Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Digestive System Diseases

Mouth and Tooth Diseases

Rare Diseases

Lung Neoplasms

Carcinoma

Cholangiocarcinoma

Uterine Cervical Neoplasms

Vulvar Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Neuroendocrine Tumors

Small Cell Lung Carcinoma

Microsatellite Instability

Death

Mesothelioma

Mesothelioma, Malignant

Anus Neoplasms

Carcinoid Tumor

Endometrial Neoplasms

Colorectal Neoplasms

Salivary Gland Neoplasms

Bile Duct Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Adenocarcinoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenoma

Neoplasms, Mesothelial

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Rectal Neoplasms

Anus Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Vulvar Diseases

Bile Duct Cancer

Biliary Tract Cancer

Neuroendocrine Tumor

Small Cell Lung Cancer

Malignant Mesothelioma

Anal Cancer

Vulvar Cancer

Neuroepithelioma

Oral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will receive pembrolizumab 200 mg intravenously on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years of treatment).

Participants with any advanced solid tumor that has failed at least one line of therapy and is Tumor- Mutational Burden-High (TMB-H), excluding participants with mismatch repair deficient (dMMR/MSI-H) tumors. The dosing regimen for this cohort will be 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to approximately 2 years of treatment).

pembrolizumab

Toll Free Number

Australian Medical Information Centre

MSD Online

Medical Information Centre Centre d'information medicale Merck Canada Inc.

Maria Elena Azara Hernandez

Francesca Carvajal

Artur Fijolek

Dominique Blazy

German Medical Information Center

Gally Teper

Barbara Capaccetti

Jongho Ahn

Juan Marques

Caroline Doornebos

Tony Johansson

Oscar Espinoza

Cesar Recto

Thomas Johansson

Paula Martins de Jesus

Tatiana Serebriakova

Khanyi Mzolo

Lourdes Lopez-Bravo

I-Hua Su

Medical Director

In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

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

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ at any time during the trial. Responses will be determined by independent central radiologic review, with confirmatory assessment as required per RECIST 1.1. Participants with unknown or missing response information will be treated as non-responders. The percentage of participants who experience a CR or PR based on modified RECIST 1.1 will be presented.

DOR, defined in the subset of participants with a CR or PR, based on RECIST 1.1 as assessed by independent central radiologic review, as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death due to any cause, whichever occurs first. A Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Participants who are alive, have not progressed, have not initiated new anti-cancer treatment, and have not been determined to be lost to follow-up are considered ongoing responders at the time of analysis.

PFS is defined as the time from allocation to the first documented disease progression according to RECIST 1.1 as assessed by independent central radiologic review, or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. If a participant does not have a documented date of progression or death, PFS will be censored at the date of the last adequate assessment.

OS is defined as the time from randomization to death due to any cause. OS will be presented. Censoring will be performed using the date of last known contact for those who are alive at the time of analysis.

An adverse event (AE) is defined as any untoward medical occurrence in a study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this intervention. The percentage of participants with AEs will be reported.

An AE is defined as any untoward medical occurrence in a study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinue study intervention due to AEs will be reported.

Merck Sharp & Dohme LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)	NCT02628067	Advanced Cancer Anal Carcinoma Anal Cancer Biliary Cancer Cholangiocarcin... Bile Duct Cance... Neuroendocrine ... Carcinoid Tumor Endometrial Car... Endometrial Can... Cervical Carcin... Cervical Cancer Vulvar Carcinom... Vulvar Cancer Small Cell Lung... Small Cell Lung... Mesothelioma Thyroid Carcino... Thyroid Cancer Salivary Gland ... Salivary Gland ... Salivary Cancer Parotid Gland C... Advanced Solid ... Colorectal Carc...	pembrolizumab pembrolizumab	18 Years -	Merck Sharp & Dohme LLC
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)	NCT02628067	Advanced Cancer Anal Carcinoma Anal Cancer Biliary Cancer Cholangiocarcin... Bile Duct Cance... Neuroendocrine ... Carcinoid Tumor Endometrial Car... Endometrial Can... Cervical Carcin... Cervical Cancer Vulvar Carcinom... Vulvar Cancer Small Cell Lung... Small Cell Lung... Mesothelioma Thyroid Carcino... Thyroid Cancer Salivary Gland ... Salivary Gland ... Salivary Cancer Parotid Gland C... Advanced Solid ... Colorectal Carc...	pembrolizumab pembrolizumab	18 Years -	Merck Sharp & Dohme LLC
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)	NCT02628067	Advanced Cancer Anal Carcinoma Anal Cancer Biliary Cancer Cholangiocarcin... Bile Duct Cance... Neuroendocrine ... Carcinoid Tumor Endometrial Car... Endometrial Can... Cervical Carcin... Cervical Cancer Vulvar Carcinom... Vulvar Cancer Small Cell Lung... Small Cell Lung... Mesothelioma Thyroid Carcino... Thyroid Cancer Salivary Gland ... Salivary Gland ... Salivary Cancer Parotid Gland C... Advanced Solid ... Colorectal Carc...	pembrolizumab pembrolizumab	18 Years -	Merck Sharp & Dohme LLC

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