Trial 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
NCT ID:
NCT05600309
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Pembrolizumab
Conditions: 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)
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
None (Open-label)
Intervention:
Intervention type:
Biological
Intervention name:
favezelimab/pembrolizumab
Description:
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
Arm group label:
Favezelimab/Pembrolizumab
Other name:
MK-4280A
Intervention type:
Drug
Intervention name:
regorafenib
Description:
Oral
Arm group label:
Standard of Care (Regorafenib or TAS-102)
Other name:
STIVARGA®
Other name:
REGONIX®
Intervention type:
Drug
Intervention name:
TAS-102
Description:
Oral
Arm group label:
Standard of Care (Regorafenib or TAS-102)
Other name:
LONSURF®
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Anhui Medical University ( Site 1179)
Address:
City:
Hefei
Zip:
230601
Country:
China
Facility:
Name:
Chongqing Cancer Hospital ( Site 1151)
Address:
City:
Chongqing
Zip:
400030
Country:
China
Facility:
Name:
Fujian Province Cancer Hospital ( Site 1178)
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Facility:
Name:
Sun Yat-Sen University Cancer Center ( Site 1150)
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Facility:
Name:
Southern Medical University Nanfang Hospital ( Site 1154)
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Facility:
Name:
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)
Address:
City:
Guangzhou
Zip:
510655
Country:
China
Facility:
Name:
Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)
Address:
City:
Nanning
Zip:
531021
Country:
China
Facility:
Name:
Hainan General Hospital ( Site 1177)
Address:
City:
Haikou
Zip:
570311
Country:
China
Facility:
Name:
Wuhan Union Hospital Cancer Center ( Site 1162)
Address:
City:
Wuhan
Zip:
430022
Country:
China
Facility:
Name:
Hubei Cancer Hospital ( Site 1152)
Address:
City:
Wuhan
Zip:
430079
Country:
China
Facility:
Name:
Xiangya Hospital Central South University ( Site 1171)
Address:
City:
Changsha
Zip:
410008
Country:
China
Facility:
Name:
Hunan Cancer Hospital ( Site 1174)
Address:
City:
Changsha
Zip:
410013
Country:
China
Facility:
Name:
The Third Xiangya Hospital of Central South University ( Site 1175)
Address:
City:
Changsha
Zip:
410013
Country:
China
Facility:
Name:
Changzhou Cancer Hospital-Department of Oncology ( Site 1183)
Address:
City:
Changzhou
Zip:
213000
Country:
China
Facility:
Name:
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)
Address:
City:
Wuxi City
Zip:
214122
Country:
China
Facility:
Name:
Jilin Cancer Hospital ( Site 1163)
Address:
City:
Changchun
Zip:
130012
Country:
China
Facility:
Name:
Jinan Central Hospital ( Site 1167)
Address:
City:
Jinan
Zip:
250000
Country:
China
Facility:
Name:
Fudan University Shanghai Cancer Center ( Site 1176)
Address:
City:
Shangai
Zip:
201321
Country:
China
Facility:
Name:
Shanghai Tenth People's Hospital ( Site 1170)
Address:
City:
Shanghai
Zip:
200072
Country:
China
Facility:
Name:
West China Hospital Sichuan University ( Site 1172)
Address:
City:
Chengdu
Zip:
332001
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital ( Site 1161)
Address:
City:
Tianjin
Zip:
300060
Country:
China
Facility:
Name:
Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)
Address:
City:
Kunming
Zip:
650106
Country:
China
Facility:
Name:
Zhejiang Cancer Hospital ( Site 1180)
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Facility:
Name:
Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)
Address:
City:
Hangzhou
Zip:
310018
Country:
China
Start date:
June 14, 2022
Completion date:
February 21, 2025
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05600309
https://www.merckclinicaltrials.com
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=4280A-007&&kw=4280A-007
