Testing an Immunotherapy, Pembrolizumab, in Patients With Advanced Solid Tumors

About the Study

This study is looking at the effectiveness of an immunotherapy, pembrolizumab, in treating people who have been diagnosed with advanced solid tumors that have progressed on standard-of-care therapy, by radiology and through tumor biopsies. While participants may receive up to two years of treatment, the response will be measured for up to 10.5 years. 

What the Study Involves

There will be two groups in this study. All participants will receive the study drug pembrolizumab, although the dose will be different. 

Group 1:

• Participants will receive 200 mg of pembrolizumab intravenously on the first day of each 3-week cycle for up to 35 administrations (about 2 years of treatment).

Group 2:

• Participants with any advanced solid tumor that grown or come back after one or more lines of therapy and has a high Tumor Mutational Burden [excluding participants with mismatch repair deficient tumors] will receive 400 mg of pembrolizumab intravenously on the first day of each 6-week cycle for up to 18 administrations (about 2 years of treatment).

After completion of study treatment, participants are followed for up to 10 years. 

People, 18 years and older, who meet the following criteria:

Advanced solid tumor of one of the following types:

• Biliary Cancer
• Neuroendocrine Tumors of the lung, appendix, small intestine, colon, rectum, or pancreas
• Endometrial Cancer (sarcomas and mesenchymal tumors are excluded)
• Cervical Squamous Cell Cancer
• Vulvar Squamous Cell Cancer
• Thyroid Cancer
• Any advanced solid tumor which is Microsatellite Instability (MSI)-High (MSI-H) with the exception of colorectal cancer OR
• Any advanced solid tumor that didn't respond or got worse after at least one line of therapy and has a high Tumor Mutational Burden (TMB-High)
• Participants whose cancer did not improve or got worse after at least one line of standard of care therapy
• There is no limit to the number of prior treatments
• Colorectal carcinoma participants must have received at least 2 lines of standard of care treatment
• Participants must not have melanoma or non-small-cell lung cancer
• Can supply tumor tissue for study analyses (dependent on tumor type)
• Can be measured by radiology (through imaging technologies)
• Life expectancy > 3 months with adequate organ function

• Under the age of 18
• Receiving another study therapy within 4 weeks of the first dose of study treatment
• Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 7 days prior to the first dose of study treatment
• Active autoimmune disease that has required systemic treatment in the past 2 years
• Prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or not recovered from side effects from this treatment
• Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of study Day 1 or not recovered from side effects caused by these therapies
• Known additional cancer within 2 years prior to enrollment with the exception of some skin cancers
• Known active central nervous system cancers
• Has a history of or currently has lung disease with progressive scarring of the lungs that required steroids
• Active infection requiring systemic therapy, including hepatitis b, hepatitis c, and HIV, or known history of active tuberculosis
• Known psychiatric or substance abuse disorders that would interfere with ability to cooperate with the study requirements
• Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
• Previously participated in any other pembrolizumab study, or received prior therapy with other types of immunotherapies 
• Has had a stem cell tissue/solid organ transplant