A Phase 2 interventional study of MK-3475 in MSI Positive Colorectal Cancer, MSI Negative Colorectal Cancer and MSI Positive Non-Colorectal Cancers, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-06.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 2, 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 9th largest by enrollment, is the only one that started in 2013, is one of 19 in phase 2, and was the 2nd 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. 1 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 113 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:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 71 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 68 (60%) have results posted.
15 studies in Colorectal Neoplasms by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: 3 open now, 4 under way, none of them phase 3. Of 11 finished, 5 (45%) have results posted.
Among the 15 studies in Colorectal Neoplasms by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, this one is the 2nd largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2013, is one of 6 in phase 2, and was the 6th registered.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins’s Colorectal Neoplasms studies by the year they started, since 2006.
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 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins’s 15 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.
This study will be looking at whether MK-3475 (an antibody that blocks negative signals to T cells) is effective (anti-tumor activity) and safe in three different patient populations. These include: 1. patients with MSI positive colon cancer, 2. patients with MSI negative colon cancer and 3. patients with other MSI positive cancers.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Drug: MK-3475
Drug: MK-3475
Drug: MK-3475
MK-3475 10 mg/kg every 14 days
Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2
For Cohorts A and B: irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 20 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
Time frame: 20 weeks
Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2
For Cohorts A and B: Immune-related Objective Response Rate (irORR) is defined as the percentage of patients achieving a complete response (irCR) or partial response (irPR) based on irRC criteria. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation.
Time frame: 28 months
Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive Non-colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2
For Cohort C: irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 20 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
Time frame: 20 weeks
Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
For Cohorts A and C: Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions.
Time frame: 28 months
Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
For Cohorts A and C: PFS is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 20 weeks. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Time frame: 20 weeks
Overall Survival (OS)
OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Time frame: 4 years
Immune-related Progression Free Survival (irPFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Immune Related Response Criteria (irRC)
irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 28 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
Time frame: 28 weeks
Objective Response Rate (ORR) in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
ORR is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions.
Time frame: 28 months
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
When calculating the incidence of AEs, each adverse event (AE) (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.
Time frame: 28 months
Progression Free Survival (PFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
PFS is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 28 weeks. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Time frame: 28 weeks
Disease Control Rate in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Disease Control Rate (DCR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Time frame: 28 months
Does MSI as a Marker Predict Treatment Response
ORR was used to determine whether MSI is a marker that predicts treatment response. This is the same data presented in outcome measure number 8 (ORR, to test against null of 5%).
Time frame: 28 months
| Milestone | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|---|
| Started | 41 | 25 | 47 |
| Stages 1 and 2 | 24 | 25 | 21 |
| Completed | 18 | 0 | 16 |
| Not completed | 23 | 25 | 31 |
| Withdrew: Disease progression-clinical/radiologic | 11 | 24 | 16 |
| Withdrew: Death (unrelated) | 3 | 0 | 2 |
| Withdrew: Drug-related toxicity | 5 | 1 | 6 |
| Withdrew: Patient decision | 3 | 0 | 6 |
| Withdrew: Physician decision | 1 | 0 | 1 |
For Cohorts A and B: irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 20 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
| percentage of participants | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer |
|---|---|---|
| Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 | 88 (75 to 100) | 12 (4 to 36) |
For Cohorts A and B: Immune-related Objective Response Rate (irORR) is defined as the percentage of patients achieving a complete response (irCR) or partial response (irPR) based on irRC criteria. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation.
| percentage of participants | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer |
|---|---|---|
| Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 | 67 (45 to 84) | 0 (0 to 14) |
For Cohort C: irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 20 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
| percentage of participants | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|
| Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive Non-colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 | 67 (49 to 90) |
For Cohorts A and C: Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions.
| percentage of participants | Cohort A: MSI Positive Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|
| Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 54 (37 to 69) | 55 (40 to 70) |
For Cohorts A and C: PFS is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 20 weeks. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
| percentage of participants | Cohort A: MSI Positive Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|
| Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 75 (63 to 90) | 68 (56 to 83) |
OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
| Weeks | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|---|
| Overall Survival (OS) | NA (151.86 to NA) | 36.71 (21.29 to 69.43) | 148.86 (94.71 to NA) |
irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 28 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
| percentage of participants | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|---|
| Immune-related Progression Free Survival (irPFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Immune Related Response Criteria (irRC) | 70 (58 to 86) | 12 (4 to 36) | 64 (51 to 80) |
ORR is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions.
| percentage of participants | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|---|
| Objective Response Rate (ORR) in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 54 (37 to 69) | 0 (0 to 14) | 55 (40 to 70) |
When calculating the incidence of AEs, each adverse event (AE) (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.
| Participants | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|---|
| Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity | 12 | 0 | 13 |
PFS is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 28 weeks. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
| percentage of participants | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|---|
| Progression Free Survival (PFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 70 (57 to 86) | 16 (6 to 41) | 64 (51 to 79) |
Disease Control Rate (DCR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
| percentage of participants | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|---|
| Disease Control Rate in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 80 (65 to 91) | 16 (5 to 36) | 70 (55 to 83) |
ORR was used to determine whether MSI is a marker that predicts treatment response. This is the same data presented in outcome measure number 8 (ORR, to test against null of 5%).
| percentage of participants | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|---|
| Does MSI as a Marker Predict Treatment Response | 54 (37 to 69) | 0 (0 to 14) | 55 (40 to 70) |
Collected over 2 years 4 months Study treatment was administered for up to 2 years. Adverse events were accessed through 90 days after the last dose of study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A: MSI Positive Colorectal Cancer | 3/41 (7.3%) | 4/41 (9.8%) | 41/41 (100%) |
| Cohort B: MSI Negative Colorectal Cancer | 0/25 (0%) | 0/25 (0%) | 3/25 (12%) |
| Cohort C: MSI Positive Non-Colorectal Cancer | 2/47 (4.3%) | 7/47 (14.9%) | 47/47 (100%) |
| Event | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|---|
| Diabetic ketoacidosisMetabolism and nutrition disorders | 0/41 | 0/25 | 2/47 |
| Acute kidney injuryRenal and urinary disorders | 1/41 | 0/25 | 0/47 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/41 | 0/25 | 0/47 |
| PancreatitisGastrointestinal disorders | 1/41 | 0/25 | 1/47 |
| MyocarditisCardiac disorders | 1/41 | 0/25 | 1/47 |
| Infusion reactionProduct Issues | 1/41 | 0/25 | 0/47 |
| CellulitisInfections and infestations | 1/41 | 0/25 | 0/47 |
| DiarrheaGastrointestinal disorders | 0/41 | 0/25 | 1/47 |
| ColitisGastrointestinal disorders | 0/41 | 0/25 | 1/47 |
| NeuropathyNervous system disorders | 0/41 | 0/25 | 1/47 |
| Event | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer |
|---|---|---|---|
| RashSkin and subcutaneous tissue disorders | 10/41 | 2/25 | 15/47 |
| Hypothyroidism/thyroiditisEndocrine disorders | 6/41 | 0/25 | 13/47 |
| FatigueGeneral disorders | 8/41 | 1/25 | 13/47 |
| PruritusSkin and subcutaneous tissue disorders | 6/41 | 0/25 | 13/47 |
| DiarrheaGastrointestinal disorders | 10/41 | 0/25 | 9/47 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 7/41 | 0/25 | 4/47 |
| NauseaGastrointestinal disorders | 5/41 | 0/25 | 8/47 |
| Aspartate aminotransferase increased (AST)Investigations | 4/41 | 0/25 | 5/47 |
| Lymphocyte count decreasedInvestigations | 2/41 | 0/25 | 5/47 |
| NeuropathyNervous system disorders | 1/41 | 0/25 | 5/47 |
| Age, Categorical(Participants) | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 31 | 15 | 30 | 76 |
| >=65 years | 10 | 10 | 17 | 37 |
| Sex: Female, Male(Participants) | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer | Total |
|---|---|---|---|---|
| Female | 19 | 9 | 23 | 51 |
| Male | 22 | 16 | 24 | 62 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 | 4 |
| Not Hispanic or Latino | 39 | 25 | 44 | 108 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Cohort A: MSI Positive Colorectal Cancer | Cohort B: MSI Negative Colorectal Cancer | Cohort C: MSI Positive Non-Colorectal Cancer | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 3 | 1 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 1 | 7 |
| White | 34 | 21 | 44 | 99 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2013 to primary completion in Aug 2019, 71 months.
Results were first posted in Jan 2020, 5 months after primary completion.
Of 498 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 75. This study's 71 months is above that.
Counting every sponsor, half of 618 studies reached it within 49 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pembrolizumab
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins →