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)

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT02563002
• Date of registration: 28/09/2015
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme LLC
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: November 30, 2015
• Target sample size: 307
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02563002
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme LLC

Key inclusion & exclusion criteria

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 standard of care (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 study medication for chemotherapy arm (no contraception requirement for
pembrolizumab [MK-3475] arm)

- 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 or a live attenuated 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 (for male and female participants) or 120 days after the
last dose of pembrolizumab (for female participants only)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colorectal Carcinoma

Intervention(s)

Drug: mFOLFOX6

Biological: bevacizumab

Drug: FOLFIRI

Biological: pembrolizumab

Biological: cetuximab

Primary Outcome(s)

Overall Survival (OS) [Time Frame: Up to approximately 59 months]

Progression-Free Survival (PFS) Per RECIST1.1 As Assessed by Central Imaging Vendor [Time Frame: Up to approximately 59 months]

Secondary Outcome(s)

Number of Participants Who Experienced an Adverse Event (AE) [Time Frame: Up to approximately 59 months]

Number of Participants Who Discontinued Study Treatment Due to an AE [Time Frame: Up to approximately 59 months]

Overall Response Rate (ORR) Per RECIST1.1 as Assessed by Central Imaging Vendor [Time Frame: Up to approximately 59 months]

Secondary ID(s)

163238

KEYNOTE-177

MK-3475-177

2015-002024-89

3475-177

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/03/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02563002