Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.

Official Title
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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)

Conditions
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Biliary Tract Cancer

Intervention / Treatment
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* Drug: Rilvegostomig
* Drug: Placebo
* Drug: Capecitabine
* Drug: Gemcitabine/Cisplatin
* Drug: S-1 [Tegafur/Oteracil/gimeracil]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1) | Drug: Rilvegostomig<br>* Rilvegostomig IV (intravenous) Q3W<br>Drug: Capecitabine<br>* Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice<br>Drug: Gemcitabine/Cisplatin<br>* Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle<br>Drug: S-1 [Tegafur/Oteracil/gimeracil]<br>* S-1 [Tegafur/Oteracil/gimeracil] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles<br>|
| Placebo Comparator: Arm B<br>Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1) | Drug: Placebo<br>* Placebo IV (intravenous) Q3W<br>Drug: Capecitabine<br>* Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice<br>Drug: Gemcitabine/Cisplatin<br>* Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle<br>Drug: S-1 [Tegafur/Oteracil/gimeracil]<br>* S-1 [Tegafur/Oteracil/gimeracil] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival (RFS) for Arm A vs. Arm B | Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first. | Approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) for Arm A vs. Arm B | Overall survival is defined as the time from randomization until the date of death due to any cause. | up to 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary tract Cancer, Adenocarcinoma of the biliary tract, Gall bladder cancer, Intrahepatic Cholangiocarcinoma, Distal Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Klatskin Tumors, Bile duct cancer, Immunotherapy, Cholangiocarcinoma, Rilvegostomig, S-1, Gemcitabine/cisplatin, Capecitabine