Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01876511 · ClinicalTrials.gov registry record · Phase 2
Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C)
A Phase 2 study of MSI Positive Colorectal Cancer and MSI Negative Colorectal Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
- 7
- Study locations
NCT01876511: Completed Phase 2 study of MSI Positive Colorectal Cancer and MSI Negative Colorectal Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01876511 is a Phase 2 study of MSI Positive Colorectal Cancer and MSI Negative Colorectal Cancer that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 113 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01876511, a Phase 2 study of MSI Positive Colorectal Cancer and MSI Negative Colorectal Cancer, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG MK-3475
Study Locations (7)
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
- Investigator Thoracic and Gastrointestinal Oncology Branch, Center for Cancer Research, NIH - Bethesda
Pennsylvania
- University of Pennsylvania, Abramson Cancer Center - Philadelphia
- University of Pittsburgh Cancer Institute - Pittsburgh
California
- Stanford University - Stanford
Ohio
- Ohio State University - Columbus
Oregon
- Providence Portland Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2013-09 |
| Est. Completion | 2019-08 |
| Phase | Phase 2 |
What the finished NCT01876511 record still lists
NCT01876511 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower).
The record links to 3 conditions, with MSI Positive Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which MK-3475 is the first listed.
NCT01876511 lists 7 locations in 5 states (Maryland, Pennsylvania, California).
Frequently Asked Questions
What is clinical trial NCT01876511 about?
NCT01876511 is a clinical study titled "Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C)". 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. patient...
What is the current status of trial NCT01876511?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2013-09. Estimated completion is 2019-08.
What conditions does trial NCT01876511 study?
This clinical trial studies the following conditions: MSI Positive Colorectal Cancer, MSI Negative Colorectal Cancer, MSI Positive Non-Colorectal Cancers.
What interventions are being tested in trial NCT01876511?
The interventions under investigation include: MK-3475 (DRUG).
Who is sponsoring clinical trial NCT01876511?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01876511 being conducted?
This trial has 7 study locations across California, Maryland, Ohio, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01876511's enrollment target sits among peer trials
113 631st of 2000 higher than 1,370 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00748254 · 113 participants
Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis
- NCT04753190 · 113 participants · NA
Light Timing Study
- NCT05799248 · 113 participants · Phase 3
Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management
- NCT07216105 · 113 participants · Phase 1
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia