To find out if adding pembrolizumab to standard of care chemotherapy drugs (cisplatin and gemcitabine) will improve long-term response of intrahepatic cholangiocarcinoma after surgery, compared to treatment with surgery and standard chemotherapy alone.
Provision of signed Informed Consent prior to any screening procedures being performed.
Age ≥ 18 years at the time of informed consent.
Histologically (or cytologically) confirmed diagnosis of intrahepatic cholangiocarcinoma or adenocarcinoma of suspected biliary origin/ cholangiocarcinoma that is measurable according to RECIST 1.1 criteria.
T-stage ≥ Ib (Ib - IIIb)
Has received prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).
Has had previous systemic therapy for ICC.
Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasm.
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
Single group
Pembrolizumab
DrugGiven by IV (vein)
Gemcitabine
DrugGiven by IV (vein)
Cisplatin
DrugGiven by IV (vein)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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