Study of Tislelizumab (BGB-A317) Combined With or Without BGB-A1217 in Patients With Previously Treated Recurrent or Metastatic Cervical Cancer

Phase 1

• Conditions: Previously Treated Recurrent or Metastatic Cervical Cancer; MedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10008231Term: Cervical cancer recurrentSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004657-77-BG
• Lead Sponsor: BeiGene, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-16
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified