Phase 2 Study Investigating Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody BGB-A1217 in Patients With Previously Treated Recurrent or Metastatic Cervical Cancer

BeiGene, Ltd. c/o BeiGene USA, Inc.0 sites167 target enrollmentMarch 31, 2021

Overview

No summary available.

Registry

who.int

Start Date

March 31, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

BeiGene, Ltd. c/o BeiGene USA, Inc.

•Adult patients (\= 18 years of age or the legal age of consent, at the time of voluntarily signing of informed consent) with histologically or cytologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix and who had progression on or after one or more lines of chemotherapy for management of recurrent or metastatic disease and are not amenable to curative treatment are eligible. Patients must submit qualified archival tumor tissue with an associated pathology report or agree to a tumor biopsy for determination of PD\-L1 expression and other biomarker analyses. Patients must have an ECOG PS of \= 1 and life expectancy \= 12 weeks with adequate organ functions. Patients must have \= 1 measurable lesion as defined per RECIST v1\.1\.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 157
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 17

•Patients who have received prior therapy with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, TIGIT or any other antibody or drug specifically targeting T\-cell costimulation or checkpoint pathways are excluded.