A Phase II, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/Metastatic Solid Tumors
Status: Recruiting
Location: See all (95) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
eVOLVE-02 study will evaluate the efficacy and safety of volrustomig as monotherapy or in combination with anti-cancer agents in participants with advanced/metastatic solid tumors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 at the time of signing the ICF.
• Provision of tumor sample to assess the PD-L1 expression (if applicable).
• ECOG performance status of 0 or 1.
• Measurable disease according to RECIST 1.1 (variations of RECIST 1.1 if applicable).
• Life expectancy ≥ 12 weeks.
• Adequate organ and bone marrow function.
• Body weight \> 35 kg
• Capable of giving signed informed consent.
Locations
United States
California
Research Site
WITHDRAWN
Los Angeles
Maryland
Research Site
NOT_YET_RECRUITING
Baltimore
New York
Research Site
NOT_YET_RECRUITING
New York
Research Site
NOT_YET_RECRUITING
Stony Brook
Ohio
Research Site
NOT_YET_RECRUITING
Columbus
Pennsylvania
Research Site
NOT_YET_RECRUITING
Philadelphia
Other Locations
Australia
Research Site
RECRUITING
Clayton
Research Site
NOT_YET_RECRUITING
Nedlands
Brazil
Research Site
RECRUITING
Ijuí
Research Site
RECRUITING
Londrina
Research Site
NOT_YET_RECRUITING
Porto Alegre
Research Site
NOT_YET_RECRUITING
Santo André
Research Site
RECRUITING
São Caetano Do Sul
Research Site
NOT_YET_RECRUITING
Vitória
Research Site
RECRUITING
Vitória
Canada
Research Site
NOT_YET_RECRUITING
Edmonton
Research Site
RECRUITING
Montreal
China
Research Site
NOT_YET_RECRUITING
Anyang
Research Site
RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
RECRUITING
Beijing
Research Site
ACTIVE_NOT_RECRUITING
Beijing
Research Site
ACTIVE_NOT_RECRUITING
Beijing
Research Site
WITHDRAWN
Bengbu
Research Site
RECRUITING
Changchun
Research Site
WITHDRAWN
Changchun
Research Site
COMPLETED
Changsha
Research Site
RECRUITING
Changsha
Research Site
COMPLETED
Changsha
Research Site
RECRUITING
Changsha
Research Site
COMPLETED
Chengdu
Research Site
ACTIVE_NOT_RECRUITING
Chengdu
Research Site
RECRUITING
Chengdu
Research Site
ACTIVE_NOT_RECRUITING
Chongqing
Research Site
WITHDRAWN
Chongqing
Research Site
ACTIVE_NOT_RECRUITING
Dongguan
Research Site
RECRUITING
Dongguan
Research Site
COMPLETED
Fuzhou
Research Site
RECRUITING
Fuzhou
Research Site
NOT_YET_RECRUITING
Fuzhou
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
ACTIVE_NOT_RECRUITING
Hangzhou
Research Site
RECRUITING
Hangzhou
Research Site
NOT_YET_RECRUITING
Harbin
Research Site
WITHDRAWN
Hefei
Research Site
RECRUITING
Jining
Research Site
NOT_YET_RECRUITING
Kunming
Research Site
COMPLETED
Kunming
Research Site
RECRUITING
Nanchang
Research Site
NOT_YET_RECRUITING
Nanjing
Research Site
ACTIVE_NOT_RECRUITING
Nanning
Research Site
RECRUITING
Nanning
Research Site
NOT_YET_RECRUITING
Shandong
Research Site
COMPLETED
Shandong
Research Site
RECRUITING
Shandong
Research Site
RECRUITING
Shandong
Research Site
ACTIVE_NOT_RECRUITING
Shanghai
Research Site
RECRUITING
Shanghai
Research Site
ACTIVE_NOT_RECRUITING
Shenyang
Research Site
COMPLETED
Tianjin
Research Site
RECRUITING
Tianjin
Research Site
RECRUITING
Wuhan
Research Site
WITHDRAWN
Wuhan
Research Site
ACTIVE_NOT_RECRUITING
Wuhan
Research Site
RECRUITING
Wuhan
Research Site
RECRUITING
Wuhou District
Research Site
NOT_YET_RECRUITING
Zhengzhou
Germany
Research Site
NOT_YET_RECRUITING
Cologne
Research Site
NOT_YET_RECRUITING
Frankfurt
Research Site
NOT_YET_RECRUITING
Gauting
Research Site
NOT_YET_RECRUITING
Großhansdorf
Research Site
NOT_YET_RECRUITING
Hamburg
Research Site
NOT_YET_RECRUITING
Heidelberg
Research Site
NOT_YET_RECRUITING
Mainz
Research Site
NOT_YET_RECRUITING
Münster
Research Site
NOT_YET_RECRUITING
Offenbach
Research Site
NOT_YET_RECRUITING
Regensburg
Italy
Research Site
NOT_YET_RECRUITING
Alessandria
Research Site
NOT_YET_RECRUITING
Bergamo
Research Site
NOT_YET_RECRUITING
Orbassano
Japan
Research Site
NOT_YET_RECRUITING
Kashiwa
Research Site
NOT_YET_RECRUITING
Yokohama
Republic of Korea
Research Site
NOT_YET_RECRUITING
Incheon
Research Site
RECRUITING
Namdong-gu
Research Site
RECRUITING
Seoul
Taiwan
Research Site
NOT_YET_RECRUITING
Kaohsiung City
Research Site
NOT_YET_RECRUITING
Kaohsiung City
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Taipei
Research Site
NOT_YET_RECRUITING
Taipei
United Kingdom
Research Site
RECRUITING
Cambridge
Research Site
NOT_YET_RECRUITING
Glasgow
Research Site
RECRUITING
Manchester
Viet Nam
Research Site
RECRUITING
Hanoi
Research Site
RECRUITING
Ho Chi Minh City
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
+18772409479
Time Frame
Start Date: 2024-08-22
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 257
Treatments
Experimental: Sub-study 1
Volrustomig monotherapy
Experimental: Sub-study 2
Volrustomig monotherapy
Experimental: Sub-study 3 Arm A
Volrustomig in combination with carboplatin plus paclitaxel
Experimental: Sub-study 3 Arm B
Volrustomig in combination with carboplatin plus paclitaxel
Experimental: Sub-study 3 Arm C
Volrustomig in combination with 5-FU plus platinum
Experimental: Sub-study 4 Arm A
Volrustomig in combination with cisplatin + 5-FU
Experimental: Sub-study 4 Arm B
Volrustomig in combination with cisplatin + paclitaxel
Experimental: Sub-study 5
Volrustomig monotherapy
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca