Clinical trial · Interventional
Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C)
Phase 2 Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors
NCT01876511CI-TRIAL-00043247completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MSI Negative Colorectal Cancer | — | UNRESOLVED | — |
| MSI Positive Colorectal Cancer | — | UNRESOLVED | — |
| MSI Positive Non-Colorectal Cancers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK-3475 | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A: MSI Positive Colorectal Cancer
- interventionNames
- Drug: MK-3475
- type
- EXPERIMENTAL
- label
- Cohort B: MSI Negative Colorectal Cancer
- interventionNames
- Drug: MK-3475
- type
- EXPERIMENTAL
- label
- Cohort C: MSI Positive Non-Colorectal Cancer
- interventionNames
- Drug: MK-3475
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cohort A only: Patients with microsatellite instability (MSI) positive colorectal cancer * Cohort B only: Patients with MSI negative colorectal cancer * Cohort C only: Patients with MSI positive non-colorectal cancer - * Have measurable disease * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 * Adequate organ function as defined by study-specified laboratory tests * Must use acceptable form of birth control through the study and for 28 days after final dose of study drug * Signed informed consent form * Willing and able to comply with study procedures * Agree to have a biopsy of participants' cancer * Patients with colon cancer must have received at least two prior cancer therapy regimens. * Patients with other cancer types must have received at least one prior cancer therapy * Progressive disease Exclusion Criteria: * Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements. * Patients who have had chemotherapy or biological cancer therapy within 2 weeks prior to the first dose of study drug * Patients who have had radiation within 2 weeks prior to the first dose of study drug * Patients who have undergone major surgery within 4 weeks of dosing of investigational agent * Patients who have received another investigational product or investigational device within 4 weeks prior to receiving study drug * Patients who have received any of the following concomitant therapy: Interleukin-2 (IL-2), interferon, or other non-study immunotherapy regimens, immunosuppressive agents, other investigational therapies or chronic use of systemic corticosteroids within one week prior to first dose of study drug * Patients who have received a live vaccine within 4 weeks prior to or after any dose of MK-3475 (exception: inactivated flu vaccines) * Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration * Patient who have had prior treatment with anti-PD-1 (anti-programmed cell death protein 1), anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies * Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus (SLE) autoimmune vasculitis, central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin. * Patients who have known history of infection with HIV, hepatitis B, or hepatitis C * Patients with evidence of interstitial lung disease * Systemically active steroid use * Patients on home oxygen * Patients with oxygen saturation of \<92% on room air by pulse oximetry * Pregnant or lactating * Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures * Patient with known active central nervous system metastases and/or carcinomatous meningitis. * Patients with primary brain tumors. * Requires any other form of systemic or localized antineoplastic therapy while on study * Has any tissue or organ allograft * Patients with history of allogeneic hematopoeitic stem cell transplant
References
Publications (2)
- BACKGROUNDLe DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8. PMID 28596308
- BACKGROUNDLe DT, Uram JN, Wang H, Bartlett BR, Kemberling H, Eyring AD, Skora AD, Luber BS, Azad NS, Laheru D, Biedrzycki B, Donehower RC, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Duffy SM, Goldberg RM, de la Chapelle A, Koshiji M, Bhaijee F, Huebner T, Hruban RH, Wood LD, Cuka N, Pardoll DM, Papadopoulos N, Kinzler KW, Zhou S, Cornish TC, Taube JM, Anders RA, Eshleman JR, Vogelstein B, Diaz LA Jr. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency. N Engl J Med. 2015 Jun 25;372(26):2509-20. doi: 10.1056/NEJMoa1500596. Epub 2015 May 30. PMID 26028255