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 (59) 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WITHDRAWN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
Stony Brook
Ohio
Research Site
NOT_YET_RECRUITING
Columbus
Other Locations
Brazil
Research Site
RECRUITING
Ijuí
Research Site
RECRUITING
Londrina
Research Site
RECRUITING
São Caetano Do Sul
Research Site
RECRUITING
Vitória
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
WITHDRAWN
Bengbu
Research Site
NOT_YET_RECRUITING
Changchun
Research Site
WITHDRAWN
Changchun
Research Site
ACTIVE_NOT_RECRUITING
Changsha
Research Site
RECRUITING
Changsha
Research Site
COMPLETED
Changsha
Research Site
RECRUITING
Changsha
Research Site
ACTIVE_NOT_RECRUITING
Chengdu
Research Site
RECRUITING
Chengdu
Research Site
RECRUITING
Chongqing
Research Site
WITHDRAWN
Chongqing
Research Site
ACTIVE_NOT_RECRUITING
Dongguan
Research Site
RECRUITING
Dongguan
Research Site
COMPLETED
Fuzhou
Research Site
NOT_YET_RECRUITING
Fuzhou
Research Site
ACTIVE_NOT_RECRUITING
Hangzhou
Research Site
RECRUITING
Hangzhou
Research Site
WITHDRAWN
Hefei
Research Site
RECRUITING
Jining
Research Site
RECRUITING
Kunming
Research Site
RECRUITING
Nanchang
Research Site
NOT_YET_RECRUITING
Nanjing
Research Site
ACTIVE_NOT_RECRUITING
Nanning
Research Site
RECRUITING
Nanning
Research Site
ACTIVE_NOT_RECRUITING
Shandong
Research Site
NOT_YET_RECRUITING
Shandong
Research Site
RECRUITING
Shandong
Research Site
RECRUITING
Shandong
Research Site
ACTIVE_NOT_RECRUITING
Shanghai
Research Site
RECRUITING
Shanghai
Research Site
RECRUITING
Shenyang
Research Site
ACTIVE_NOT_RECRUITING
Tianjin
Research Site
RECRUITING
Tianjin
Research Site
RECRUITING
Wuhan
Research Site
RECRUITING
Wuhan
Research Site
ACTIVE_NOT_RECRUITING
Wuhan
Research Site
RECRUITING
Wuhan
Research Site
RECRUITING
Wuhan
Research Site
RECRUITING
Wuhou District
Research Site
NOT_YET_RECRUITING
Zhengzhou
Republic of Korea
Research Site
RECRUITING
Namdong-gu
Research Site
RECRUITING
Seoul
Taiwan
Research Site
NOT_YET_RECRUITING
Taichung
Research Site
RECRUITING
Taipei
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