Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

Stage IV Breast Cancer Clinical Trial

— ASCENT-07  

Official title:

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840211
• Other study ID #: GS-US-598-6168
• Secondary ID: 2022-502593-17-0
• Status: Recruiting
• Phase: Phase 3
• Start date: May 8, 2023
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 654
• Est. completion date: December 2028
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Able to understand and give written informed consent.

• Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site.

• Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site.

• Documented evidence of HER2- status.

• Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria.

• Candidate for the first chemotherapy in the locally advanced or metastatic setting.

• Eligible for capecitabine, nab-paclitaxel, or paclitaxel.

• Individuals must have at least one of the following:

• Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting.

• Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting.

• Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access a CDK 4/6 inhibitor) in the metastatic setting.

• Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting.

• Individuals may have received prior targeted therapies, including but not limited to PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations), or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies.

• Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.

• Demonstrates adequate organ function.

• Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

• Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.

• Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.

• Current enrollment in another clinical study and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer.

• Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization.

• Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I.

• Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.

• Have an active second malignancy.

• Have an active serious infection requiring antibiotics.

• Have active hepatitis B virus (HBV) or hepatitis C virus (HCV).

• Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.

• Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage IV Breast Cancer

Intervention

Drug:
• Sacituzumab Govitecan-hziy
Administered intravenously
• Paclitaxel
Administered intravenously
• Nab-paclitaxel
Administered intravenously
• Capecitabine
Administered orally

Locations

Country	Name	City	State
Argentina	Hospital Britanico de Buenos Aires	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas de Mar del Plata	Buenos Aires
Argentina	Instituto Alexander Fleming	C.a.b.a.
Argentina	Hospital Alemán	Caba
Argentina	Centro Privado de RMI Rio Cuarto S.A.	Cordoba
Argentina	Instituto de Oncología de Rosario	Rosario
Argentina	CER San Juan Centro Polivalente de Asistencia e Investigación Clínica	San Juan
Australia	Icon Cancer Centre Wesley	Auchenflower	Queensland
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Icon Cancer Centre Hobart	Hobart	Tasmania
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Austin Health	Melbourne	Victoria
Australia	Breast Cancer Research Centre - WA	Nedlands	Western Australia
Australia	Royal Brisbane and Women's Hospital	Queensland	ME
Australia	Sunshine Hospital (Western Health)	St Albans	Victoria
Australia	GenesisCare North Shore (Oncology)	St Leonards	New South Wales
Austria	University Hospital Innsbruck	Innsbruck
Austria	Universitätsklinik für Innere Medizin 3 der PMU	Salzburg
Austria	Klinikum Wels-Grieskirchen	Wels
Austria	Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie	Wien
Belgium	GZA Ziekenhuizen - Campus Sint-Augustinus	Antwerpen
Belgium	AZ Klina	Brasschaat
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Universitaire Ziekenhuis Leuven	Leuven
Belgium	CHU UCL Namur-Site STE. Elisabeth	Namur
Brazil	Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará	Fortaleza
Brazil	Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias	Goiânia
Brazil	Oncosite - Centro de Pesquisa Clinica e Oncologia	Ijui
Brazil	Catarina Pesquisa Clinica	Itajai
Brazil	Oncoclinicas do Brasil Servicos Medicos AS	Minas Gerais
Brazil	Liga Norte-Rio-Grandense Contra o Câncer	Natal
Brazil	CIONC-Centro Integrado de Oncologia de Curitiba	Paraana
Brazil	Hospital Erasto Gaertner	Paraná
Brazil	IMIP - Instituto de Medicina Integral Professor Fernando Figueira	Pernambuco
Brazil	HGB - Hospital Giovanni Battista/Mãe de Deus Center	Porto Alegre
Brazil	Hospital de Clínicas de Porto Alegre - HCPA	Porto Alegre
Brazil	Hospital São Lucas da PUCRS	Porto Alegre
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre
Brazil	Instituto Americas	Rio de Janeiro
Brazil	Clínica de Oncologia de Porto Alegre Ltda - CLINIONCO	Rio Grande Do Sul
Brazil	Instituto do Câncer - Hospital São Vicente de Paulo	Rio Grande Do Sul
Brazil	Unidade de PesquisasClinicas em Oncologia - UPCO	Rio Grande Do Sul
Brazil	CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia	Santo Andre
Brazil	Clinica de pesquisa e centro de estudos em oncologia ginecológica e mamaria	São Paulo
Brazil	Instituto Hemomed Oncologia e Hematologia	São Paulo
Canada	BC Cancer - Kelowna	Kelowna
Canada	The Ottawa Hospital Cancer Centre	Ottawa
Canada	CHU de Québec-Université Laval, Hôpital du Saint-Sacrement	Quebec
Canada	Humber River Hospital	Toronto
Canada	BC Cancer-Victoria	Victoria
Chile	Centro de Investigacion Clinica Bradford Hill	Recoleta
Chile	Centro del Cancer UC	Region Metropolitana
Chile	Centro de Oncología de Precisión (COP)	Santiago Region
Chile	James Lind Centro de Investigacion del Cancer	Temuco
Chile	Oncocentro APYS	Vina del Mar
China	The First Affiliated Hospital of USTC (Anhui Provincial Hospital)	Anhui
China	Peking University People's Hospital	Beijing
China	The First Hospital of Jilin University	Changchun
China	Xiangya Hospital Central South University	Changsha
China	West China Hospital Sichuan University	Chengdu
China	Chongqing University Cancer Hospital	Chongqing
China	Fujian Cancer Hospital	Fujian
China	Fujian Medical University Union Hospital	Fuzhou
China	Sun Yat-Sen University Cancer Center	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou
China	Sir Run Run Shaw Hospital,Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Cancer Hospital	Hangzhou
China	Harbin Medical University Cancer Hospital	Heilongjiang
China	Jiangsu Province Hospital	Jiangsu
China	The First Affiliated Hospital of Soochow University	Jiangsu
China	The Nanchang Third Hospital	Jiangxi
China	The Second Hospital of Jilin University	Jilin Sheng
China	Affiliated Cancer Hospital of Shandong First Medical University	Jinan
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	General Hospital of Ningxia Medical University	Ningxia Hui
China	The Affiliated Hospital Of Qingdao University	Qingdao
China	Fudan University Shanghai Cancer Center	Shanghai
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Hubei Cancer Hospital	Wuhan
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Zhejiang
China	Henan Cancer Hospital	Zhengzhou
Czechia	Fakultni Nemocnice Brno	Brno
Czechia	Masaryk Memorial Cancer Institute	Brno
Czechia	University Hospital Olomouc	Olomouc
Czechia	Multiscan s.r.o	Pardubice
Czechia	Charles General University Hospital, Prague	Prague
Czechia	Fakultni nemocnice v Motole	Prague 4
Czechia	Krajska nemocnice Tomase Bati Zlin	Zlin
France	CHU Jean Minjoz	Besancon
France	Institut Bergonié	Bordeaux
France	Centre Georges François Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Ico René Gauducheau	Loire Atlantique
France	Centre Leon Berard	Lyon
France	Institut Paoli Calmettes	Marseille
France	Institut Regional du Cancer de Montpellier	Montpellier Cedex 5
France	Institut Curie	Paris
France	Centre Hospitalier Lyon-Sud	Pierre-benite
France	Hopital Privé des Cotes d'Armor	Plerin
France	Centre Jean Bernard Service d'Oncologie Médicale	Rennes Cedex
France	Centre Henri Becquerel	Rouen
France	Institut Universitaire du Cancer de Toulouse Oncopole	Toulouse Cedex 9
France	Institut Gustave Roussy	Villejuif
Germany	University Hospital rechts der Isar Technical University of Munich	Bayern
Germany	HELIOS Klinikum Berlin-Buch	Berlin
Germany	Vivantes Klinikum am Urban	Berlin
Germany	Marienhospital Bottrop	Bottrop
Germany	Universitätsklinik Erlangen	Erlangen
Germany	SRH Wald-Klinikum Gera GmbH	Gera
Germany	Universitatsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Nationales Centrum für Tumorerkrankungen Heidelberg	Heidelberg
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	LMU Klinikum der Universitat München	München
Germany	Universitatsklinikum Munster	Munster
Germany	Universitäts - Frauenklinik	Tübingen
Greece	Alexandra General Hospital	Athens
Greece	Attikon Hospital	Athens
Greece	University Hospital of Heraklion	Heraklion
Greece	University Hospital of Larissa	Larissa
Greece	University Hospital of Patras	Patras
Greece	Bioclinic of Thessaloniki	Thessaloniki
Greece	Euromedica General Clinic of Thessaloniki	Thessaloniki
Hong Kong	Hong Kong Integrated Oncology Centre	Hong Kong
Hong Kong	Prince of Wales Hospital	New Territories
Hong Kong	Queen Mary Hospital	Pok Fu Lam
Hungary	Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika	Budapest
Hungary	Debreceni Egyetem Klinikai Központ	Debrecen
Hungary	Bács-Kiskun Varmegyei Oktatokorhaz, Onkaradiologiai Kozpont	Kecskemét
Hungary	Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Onkoradiologia	Nyiregyhaza
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged
Israel	Oncology Institute Rambam Health Care Campus	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona	Ancona AN
Italy	Centro di Riferimento Oncologico - IRCCS	Aviano
Italy	ASST Papa Giovanni XXIII	Bergamo
Italy	Humanitas Gavazzeni	Bergamo
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola	Bologna
Italy	Humanitas Istituto Clinico Catanese	Catania
Italy	Azienda Ospedaliera Mater Domini	Catanzaro
Italy	IRCCS Ospedale Policlinico San Martino	Genova GE
Italy	Istituto Europeo di Oncologia	Milan
Italy	Fondazione IRCCS San Raffaele del Monte Tabor	Milano
Italy	Azienda Ospedaliera San Gerardo	Monza
Italy	Istituto Nazionale Tumori IRCCS Fondazione G. Pascale	Napoli
Italy	Istituto Oncologico Veneto IOV	Padova
Italy	Irccs Crob	Rionero in Vulture
Italy	Azienda Ospedaliero-Universitaria Policlinico Umberto I	Roma
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma
Italy	Istituto Clinico Humanitas	Rozzano
Japan	Aichi Cancer Center Hospital	Aichi
Japan	Tohoku University Hospital	Aoba-ku
Japan	Juntendo University Hospital	Bunkyo-ku
Japan	Chiba Cancer Center	Chiba
Japan	National Cancer Center Hospital	Chuo-ku
Japan	Osaka Prefectural Hospital Organization Osaka International Cancer Institute	Chuo-ku
Japan	National Hospital Organization Shikoku Cancer Center	Ehime
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Social Medical Corporation Hakuaikai Sagara Hospital	Kagoshima-shi
Japan	Tokai University Hospital	Kanagawa
Japan	National Cancer Center Hospital East	Kashiwa
Japan	Saitama Cancer Center	Kitaadachi-gun
Japan	Cancer Institute Hospital of JFCR	Koto-Ku
Japan	Kumamoto University Hospital	Kumamoto- shi
Japan	Kyoto University Hospital	Kyoto-shi
Japan	National Hospital Organization Kyushu Cancer Center	Minami-ku
Japan	Nagoya University Hospital	Nagoya
Japan	Hiroshima City Hiroshima Citizens Hospital	Naka-ku
Japan	Hyogo Medical University Hospital	Nishinomiya-shi
Japan	Okayama University Hospital	Okayama
Japan	Gunma Prefectural Cancer Center	Ota
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjuku-ku
Japan	Showa University Hospital	Tokyo
Japan	Kanagawa Cancer Center	Yokohama
Korea, Republic of	Samsung Medical Center	Gangnam-Gu
Korea, Republic of	National Cancer Center	Goyang-si Gyeonggi-do
Korea, Republic of	Kyungpook National University Chilgok Hospital	Gyeongsangbuk-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching
Malaysia	Institut Kanser Negara	Putrajaya
Mexico	Centro de Investigacion y Avances Medicos Especializados	Cancún
Mexico	FUCAM	México
Mexico	COI Centro Oncologico Internacional S.A.P.I. de C.V.	Mexico City
Mexico	Clinica Integral Internacional de Oncologia S de RL de CV	Puebla
Mexico	Centro Medico Zambrano Hellion	San Pedro Garza García
Mexico	Centro de Atención e Investigación Clínica en Oncología	Yucatán
Poland	Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku	Gdansk
Poland	Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o	Krakow
Poland	Instytut MSF Sp. z o.o.	Lodz
Poland	Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie	Lublin
Poland	LUX MED Onkologia Sp. Zo.o.	Warszawa
Poland	Maria Sklodowska - Curie Institute of Oncology	Warszawa
Portugal	Centro Clinico Academico - Hospital de Braga	Braga
Portugal	Hospital da Senhora da Oliveira Guimaraes	Guimarães
Portugal	Centro Hospitalar de Lisboa Central, E.P.E . - Hospital de Santo Antonio dos Capuchos	Lisbon
Portugal	Centro Hospitalar Lisboa Norte, EPE	Lisbon
Portugal	Fundacao Champalimaud	Lisbon
Portugal	Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano	Matosinhos
Singapore	National Cancer Centre Singapore	Singapore
Singapore	National University Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
South Africa	Wilgers Oncology Centre	Gauteng
South Africa	The Medical Oncology Centre of Rosebank	Johannesburg
South Africa	Cape Town Oncology Trials	Kraaifontein
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitari Dexeus	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital de Basurto	Bilbo
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital General Universitario De Elche	Elche
Spain	Hospital Universitario de Jaen	Jaen
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Clínico Universitario de Santiago de Compostela - CHUS	Santiago de Compostela
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario Virgen del Rocio	Seville
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Instituto Valenciano De Oncologia (IVO)	Valencia
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City
Taiwan	Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare	New Taipei City
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chi Mei Hospital, Liouying	Tainan City
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan City
United Kingdom	Barts Cancer Institute	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	University College London Hospitals	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United States	Investigational Drug Services, AdventHealth Orlando	Altamonte Springs	Florida
United States	Georgia Cancer Specialist - Annex	Atlanta	Georgia
United States	Piedmont Cancer Institute	Atlanta	Georgia
United States	MultiCare Regional Cancer Center - Auburn	Auburn	Washington
United States	Hematology Oncology Clinic	Baton Rouge	Louisiana
United States	Florida Cancer Specialists	Brooksville	Florida
United States	Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers	Chandler	Arizona
United States	Cleveland Clinic	Cleveland	Ohio
United States	Astera Cancer Care	East Brunswick	New Jersey
United States	US Oncology Investigational Products Center (IPC)	Fairfax	Virginia
United States	Prisma Health - Upstate	Greenville	South Carolina
United States	Penn State Cancer Institute	Hershey	Pennsylvania
United States	Saint Luke's Cancer Institute	Kansas City	Missouri
United States	The University of Kansas Hospital	Kansas City	Kansas
United States	Florida Cancer Specialist	Leesburg	Florida
United States	Rocky Mountain Cancer Centers, LLP	Littleton	Colorado
United States	Los Angeles Hematology Oncology Medical Group	Los Angeles	California
United States	Northwest Georgia Oncology Centers	Marietta	Georgia
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Yale-New Haven Hospital-Yale Cancer Center	New Haven	Connecticut
United States	Memorial Sloan-Kettering Cancer Center (MSKCC) - New York	New York	New York
United States	US Oncology Investigational Products Center (IPC)	Norfolk	Virginia
United States	Stanford Cancer Institute	Palo Alto	California
United States	Magee-Womens of UPMC	Pittsburgh	Pennsylvania
United States	David C. Pratt Cancer Center	Saint Louis	Missouri
United States	Florida Cancer Specialist	Saint Petersburg	Florida
United States	University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Czechia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Poland,  Portugal,  Singapore,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.	Up to approximately 29 months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization until the date of death from any cause.	Until death, up to approximately 60 months
Secondary	Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.	Until progression, up to approximately 60 months
Secondary	Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16	The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).; The Physical Functioning domain includes 5 questions in which participants will be asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 4 (excellent), with a higher score representing a high QoL.	Baseline, Week 16
Secondary	Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores	Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.	Up to approximately 60 months
Secondary	Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.	Until progression or death, up to approximately 60 months
Secondary	Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.	Up to approximately 60 months
Secondary	Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1	DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).	Until progression or death, up to approximately 60 months
Secondary	Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		First dose date up to 30 days post last dose, up to approximately 60 months
Secondary	Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities		First dose date up to 30 days post last dose, up to approximately 60 months

External Links

•   Gilead Clinical Trials Website