64] 0 0
Kagawa
Country [65] 0 0
Japan
State/province [65] 0 0
Osaka
Country [66] 0 0
Japan
State/province [66] 0 0
Saitama
Country [67] 0 0
Japan
State/province [67] 0 0
Shizuoka
Country [68] 0 0
Japan
State/province [68] 0 0
Fukuoka
Country [69] 0 0
Japan
State/province [69] 0 0
Tokyo
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Seoul
Country [71] 0 0
Malaysia
State/province [71] 0 0
Kuala Lumpur
Country [72] 0 0
Malaysia
State/province [72] 0 0
Selangor
Country [73] 0 0
Malaysia
State/province [73] 0 0
Wilayah Persekutuan Putrajaya
Country [74] 0 0
Norway
State/province [74] 0 0
Akershus
Country [75] 0 0
Norway
State/province [75] 0 0
Sor-Trondelag
Country [76] 0 0
Norway
State/province [76] 0 0
Troms
Country [77] 0 0
Norway
State/province [77] 0 0
Vestfold
Country [78] 0 0
Norway
State/province [78] 0 0
Oslo
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Baskortostan, Respublika
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Kirovskaya Oblast
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Moskva
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Sankt-Peterburg
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Tomskaya Oblast
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Yaroslavskaya Oblast
Country [85] 0 0
South Africa
State/province [85] 0 0
Eastern Cape
Country [86] 0 0
South Africa
State/province [86] 0 0
Gauteng
Country [87] 0 0
South Africa
State/province [87] 0 0
Western Cape
Country [88] 0 0
Spain
State/province [88] 0 0
Barcelona
Country [89] 0 0
Spain
State/province [89] 0 0
Madrid
Country [90] 0 0
Spain
State/province [90] 0 0
Sevilla
Country [91] 0 0
Taiwan
State/province [91] 0 0
Changhua
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taichung
Country [93] 0 0
Taiwan
State/province [93] 0 0
Tainan
Country [94] 0 0
Taiwan
State/province [94] 0 0
Taipei
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taoyuan
Country [96] 0 0
Turkey
State/province [96] 0 0
Adana
Country [97] 0 0
Turkey
State/province [97] 0 0
Ankara
Country [98] 0 0
Turkey
State/province [98] 0 0
Antalya
Country [99] 0 0
Turkey
State/province [99] 0 0
Istanbul
Country [100] 0 0
Turkey
State/province [100] 0 0
Izmir
Country [101] 0 0
Ukraine
State/province [101] 0 0
Dnipropetrovska Oblast
Country [102] 0 0
Ukraine
State/province [102] 0 0
Ivano-Frankivska Oblast
Country [103] 0 0
Ukraine
State/province [103] 0 0
Kirovohradska Oblast
Country [104] 0 0
Ukraine
State/province [104] 0 0
Odeska Oblast
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Camden
Country [106] 0 0
United Kingdom
State/province [106] 0 0
London, City Of
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Warwickshire
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Cardiff
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05064059