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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)-China Extension Study

Primary Purpose

Colorectal Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
favezelimab/pembrolizumab
regorafenib
TAS-102
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1),, Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1), Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Affiliated Hospital of Anhui Medical University ( Site 1179)
  • Chongqing Cancer Hospital ( Site 1151)
  • Fujian Province Cancer Hospital ( Site 1178)
  • Sun Yat-Sen University Cancer Center ( Site 1150)
  • Southern Medical University Nanfang Hospital ( Site 1154)
  • The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)
  • Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)
  • Hainan General Hospital ( Site 1177)
  • Wuhan Union Hospital Cancer Center ( Site 1162)
  • Hubei Cancer Hospital ( Site 1152)
  • Xiangya Hospital Central South University ( Site 1171)
  • Hunan Cancer Hospital ( Site 1174)
  • The Third Xiangya Hospital of Central South University ( Site 1175)
  • Changzhou Cancer Hospital-Department of Oncology ( Site 1183)
  • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)
  • Jilin Cancer Hospital ( Site 1163)
  • Jinan Central Hospital ( Site 1167)
  • Fudan University Shanghai Cancer Center ( Site 1176)
  • Shanghai Tenth People's Hospital ( Site 1170)
  • West China Hospital Sichuan University ( Site 1172)
  • Tianjin Medical University Cancer Institute and Hospital ( Site 1161)
  • Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)
  • Zhejiang Cancer Hospital ( Site 1180)
  • Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Favezelimab/Pembrolizumab

Standard of Care (Regorafenib or TAS-102)

Arm Description

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.

Participants will receive 160 mg regorafenib orally daily on Days 1-21 of each 28-day cycle. Participants will also receive 35 mg/m^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day treatment cycle.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 26, 2022
Last Updated
July 21, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05600309
Brief 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)-China Extension Study
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this China extension study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in adult Chinese 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.
Detailed Description
The China extension study will include participants previously enrolled in China in the global study for MK-4280A-007 (NCT05064059) plus those enrolled during the China extension enrollment period. A total of approximately 94 Chinese participants will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1),, Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1), Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
None (Open-label)
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Favezelimab/Pembrolizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care (Regorafenib or TAS-102)
Arm Type
Active Comparator
Arm Description
Participants will receive 160 mg regorafenib orally daily on Days 1-21 of each 28-day cycle. Participants will also receive 35 mg/m^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day treatment cycle.
Intervention Type
Biological
Intervention Name(s)
favezelimab/pembrolizumab
Other Intervention Name(s)
MK-4280A
Intervention Description
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
Intervention Type
Drug
Intervention Name(s)
regorafenib
Other Intervention Name(s)
STIVARGA®, REGONIX®
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
TAS-102
Other Intervention Name(s)
LONSURF®
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 26 months
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Up to approximately 19 months
Title
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
Description
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.
Time Frame
Up to approximately 19 months
Title
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Description
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.
Time Frame
Up to approximately 19 months
Title
Number of Participants Who Experience at least One Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 27 months
Title
Number of Participants Who Discontinue Study Treatment Due to an AE
Description
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.
Time Frame
Up to approximately 24 months
Title
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
Description
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.
Time Frame
Baseline and up to approximately 25 months
Title
Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
Description
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.
Time Frame
Baseline and up to approximately 25 months
Title
Change from Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score
Description
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.
Time Frame
Baseline and up to approximately 25 months
Title
Change from Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
Description
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.
Time Frame
Baseline and up to approximately 25 months
Title
Time to Deterioration (TTD) in EORTC QLQ-C30 GHS (Item 29) and QoL (Item 30) Combined Score
Description
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.
Time Frame
Baseline and up to approximately 25 months
Title
TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Description
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.
Time Frame
Baseline and up to approximately 25 months
Title
TTD in in EORTC QLQ-C30 Appetite Loss (Item 13) Score
Description
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.
Time Frame
Baseline and up to approximately 25 months
Title
TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
Description
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.
Time Frame
Baseline and up to approximately 25 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
The Second Affiliated Hospital of Anhui Medical University ( Site 1179)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Chongqing Cancer Hospital ( Site 1151)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Fujian Province Cancer Hospital ( Site 1178)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Sun Yat-Sen University Cancer Center ( Site 1150)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Southern Medical University Nanfang Hospital ( Site 1154)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
531021
Country
China
Facility Name
Hainan General Hospital ( Site 1177)
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Wuhan Union Hospital Cancer Center ( Site 1162)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Hubei Cancer Hospital ( Site 1152)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Xiangya Hospital Central South University ( Site 1171)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Hunan Cancer Hospital ( Site 1174)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The Third Xiangya Hospital of Central South University ( Site 1175)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Changzhou Cancer Hospital-Department of Oncology ( Site 1183)
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Facility Name
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)
City
Wuxi City
State/Province
Jiangsu
ZIP/Postal Code
214122
Country
China
Facility Name
Jilin Cancer Hospital ( Site 1163)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Jinan Central Hospital ( Site 1167)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 1176)
City
Shangai
State/Province
Shanghai
ZIP/Postal Code
201321
Country
China
Facility Name
Shanghai Tenth People's Hospital ( Site 1170)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
West China Hospital Sichuan University ( Site 1172)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
332001
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital ( Site 1161)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650106
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 1180)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Facility Name
Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com
Description
Merck Clinical Trials Information

Learn more about this trial

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)-China Extension Study

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