AdvanTIG-202: Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Previously Treated Recurrent or Metastatic Cervical Cancer

BeiGene178 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Cervical Cancer

Interventions

TislelizumabBIOLOGICAL

200 mg administered intravenously once every 3 weeks on day 1 of each cycle

OciperlimabBIOLOGICAL

900 mg administered intravenously once every 3 weeks on day 1 of each cycle

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically or cytologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix. 2. 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). 3. Measurable disease as assessed by RECIST v1.1. 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 v1.1. 4. 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). 5. Participant must have adequate organ function as indicated by the screening laboratory values obtained within 7 days before the first study treatment. Exclusion Criteria: 1. 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. 2. 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). 3. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks of intervention). 4. 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. 5. 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

Locations (68)

Outcomes

Primary Outcomes

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

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%.

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.

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

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

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.

Secondary Outcomes

Cohort 2: Objective Response Rate (ORR) Assessed by an Independent Review Committee 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 10.40 months for Cohort 2.

ORR Assessed by the Investigator in PD-L1-Positive Participants

ORR is defined as the percentage of participants who had confirmed CR or PR as assessed by the investigator per RECIST v1.1 in the PD-L1 Score \>= 5% Safety Analysis Set.

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 and 10.40 months for Cohort 2.

ORR as Assessed by the Investigator in All Treated Participants

Data from ClinicalTrials.gov

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"Mhat uni hospital" ood

Panagyurishte, Bulgaria

Complex Oncology Center Rousse Eood

Rousse, Bulgaria

Medical center nadezhda clinical eood

Sofia, Bulgaria

Acibadem city clinic tokuda umhat ead, department of medical oncology

Sofia, Bulgaria

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Southwest Hospital

Chongqing, Chongqing Municipality, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

Sun yat-sen memorial hospital, sun yat-sen university (south)

Guanzhou, Guangdong, China

The Tumor Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, China

...and 58 more locations

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

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 and 10.40 months for Cohort 2.

Duration of Response (DOR) Assessed by the IRC

DOR is defined as the time from the first confirmed objective response until the first documentation of progression or death, whichever occurred first, assessed by the IRC according to RECIST v1.1 in the Safety Analysis Set.

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 and 10.40 months for Cohort 2.

Duration of Response (DOR) Assessed by the Investigator

DOR is defined as the time from the first confirmed objective response until the first documentation of progression or death, whichever comes first, assessed by the investigator according to RECIST v1.1 in the Safety Analysis Set. Data was based on number of responders.

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 and 10.40 months for Cohort 2.

Progression Free Survival (PFS)

Defined as the time from the date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurred first as assessed by both the IRC and the investigator's review per RECIST v1.1 in the Safety Analysis Set.

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 and 10.40 months for Cohort 2.

Time to Response (TTR) Assessed by the IRC

TTR is defined as the time from the date of first dose of study drug to the first documentation of response as assessed by the IRC per RECIST v1.1, in the Safety Analysis Set.

Time frame: 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

TTR is defined as the time from the date of first dose of study drug to the first documentation of response as assessed by the investigator per RECIST v1.1, in the Safety Analysis Set.

Time frame: 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)

DCR is defined as the percentage of participants who achieve CR, PR, or stable disease (SD) as assessed by both the IRC and investigator per RECIST v1.1 in the Safety Analysis Set.

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 and 10.40 months for Cohort 2.

Clinical Benefit Rate (CBR)

Defined as the percentage of participants who achieve CR, PR, or durable SD (SD ≥ 24 weeks) as assessed by both the IRC and investigator per RECIST v1.1 in the Safety Analysis Set.

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 and 10.40 months for Cohort 2.

Overall Survival (OS)

Overall survival is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.

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 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

The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. Lower scores in symptom scales indicate better quality of life.

Time frame: 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

QLQ-CX24 is the cervical cancer module of the QLQ-C30. CX24 is comprised of 24 questions grouped into 3 symptom scales and 6 single symptom items. Each question is answered on a scale from 1 (not at all) to 4 (very much). The scales include Symptom Experience (11 items), Body Image (3 items) and Sexual/vaginal Functioning (4 items). The single symptom items include Lymphedema, Peripheral Neuropathy, Menopausal Symptoms, Sexual Worry, Sexual Activity and Sexual Enjoyment. Raw scores are transformed into a 0 to 100 scale via linear transformation. The Index score is calculated as the average of the 3 symptom scales and 6 single item scores. Lower scores indicate better HRQoL.

Time frame: 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)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether considered related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgement (eg, may jeopardize the patient or may require medical/surgical intervention to prevent one of the outcomes listed above).

Time frame: 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

The timepoints are defined as predose (within 60 minutes before starting infusion) and postdose (within 30 minutes after the end of infusion).

Time frame: Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle was 21 days)

Serum Tislelizumab Concentrations at Specified Timepoints

The timepoints are defined as predose (within 60 minutes before starting infusion) and postdose (within 30 minutes after the end of infusion).

Time frame: Day 1 of Cycles 1, 2, 5, 9, and 17 (each cycle is 21 days)

Number of Participants Who Developed Positive Anti-drug Antibodies (ADAs) to Ociperlimab

Number and percentage of participants who developed detectable ADAs to ociperlimab during the treatment period.

Time frame: 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

Number and percentage of participants who developed detectable ADAs during the treatment period.

Time frame: 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).