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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502916-35-01 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Arcus Biosciences, Inc. | INDUSTRY |
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The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.
The study includes multiple substudy arms (Substudy A, B, C), which will evaluate immunotherapy-based combinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1: Domvanalimab + Zimberelimab | Experimental | Domvanalimab and Zimberelimab, both administered by IV infusion |
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| A2: Domvanalimab + Zimberelimab | Experimental | Domvanalimab and Zimberelimab, both administered by IV infusion |
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| A3: Quemliclustat + Zimberelimab | Experimental | Quemliclustat and Zimberelimab, both administered by IV infusion |
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| B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy | Experimental | Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion |
|
| B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy | Experimental | Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domvanalimab | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Up to 58 months | |
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | Up to 58 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From date of first dose until the date of death due to any cause (approximately 58 months) | |
| Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1 | Up to 58 months |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35294 | United States | ||
| University of California San Diego (UCSD) |
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| B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy | Experimental | Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion |
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| B4: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy | Experimental | Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion |
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| B5: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy | Experimental | Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion |
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| C1: Quemliclustat + Zimberelimab + Docetaxel | Experimental | Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion |
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| C2: Domvanalimab + Zimberelimab + Docetaxel | Experimental | Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion |
|
| Quemliclustat | Drug | Administered as specified in the treatment arm |
|
| Zimberelimab | Drug | Administered as specified in the treatment arm |
|
| Docetaxel | Drug | Administered as specified in the treatment arm |
|
| Platinum-Based Doublet | Drug | Administered as specified in the treatment arm |
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| Disease Control Rate (DCR) | Up to 58 months |
| Duration of response (DoR) as determined by the Investigator according to RECIST v1.1 | Up to 58 months |
| Investigational study treatments peak plasma or serum concentration (Cmax) | Up to 58 months |
| Investigational study treatments time of peak concentration (Tmax) | Up to 58 months |
| Investigational study treatments area under the plasma or serum concentration versus time curve (AUC) | Up to 58 months |
| Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants | Up to 58 months |
| La Jolla |
| California |
| 92093 |
| United States |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Hematology Oncology Associates Of The Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Florida Cancer Specialists (Administration and Drug Shipment) | The Villages | Florida | 32163 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Ochsner Clinic Foundation | Jefferson | Louisiana | 70121 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Medical Oncology Associated, PS (dba Summit Cancer Centers) | Spokane | Washington | 99208 | United States |
| The Border Cancer Hospital | Albury | New South Wales | Australia |
| Pindara Private Hospital | Benowa | Queensland | 4217 | Australia |
| Cancer Research SA Pty Ltd | Adelaide | South Australia | 5000 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| CHU Bordeaux Centre Francois Magendie Hôpital du Haut Lévèque | Bordeaux | 33604 | France |
| Hospices Civils de Lyon Centre Hospitalier Lyon Sud | Lyon | 69495 | France |
| Institut De Cancerologie Strasbourg Europe ICANS | Strasboug | 67033 | France |
| Hopital FOCH | Suresnes | France |
| LTD High Technology Hospital Medcenter | Batumi | Georgia |
| Caucasus Medical Center | Tbilisi | Georgia |
| Israel Georgian Medical Research Clinic Healthycore | Tbilisi | Georgia |
| JSC K. Eristavi National Center of Experimental and Clinical Surgery | Tbilisi | Georgia |
| Ltd Pineo Medical Ecosystem | Tbilisi | Georgia |
| Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST | Meldola | Italy |
| stituto Nazionale per lo Studio e la Cura dei Tumori | Milan | Italy |
| Istituto Oncologico Veneto IRCCS | Padova | 35128 | Italy |
| Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) | Pesaro | Italy |
| Fondazione IRCCS Istituto Nazionale dei tumori di Milano | Rome | Italy |
| Szpitale Pomorskie sp. z o.o | Gdynia | Poland |
| Uniwersyteckie Centrum Kliniczne, im. prof. K. Gibińskiego | Katowice | Poland |
| Medpolonia Sp. Z.o.o. | Poznan | Poland |
| Centrum Onkologii - Instytut im. Marii Sk?odowskiej-Curie | Warsaw | Poland |
| Samsung Changwon Hospital | Changwon-Si | South Korea |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Chonam National University Hwasun Hospital | Hwasun-gun | 58128 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 8041 | Spain |
| Hospital Universitari Mutua Terrassa | Barcelona | 8221 | Spain |
| UOMI Cancer Centre | Barcelona | Spain |
| Complejo Hospitalario Universitario Insular Materno Infantil De Gran Canaria | Las Palmas de Gran Canaria | 35016 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | Spain |
| Hospital Quirónsalud Málaga | Málaga | Spain |
| Hospital Universitario De La Virgen De Valme | Seville | 41001 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital 9 de Octubre Vithas Valencia | Valencia | 46015 | Spain |
| Hospital Universitario y Politécnico la Fe | Valencia | 46026 | Spain |
| Hualien Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation | Hualien City | 970 | Taiwan |
| E-DA Healthcare Group E-DA Hospital | Kaoshiung | 970 | Taiwan |
| Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare | New Taipei City | 23561 | Taiwan |
| Mackey Memorial Hospital | Taipei | 104 | Taiwan |
| National Taiwan University Hospital Yumlin Branch | Yunlin County | Taiwan |
| Barts Health NHS Trust St Bartholomew's Hospital | London | W1G 6AF | United Kingdom |
| ID | Term |
|---|---|
| C000723779 | quemliclustat |
| C000719848 | zimberelimab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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