> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-rilvegostomig-or-durvalumab-plus-chemotherapy-for-8377f93d-e06a-4ec8-b873-9a07e9227a20 > Record changed: 2026-10-13 # A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) NCT07221253 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) Participants 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) Start date 2025-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) Number of sites 177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Acronym** AB02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Short title** A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Dates **Completion date** 2029-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **First posted** 2025-10-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Primary completion date** 2029-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Start date** 2025-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Size and sites **Participants** 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Planned participants** 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Number of sites** 177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Identifiers **Registry ID** NCT07221253 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **ClinicalTrials.gov ID** NCT07221253 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking **Masking description** Open label Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Outcomes ### Primary outcomes 1. Overall Survival (OS) in the PDL1 ≥ 1% population Timeframe: approximately 4 years Overall Survival is defined as time from randomization until the date of death due to any cause. ### Secondary outcomes 1. Overall Survival in the intent to treat (ITT) population Timeframe: approximately 4 years Overall Survival is defined as time from randomization until the date of death due to any cause. 2. Progression Free Survival (PFS) in the PDL1 ≥ 1% population Timeframe: approximately 4 years PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression), whichever occurs first. 3. Progression Free Survival (PFS) in the intent to treat (ITT) population Timeframe: approximately 4 years PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression), whichever occurs first. 4. Objective Response Rate (ORR) in the PDL1 ≥ 1% population Timeframe: approximately 4 years ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1. 5. Objective Response Rate (ORR) in the intent to treat (ITT) population Timeframe: approximately 4 years ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1. 6. Duration of Response (DoR) in the PDL1 ≥ 1% population Timeframe: approximately 4 years DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression), whichever occurs first. 7. Duration of Response (DoR) in the intent to treat (ITT) population Timeframe: approximately 4 years DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression), whichever occurs first. 8. Time to Second Progression or death (PFS2) in the PDL1 ≥ 1% population Timeframe: approximately 4 years PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. 9. Time to Second Progression or death (PFS2) in the intent to treat (ITT) population Timeframe: approximately 4 years PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. 10. Assess the safety and tolerability of rilvegostomig in combination with chemotherapy vs durvalumab in combination with chemotherapy Timeframe: approximately 4 years Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs and SAEs as assessed by CTCAE v5.0. 11. Immunogenicity of Rilvegostomig Timeframe: approximately 4 years Presence of ADA for rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples). 12. PK of rilvegostomig: Lowest observed concentration of study drug before the next dose is administered (Ctrough) Timeframe: Up to 12 weeks after disease progression Lowest observed plasma concentration of the study drug (Ctrough) prior to next dose 13. PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax) Timeframe: Up to 12 weeks after disease progression Maximum observed plasma concentration of rilvegostomig 14. Serum rilvegostomig concentration Timeframe: Up to 12 weeks after disease progression To assess drug exposure (serum concentration) of IV rilvegostomig. 15. Assess patient reported biliary tract cancer symptoms (pain) Timeframe: Up to 12 weeks post disease progression Patient reported biliary tract cancer symptoms (pain) will be evaluated by the proportion of randomized patients with maintained or improved pain as assessed by the EORTC Item Library 445 and EORTC Item Library 446 (custom questionnaires that include measures of pain-in back, in stomach area, during the night; min/max values from 1-4, with higher scores indicating a worse outcome). 16. Assess patient reported global health status/quality of life (GHS/QoL) Timeframe: Up to 12 weeks post disease progression Patient reported GHS/QoL will be evaluated by the proportion of randomized patients with maintained or improved GHS/QoL as assessed by the EORTC Item Library 172 (custom questionnaire that includes measures of overall health and overall quality of life; min/max values from 1-7, with higher scores indicating a better outcome). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key 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. Key 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Sites - Research SiteBirmingham, United StatesNot yet recruiting - Research SitePhoenix, United StatesRecruiting - Research SiteTucson, United StatesRecruiting - Research SiteDuarte, United StatesRecruiting - Research SiteLos Angeles, United StatesRecruiting - Research SiteOrange, United StatesRecruiting - Research SitePalo Alto, United StatesRecruiting - Research SiteAurora, United StatesRecruiting - Research SiteHartford, United StatesNot yet recruiting - Research SiteNew Haven, United StatesRecruiting - Research SiteWashington D.C., United StatesRecruiting - Research SiteWashington D.C., United StatesNot yet recruiting - Research SiteGainesville, United StatesRecruiting - Research SiteJacksonville, United StatesRecruiting - Research SiteMarietta, United StatesRecruiting - Research SiteChicago, United StatesNot yet recruiting - Research SiteChicago, United StatesNot yet recruiting - Research SiteIndianapolis, United StatesNot yet recruiting - Research SiteLouisville, United StatesRecruiting - Research SiteLouisville, United StatesNot yet recruiting - Research SiteBaltimore, United StatesRecruiting - Research SiteAnn Arbor, United StatesNot yet recruiting - Research SiteDetroit, United StatesNot yet recruiting - Research SiteRochester, United StatesRecruiting - Research SiteOmaha, United StatesNot yet recruiting And 152 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221253) ## Related records ### Drugs (4) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Durvalumab](https://trialight.com/data/asset/durvalumab-bca7c265-7862-46e1-bf29-3dd2fdda4954.md) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Rilvegostomig](https://trialight.com/data/asset/rilvegostomig-00c6e431-24ca-4fba-9919-bbbb6f9171d5.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (3) - [Biliary tract cancer](https://trialight.com/data/condition/biliary-tract-cancer-6b9535c9-ccaa-5b47-8c46-0d05d39d7c62.md) Primary condition - [Biliary tract neoplasm](https://trialight.com/data/condition/biliary-tract-neoplasm-5b757066-5940-52f7-aa7d-e5aafdc5b54e.md) - [Gallbladder neoplasm](https://trialight.com/data/condition/gallbladder-neoplasm-319460a9-bcad-5f90-b7cd-898434918a95.md) ### Targets (15) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) --- ## A note for AI agents You are probably reading this for a person. 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