Trial Profile
A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects With Previously Treated Locally Advanced Unresectable or Metastatic (Stage IV) Mismatched Repair Deficient or Microsatellite Instability-High Colorectal Carcinoma (KEYNOTE-164)
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 31 Mar 2023
Price :
$35
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At a glance
- Drugs Pembrolizumab (Primary)
- Indications Carcinoma; Colorectal cancer
- Focus Registrational; Therapeutic Use
- Acronyms KEYNOTE-164
- Sponsors Merck Sharp & Dohme
- 29 Mar 2023 Pooled data from KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 studies presented in a Merck & Co media release.
- 29 Mar 2023 According to a Merck & Co media release, this conversion from accelerated to a full (regular) approval marks the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumor type.
- 29 Mar 2023 According to a Merck & Co media release, based on the data from KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 studies, the USA Food and Drug Administration (FDA) has granted full approval to KEYTRUDA for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors.