Trial Search Results

Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)

In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy.

There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti-vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody.

The primary hypothesis is that Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by central imaging vendor in participants with locally advanced unresectable or metastatic MMR deficient or MSI high CRC is greater than 15%.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Merck Sharp & Dohme Corp.

Intervention(s):

  • Biological: Pembrolizumab

Phase:

Phase 2

Eligibility


Inclusion criteria:

   - Histologically-proven locally advanced unresectable or metastatic high colorectal
   carcinoma

   - Locally confirmed MMR deficient or MSI-H status

   - Has been previously treated with standard therapies, which must include, for Cohort A,
   fluoropyrimidine, oxaliplatin, and irinotecan, and for Cohort B, at least one line of
   systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine
   + irinotecan +/- anti-VEGF/EGFR monoclonal antibody (mAb).

   - Eastern Cooperative Oncology Group performance status of 0 or 1

   - Life expectancy of greater than 3 months

   - Provides an archival or newly obtained (≤60 days prior to first dose of study
   treatment) tumor tissue sample (Cohort B)

   - At least one measurable lesion

   - Female participants of childbearing potential should be willing to use acceptable
   methods of contraception or be surgically sterile, or abstain from heterosexual
   activity for the course of the study through 120 days after the last dose of study
   treatment

   - Male participants should agree to use an adequate method of contraception starting
   with the first dose of study treatment through 120 days after the last dose of study
   treatment

   - Adequate organ function

Exclusion criteria:

   - Currently participating in another study and receiving trial treatment, participated
   in a study of an investigational agent and received trial treatment within 4 weeks of
   the first dose of treatment in this study, or used an investigational device within 4
   weeks of the first dose of treatment in this study

   - Active autoimmune disease that has required systemic treatment in past 2 years

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy within 7 days prior to the first dose of trial
   treatment

   - Known active central nervous system metastases and/or carcinomatous meningitis

   - Prior monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or
   radiation therapy within 2 weeks prior to study Day 1 or not recovered (i.e., ≤ Grade
   1 or at baseline) from adverse events (AEs) due to a previously administered agent

   - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

   - Has a known additional malignancy that is progressing or requires active treatment.
   Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the
   skin that has undergone potentially curative therapy or in situ cervical cancer.

   - Received a live vaccine within 30 days of planned start of study treatment

   - Known history of human immunodeficiency virus (HIV)

   - Known active Hepatitis B or C

   - Has known history of, or any evidence of interstitial lung disease or active,
   noninfectious pneumonitis

   - Active infection requiring systemic therapy

   - Known psychiatric or substance abuse disorders that would interfere with cooperation
   with the requirements of the study

   - Pregnant or breastfeeding, or expecting to conceive or father children within the
   projected duration of the study, starting with the screening visit through 120 days
   after the last dose of study treatment

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting