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 (50) 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:

‣ For inclusion in the study, patients should fulfill the following criteria:

• Age ≥18 at the time of signing the ICF.

• Provision of tumor sample to assess the PD-L1 expression.

• Measurable disease according to RECIST 1.1.

• ECOG performance status of 0 or 1.

• Life expectancy ≥ 12 weeks.

• Adequate organ and bone marrow function.

• Body weight \> 35 kg.

• Capable of giving signed informed consent.

• For sub-study 1, participants with R/M cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology, that: have experienced disease progression during or after treatment with standard systematic therapy per local guideline; have received at least 1 line but no more than 2 lines of prior systemic treatment regimens for R/M cervical cancer.

⁃ For sub-study 2, for participants with OPC must have documented HPV status.

⁃ For sub-study 2, participants with R/M HNSCC, that: (a) Are histologically or cytologically documented R/M HNSCC of the OP, OC, HP, and LX that is considered incurable by local therapies; (b) Participants that have not been treated in R/M setting must have: (i) a documented PD-L1 positive result, (ii) with no prior systemic anti-cancer therapy for R/M HNSCC; (c) Platinum refractory participants must have relapsed from or are refractory to the first line of prior platinum-containing regimen.

⁃ For sub-study 3, participants with R/M HNSCC, that: (a) Are histologically or cytologically documented R/M HNSCC of the OP, OC, HP, and LX that is considered incurable by local therapies; (b) Participants that have not been treated in R/M setting

Locations
United States
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
NOT_YET_RECRUITING
Ijuí
Research Site
NOT_YET_RECRUITING
Londrina
Research Site
NOT_YET_RECRUITING
São Caetano Do Sul
Research Site
NOT_YET_RECRUITING
Vitória
China
Research Site
RECRUITING
Beijing
Research Site
RECRUITING
Beijing
Research Site
RECRUITING
Beijing
Research Site
RECRUITING
Bengbu
Research Site
WITHDRAWN
Changchun
Research Site
ACTIVE_NOT_RECRUITING
Changsha
Research Site
ACTIVE_NOT_RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Changsha
Research Site
RECRUITING
Chengdu
Research Site
ACTIVE_NOT_RECRUITING
Chengdu
Research Site
NOT_YET_RECRUITING
Chengdu
Research Site
RECRUITING
Chongqing
Research Site
NOT_YET_RECRUITING
Dongguan
Research Site
RECRUITING
Dongguan
Research Site
RECRUITING
Fuzhou
Research Site
NOT_YET_RECRUITING
Fuzhou
Research Site
NOT_YET_RECRUITING
Hangzhou
Research Site
ACTIVE_NOT_RECRUITING
Hangzhou
Research Site
RECRUITING
Jining
Research Site
RECRUITING
Kunming
Research Site
RECRUITING
Nanchang
Research Site
ACTIVE_NOT_RECRUITING
Nanning
Research Site
NOT_YET_RECRUITING
Nanning
Research Site
ACTIVE_NOT_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
NOT_YET_RECRUITING
Tianjin
Research Site
RECRUITING
Wuhan
Research Site
NOT_YET_RECRUITING
Wuhan
Research Site
ACTIVE_NOT_RECRUITING
Wuhan
Research Site
NOT_YET_RECRUITING
Wuhan
Research Site
RECRUITING
Wuhan
Research Site
NOT_YET_RECRUITING
Wuhou District
Republic of Korea
Research Site
NOT_YET_RECRUITING
Namdong-gu
Research Site
NOT_YET_RECRUITING
Seoul
Taiwan
Research Site
NOT_YET_RECRUITING
Taichung
Research Site
NOT_YET_RECRUITING
Taipei
Viet Nam
Research Site
NOT_YET_RECRUITING
Hanoi
Research Site
NOT_YET_RECRUITING
Ho Chi Minh City
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-08-22
Estimated Completion Date: 2027-10-07
Participants
Target number of participants: 110
Treatments
Experimental: Sub-study 1
Volrustomig monotherapy
Experimental: Sub-study 2
Volrustomig monotherapy
Experimental: Sub-study 3
Volrustomig in combination with carboplatin plus paclitaxel or 5-FU plus platinum
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov