NCT07221253RecruitingPhase 3
Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 1,100
- Locations
- 198
- Primary Endpoint
- Overall Survival (OS) in the PDL1 ≥ 1% population
Study Overview
Brief Summary
The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Open label
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).
- •Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting
- •Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
- •Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
- •ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.
- •Adequate bone marrow and organ function.
Exclusion Criteria
- •Ampullary carcinoma
- •Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.
- •Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.
- •Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.
- •Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
- •Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.
Arms & Interventions
Control Arm
Active Comparator
Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)
Intervention: Gemcitabine/Cisplatin (Drug)
Experimental Arm
Experimental
Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)
Intervention: Gemcitabine/Cisplatin (Drug)
Control Arm
Active Comparator
Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)
Intervention: Durvalumab (Drug)
Experimental Arm
Experimental
Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)
Intervention: Rilvegostomig (Drug)
Outcomes
Primary Outcomes
Overall Survival (OS) in the PDL1 ≥ 1% population
Time Frame: approximately 4 years
Overall Survival is defined as time from randomization until the date of death due to any cause.
Secondary Outcomes
- PK of rilvegostomig: Lowest observed concentration of study drug before the next dose is administered (Ctrough)(Up to 12 weeks after disease progression)
- PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)(Up to 12 weeks after disease progression)
- Overall Survival in the intent to treat (ITT) population(approximately 4 years)
- Progression Free Survival (PFS) in the PDL1 ≥ 1% population(approximately 4 years)
- Progression Free Survival (PFS) in the intent to treat (ITT) population(approximately 4 years)
- Objective Response Rate (ORR) in the PDL1 ≥ 1% population(approximately 4 years)
- Objective Response Rate (ORR) in the intent to treat (ITT) population(approximately 4 years)
- Duration of Response (DoR) in the PDL1 ≥ 1% population(approximately 4 years)
- Duration of Response (DoR) in the intent to treat (ITT) population(approximately 4 years)
- Time to Second Progression or death (PFS2) in the PDL1 ≥ 1% population(approximately 4 years)
- Time to Second Progression or death (PFS2) in the intent to treat (ITT) population(approximately 4 years)
- Assess the safety and tolerability of rilvegostomig in combination with chemotherapy vs durvalumab in combination with chemotherapy(approximately 4 years)
- Immunogenicity of Rilvegostomig(approximately 4 years)
- Serum rilvegostomig concentration(Up to 12 weeks after disease progression)
- Assess patient reported biliary tract cancer symptoms (pain)(Up to 12 weeks post disease progression)
- Assess patient reported global health status/quality of life (GHS/QoL)(Up to 12 weeks post disease progression)
Investigators
Study Sites (198)
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