Brief Summary
In this study, participants with multiple types of advancedat a late stage, far along (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).
Intervention / Treatment
- Biological: pembrolizumab
- Biological: pembrolizumab
Inclusion Criteria
– Histologically or cytologically-documented, advanced solid tumoura tissue mass that forms from groups of unhealthy cells of one of the following types:
- Anal Squamous Cell Carcinomacancer arising from tissues that line organs
- Biliary Adenocarcinomacancer arising from mucus-producing glands in organs (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers)
- Neuroendocrine Tumors (well- and moderately-differentiated) of the lung, appendix, small intestinea section of the gastrointestinal tract that recieves food from the stomach and absorbs the nutrients from food, also called small bowel, colonthe longest portion of the large bowel that absorbs water and salts from ingested food, rectumthe last section of the large intestine/bowel that holds waste until it is ready to be removed from the body, or pancreasa long, flat organ that sits between the stomach and the spine that plays a key role in digestion and blood sugar regulation
- Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)
- Cervical Squamous Cell Carcinoma
- Vulvar Squamous Cell Carcinoma
- Small Cell Lung Carcinoma
- Mesothelioma
- Thyroid Carcinoma
- Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)
- Any advanced solid tumor, with the exception of colorectalrelating to the colon or rectum in the large bowel/intestine carcinoma (CRC), which is Microsatellite Instability (MSI)-High (MSI-H) OR
- Any advanced solid tumor (including Colorectal Carcinoma [CRC]) which is Mismatch Repair Deficient (dMMR)/MSI-H in participants from mainland China who are of Chinese descent. (CRC participants will have a histologically proven locally advanced unresectable or metastatic CRC which is dMMR/MSI-H that has received 2 prior lines of therapy) OR
- Any advanced solid tumor that has failed at least one line of therapy and is TMB-H (≥10 mut/Mb, F1CDx assay), excluding dMMR/MSI-H tumors.
Note: For participants to be eligible for enrollment they must have failed at least one line of standard of care systemic therapy (ie, not treatment naïve), with the exception of CRC participants who must have failed at least 2 lines of standard of care systemic therapy, as per CRC specific eligibility criteria. Participants must not have melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) or NSCLC.
- Progression of tumor or intolerance to therapies known to provide clinical benefit. There is no limit to the number of prior treatment regimens
- Can supply tumor tissuea group of cells that work together to perform a function for study analyses (dependent on tumor type)
- Radiologically-measurable disease
- Performance status of 0 or 1 on the Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Scale within 3 days prior to first dosethe amount of medication taken of pembrolizumab
- Life expectancy of at least 3 months
- Adequate organ function
- Female participants of childbearing potential must be willing to use adequate contraception during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows: MK-3475 (120 days)