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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) |
|
| Experimental Arm | Experimental | Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilvegostomig | Drug | Rilvegostomig IV (intravenous) Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in the PDL1 ≥ 1% population | Overall Survival is defined as time from randomization until the date of death due to any cause. | approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival in the intent to treat (ITT) population | Overall Survival is defined as time from randomization until the date of death due to any cause. | approximately 4 years |
| Progression Free Survival (PFS) in the PDL1 ≥ 1% population |
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Key inclusion Criteria:
Key exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Not yet recruiting | Birmingham | Alabama | 35233 | United States | |
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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Open label
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| Durvalumab | Drug | Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W. |
|
|
| Gemcitabine/Cisplatin | Drug | Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle |
|
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.
| approximately 4 years |
| Progression Free Survival (PFS) in the intent to treat (ITT) population | 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. | approximately 4 years |
| Objective Response Rate (ORR) in the PDL1 ≥ 1% population | ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1. | approximately 4 years |
| Objective Response Rate (ORR) in the intent to treat (ITT) population | ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1. | approximately 4 years |
| Duration of Response (DoR) in the PDL1 ≥ 1% population | 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. | approximately 4 years |
| Duration of Response (DoR) in the intent to treat (ITT) population | 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. | approximately 4 years |
| Time to Second Progression or death (PFS2) in the PDL1 ≥ 1% population | 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. | approximately 4 years |
| Time to Second Progression or death (PFS2) in the intent to treat (ITT) population | 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. | approximately 4 years |
| Assess the safety and tolerability of rilvegostomig in combination with chemotherapy vs durvalumab in combination with chemotherapy | Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs and SAEs as assessed by CTCAE v5.0. | approximately 4 years |
| Immunogenicity of Rilvegostomig | Presence of ADA for rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples). | approximately 4 years |
| PK of rilvegostomig: Lowest observed concentration of study drug before the next dose is administered (Ctrough) | Lowest observed plasma concentration of the study drug (Ctrough) prior to next dose | Up to 12 weeks after disease progression |
| PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax) | Maximum observed plasma concentration of rilvegostomig | Up to 12 weeks after disease progression |
| Serum rilvegostomig concentration | To assess drug exposure (serum concentration) of IV rilvegostomig. | Up to 12 weeks after disease progression |
| Assess patient reported biliary tract cancer symptoms (pain) | 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). | Up to 12 weeks post disease progression |
| Assess patient reported global health status/quality of life (GHS/QoL) | 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). | Up to 12 weeks post disease progression |
| Not yet recruiting |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Research Site | Recruiting | Tucson | Arizona | 85719 | United States |
| Research Site | Recruiting | Duarte | California | 91010 | United States |
| Research Site | Recruiting | Orange | California | 92868 | United States |
| Research Site | Recruiting | Palo Alto | California | 94304 | United States |
| Research Site | Not yet recruiting | Santa Monica | California | 90404 | United States |
| Research Site | Recruiting | Aurora | Colorado | 80045 | United States |
| Research Site | Not yet recruiting | Hartford | Connecticut | 06102 | United States |
| Research Site | Not yet recruiting | New Haven | Connecticut | 06510 | United States |
| Research Site | Not yet recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Not yet recruiting | Washington D.C. | District of Columbia | 20037 | United States |
| Research Site | Not yet recruiting | Jacksonville | Florida | 32209 | United States |
| Research Site | Not yet recruiting | Jacksonville | Florida | 32224 | United States |
| Research Site | Recruiting | Marietta | Georgia | 30060 | United States |
| Research Site | Not yet recruiting | Chicago | Illinois | 60612 | United States |
| Research Site | Not yet recruiting | Chicago | Illinois | 60637 | United States |
| Research Site | Not yet recruiting | Indianapolis | Indiana | 46202 | United States |
| Research Site | Not yet recruiting | Louisville | Kentucky | 40217 | United States |
| Research Site | Recruiting | Baltimore | Maryland | 21231 | United States |
| Research Site | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Not yet recruiting | Detroit | Michigan | 48202 | United States |
| Research Site | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
| Research Site | Not yet recruiting | Omaha | Nebraska | 68198-5885 | United States |
| Research Site | Recruiting | Santa Fe | New Mexico | 87505 | United States |
| Research Site | Not yet recruiting | New York | New York | 10016 | United States |
| Research Site | Not yet recruiting | New York | New York | 10032 | United States |
| Research Site | Withdrawn | New York | New York | 10065 | United States |
| Research Site | Not yet recruiting | Portland | Oregon | 97239 | United States |
| Research Site | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Not yet recruiting | Philadelphia | Pennsylvania | 19111 | United States |
| Research Site | Not yet recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Site | Recruiting | Providence | Rhode Island | 02903 | United States |
| Research Site | Recruiting | Pierre | South Dakota | 57501 | United States |
| Research Site | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
| Research Site | Not yet recruiting | Houston | Texas | 77030 | United States |
| Research Site | Not yet recruiting | Clayton | 3168 | Australia |
| Research Site | Recruiting | Darlinghurst | 2010 | Australia |
| Research Site | Not yet recruiting | Gosford | 2250 | Australia |
| Research Site | Recruiting | Murdoch | 6150 | Australia |
| Research Site | Not yet recruiting | Anderlecht | 1070 | Belgium |
| Research Site | Recruiting | Edegem | 2650 | Belgium |
| Research Site | Recruiting | Leuven | 3000 | Belgium |
| Research Site | Not yet recruiting | Liège | 4000 | Belgium |
| Research Site | Recruiting | Roeselare | 8800 | Belgium |
| Research Site | Recruiting | Barretos | 14784-400 | Brazil |
| Research Site | Recruiting | Natal | 59075-740 | Brazil |
| Research Site | Recruiting | Porto Alegre | 91350-200 | Brazil |
| Research Site | Recruiting | Ribeirão Preto | 14026-040 | Brazil |
| Research Site | Recruiting | São Paulo | 01246-000 | Brazil |
| Research Site | Recruiting | Vitória | 29043-272 | Brazil |
| Research Site | Not yet recruiting | Calgary | Alberta | T2N 5G2 | Canada |
| Research Site | Not yet recruiting | Vancouver | British Columbia | VSZ 4E6 | Canada |
| Research Site | Recruiting | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Research Site | Recruiting | Barrie | Ontario | L4M 6M2 | Canada |
| Research Site | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Not yet recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Research Site | Recruiting | Québec | Quebec | G1J 1Z4 | Canada |
| Research Site | Recruiting | Beijing | 100020 | China |
| Research Site | Recruiting | Beijing | 102218 | China |
| Research Site | Recruiting | Changchun | 130021 | China |
| Research Site | Recruiting | Changde | 415000 | China |
| Research Site | Recruiting | Changsha | 410005 | China |
| Research Site | Withdrawn | Changsha | 410013 | China |
| Research Site | Recruiting | Chengdu | 610078 | China |
| Research Site | Recruiting | Fuzhou | 350005 | China |
| Research Site | Recruiting | Guangzhou | 510515 | China |
| Research Site | Recruiting | Hangzhou | 310022 | China |
| Research Site | Recruiting | Hefei | 230001 | China |
| Research Site | Recruiting | Kunming | 650101 | China |
| Research Site | Withdrawn | Lishui | 323000 | China |
| Research Site | Recruiting | Luoyang | 471023 | China |
| Research Site | Recruiting | Nanchang | 330000 | China |
| Research Site | Recruiting | Nanning | 530000 | China |
| Research Site | Recruiting | Shandong | China |
| Research Site | Recruiting | Shanghai | 200032 | China |
| Research Site | Recruiting | Shenyang | 110016 | China |
| Research Site | Recruiting | Weifang | 261000 | China |
| Research Site | Recruiting | Wuhan | 430030 | China |
| Research Site | Recruiting | Xi'an | 710061 | China |
| Research Site | Recruiting | Clichy | 92118 | France |
| Research Site | Recruiting | Grenoble | 38043 | France |
| Research Site | Recruiting | Marseille | 13385 | France |
| Research Site | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
| Research Site | Not yet recruiting | Aachen | 52074 | Germany |
| Research Site | Not yet recruiting | Berlin | 10365 | Germany |
| Research Site | Not yet recruiting | Berlin | 13353 | Germany |
| Research Site | Not yet recruiting | Bonn | 53127 | Germany |
| Research Site | Not yet recruiting | Düsseldorf | 40225 | Germany |
| Research Site | Not yet recruiting | Essen | 45122 | Germany |
| Research Site | Not yet recruiting | Frankfurt | 60488 | Germany |
| Research Site | Not yet recruiting | Freiburg im Breisgau | 79106 | Germany |
| Research Site | Not yet recruiting | Hamburg | 20249 | Germany |
| Research Site | Not yet recruiting | Hamburg | 22763 | Germany |
| Research Site | Not yet recruiting | Heidelberg | 69120 | Germany |
| Research Site | Not yet recruiting | Heilbronn | 74078 | Germany |
| Research Site | Not yet recruiting | Karlsruhe | 76133 | Germany |
| Research Site | Not yet recruiting | Magdeburg | 39120 | Germany |
| Research Site | Not yet recruiting | München | 81675 | Germany |
| Research Site | Not yet recruiting | München | 81737 | Germany |
| Research Site | Not yet recruiting | Ulm | 89081 | Germany |
| Research Site | Not yet recruiting | Delhi | 110029 | India |
| Research Site | Not yet recruiting | Hyderabad | 500032 | India |
| Research Site | Not yet recruiting | Kolhāpur | 416234 | India |
| Research Site | Not yet recruiting | Kolkata | 700063 | India |
| Research Site | Not yet recruiting | Mumbai | 400012 | India |
| Research Site | Not yet recruiting | Nashik | 422002 | India |
| Research Site | Not yet recruiting | Surat | 395002 | India |
| Research Site | Not yet recruiting | Castellana Grotte | 70013 | Italy |
| Research Site | Recruiting | Milan | 20132 | Italy |
| Research Site | Recruiting | Pisa | 56126 | Italy |
| Research Site | Recruiting | Rome | 00168 | Italy |
| Research Site | Recruiting | Rozzano | 20089 | Italy |
| Research Site | Recruiting | Chiba | 260-8717 | Japan |
| Research Site | Recruiting | Kashiwa | 227-8577 | Japan |
| Research Site | Recruiting | Kawasaki-shi | 216-8511 | Japan |
| Research Site | Recruiting | Kōtoku | 135-8550 | Japan |
| Research Site | Recruiting | Matsuyama | 790-0024 | Japan |
| Research Site | Recruiting | Nagoya | 464-8681 | Japan |
| Research Site | Not yet recruiting | Nagoya | 466-8560 | Japan |
| Research Site | Recruiting | Osaka | 541-8567 | Japan |
| Research Site | Recruiting | Suita-shi | 565-0871 | Japan |
| Research Site | Recruiting | Takatsuki-shi | 569-8686 | Japan |
| Research Site | Recruiting | Ube | 755-8505 | Japan |
| Research Site | Recruiting | Yokohama | 241-8515 | Japan |
| Research Site | Recruiting | Amsterdam | 1081 HV | Netherlands |
| Research Site | Recruiting | Groningen | 9713 GZ | Netherlands |
| Research Site | Recruiting | Maastricht | 6202 AZ | Netherlands |
| Research Site | Not yet recruiting | Utrecht | 3584 CX | Netherlands |
| Research Site | Not yet recruiting | Koszalin | 75-581 | Poland |
| Research Site | Not yet recruiting | Krakow | 30-688 | Poland |
| Research Site | Withdrawn | Lodz | 92-213 | Poland |
| Research Site | Not yet recruiting | Olsztyn | 10-228 | Poland |
| Research Site | Not yet recruiting | Warsaw | 02-034 | Poland |
| Research Site | Recruiting | Busan | 48108 | South Korea |
| Research Site | Not yet recruiting | Daegu | 41404 | South Korea |
| Research Site | Recruiting | Seongnam-si | 13496 | South Korea |
| Research Site | Recruiting | Seongnam-si | 13620 | South Korea |
| Research Site | Recruiting | Seoul | 03080 | South Korea |
| Research Site | Recruiting | Seoul | 03722 | South Korea |
| Research Site | Recruiting | Seoul | 05505 | South Korea |
| Research Site | Recruiting | Seoul | 06351 | South Korea |
| Research Site | Not yet recruiting | Seoul | 06591 | South Korea |
| Research Site | Recruiting | Barcelona | 08036 | Spain |
| Research Site | Not yet recruiting | L'Hospitalet de Llobregat | 08908 | Spain |
| Research Site | Recruiting | Madrid | 28007 | Spain |
| Research Site | Not yet recruiting | Madrid | 28040 | Spain |
| Research Site | Recruiting | Santander | 39008 | Spain |
| Research Site | Recruiting | Kaohsiung City | 82445 | Taiwan |
| Research Site | Recruiting | Kaohsiung City | 833 | Taiwan |
| Research Site | Recruiting | Taichung | 40447 | Taiwan |
| Research Site | Recruiting | Taichung | 40705 | Taiwan |
| Research Site | Recruiting | Tainan | 704 | Taiwan |
| Research Site | Recruiting | Taipei | 10002 | Taiwan |
| Research Site | Recruiting | Taipei | 112 | Taiwan |
| Research Site | Recruiting | Taoyuan | 333 | Taiwan |
| Research Site | Recruiting | Bangkok | 10700 | Thailand |
| Research Site | Recruiting | Chiang Mai | 50200 | Thailand |
| Research Site | Recruiting | Hat Yai | 90110 | Thailand |
| Research Site | Recruiting | Khon Kaen | 40002 | Thailand |
| Research Site | Recruiting | Muang | 34000 | Thailand |
| Research Site | Not yet recruiting | Ongkharak | 26120 | Thailand |
| Research Site | Not yet recruiting | Ankara | 06100 | Turkey (Türkiye) |
| Research Site | Not yet recruiting | Erzurum | 25240 | Turkey (Türkiye) |
| Research Site | Not yet recruiting | Istanbul | 34010 | Turkey (Türkiye) |
| Research Site | Not yet recruiting | Konya | 42080 | Turkey (Türkiye) |
| Research Site | Not yet recruiting | Seyhan | 1060 | Turkey (Türkiye) |
| Research Site | Not yet recruiting | Birmingham | B15 2GW | United Kingdom |
| Research Site | Not yet recruiting | Glasgow | G12 OYN | United Kingdom |
| Research Site | Recruiting | Greater London | SW3 6JJ | United Kingdom |
| Research Site | Not yet recruiting | Leeds | LS9 7TF | United Kingdom |
| Research Site | Not yet recruiting | London | NW3 2QG | United Kingdom |
| Research Site | Not yet recruiting | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D012008 | Recurrence |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005705 | Gallbladder Diseases |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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