Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001)
May 28, 2025 updated by: Merck Sharp & Dohme LLC
A Phase 1 Trial of MK-4280 as Monotherapy and in Combination With Pembrolizumab With or Without Chemotherapy or Lenvatinib (E7080/MK-7902) in Subjects With Advanced Solid Tumors
This is a safety and pharmacokinetics study of favezelimab as monotherapy and in combination with pembrolizumab AND favezelimab/pembrolizumab as monotherapy in adults with metastatic solid tumors for which there is no available therapy which may convey clinical benefit.
Part A of this study is a dose escalation design in which participants receive favezelimab as monotherapy or favezelimab in combination with pembrolizumab.
Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RP2D), as determined by dose-limiting toxicity, for favezelimab in combination with pembrolizumab or pembrolizumab and lenvatinib in participants with advanced solid tumors.
Part B will also assess the efficacy of favezelimab as monotherapy; favezelimab in combination with pembrolizumab with and without chemotherapy; favezelimab in combination with pembrolizumab and lenvatinib; and favezelimab/pembrolizumab as monotherapy in expansion cohorts.
Participants who have completed the initial course of treatment and have investigator-determined progressive disease may be eligible for a second course of an additional 17 cycles of study treatment.
Study Overview
Status
Status
Completed
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
All participants who completed the first course were eligible for second course treatment after Sponsor consultation if there was investigator-determined progressive disease after initial treatment had been been completed.
Study Type
Study Type
Interventional
Enrollment (Actual)
Enrollment
481
Phase
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Part A and Part B: Has histologically or cytologically-confirmed metastatic solid tumor.
- Has measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 1.1 criteria.
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Demonstrates adequate organ function.
- If female, is not pregnant or breastfeeding, and if of child-bearing potential, is willing to use an adequate method of contraception for the course of the study and for at least 180 days after the last dose of chemotherapy, 120 days after the last dose of pembrolizumab or favezelimab, or 30 days after the last dose of lenvatinib, whichever occurs last.
- If male with a female partner(s) of child-bearing potential, both must agree to use an adequate method of contraception starting with the first dose of study drug through 95 days after the last dose of study drug.
Exclusion Criteria:
- Has had chemotherapy, radiation or biological cancer therapy within 4 weeks prior to the first dose of study drug, or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 0 or 1 from the AEs due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related [ir]AEs).
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.
- Has received previous treatment with another agent targeting the lymphocyte-activation gene 3 (LAG-3) receptor.
- Has received previous treatment with an immunomodulatory therapy (e.g., anti-programmed cell death-1/anti-programmed cell death-ligand 1 [anti-PD-1/anti-PD-L1] or cytotoxic T-lymphocyte-associated protein 4 [CTLA 4] agent) and was discontinued from that therapy due to a Grade 3 or higher irAE.
- Is expected to require any other form of antineoplastic therapy while on study.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication.
- Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Time frame exceptions include successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer, or other in situ cancers.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has had a severe hypersensitivity reaction to treatment with another monoclonal antibody.
- Has an active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
- Has an active infection requiring therapy.
- Has history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has had a prior stem cell or bone marrow transplant.
- Has a known history of or screens positive for Human Immunodeficiency Virus (HIV), active chronic or acute Hepatitis B or Hepatitis C.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Is a regular user as determined by investigator judgement (including "recreational use") of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol), at the time of signing informed consent.
- Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
- Has clinically significant heart disease that affects normal activities.
- Has received a live-virus vaccine within 30 days of planned start of study drug. Seasonal flu vaccines that do not contain live virus are permitted.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
18
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Part A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
|
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Experimental: Part A: Favezelimab 21 mg Monotherapy
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
|
|
Experimental: Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
|
|
Experimental: Part A: Favezelimab 210 mg Monotherapy
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
|
|
Experimental: Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
|
|
Experimental: Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
|
Experimental: Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
|
Experimental: Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
|
Experimental: Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
|
Experimental: Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
|
Experimental: Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
|
|
Experimental: Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
|
Experimental: Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B)
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
|
Experimental: Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C)
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
IV infusion
Other Names:
|
|
Experimental: Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3)
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
|
IV infusion
Other Names:
IV infusion
Other Names:
IV infusion
Other Names:
IV infusion
Other Names:
IV infusion
Other Names:
|
|
Experimental: Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4)
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
|
IV infusion
Other Names:
IV infusion
Other Names:
IV infusion
Other Names:
IV infusion
Other Names:
IV infusion
Other Names:
|
|
Experimental: Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
|
IV infusion
Other Names:
|
|
Experimental: Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6)
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
|
IV infusion
Other Names:
IV infusion
Other Names:
Oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
Time Frame: Up to 21 days (Cycle 1)
|
DLTs were assessed during the first cycle (21 days) & were defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with bleeding; Gr 3 nonhematologic toxicity lasting ≥3 days despite optimal supportive care (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention was required, lead to hospitalization, or persisted for >1 week); Gr 3 or 4 febrile neutropenia; any drug-related AE that caused the participant to discontinue treatment during Cycle 1; Grade 5 toxicity; Any treatment-related toxicity that causes ≥2-week delay in initiation of Cycle 2.
|
Up to 21 days (Cycle 1)
|
|
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to approximately 31.3 months
|
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
The number of participants who experienced an AE is presented.
|
Up to approximately 31.3 months
|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to approximately 28.3 months
|
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
The number of participants who discontinued study treatment due to an AE is presented.
|
Up to approximately 28.3 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Response Rate (ORR) for Part B Participants
Time Frame: Up to approximately 92 months
|
ORR was defined as the percentage of participants who had 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) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
The percentage of participants who experienced a CR or PR is presented.
|
Up to approximately 92 months
|
|
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab
Time Frame: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of favezelimab.
In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
|
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
|
Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab
Time Frame: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of favezelimab.
In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
|
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
|
Maximum Serum Concentration (Cmax) of Favezelimab
Time Frame: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
Blood for serum samples was collected at pre-specified time points to determine the Cmax of favezelimab.
In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
|
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
|
AUC0-inf of Pembrolizumab
Time Frame: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of pembrolizumab.
In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
|
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
|
AUC0-21 Days of Pembrolizumab
Time Frame: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of pembrolizumab.
In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
|
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
|
Cmax of Pembrolizumab
Time Frame: Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
Blood for serum samples was collected at pre-specified time points to determine the Cmax of pembrolizumab.
In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
|
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
|
|
Predose Serum Concentration of Favezelimab
Time Frame: Predose on Day 1 of cycles 1-4, 6, and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
|
Blood for serum samples was collected at pre-specified time points to determine the predose serum concentration of favezelimab, which is presented.
|
Predose on Day 1 of cycles 1-4, 6, and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
|
|
AUC0-inf of Lenvatinib
Time Frame: Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
|
Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of lenvatinib.
|
Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
|
|
AUC0-21 Days of Lenvatinib
Time Frame: Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
|
Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of lenvatinib.
|
Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
|
|
Cmax of Lenvatinib
Time Frame: Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
|
Blood for serum samples was collected at pre-specified time points to determine the Cmax of lenvatinib.
|
Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) - Full Text View - ClinicalTrials.gov
- Garralda E, Sukari A, Lakhani NJ, Patnaik A, Lou Y, Im SA, Golan T, Geva R, Wermke M, de Miguel M, Palcza J, Jha S, Chaney M, Abraham AK, Healy J, Falchook GS. A first-in-human study of the anti-LAG-3 antibody favezelimab plus pembrolizumab in previously treated, advanced microsatellite stable colorectal cancer. ESMO Open. 2022 Dec;7(6):100639. doi: 10.1016/j.esmoop.2022.100639. Epub 2022 Dec 6.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
Study Start
May 2, 2016
Primary Completion (Actual)
Primary Completion
March 15, 2024
Study Completion (Actual)
Study Completion
March 15, 2024
Study Registration Dates
First Submitted
First Submitted
March 22, 2016
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
March 22, 2016
First Posted (Estimated)
First Posted
March 25, 2016
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
May 30, 2025
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
May 28, 2025
Last Verified
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Antineoplastic Agents, Immunological
- Calcium-Regulating Hormones and Agents
- Immune Checkpoint Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Protein Kinase Inhibitors
- Micronutrients
- Topoisomerase I Inhibitors
- Topoisomerase Inhibitors
- Protective Agents
- Antidotes
- Vitamin B Complex
- Vitamins
- Oxaliplatin
- Irinotecan
- Calcium
- Fluorouracil
- Pembrolizumab
- Leucovorin
- Levoleucovorin
- Lenvatinib
Other Study ID Numbers
Other Study ID Numbers
- 4280-001
- MK-4280-001 (Other Identifier: Merck Protocol Number)
- 183971 (Other Identifier: JAPIC-CTI)
- 2017-001464-38 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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