Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)



Status:Recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/14/2018
Start Date:November 30, 2015
End Date:September 18, 2019
Contact:Toll Free Number
Phone:1-888-577-8839

Use our guide to learn which trials are right for you!

A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)

In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly
assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of
care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The
primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS)
or overall survival (OS) compared to current SOC chemotherapy.


Inclusion Criteria:

- Locally confirmed dMMR or MSI-H stage IV colorectal carcinoma

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days
prior to study start

- Life expectancy of at least 3 months

- Measurable disease

- Female participants of childbearing potential must be willing to use adequate
contraception for the course of the study starting with the first dose of study
medication through 180 days after the last dose of SOC therapy or 120 days after the
last pembrolizumab dose

- Male participants must agree to use adequate contraception for the course of the study
starting with the first dose of study medication through 180 days after the last dose
of SOC therapy or 120 days after the last pembrolizumab dose

- Adequate organ function

Exclusion Criteria:

- Has received prior systemic therapy for Stage IV colorectal cancer. May have received
prior adjuvant chemotherapy for colorectal cancer as long as it was completed at least
6 months prior to randomization on this study

- Currently participating and receiving treatment in another study, or participated in a
study of an investigational agent and received treatment, or used an investigational
device within 4 weeks of randomization

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

- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
of immunosuppressive therapy within 7 days prior to randomization on this study

- Radiation therapy within 4 weeks prior to randomization on this study and not
recovered to baseline from adverse events due to radiation therapy

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

- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to randomization on this study

- Has received prior therapy with an immune checkpoint inhibitor (e.g., anti-programmed
cell death [PD]-1, anti-PD ligand 1 [L1], anti-PD-L2 agent, or anti-cytotoxic
T-lymphocyte-associated protein 4 [CTLA-4] agent, etc.)

- Another malignancy that is progressing or requires active treatment with the exception
of non-melanomatous skin cancer that has undergone potentially curative therapy and in
situ cervical carcinoma

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

- Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or C

- Known history of, or any evidence of interstitial lung disease or active,
non-infectious pneumonitis

- Known history of active tuberculosis (Bacillus tuberculosis [TB])

- Active infection requiring systemic therapy

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

- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 180 days
after the last dose of SOC or 120 days after the last dose of pembrolizumab
We found this trial at
63
sites
2004
mi
from 98109
Columbus, OH
Click here to add this to my saved trials
1903
mi
from 98109
Ann Arbor, MI
Click here to add this to my saved trials
1026
mi
from 98109
Aurora, CO
Click here to add this to my saved trials
1775
mi
from 98109
Austin, TX
Click here to add this to my saved trials
2328
mi
from 98109
Baltimore, MD
Click here to add this to my saved trials
2485
mi
from 98109
Boston, MA
Click here to add this to my saved trials
2402
mi
from 98109
Bronx, NY
Click here to add this to my saved trials
2110
mi
from 98109
Buffalo, NY
Click here to add this to my saved trials
1733
mi
from 98109
Chicago, IL
Click here to add this to my saved trials
1967
mi
from 98109
Cincinnati, OH
Click here to add this to my saved trials
2020
mi
from 98109
Cleveland, OH
Click here to add this to my saved trials
1682
mi
from 98109
Dallas, TX
Click here to add this to my saved trials
1933
mi
from 98109
Detroit, MI
Click here to add this to my saved trials
2341
mi
from 98109
Durham, NC
Click here to add this to my saved trials
2436
mi
from 98109
East Setauket, NY
Click here to add this to my saved trials
2616
mi
from 98109
Fort Myers, FL
Click here to add this to my saved trials
1685
mi
from 98109
Franklin, WI
Click here to add this to my saved trials
2450
mi
from 98109
Gainesville, FL
Click here to add this to my saved trials
1825
mi
from 98109
Goshen, IN
Click here to add this to my saved trials
Greenville, South Carolina 29605
2227
mi
from 98109
Greenville, SC
Click here to add this to my saved trials
1739
mi
from 98109
Harvey, IL
Click here to add this to my saved trials
2679
mi
from 98109
Honolulu, HI
Click here to add this to my saved trials
1890
mi
from 98109
Houston, TX
Click here to add this to my saved trials
1557
mi
from 98109
Iowa City, IA
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
1939
mi
from 98109
Louisville, KY
Click here to add this to my saved trials
2164
mi
from 98109
Marietta, GA
Click here to add this to my saved trials
1712
mi
from 98109
Naperville, IL
Click here to add this to my saved trials
1970
mi
from 98109
Nashville, TN
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
2388
mi
from 98109
New Brunswick, NJ
Click here to add this to my saved trials
2432
mi
from 98109
New Haven, CT
Click here to add this to my saved trials
2400
mi
from 98109
New York, NY
Click here to add this to my saved trials
North Ryde, 2113
Phone: 61 2 8988 8428
7748
mi
from 98109
North Ryde,
Click here to add this to my saved trials
679
mi
from 98109
Oakland, CA
Click here to add this to my saved trials
984
mi
from 98109
Orange, CA
Click here to add this to my saved trials
704
mi
from 98109
Palo Alto, CA
Click here to add this to my saved trials
2373
mi
from 98109
Philadelphia, PA
Click here to add this to my saved trials
1116
mi
from 98109
Phoenix, AZ
Click here to add this to my saved trials
2132
mi
from 98109
Pittsburgh, PA
Click here to add this to my saved trials
1799
mi
from 98109
Plainfield, IL
Click here to add this to my saved trials
147
mi
from 98109
Portland, OR
Click here to add this to my saved trials
2374
mi
from 98109
Poughkeepsie, NY
Click here to add this to my saved trials
1702
mi
from 98109
Racine, WI
Click here to add this to my saved trials
1450
mi
from 98109
Rochester, MN
Click here to add this to my saved trials
617
mi
from 98109
Roseville, CA
Click here to add this to my saved trials
626
mi
from 98109
Sacramento, CA
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
2527
mi
from 98109
Saint Petersburg, FL
Click here to add this to my saved trials
701
mi
from 98109
Salt Lake City, UT
Click here to add this to my saved trials
681
mi
from 98109
San Francisco, CA
Click here to add this to my saved trials
713
mi
from 98109
San Jose, CA
Click here to add this to my saved trials
684
mi
from 98109
San Leandro, CA
Click here to add this to my saved trials
710
mi
from 98109
Santa Clara, CA
Click here to add this to my saved trials
635
mi
from 98109
Santa Rosa, CA
Click here to add this to my saved trials
2
mi
from 98109
Seattle, WA
Click here to add this to my saved trials
1263
mi
from 98109
Sioux Falls, SD
Click here to add this to my saved trials
2378
mi
from 98109
Somerville, NJ
Click here to add this to my saved trials
South San Francisco, California 94080
689
mi
from 98109
South San Francisco, CA
Click here to add this to my saved trials
705
mi
from 98109
Stanford, CA
Click here to add this to my saved trials
1220
mi
from 98109
Tucson, AZ
Click here to add this to my saved trials
1762
mi
from 98109
Tyler, TX
Click here to add this to my saved trials
655
mi
from 98109
Vallejo, CA
Click here to add this to my saved trials
671
mi
from 98109
Walnut Creek, CA
Click here to add this to my saved trials
2322
mi
from 98109
Washington,
Click here to add this to my saved trials