Clinical Trials/NCT04693234

NCT04693234

Completed

Phase 2

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

BeiGene68 sites in 5 countries178 target enrollmentFebruary 15, 2021

ConditionsCervical Cancer

InterventionsTislelizumab Ociperlimab

DrugsTislelizumab Ociperlimab

Overview

Phase: Phase 2
Intervention: Tislelizumab
Conditions: Cervical Cancer
Sponsor: BeiGene
Enrollment: 178
Locations: 68
Primary Endpoint: Cohort 1: Objective Response Rate (ORR) Assessed by an Independent Review Committee (IRC) in PD-L1-Positive Participants
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study tested how well and how safely the drug tislelizumab, given either alone or with another drug called ociperlimab (BGB-A1217), worked in people with cervical cancer that had come back or spread after previous treatments. The study included two groups and took place at multiple medical centers.

Registry

clinicaltrials.gov

Start Date

February 15, 2021

End Date

August 31, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

BeiGene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
•Progression on or after one or more lines of chemotherapy for management of recurrent or metastatic disease and is not amenable to curative treatment (eg, systemic chemotherapy, surgery, or radiotherapy).
•Measurable disease as assessed by RECIST v1.
•Note: A lesion in an area subjected to prior loco-regional therapy, including previous radiotherapy, is not considered measurable unless there has been demonstrated progression in the lesion since the therapy as defined by RECIST v1.
•Participants must submit qualified archival tumor tissue (formalin-fixed paraffin-embedded block containing tumor \[preferred\] or approximately 15 \[at least 6\] unstained slides) with an associated pathology report, or agree to a tumor biopsy for determination of Programmed death-ligand 1 (PD-L1) expression and other biomarker analyses (fresh tumor biopsies are strongly recommended at baseline in participants with readily accessible tumor lesions and who consent to the biopsies).
•Participant must have adequate organ function as indicated by the screening laboratory values obtained within 7 days before the first study treatment.

Exclusion Criteria

•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.
•Any active malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of breast).
•Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks of intervention).
•Any major surgical procedure ≤ 28 days before first dose of study drug. Participants must have recovered adequately from the toxicity and/or complications from the intervention before the first dose of study drug.
•Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc.) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.
•Note: Other protocol defined Inclusion/Exclusion criteria may apply

Arms & Interventions

Cohort 1: Ociperlimab + Tislelizumab

Tislelizumab 200 milligrams (mg) intravenously (IV) once every 3 weeks (Q3W) combined with ociperlimab (BGB-A1217) 900 mg IV Q3W

Intervention: Tislelizumab

Cohort 1: Ociperlimab + Tislelizumab

Tislelizumab 200 milligrams (mg) intravenously (IV) once every 3 weeks (Q3W) combined with ociperlimab (BGB-A1217) 900 mg IV Q3W

Intervention: Ociperlimab

Cohort 2: Tislelizumab

Tislelizumab 200 mg IV Q3W monotherapy

Intervention: Tislelizumab

Outcomes

Primary Outcomes

Cohort 1: Objective Response Rate (ORR) Assessed by an Independent Review Committee (IRC) in PD-L1-Positive Participants

Time Frame: Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1.

ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the IRC per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). PD-L1-positive refers to participants whose tumors had a PD-L1 TAP score ≥ 5%.

Cohort 1: ORR Assessed by the IRC in All Treated Participants

Time Frame: Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1.

ORR is defined as the percentage of participants who had a confirmed CR or PR as assessed by the IRC per RECIST v1.1.

Secondary Outcomes

Cohort 2: Objective Response Rate (ORR) Assessed by an Independent Review Committee in All Treated Participants(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 10.40 months for Cohort 2.)
ORR Assessed by the Investigator in PD-L1-Positive Participants(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2.)
ORR as Assessed by the Investigator in All Treated Participants(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2.)
Serum Tislelizumab Concentrations at Specified Timepoints(Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle is 21 days))
Duration of Response (DOR) Assessed by the IRC(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2.)
Duration of Response (DOR) Assessed by the Investigator(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2.)
Progression Free Survival (PFS)(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2.)
Time to Response (TTR) Assessed by the IRC(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up was 7.36 months for Cohort 1 and 10.40 months for Cohort 2.)
Time to Response (TTR) Assessed by the Investigator(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up was 7.36 months for Cohort 1 and 10.40 months for Cohort 2.)
Disease Control Rate (DCR)(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2.)
Clinical Benefit Rate (CBR)(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2.)
Overall Survival (OS)(Up to the primary efficacy analysis data cut-off date on June 16, 2022, the median follow-up duration was 7.36 months for Cohort 1 and 10.40 months for Cohort 2.)
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life, Physical Functioning, and Pain Scores(Baseline to Cycles 3 and 5 ( Each cycle was 21 days))
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Index Score(Baseline to Cycles 3 and 5 ( Each cycle was 21 days))
Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(From the first dose of study drug to 30 days after the last dose; maximum treatment exposure was 23.5 months.)
Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints(Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle was 21 days))
Number of Participants Who Developed Positive Anti-drug Antibodies (ADAs) to Ociperlimab(Samples for ADA analysis were collected predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at the Safety Follow-up Visit (30 days after last dose) up to the immunogenicity data cut-off date of June 1, 2023 (approximately 21 months).)
Number of Participants Who Developed Anti-drug Antibodies (ADAs) to Tislelizumab(Samples for ADA analysis were collected predose on Day 1 of Cycles 1, 2, 5, 9 and 17, and at the Safety Follow-up Visit (30 days after last dose), up to the immunogenicity data cut-off date of June 1, 2023 (approximately 21 months).)