A Phase 1 interventional study of Pembrolizumab and Binimetinib in Metastatic Colorectal Cancer, sponsored by Merck Sharp & Dohme LLC. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
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Among 33 studies testing pembrolizumab in Colorectal Neoplasms — 5 open to participants now, 10 under way, 1 of them phase 3. pembrolizumab · Colorectal Neoplasms.
Among the 33 studies testing pembrolizumab in Colorectal Neoplasms, this one is the 8th largest by enrollment, is one of 3 that started in 2018, is one of 5 in phase 1, and was the 14th registered.
6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.
Browse Colorectal Neoplasms studies →5 of the 33 studies testing pembrolizumab in Colorectal Neoplasms are open now, in 4 countries. Recruiting first, the newest first:
Second Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18–70
Federation Francophone de Cancerologie Digestive · Sites in France
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–72
Zealand University Hospital · Sites in Denmark
Ages 18–99
Shanghai Zhongshan Hospital
Ages 18+
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 23 · Phase 3 4 · Phase 4 1
First in 2010; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 116 is above the median of 76 across 4,802 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 45 across the 33 interventional studies. Of the 18 that completed or were terminated, 16 (89%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 33 have an industry lead sponsor. The 10 most frequent:
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
25 studies in Colorectal Neoplasms by Merck & Co., Inc: 1 open now, 3 under way, 1 of them phase 3. Of 21 finished, 19 (90%) have results posted.
Among the 25 studies in Colorectal Neoplasms by Merck & Co., Inc, this one is the 11th largest by enrollment of the 24 interventional ones that give a count, is one of 3 that started in 2018, is one of 9 in phase 1, and was the 13th registered.
Merck & Co., Inc’s Colorectal Neoplasms studies by the year they started, since 2004.
1 of the studies testing pembrolizumab in Colorectal Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02628067Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158) | 2027-05-04 |
Add it to your calendar (.ics) → With an account.
Among the 33 studies testing pembrolizumab in Colorectal Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Merck & Co., Inc’s 25 in Colorectal Neoplasms:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) for the following combinations: pembrolizumab plus binimetinib (Cohort A), pembrolizumab plus mFOLFOX7 (oxaliplatin 85 mg/m\^2; leucovorin [calcium folinate] 400 mg/m\^2; fluorouracil [5-FU] 2400 mg/m\^2) (Cohort B), pembrolizumab plus mFOLFOX7 and binimetinib (Cohort C), pembrolizumab plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin [calcium folinate]400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) (Cohort D), and pembrolizumab plus FOLFIRI and binimetinib (Cohort E).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participants eligible to participate if not pregnant, not breastfeeding, and is not a woman of (WOCBP) or is a WOCBP who agrees to follow contraceptive guidance during the treatment period and for ≥180 days after the last dose of study treatment
Has been previously treated with fluoropyrimidine, irinotecan, and oxaliplatin
Must not have received prior systemic chemotherapy for Stage IV CRC
Must have been previously treated with 1 including a fluoropyrimidine plus an oxaliplatin-based regimen
Exclusion Criteria:
A who has a positive urine pregnancy test within 24 hours before the first dose of study treatment
Has retinal degenerative disease
Has a known history of Gilbert's Syndrome
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in Cohort A will receive pembrolizumab (200 mg) intravenous (IV) every 3 weeks (Q3W) plus binimetinib orally at of 30 mg twice a day (BID) until disease progression or discontinuation.
Biological: Pembrolizumab · Drug: Binimetinib
Participants in Cohort A will receive pembrolizumab (200 mg) IV Q3W plus binimetinib orally at 45 mg BID (Dose Level 2 \[DL2\]) until disease progression or discontinuation.
Biological: Pembrolizumab · Drug: Binimetinib
Participants in Cohort B will receive 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 Q2W until disease progression or discontinuation.
Biological: Pembrolizumab · Drug: Oxaliplatin · Drug: Leucovorin · Drug: 5-Fluorouracil [5-FU]
During Part 2, participants in Cohort B will receive pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.
Biological: Pembrolizumab · Drug: Oxaliplatin · Drug: Leucovorin · Drug: 5-Fluorouracil [5-FU]
Participants in Cohort C will receive pembrolizumab 200 mg IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.
Biological: Pembrolizumab · Drug: Binimetinib · Drug: Oxaliplatin · Drug: Leucovorin · Drug: 5-Fluorouracil [5-FU]
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 until disease progression or discontinuation.
Biological: Pembrolizumab · Drug: Leucovorin · Drug: 5-Fluorouracil [5-FU] · Drug: Irinotecan
During Part 2, participants in Cohort D will receive 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) until disease progression or discontinuation.
Biological: Pembrolizumab · Drug: Leucovorin · Drug: 5-Fluorouracil [5-FU] · Drug: Irinotecan
Participants in Cohort E will receive 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) Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.
Biological: Pembrolizumab · Drug: Binimetinib · Drug: Leucovorin · Drug: 5-Fluorouracil [5-FU] · Drug: Irinotecan
During Part 2, participants in Cohort E received 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) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation. Cohort A During Part 2, participants in Cohort E received 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) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation.
Biological: Pembrolizumab · Drug: Binimetinib · Drug: Leucovorin · Drug: 5-Fluorouracil [5-FU] · Drug: Irinotecan
200 mg Pembrolizumab solution for IV infusion Q3W
Also known as: MK-3475
tablet orally BID at 30 or 45 mg depending upon DLT profile
Also known as: MEK162, ARRY-162, ARRY-438162
85 mg/m\^2 as IV infusion. Administered Q2W as part of mFOLFOX7 cocktail. Dose may be de-escalated to 70 mg/m\^2 if the standard dose of mFOLFOX7 is deemed too toxic per mTPI, based upon occurrence of DLTs.
400 mg/m\^2 as IV infusion. Administered Q2W as part of mFOLFOX7 or FOLFIRI cocktail, depending upon allocation.
Also known as: calcium folinate
2400 mg/m\^2 over 46-48 hours as IV infusion. Administered Q2W as part of mFOLFOX7 or FOLFIRI cocktail, depending upon allocation. Dose may be de-escalated to 2000 mg/m\^2 if the standard dose of mFOLFOX7 or FOLFIRI is deemed too toxic per mTPI, based upon occurrence of DLTs.
180 mg/m\^2 as IV infusion. Administered Q2W as part of FOLFIRI cocktail. Dose may be de-escalated to 150 mg/m\^2 if the standard dose of FOLFIRI is deemed too toxic per mTPI, based upon occurrence of DLTs.
Percentage of Participants Who Experienced Dose-Limiting Toxicity (DLT)
The occurrence of any of the following toxicities during Part 1 of the study (the first 21 days for Cohort A, first 28 days for Cohorts B,C, D, \& E), if possibly, probably or definitely related to study treatment, was considered a DLT: Grade (Gr) 4 non hematologic toxicity, Gr 4 hematologic toxicity lasting \>7 days, Gr 3 thrombocytopenia, Any non-hematologic AE ≥Gr 3 in severity, Any Gr 3 or Gr 4 non-hematologic laboratory value, Febrile neutropenia Gr 3 or Gr 4, Any prolonged delay in initiating study therapy due to a treatment-related AE that started during the DLT period, Any treatment-related toxicity that causes the participant to discontinue treatment during the DLT period, Missing \>25% of binimetinib doses as a result of drug-related AE(s), Gr 5 toxicity, Cardiac disorders and vascular disorders, Eye disorders (Retinopathy or retinal detachment Gr ≥ 3).
Time frame: Up to approximately first 28 days of treatment
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
ORR was determined in all participants and was defined as the percentage of participants who had a confirmed 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) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). The percentage of participants who experienced CR or PR is presented. Per Protocol, analysis was per cohort.
Time frame: Up to Approximately 64 months
| Milestone | Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg | Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg | Cohort B Part 1: Pembrolizumab + mFOLFOX7 | Cohort B Part 2: Pembrolizumab + mFOLFOX7 | Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg | Cohort D Part 1: Pembrolizumab + FOLFIRI | Cohort D Part 2: Pembrolizumab + FOLFIRI | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg |
|---|---|---|---|---|---|---|---|---|---|
| Started | 6 | 16 | 15 | 16 | 11 | 16 | 16 | 9 | 11 |
| Treated | 6 | 14 | 15 | 16 | 11 | 16 | 16 | 9 | 11 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 6 | 16 | 15 | 16 | 11 | 16 | 16 | 9 | 11 |
| Withdrew: Death | 5 | 16 | 13 | 11 | 9 | 12 | 11 | 6 | 7 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Sponsor decision | 1 | 0 | 2 | 3 | 2 | 3 | 3 | 3 | 4 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
The occurrence of any of the following toxicities during Part 1 of the study (the first 21 days for Cohort A, first 28 days for Cohorts B,C, D, \& E), if possibly, probably or definitely related to study treatment, was considered a DLT: Grade (Gr) 4 non hematologic toxicity, Gr 4 hematologic toxicity lasting \>7 days, Gr 3 thrombocytopenia, Any non-hematologic AE ≥Gr 3 in severity, Any Gr 3 or Gr 4 non-hematologic laboratory value, Febrile neutropenia Gr 3 or Gr 4, Any prolonged delay in initiating study therapy due to a treatment-related AE that started during the DLT period, Any treatment-related toxicity that causes the participant to discontinue treatment during the DLT period, Missing \>25% of binimetinib doses as a result of drug-related AE(s), Gr 5 toxicity, Cardiac disorders and vascular disorders, Eye disorders (Retinopathy or retinal detachment Gr ≥ 3).
| Percetange of Participants | Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg | Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg | Cohort B Part 1: Pembrolizumab + mFOLFOX7 | Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg | Cohort D Part 1: Pembrolizumab + FOLFIRI | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg | Cohort E Part 1: MK-3475 200 mg Q3W + FOLFIRI Q2W + Binimetinib 45 mg BID |
|---|---|---|---|---|---|---|---|
| Percentage of Participants Who Experienced Dose-Limiting Toxicity (DLT) | 16.7 (4.0 to 39.1) | 0.0 (0.0 to 10.2) | 0.0 (0.0 to 9.6) | 27.3 (13.4 to 45.0) | 7.1 (1.4 to 19.4) | 33.3 (17.0 to 53.1) | 45.5 (28.4 to 63.3) |
ORR was determined in all participants and was defined as the percentage of participants who had a confirmed 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) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). The percentage of participants who experienced CR or PR is presented. Per Protocol, analysis was per cohort.
| Percentage of participants | Cohort A | Cohort B | Cohort C | Cohort D | Cohort E |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | 0.0 (0.0 to 16.8) | 61.3 (42.2 to 78.2) | 27.3 (6.0 to 61.0) | 25.0 (11.5 to 43.4) | 20.0 (5.7 to 43.7) |
Collected over Up to approximately 64 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg | 5/6 (83.3%) | 1/6 (16.7%) | 6/6 (100%) |
| Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg | 16/16 (100%) | 7/14 (50%) | 14/14 (100%) |
| Cohort B Part 1: Pembrolizumab + mFOLFOX7 | 13/15 (86.7%) | 5/15 (33.3%) | 15/15 (100%) |
| Cohort B Part 2: Pembrolizumab + mFOLFOX | 12/16 (75%) | 8/16 (50%) | 16/16 (100%) |
| Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg | 9/11 (81.8%) | 7/11 (63.6%) | 11/11 (100%) |
| Cohort D Part 1: Pembrolizumab + FOLFIRI | 13/16 (81.3%) | 6/16 (37.5%) | 16/16 (100%) |
| Cohort D Part 2: Pembrolizumab + FOLFIRI | 11/16 (68.8%) | 2/16 (12.5%) | 16/16 (100%) |
| Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg | 6/9 (66.7%) | 5/9 (55.6%) | 9/9 (100%) |
| Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg | 7/11 (63.6%) | 7/11 (63.6%) | 11/11 (100%) |
| Event | Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg | Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg | Cohort B Part 1: Pembrolizumab + mFOLFOX7 | Cohort B Part 2: Pembrolizumab + mFOLFOX | Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg | Cohort D Part 1: Pembrolizumab + FOLFIRI | Cohort D Part 2: Pembrolizumab + FOLFIRI | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg |
|---|---|---|---|---|---|---|---|---|---|
| Small intestinal obstructionGastrointestinal disorders | 0/6 | 1/14 | 0/15 | 1/16 | 2/11 | 1/16 | 0/16 | 1/9 | 0/11 |
| PyrexiaGeneral disorders | 0/6 | 0/14 | 0/15 | 0/16 | 2/11 | 1/16 | 0/16 | 1/9 | 1/11 |
| Intestinal obstructionGastrointestinal disorders | 1/6 | 0/14 | 0/15 | 0/16 | 0/11 | 0/16 | 0/16 | 0/9 | 0/11 |
| Infusion related reactionInjury, poisoning and procedural complications | 0/6 | 0/14 | 1/15 | 2/16 | 0/11 | 0/16 | 0/16 | 0/9 | 1/11 |
| Large intestine perforationGastrointestinal disorders | 0/6 | 0/14 | 0/15 | 0/16 | 1/11 | 0/16 | 0/16 | 1/9 | 0/11 |
| VomitingGastrointestinal disorders | 0/6 | 1/14 | 0/15 | 0/16 | 1/11 | 0/16 | 0/16 | 1/9 | 1/11 |
| Anal abscessInfections and infestations | 0/6 | 0/14 | 0/15 | 0/16 | 0/11 | 0/16 | 0/16 | 1/9 | 1/11 |
| SyncopeNervous system disorders | 0/6 | 0/14 | 0/15 | 0/16 | 0/11 | 1/16 | 0/16 | 1/9 | 0/11 |
| Confusional statePsychiatric disorders | 0/6 | 1/14 | 0/15 | 0/16 | 0/11 | 0/16 | 0/16 | 1/9 | 0/11 |
| EmbolismVascular disorders | 0/6 | 0/14 | 0/15 | 0/16 | 0/11 | 1/16 | 0/16 | 1/9 | 0/11 |
| Event | Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg | Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg | Cohort B Part 1: Pembrolizumab + mFOLFOX7 | Cohort B Part 2: Pembrolizumab + mFOLFOX | Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg | Cohort D Part 1: Pembrolizumab + FOLFIRI | Cohort D Part 2: Pembrolizumab + FOLFIRI | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg |
|---|---|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 1/6 | 7/14 | 11/15 | 12/16 | 9/11 | 9/16 | 7/16 | 8/9 | 11/11 |
| DiarrhoeaGastrointestinal disorders | 5/6 | 8/14 | 11/15 | 8/16 | 10/11 | 13/16 | 12/16 | 8/9 | 9/11 |
| VomitingGastrointestinal disorders | 2/6 | 7/14 | 4/15 | 10/16 | 7/11 | 7/16 | 9/16 | 7/9 | 8/11 |
| FatigueGeneral disorders | 4/6 | 10/14 | 11/15 | 11/16 | 7/11 | 9/16 | 8/16 | 7/9 | 7/11 |
| Neuropathy peripheralNervous system disorders | 0/6 | 1/14 | 7/15 | 12/16 | 8/11 | 2/16 | 0/16 | 1/9 | 1/11 |
| Dermatitis acneiformSkin and subcutaneous tissue disorders | 4/6 | 5/14 | 3/15 | 3/16 | 8/11 | 2/16 | 1/16 | 6/9 | 5/11 |
| PruritusSkin and subcutaneous tissue disorders | 1/6 | 2/14 | 4/15 | 7/16 | 1/11 | 7/16 | 4/16 | 6/9 | 2/11 |
| ConstipationGastrointestinal disorders | 1/6 | 4/14 | 7/15 | 10/16 | 7/11 | 6/16 | 3/16 | 4/9 | 6/11 |
| Abdominal painGastrointestinal disorders | 2/6 | 2/14 | 3/15 | 2/16 | 6/11 | 6/16 | 10/16 | 3/9 | 4/11 |
| AnaemiaBlood and lymphatic system disorders | 1/6 | 2/14 | 4/15 | 5/16 | 3/11 | 9/16 | 3/16 | 5/9 | 4/11 |
| Age, Continuous(Years) | Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg | Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg | Cohort B Part 1: Pembrolizumab + mFOLFOX7 | Cohort B Part 2: Pembrolizumab + mFOLFOX7 | Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg | Cohort D Part 1: Pembrolizumab + FOLFIRI | Cohort D Part 2: Pembrolizumab + FOLFIRI | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg | Cohort E Part 1: MK-3475 200 mg Q3W + FOLFIRI Q2W + Binimetinib 45 mg BID | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 55.0 ± 9.3 | 59.4 ± 11.3 | 55.5 ± 11.6 | 50.3 ± 12.0 | 54.8 ± 14.1 | 56.3 ± 11.7 | 52.5 ± 13.8 | 57.9 ± 11.4 | 48.2 ± 10.4 | 54.4 ± 12.1 |
| Sex: Female, Male(Participants) | Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg | Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg | Cohort B Part 1: Pembrolizumab + mFOLFOX7 | Cohort B Part 2: Pembrolizumab + mFOLFOX7 | Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg | Cohort D Part 1: Pembrolizumab + FOLFIRI | Cohort D Part 2: Pembrolizumab + FOLFIRI | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg | Cohort E Part 1: MK-3475 200 mg Q3W + FOLFIRI Q2W + Binimetinib 45 mg BID | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 11 | 7 | 3 | 3 | 11 | 5 | 5 | 4 | 50 |
| Male | 5 | 5 | 8 | 13 | 8 | 5 | 11 | 4 | 7 | 66 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg | Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg | Cohort B Part 1: Pembrolizumab + mFOLFOX7 | Cohort B Part 2: Pembrolizumab + mFOLFOX7 | Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg | Cohort D Part 1: Pembrolizumab + FOLFIRI | Cohort D Part 2: Pembrolizumab + FOLFIRI | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg | Cohort E Part 1: MK-3475 200 mg Q3W + FOLFIRI Q2W + Binimetinib 45 mg BID | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 | 1 | 2 | 3 | 0 | 0 | 0 | 8 |
| Not Hispanic or Latino | 6 | 15 | 13 | 15 | 9 | 13 | 16 | 8 | 10 | 105 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg | Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg | Cohort B Part 1: Pembrolizumab + mFOLFOX7 | Cohort B Part 2: Pembrolizumab + mFOLFOX7 | Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg | Cohort D Part 1: Pembrolizumab + FOLFIRI | Cohort D Part 2: Pembrolizumab + FOLFIRI | Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg | Cohort E Part 1: MK-3475 200 mg Q3W + FOLFIRI Q2W + Binimetinib 45 mg BID | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 3 | 0 | 0 | 2 | 1 | 1 | 0 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 1 | 6 |
| White | 4 | 15 | 11 | 15 | 9 | 14 | 13 | 8 | 10 | 99 |
| More than one race | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Feb 2018 to primary completion in Sep 2021, 42 months.
Results were first posted in Oct 2024, 3 years 1 month after primary completion.
Of 268 industry-sponsored phase 1 interventional studies under Colorectal Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's 42 months is below that.
Counting every sponsor, half of 434 studies reached it within 48 months; a quarter within 31 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pembrolizumab · Binimetinib