Trial · NCT01876511
Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C)
NCT01876511, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2020-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C). Trials, record NCT01876511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01876511
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C)
- NCT number
- NCT01876511
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 113 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- MSI Positive Colorectal Cancer, MSI Negative Colorectal Cancer, MSI Positive Non-Colorectal Cancers
- Interventions
- MK-3475
- First posted
- 2013-06-12
- Last updated
- 2020-02-06
- Results first posted
- 2020-01-07
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 20 weeks | 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. |
| Primary | Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 | 28 months | 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. |
| Primary | 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 | 20 weeks | 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. |
| Primary | Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 28 months | 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. |
| Primary | Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 20 weeks | 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. |
| Secondary | Overall Survival (OS) | 4 years | 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. |
| Secondary | Immune-related Progression Free Survival (irPFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Immune Related Response Criteria (irRC) | 28 weeks | 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. |
| Secondary | Objective Response Rate (ORR) in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 28 months | 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. |
| Secondary | Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity | 28 months | 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. |
| Secondary | 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) | 28 weeks | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 20 weeks | It was a pre-specified objective to complete this objective in Cohort A and B only. Per protocol during stages 1 and 2, the study enrollment goal was 25 for Cohort A and B. However, only 24 subjects were enrolled in Cohort A. Additional subjects for this study were enrolled during the second expansion portion of this protocol. | percentage of participants | NUMBER |
| PRIMARY | Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 | 28 months | It was a pre-specified objective to complete this objective in Cohort A and B only. Per protocol during stages 1 and 2, the study enrollment goal was 25 for Cohort A and B. However, only 24 subjects were enrolled in Cohort A. Additional subjects for this study were enrolled during the second expansion portion of this protocol. | percentage of participants | NUMBER |
| PRIMARY | 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 | 20 weeks | It was a pre-specified objective to complete this objective in Cohort C only. Per protocol during stages 1 and 2, the study enrollment goal was 21 for Cohort C. Additional subjects for this study were enrolled during the second expansion portion of this protocol. | percentage of participants | NUMBER |
| PRIMARY | Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 28 months | It was a pre-specified objective to complete this objective in Cohort A and C only. | percentage of participants | NUMBER |
| PRIMARY | Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 20 weeks | It was a pre-specified objective to complete this objective in Cohort A and C only. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | 4 years | Weeks | MEDIAN | |
| SECONDARY | Immune-related Progression Free Survival (irPFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Immune Related Response Criteria (irRC) | 28 weeks | percentage of participants | NUMBER | |
| SECONDARY | Objective Response Rate (ORR) in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 28 months | percentage of participants | NUMBER | |
| SECONDARY | Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity | 28 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | 28 weeks | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Cohort A: MSI Positive Colorectal Cancer | 88 | 95% Confidence Interval 75 to 100 | percentage of participants | |
| 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 | Cohort B: MSI Negative Colorectal Cancer | 12 | 95% Confidence Interval 4 to 36 | percentage of participants | |
| Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 | Cohort A: MSI Positive Colorectal Cancer | 67 | 95% Confidence Interval 45 to 84 | percentage of participants | |
| Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 | Cohort B: MSI Negative Colorectal Cancer | 0 | 95% Confidence Interval 0 to 14 | percentage of participants | |
| 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 | Cohort C: MSI Positive Non-Colorectal Cancer | 67 | 95% Confidence Interval 49 to 90 | percentage of participants | |
| Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Cohort A: MSI Positive Colorectal Cancer | 54 | 95% Confidence Interval 37 to 69 | percentage of participants | |
| Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Cohort C: MSI Positive Non-Colorectal Cancer | 55 | 95% Confidence Interval 40 to 70 | percentage of participants | |
| Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Cohort A: MSI Positive Colorectal Cancer | 75 | 95% Confidence Interval 63 to 90 | percentage of participants | |
| Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Cohort C: MSI Positive Non-Colorectal Cancer | 68 | 95% Confidence Interval 56 to 83 | percentage of participants | |
| Overall Survival (OS) | Cohort A: MSI Positive Colorectal Cancer | NA | 95% Confidence Interval 151.86 to NA | Weeks |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: MSI Positive Colorectal Cancer | 41 | |
| Overall Study | STARTED | Cohort B: MSI Negative Colorectal Cancer | 25 | |
| Overall Study | STARTED | Cohort C: MSI Positive Non-Colorectal Cancer | 47 | |
| Overall Study | Stages 1 and 2 | Cohort A: MSI Positive Colorectal Cancer | 24 | |
| Overall Study | Stages 1 and 2 | Cohort B: MSI Negative Colorectal Cancer | 25 | |
| Overall Study | Stages 1 and 2 | Cohort C: MSI Positive Non-Colorectal Cancer | 21 | |
| Overall Study | COMPLETED | Cohort A: MSI Positive Colorectal Cancer | 18 | |
| Overall Study | COMPLETED | Cohort B: MSI Negative Colorectal Cancer | 0 | |
| Overall Study | COMPLETED | Cohort C: MSI Positive Non-Colorectal Cancer | 16 | |
| Overall Study | NOT COMPLETED | Cohort A: MSI Positive Colorectal Cancer | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events81
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Cohort A: MSI Positive Colorectal Cancer | 3 | 41 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Cohort B: MSI Negative Colorectal Cancer | 0 | 25 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Cohort C: MSI Positive Non-Colorectal Cancer | 4 | 47 | 4 |
| other | Hypothyroidism/thyroiditis | Endocrine disorders | Cohort A: MSI Positive Colorectal Cancer | 6 | 41 | 6 |
| other | Hypothyroidism/thyroiditis | Endocrine disorders | Cohort B: MSI Negative Colorectal Cancer | 0 | 25 | 0 |
| other | Hypothyroidism/thyroiditis | Endocrine disorders | Cohort C: MSI Positive Non-Colorectal Cancer | 13 | 47 | 13 |
| other | Diarrhea | Gastrointestinal disorders | Cohort A: MSI Positive Colorectal Cancer | 10 | 41 | 10 |
| other | Diarrhea | Gastrointestinal disorders | Cohort B: MSI Negative Colorectal Cancer | 0 | 25 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Cohort C: MSI Positive Non-Colorectal Cancer | 9 | 47 | 9 |
| other | Nausea | Gastrointestinal disorders | Cohort A: MSI Positive Colorectal Cancer | 5 | 41 | 5 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: MSI Positive Colorectal Cancer | 3 | 41 |
| Total, all-cause mortality | Cohort B: MSI Negative Colorectal Cancer | 0 | 25 |
| Total, all-cause mortality | Cohort C: MSI Positive Non-Colorectal Cancer | 2 | 47 |
| Total, other adverse events | Cohort A: MSI Positive Colorectal Cancer | 41 | 41 |
| Total, other adverse events | Cohort B: MSI Negative Colorectal Cancer | 3 | 25 |
| Total, other adverse events | Cohort C: MSI Positive Non-Colorectal Cancer | 47 | 47 |
| Total, serious adverse events | Cohort A: MSI Positive Colorectal Cancer | 4 | 41 |
| Total, serious adverse events | Cohort B: MSI Negative Colorectal Cancer | 0 | 25 |
| Total, serious adverse events | Cohort C: MSI Positive Non-Colorectal Cancer | 7 | 47 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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