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Small Molecule
5-Fluorouracil [5-FU] for Colorectal Cancer
Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will test different combinations of drugs to find the safest and best tolerated dose for each combination to treat colorectal cancer.
Eligible Conditions
- Metastatic Colorectal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with a dose limiting toxicity (DLT)
Secondary outcome measures
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
Trial Design
5Treatment groups
Experimental Treatment
Group I: Pembrolizumab + mFOLFOX7 + Binimetinib (Cohort C)Experimental Treatment5 Interventions
After an RP2D for mFOLFOX7 is identified in Part 1 for Cohort B, participants may enroll in Cohort C and receive pembrolizumab 200 mg IV Q3W plus mFOLFOX7 at the preliminary RP2D Q2W in combination with binimetinib orally at a starting dose of 30 mg BID during Part 1. Based on DLTs assessed during the initial 28 days of Cycle 1, the dose of binimetinib may be escalated to 45 mg orally BID (DL2). Once a preliminary RP2D for binimetinib is identified in Part 1 for this cohort, participants in Part 2 will receive pembrolizumab 200 mg IV Q3W plus mFOLFOX7 at the RP2D determined for Cohort B Q2W plus binimetinib orally at the RP2D determined for Cohort C in Part 1.
Group II: Pembrolizumab + mFOLFOX7 (Cohort B)Experimental Treatment4 Interventions
During Part 1, participants in Cohort B will receive a standard dose (DL1) of pembrolizumab 200 mg IV Q3W plus mFOLFOX7 (oxaliplatin 85 mg/m^2; leucovorin [calcium folinate] 400 mg/m^2; fluorouracil [5-FU] 2400 mg/m^2 over 46-48 hours) IV every 2 weeks (Q2W). Based on DLTs assessed during the initial 28 days of Cycle 1, the dose of mFOLFOX7 may be de-escalated to oxaliplatin 70 mg/m^2; leucovorin (calcium folinate) 400 mg/m^2; 5-FU 2000 mg/m^2 over 46-48 hours] IV Q2W. Once a preliminary RP2D for mFOLFOX7 is identified in Part 1 for Cohort B, participants will receive pembrolizumab 200 mg IV Q3W plus mFOLFOX7 at the preliminary RP2D during Part 2.
Group III: Pembrolizumab + FOLFIRI + Binimetinib (Cohort E)Experimental Treatment5 Interventions
After an RP2D for FOLFIRI is identified in Part 1 for Cohort D, participants may enroll in Cohort E and receive pembrolizumab 200 mg IV Q3W plus FOLFIRI at the preliminary RP2D Q2W in combination with binimetinib orally at a starting dose of 30 mg BID during Part 1. Based on DLTs assessed during the initial 28 days of Cycle 1, the dose of binimetinib may be escalated to 45 mg orally BID (DL2). Once a preliminary RP2D for binimetinib is identified in Part 1 for this cohort, participants in Part 2 will receive pembrolizumab 200 mg IV Q3W plus FOLFIRI at the RP2D determined for Cohort D Q2W plus binimetinib orally at the RP2D determined for Cohort E in Part 1.
Group IV: Pembrolizumab + FOLFIRI (Cohort D)Experimental Treatment4 Interventions
During Part 1, participants in Cohort D will receive a standard dose (DL1) of pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m^2; leucovorin [calcium folinate] 400 mg/m^2; 5-FU 2400 mg/m^2 over 46-48 hours) IV Q2W. Based on DLTs assessed during the initial 28 days of Cycle 1, the dose of FOLFIRI may be de-escalated to irinotecan 150 mg/m^2; leucovorin (calcium folinate) 400 mg/m^2; 5-FU 2000 mg/m^2 over 46-48 hours) IV Q2W. Once a preliminary RP2D for FOLFIRI is identified in Part 1 for Cohort D, participants will receive pembrolizumab 200 mg IV Q3W plus FOLFIRI at the preliminary RP2D during Part 2.
Group V: Pembrolizumab + Binimetinib (Cohort A)Experimental Treatment2 Interventions
During Part 1, participants in Cohort A will receive a standard dose (DL1) of pembrolizumab (200 mg) intravenous (IV) every 3 weeks (Q3W) plus binimetinib orally at a starting dose of 30 mg twice a day (BID). Based on dose-limiting toxicities (DLT) assessed during the initial 21 days of Cycle 1, the dose of binimetinib may be escalated to 45 mg orally BID (Dose Level 2 [DL2]). Once a preliminary RP2D for binimetinib is identified in Part 1 for Cohort A, participants will receive pembrolizumab 200 mg IV Q3W plus binimetinib orally at the preliminary RP2D during Part 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-Fluorouracil [5-FU]
2018
Completed Phase 1
~120
Irinotecan
2017
Completed Phase 4
~2680
Pembrolizumab
2017
Completed Phase 2
~2010
Binimetinib
2018
Completed Phase 3
~1100
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,714 Total Patients Enrolled
Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,283 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,439 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still spots available for this medical experiment?
"The data hosted on clinicaltrials.gov suggests that this medical study is not currently enrolling participants. Although initially posted in February of 2018, the last update was made back in June 2022 and there are no further openings for recruitment at present. However, 2485 other trials have open slots available right now."
Answered by AI
How many participants may partake in this investigation?
"Currently, this particular medical trial is not recruiting new candidates. Originally posted on February 16th 2018 and last updated on June 16th 2022, there are now 876 clinical trials for colorectal cancer and 1,609 studies utilizing Pembrolizumab that are actively enrolling participants."
Answered by AI
To what extent could patients be endangered by Pembrolizumab treatments?
"Our risk assessment team at Power rated pembrolizumab a 1 on the safety scale due to it being an initial phase trial and limited data supporting efficacy."
Answered by AI
Are there any other research projects that have used Pembrolizumab as a focus?
"At present, 1609 clinical trials centred on the efficacy of Pembrolizumab are underway. 311 of those have made it to Phase 3 testing and many are being conducted in Guangzhou, Guangdong. However, there exists a total of 63265 sites across the globe where experiments with this drug take place."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
University of Chicago ( Site 0105)
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I applied to this site due to abdominal pain that a level 10. I believe if something is there it will be found through this process.
PatientReceived 2+ prior treatments
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