This is a pilot study of pembrolizumab-based therapy in previously treated extrapulmonary poorly differentiated neuroendocrine carcinoma
A Pilot Study of Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
There are two parts of the study. In Part A, subjects are treated with pembrolizumab alone, and in Part B with pembrolizumab plus chemotherapy (physician's choice, paclitaxel or irinotecan). Adaptive Simon's two-stage design is used. The overall plan hinges on the activity of single agent pembrolizumab in the first stage of Part A. If there is sufficient activity in the first stage of Part A, the study will expand to the second stage of Part A and forgo Part B. If there is insufficient activity in the first stage of Part A, the study will proceed to the first stage of Part B (pembrolizumab plus chemotherapy).
High Grade Malignant Neuroendocrine Carcinoma (Diagnosis) NEC Paclitaxel Irinotecan Pembrolizumab Albumin-Bound Paclitaxel
Open to people ages 18 years and up
Have progressed during or after completion of first line systemic therapy
a. No limit to the number of prior chemotherapy regimens
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Has Merkel cell carcinoma, small cell lung carcinoma, or large cell NEC of lung
Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03136055.
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