cancer
Conditions
Interventions
None listed
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Have histologically or cytologically-documented, locally-advanced, or metastatic solid malignancy that has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the patient and treating physician. There is no limit to the number of prior treatment regimens.;2. Have one of the following advanced (unresectable and/or metastatic) solid tumor indications for which no curative therapy exist:;A1 Colon or Rectal Adenocarcinoma A2 Anal Canal Squamous Cell Carcinoma A3 Pancreas Adenocarcinoma A4 Esophageal Squamous Cell Carcinoma or Adenocarcinoma (Including GE Junction) A5 Biliary Tract Adenocarcinoma (Gallbladder and Biliary Tree but excluding Ampulla of Vater Cancers) A6 Carcinoid Tumors A7 Neuroendocrine Carcinomas (Well or moderately differentiated Pancreatic Neuroendocrine Tumor) B1 ER Positive HER2 Negative Breast Cancer a B2 Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma B3 Endometrial Carcinoma b B4 Cervical Squamous Cell Cancer B5 Vulvar Squamous Cell Carcinoma C1 Small Cell Lung Cancer C2 Mesothelioma (Malignant Pleural Mesothelioma) D1 Thyroid Cancer (Papillary or Follicular Subtype) D2 Salivary Gland Carcinoma b D3 Nasopharyngeal Carcinoma E1 Glioblastoma Multiforme c E2 Leiomyosarcoma E3 Prostate Adenocarcinoma d a Note: ER positive HER2 negative status for breast cancer cohort defined by local standards. b Note: All carcinoma subtypes are allowed however sarcomas or mesenchymal tumors are excluded. c Note: Glioblastoma multiforme subjects with any prior bevacizumab treatment are NOT eligible. d Note: Subjects with prostate cancer who are currently on LHRH analogs are eligible for this study and may continue to take the LHRH analogs while participating in this study.;3. Have provided tissue for biomarker analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated (tumors progressing in a prior site of radiation are allowed for PD-L1 characterization, other exceptions may be considered after Sponsor consultation). ;4. Have a PD-L1 positive tumor as determined by IHC at a central laboratory from either an archived formalin fixed paraffin embedded (FFPE) tumor sample or a newly obtained biopsy.;5. Have measurable disease based on RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. ;6. Have a performance status of 0 or 1 on the ECOG Performance Scale.;7. Demonstrate adequate organ function as defined in the protocol.
Exclusion criteria
Exclusion criteria: 1. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.;2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.;Note: Systemic steroid therapy allowed for subjects in the GBM cohort as long as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate preliminary signals of potential anti-tumor activity of MK-3475 in subjects with a given a histopathologic type of PD-L1 positive advanced solid tumor based on RECIST 1.1 as determined by the investigator in the tumor indications below. | — |
Secondary
| Measure | Time frame |
|---|---|
| Across-Indication Secondary Objective (1) Objective: To determine the safety and tolerability of MK-3475 across selected PD-L1 positive advanced solid tumors. Within-Indication Secondary Objectives The following secondary objectives will be evaluated separately in each of the 20 disease indications listed in Section 3.1. (1) Objective: To evaluate the progression-free survival (PFS) in subjects with a given PD-L1 positive advanced solid tumor type receiving MK-3475. (2) Objective: To evaluate the overall survival (OS) in subjects with a given PD-L1 positive advanced solid tumor type receiving MK-3475. (3) Objective: To evaluate the response duration in subjects with a given PD-L1 positive advanced solid tumor type receiving MK-3475. | — |
Countries
Netherlands
Outcome results
None listed