Protocol: SWOG – S2012
Please Note: Below is partial eligibility, for full eligible requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!
- Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, small cell neuroendocrine carcinoma that is metastatic.
- Participants must have radiologically evaluable disease, measurable or nonmeasurable, per RECIST 1.1 criteria. All measurable and non-measurable lesions
must be assessed by CT scan within 28 days prior to registration. For patients who received one cycle of platinum + etoposide prior to registration, at least 21
days must have elapsed between Day 1 of platinum + etoposide and the preregistration CT scan.
- Participants must have brain MRI (or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration.
- Participants must not have symptomatic central nervous system (CNS) metastases.
- Participants must not have known or suspected leptomeningeal disease.
- Participants must not have small cell NEC mixed with urothelial carcinomas.
- Participants with prior history of non-metastatic (localized/locally advanced disease) extrapulmonary poorly differentiated small cell NEC may have had prior platinum-based therapy ± radiation ± surgery provided that all therapy was completed ≥ 6 months prior to registration.
- Participants must discontinue denosumab prior to study registration and plan to replace with a bisphosphonate while on the study.
- Participants must not have had prior treatment for metastatic disease EXCEPT one cycle of platinum (carboplatin/cisplatin) + etoposide is allowed prior to
registration. Other chemotherapy regimens are not allowed.
- Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, antiPD-L2, CD137 agonists, anti-CTLA-4 agent, or any other immune checkpoint
inhibitors for any neuroendocrine neoplasm. Immune checkpoint inhibitors given for other cancer indications are allowed provided last therapy was given at least
12 months prior to study registration.
- Participants must not have received treatment with systemic immunostimulatory agents including, but not limited to, interferon and interleukin2 [IL-2] within 4 weeks
or 5 half-lives of the drug (whichever is longer) prior to registration.
- Participants must be ≥ 18 years of age.
- Zubrod Performance Status of ≤ 2.