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A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE-158)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501253-37-00
Acronym
MK-3475-158
Enrollment
635
Registered
2023-02-07
Start date
2016-02-02
Completion date
Unknown
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(A) Anal Squamous Cell Carcinoma, appendix, (B) Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers) (C) Neuroendocrine Tumors (well- and moderately differentiated) of the lung, colon, (D) Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded), (E) Cervical Squamous Cell Carcinoma, excluding subjects with dMMR/MSI-H tumors., F1CDx assay), (F) Vulvar Squamous Cell Carcinoma, (G) Small Cell Lung Carcinoma, (H) Mesothelioma, (I) Thyroid Carcinoma, (J) Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded), OR (K) Any advanced solid tumor, or pancreas, rectum, small intestine, which is microsatellite instability (MSI)-high (MSI-H). (L) Any advanced solid tumor (including CRC) which is mismatch repair deficient (dMMR)/MSI-H in subjects from mainland China who are of Chinese descent. (M) Any advanced solid tumor that has failed at least one line of therapy and is Tumor Mutational Burden-High (TMB-H) (≥10 mut/Mb, with the exception of colorectal carcinoma (CRC)

Brief summary

Objective Response Rate (ORR)

Detailed description

Duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS), Percentage of Participants with Adverse Events, Percentage of Participants who Discontinued Study Intervention due to Adverse Events

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Objective Response Rate (ORR)

Secondary

MeasureTime frame
Duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS), Percentage of Participants with Adverse Events, Percentage of Participants who Discontinued Study Intervention due to Adverse Events

Countries

Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026