A Phase 3 interventional study of mFOLFOX6 and FOLFIRI in Colorectal Carcinoma, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, 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 5th largest by enrollment, is one of 7 that started in 2015, is one of 4 in phase 3, and was the 9th 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. 7 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 307 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 7th largest by enrollment of the 24 interventional ones that give a count, is one of 3 that started in 2015, is one of 6 in phase 3, and was the 10th 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.
In this study, participants with stage IV Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal carcinoma (CRC) will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
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.
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.
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.
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.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
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.
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.
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.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
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.
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.
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Participants that have stopped the initial course of pembrolizumab and have stable disease but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 year additional).
Biological: Pembrolizumab
Participants receive 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Participants that have stopped pembrolizumab and have stable disease but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 year additional).
Drug: mFOLFOX6 · Drug: FOLFIRI · Biological: Pembrolizumab · Biological: Bevacizumab · Biological: Cetuximab
Regimen consists of oxaliplatin 85 mg/m\^2 IV on Day 1, leucovorin 400 mg/m\^2 or levoleucovorin 200 mg/m\^2 IV on Day 1, 5-fluorouracil (5-FU) 400 mg/m\^2 IV bolus on Day 1 and then 1200 mg/m\^2/day IV over 2 days for total dose of 2400 mg/m\^2 in each 2-week cycle
Regimen consists of irinotecan 180 mg/m\^2 IV on Day 1, leucovorin 400 mg/m\^2 or levoleucovorin 200 mg/m\^2 IV on Day 1, 5-FU 400 mg/m\^2 IV bolus on Day 1 and then 1200 mg/m\^2/day IV over 2 days for total dose of 2400 mg/m\^2 in each 2-week cycle
IV infusion
Also known as: MK-3475, SCH 900475, KEYTRUDA®
IV infusion
IV infusion
Progression-Free Survival (PFS) Per RECIST1.1 As Assessed by Central Imaging Vendor
PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Hazards ratio (HR) and associated 95% confidence intervals (CIs) from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol.
Time frame: Up to approximately 59 months
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. HR and associated 95% CIs from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol.
Time frame: Up to approximately 59 months
Overall Response Rate (ORR) Per RECIST1.1 as Assessed by Central Imaging Vendor
ORR was defined as the percentage of the participants who experienced 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) and was assessed using RECIST 1.1 as assessed by the central imaging vendor. The percentage of participants who experienced a CR or PR was presented for the first course of study treatment per protocol.
Time frame: Up to approximately 59 months
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE was presented for the first course study treatment per protocol.
Time frame: Up to approximately 59 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE was presented for the first course study treatment per protocol.
Time frame: Up to approximately 59 months
| Milestone | Pembrolizumab | Standard of Care (SOC) |
|---|---|---|
| Started | 153 | 154 |
| Treated | 153 | 143 |
| Received second course of pembrolizumab | 12 | 5 |
| Switched over to pembrolizumab | 0 | 7 |
| Completed | 0 | 0 |
| Not completed | 153 | 154 |
| Withdrew: Death | 72 | 87 |
| Withdrew: Lost to follow-up | 5 | 0 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Withdrawal by subject | 2 | 10 |
| Withdrew: Sponsor decision | 74 | 55 |
PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Hazards ratio (HR) and associated 95% confidence intervals (CIs) from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol.
| Months | Pembrolizumab | Standard of Care (SOC) |
|---|---|---|
| Progression-Free Survival (PFS) Per RECIST1.1 As Assessed by Central Imaging Vendor | 16.5 (5.4 to 38.1) | 8.2 (6.1 to 10.2) |
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. HR and associated 95% CIs from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol.
| Months | Pembrolizumab | Standard of Care (SOC) |
|---|---|---|
| Overall Survival (OS) | NA (49.2 to NA) | 36.7 (27.6 to NA) |
ORR was defined as the percentage of the participants who experienced 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) and was assessed using RECIST 1.1 as assessed by the central imaging vendor. The percentage of participants who experienced a CR or PR was presented for the first course of study treatment per protocol.
| Percentage of Participants | Pembrolizumab | Standard of Care (SOC) |
|---|---|---|
| Overall Response Rate (ORR) Per RECIST1.1 as Assessed by Central Imaging Vendor | 45.1 (37.1 to 53.3) | 33.1 (25.8 to 41.1) |
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE was presented for the first course study treatment per protocol.
| Participants | Pembrolizumab | Standard of Care (SOC) |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | 149 | 142 |
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE was presented for the first course study treatment per protocol.
| Participants | Pembrolizumab | Standard of Care (SOC) |
|---|---|---|
| Number of Participants Who Discontinued Study Treatment Due to an AE | 21 | 20 |
Collected over Up to approximately 91 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab First Course | 68/153 (44.4%) | 62/153 (40.5%) | 145/153 (94.8%) |
| Standard of Care (SOC) First Course | 58/154 (37.7%) | 76/143 (53.1%) | 142/143 (99.3%) |
| SOC Switched Over to Pembrolizumab | 30/57 (52.6%) | 27/57 (47.4%) | 53/57 (93%) |
| Pembrolizumab Second Course | 4/12 (33.3%) | 3/12 (25%) | 11/12 (91.7%) |
| SOC Switched Over to Pembrolizumab-Second Course | 2/5 (40%) | 1/5 (20%) | 4/5 (80%) |
| Event | Pembrolizumab First Course | Standard of Care (SOC) First Course | SOC Switched Over to Pembrolizumab | Pembrolizumab Second Course | SOC Switched Over to Pembrolizumab-Second Course |
|---|---|---|---|---|---|
| Acute kidney injuryRenal and urinary disorders | 3/153 | 2/143 | 3/57 | 0/12 | 1/5 |
| Adrenal insufficiencyEndocrine disorders | 2/153 | 0/143 | 0/57 | 1/12 | 0/5 |
| COVID-19Infections and infestations | 0/153 | 0/143 | 0/57 | 1/12 | 0/5 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/153 | 0/143 | 0/57 | 1/12 | 0/5 |
| Tumour painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/153 | 0/143 | 0/57 | 1/12 | 0/5 |
| DiarrhoeaGastrointestinal disorders | 4/153 | 9/143 | 1/57 | 0/12 | 0/5 |
| Small intestinal obstructionGastrointestinal disorders | 2/153 | 5/143 | 3/57 | 0/12 | 0/5 |
| Abdominal painGastrointestinal disorders | 7/153 | 2/143 | 2/57 | 0/12 | 0/5 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/153 | 6/143 | 0/57 | 0/12 | 0/5 |
| PneumoniaInfections and infestations | 3/153 | 2/143 | 2/57 | 0/12 | 0/5 |
| Event | Pembrolizumab First Course | Standard of Care (SOC) First Course | SOC Switched Over to Pembrolizumab | Pembrolizumab Second Course | SOC Switched Over to Pembrolizumab-Second Course |
|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 65/153 | 89/143 | 17/57 | 2/12 | 0/5 |
| NauseaGastrointestinal disorders | 47/153 | 85/143 | 16/57 | 1/12 | 0/5 |
| FatigueGeneral disorders | 58/153 | 70/143 | 9/57 | 2/12 | 0/5 |
| Decreased appetiteMetabolism and nutrition disorders | 36/153 | 57/143 | 2/57 | 1/12 | 0/5 |
| VomitingGastrointestinal disorders | 33/153 | 53/143 | 12/57 | 0/12 | 0/5 |
| ConstipationGastrointestinal disorders | 26/153 | 45/143 | 13/57 | 0/12 | 0/5 |
| StomatitisGastrointestinal disorders | 10/153 | 43/143 | 4/57 | 0/12 | 0/5 |
| HeadacheNervous system disorders | 21/153 | 22/143 | 17/57 | 0/12 | 0/5 |
| Abdominal painGastrointestinal disorders | 34/153 | 41/143 | 8/57 | 0/12 | 0/5 |
| PruritusSkin and subcutaneous tissue disorders | 25/153 | 12/143 | 15/57 | 0/12 | 1/5 |
All randomized participants
| Age, Continuous(Years) | Pembrolizumab | Standard of Care (SOC) | Total |
|---|---|---|---|
| Mean | 61.9 ± 14.9 | 60.6 ± 14.8 | 61.2 ± 14.8 |
| Sex: Female, Male(Participants) | Pembrolizumab | Standard of Care (SOC) | Total |
|---|---|---|---|
| Female | 82 | 72 | 154 |
| Male | 71 | 82 | 153 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab | Standard of Care (SOC) | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 10 | 21 |
| Not Hispanic or Latino | 128 | 131 | 259 |
| Unknown or Not Reported | 14 | 13 | 27 |
| Race (NIH/OMB)(Participants) | Pembrolizumab | Standard of Care (SOC) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 24 | 26 | 50 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 5 | 14 |
| White | 113 | 116 | 229 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 7 | 14 |
No study locations are listed for this record.
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 Nov 2015 to primary completion in Feb 2021, 62 months.
Results were first posted in Mar 2022, 1 year after primary completion.
Of 69 industry-sponsored phase 3 interventional studies under Colorectal Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 54. This study's 62 months is above that.
Counting every sponsor, half of 175 studies reached it within 50 months; a quarter within 35 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pembrolizumab