Clinical trial · Interventional
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
NCT06109779CI-TRIAL-00117596active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Gemcitabine/Cisplatin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Rilvegostomig | Drug | — | UNRESOLVED |
| S-1 [Tegafur/Oteracil/gimeracil] | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
- interventionNames
- Drug: Rilvegostomig
- Drug: Capecitabine
- Drug: Gemcitabine/Cisplatin
- Drug: S-1 [Tegafur/Oteracil/gimeracil]
- type
- PLACEBO_COMPARATOR
- label
- Arm B
- description
- Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
- interventionNames
- Drug: Placebo
- Drug: Capecitabine
- Drug: Gemcitabine/Cisplatin
- Drug: S-1 [Tegafur/Oteracil/gimeracil]
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1) * Provision of a tumor sample collected at surgical resection. * Randomization within 12 weeks after resection with adequate healing and removal of drains. * Confirmed to be disease-free by imaging within 28 days prior to randomization. * Eastern Cooperative Oncology Group performance status of 0 or 1 Exclusion Criteria: * Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis. * Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors. * Any anti-cancer therapy for BTC prior to surgery * Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease * Current or prior use of immunosuppressive medication within 14 days before the first dose * Thromboembolic event within 3 months * Active HBV or HCV infection unless treated.
References
Publications (0)
Data not yet available
No reference posted for this study.