Trial Outcomes & Findings for 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 (NCT NCT04693234)

Last Updated: 2025-04-27

Results Overview

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%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

178 participants

Primary outcome timeframe

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.

Results posted on

2025-04-27

Participant Flow

Participants were enrolled in multiple study centers in China, South Korea, and Europe.The first participant dosed was on March 3rd, 2021 and the last participant completed on August 31st, 2023.

The study was composed of an initial screening phase (up to 28 days), a treatment phase, an end of treatment visit, an on-site Safety Follow-up Visit, and 2 Safety Follow-up Visits by telephone after the last dose of study treatment.

Participant milestones

Participant milestones
Measure	Cohort 1: Ociperlimab + Tislelizumab Participants received tislelizumab 200 milligrams (mg) intravenously (IV) and ociperlimab 900 mg IV once every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab Participants received tislelizumab 200 mg administered intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Study STARTED	138	40
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	138	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Ociperlimab + Tislelizumab Participants received tislelizumab 200 milligrams (mg) intravenously (IV) and ociperlimab 900 mg IV once every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab Participants received tislelizumab 200 mg administered intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Overall Study Death	79	19
Overall Study Sponsor Ended Study	47	18
Overall Study Withdrawal by Subject	10	2
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Ociperlimab + Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=40 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Total n=178 Participants Total of all reporting groups
Age, Continuous	52.7 years STANDARD_DEVIATION 10.28 • n=5 Participants	51.2 years STANDARD_DEVIATION 9.74 • n=7 Participants	52.3 years STANDARD_DEVIATION 10.15 • n=5 Participants
Sex/Gender, Customized Female	138 Participants n=5 Participants	40 Participants n=7 Participants	178 Participants n=5 Participants
Race/Ethnicity, Customized Asian	117 Participants n=5 Participants	37 Participants n=7 Participants	154 Participants n=5 Participants
Race/Ethnicity, Customized White	21 Participants n=5 Participants	3 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment China	71 participants n=5 Participants	17 participants n=7 Participants	88 participants n=5 Participants
Region of Enrollment South Korea	30 participants n=5 Participants	8 participants n=7 Participants	38 participants n=5 Participants
Region of Enrollment Taiwan	10 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Ukraine	10 participants n=5 Participants	0 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Russia	8 participants n=5 Participants	3 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Thailand	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Bulgaria	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Poland	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 0	53 Participants n=5 Participants	16 Participants n=7 Participants	69 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 1	85 Participants n=5 Participants	24 Participants n=7 Participants	109 Participants n=5 Participants
Programmed Death-Ligand 1 (PD-L1) Expression PD-L1 Score >= 5%	84 Participants n=5 Participants	20 Participants n=7 Participants	104 Participants n=5 Participants
Programmed Death-Ligand 1 (PD-L1) Expression PD-L1 Score < 5%	53 Participants n=5 Participants	20 Participants n=7 Participants	73 Participants n=5 Participants
Programmed Death-Ligand 1 (PD-L1) Expression Not Evaluable	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: The PD-L1 Score ≥ 5% Safety Analysis Set includes all treated participants whose tumors had PD-L1 TAP Score ≥ 5%.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=84 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Cohort 1: Objective Response Rate (ORR) Assessed by an Independent Review Committee (IRC) in PD-L1-Positive Participants	26.2 percentage of participants Interval 17.2 to 36.9	—	—	—

PRIMARY outcome

Timeframe: 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.

Population: The Safety Analysis Set includes all participants who received at least 1 dose of any study drug.

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

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Cohort 1: ORR Assessed by the IRC in All Treated Participants	22.5 percentage of participants Interval 15.8 to 30.3	—	—	—

SECONDARY outcome

Timeframe: 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.

Population: The Safety Analysis Set includes all participants who received at least 1 dose of any study drug.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=40 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Cohort 2: Objective Response Rate (ORR) Assessed by an Independent Review Committee in All Treated Participants	32.5 percentage of participants Interval 18.6 to 49.1	—	—	—

SECONDARY outcome

Timeframe: 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.

Population: The PD-L1 Score ≥ 5% Safety Analysis Set includes all treated participants whose tumors had PD-L1 Score ≥ 5%.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=84 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=20 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
ORR Assessed by the Investigator in PD-L1-Positive Participants	25.0 percentage of participants Interval 16.2 to 35.6	30 percentage of participants Interval 11.9 to 54.3	—	—

SECONDARY outcome

Timeframe: 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.

Population: The Safety Analysis Set includes participants who received at least 1 dose of any study drug.

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

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=40 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
ORR as Assessed by the Investigator in All Treated Participants	21.0 percentage of participants Interval 14.5 to 28.8	22.5 percentage of participants Interval 10.8 to 38.5	—	—

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 by the IRC were included in the analysis

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=31 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=13 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Duration of Response (DOR) Assessed by the IRC	NA Months Interval 5.6 to Not estimable due to insufficient number of participants with events	NA Months Interval 4.1 to Not estimable due to insufficient number of participants with events	—	—

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 by the investigator were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=29 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=9 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Duration of Response (DOR) Assessed by the Investigator	NA Months Interval 5.5 to Not estimable due to insufficient number of participants with events	NA Months Interval 5.6 to Not estimable due to insufficient number of participants with events	—	—

SECONDARY outcome

Timeframe: 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.

Population: Safety Analysis Set

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=40 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Progression Free Survival (PFS) IRC	3.5 Months Interval 2.6 to 4.9	5.7 Months Interval 2.3 to 8.1	—	—
Progression Free Survival (PFS) Investigator	3.9 Months Interval 2.6 to 4.4	5.7 Months Interval 2.6 to 9.2	—	—

SECONDARY outcome

Timeframe: 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.

Population: The Safety Analysis Set. Only participants with best overall response of complete response or partial response confirmed by the IRC per RECIST v1.1 were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=31 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=13 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Time to Response (TTR) Assessed by the IRC	9.02 Weeks Standard Deviation 4.704	11.78 Weeks Standard Deviation 4.709	—	—

SECONDARY outcome

Timeframe: 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.

Population: The Safety Analysis Set. Only participants with best overall response of complete response or partial response confirmed by the investigator per RECIST v1.1 were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=29 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=9 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Time to Response (TTR) Assessed by the Investigator	10.66 Weeks Standard Deviation 3.010	8.92 Weeks Standard Deviation 3.174	—	—

SECONDARY outcome

Timeframe: 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.

Population: The Safety Analysis Set

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=40 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Disease Control Rate (DCR) IRC	63.0 percentage of participants Interval 54.4 to 71.1	67.5 percentage of participants Interval 50.9 to 81.4	—	—
Disease Control Rate (DCR) Investigator	62.3 percentage of participants Interval 53.7 to 70.4	75.0 percentage of participants Interval 58.8 to 87.3	—	—

SECONDARY outcome

Timeframe: 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.

Population: The Safety Analysis Set

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=40 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Clinical Benefit Rate (CBR) IRC	29.0 percentage of participants Interval 21.6 to 37.3	50.0 percentage of participants Interval 33.8 to 66.2	—	—
Clinical Benefit Rate (CBR) Investigator	31.2 percentage of participants Interval 23.6 to 39.6	50.0 percentage of participants Interval 33.8 to 66.2	—	—

SECONDARY outcome

Timeframe: 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.

Population: The Safety Analysis Set

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=40 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Overall Survival (OS)	9.0 Months Interval 8.1 to 10.4	NA Months Interval 10.5 to Not estimable due to insufficient number of participants with events	—	—

SECONDARY outcome

Timeframe: Baseline to Cycles 3 and 5 ( Each cycle was 21 days)

Population: The Safety Analysis Set with available EORTC QLQ-C30 values at Baseline; Only participants with data at baseline and at each time point are included.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=122 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=38 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
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 GHS/QoL: Baseline Score	64.21 Score on a scale Standard Deviation 20.821	62.06 Score on a scale Standard Deviation 22.402	—	—
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 GHS/QoL: Change from Baseline to Cycle 3 Day 1	0.37 Score on a scale Standard Deviation 22.158	5.30 Score on a scale Standard Deviation 23.088	—	—
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 GHS/QoL: Change from Baseline to Cycle 5 Day 1	3.46 Score on a scale Standard Deviation 18.355	5.13 Score on a scale Standard Deviation 21.995	—	—
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 Pain: Baseline Score	27.73 Score on a scale Standard Deviation 28.070	30.26 Score on a scale Standard Deviation 27.084	—	—
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 Physical Functioning: Baseline Score	78.91 Score on a scale Standard Deviation 19.211	76.67 Score on a scale Standard Deviation 22.501	—	—
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 Physical Functioning: Change from Baseline at Cycle 3 Day 1	-2.62 Score on a scale Standard Deviation 16.582	1.82 Score on a scale Standard Deviation 18.876	—	—
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 Physical Functioning: Change from Baseline at Cycle 5 Day 1	0.00 Score on a scale Standard Deviation 14.927	5.38 Score on a scale Standard Deviation 16.113	—	—
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 Pain: Change from Baseline at Cycle 3 Day 1	-2.08 Score on a scale Standard Deviation 21.820	-9.09 Score on a scale Standard Deviation 26.051	—	—
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 Pain: Change from Baseline at Cycle 5 Day 1	-2.16 Score on a scale Standard Deviation 22.353	-8.97 Score on a scale Standard Deviation 24.599	—	—

SECONDARY outcome

Timeframe: Baseline to Cycles 3 and 5 ( Each cycle was 21 days)

Population: The Safety Analysis Set with available EORTC QLQ-CX24 values at Baseline; Only participants with data at baseline and at each time point are included.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=122 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=38 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
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 Score	30.86 score on a scale Standard Deviation 6.942	31.43 score on a scale Standard Deviation 4.497	—	—
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 Change from Baseline at Cycle 3 Day 1	0.61 score on a scale Standard Deviation 5.915	-0.71 score on a scale Standard Deviation 4.163	—	—
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 Change from Baseline at Cycle 5 Day 1	-0.15 score on a scale Standard Deviation 5.790	1.05 score on a scale Standard Deviation 4.227	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug to 30 days after the last dose; maximum treatment exposure was 23.5 months.

Population: The Safety Analysis Set includes all participants who received at least 1 dose of any study drug.

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).

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=40 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of Participants with at least one TEAE	135 Participants	39 Participants	—	—
Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with at least one SAE	61 Participants	17 Participants	—	—

SECONDARY outcome

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

Population: The Pharmacokinetic Analysis (PK) Set includes all participants who received at least 1 dose of any component of study drug per the protocol, for whom any post-dose PK data are available.

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

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints Cycle 2 Day 1	46.60 μg/mL Geometric Coefficient of Variation 46.98	—	—	—
Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints Cycle 5 Day 1	82.57 μg/mL Geometric Coefficient of Variation 55.30	440.70 μg/mL Geometric Coefficient of Variation 25.35	—	—
Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints Cycle 9 Day 1	89.13 μg/mL Geometric Coefficient of Variation 56.58	—	—	—
Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints Cycle 17 Day 1	88.84 μg/mL Geometric Coefficient of Variation 63.62	—	—	—
Serum Ociperlimab (BGB-A1217) Concentrations at Specified Timepoints Cycle 1 Day 1	0.00 μg/mL Geometric Coefficient of Variation NA Not estimable since all values were below the limit of quantitation	363.19 μg/mL Geometric Coefficient of Variation 24.21	—	—

SECONDARY outcome

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

Population: The Pharmacokinetic Analysis Set includes all participants who received \>= 1 dose of any component of study drug per the protocol, for whom any post-dose PK data are available.

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

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=138 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) n=40 Participants Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) n=40 Participants Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Serum Tislelizumab Concentrations at Specified Timepoints Cycle 1 Day 1	0.00 μg/mL Geometric Coefficient of Variation NA Not estimable since all values were below the limit of quantitation	77.38 μg/mL Geometric Coefficient of Variation 21.78	0.00 μg/mL Geometric Coefficient of Variation NA Not estimable since all values were below the limit of quantitation	84.24 μg/mL Geometric Coefficient of Variation 18.19
Serum Tislelizumab Concentrations at Specified Timepoints Cycle 17 Day 1	45.16 μg/mL Geometric Coefficient of Variation 55.71	—	56.25 μg/mL Geometric Coefficient of Variation 21.56	—
Serum Tislelizumab Concentrations at Specified Timepoints Cycle 2 Day 1	17.86 μg/mL Geometric Coefficient of Variation 35.69	—	20.03 μg/mL Geometric Coefficient of Variation 36.62	—
Serum Tislelizumab Concentrations at Specified Timepoints Cycle 5 Day 1	36.66 μg/mL Geometric Coefficient of Variation 44.97	113.80 μg/mL Geometric Coefficient of Variation 24.68	41.51 μg/mL Geometric Coefficient of Variation 42.89	128.48 μg/mL Geometric Coefficient of Variation 24.06
Serum Tislelizumab Concentrations at Specified Timepoints Cycle 9 Day 1	42.84 μg/mL Geometric Coefficient of Variation 46.50	—	56.78 μg/mL Geometric Coefficient of Variation 28.55	—

SECONDARY outcome

Timeframe: 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).

Population: The ADA Analysis Set includes all participants who received at least 1 dose of any component of study drug for whom both baseline antidrug antibody result and at least 1 post-baseline antidrug antibody result were available.

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

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=127 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Number of Participants Who Developed Positive Anti-drug Antibodies (ADAs) to Ociperlimab	0 Participants	—	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Cohort 1: Ociperlimab + Tislelizumab n=127 Participants Participants received tislelizumab 200 mg IV and ociperlimab 900 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2: Tislelizumab n=39 Participants Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.	Cohort 2 (Predose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Predose was collected within 60 minutes before starting infusion	Cohort 2 (Postdose) Tislelizumab: 200 mg administered intravenously once every 3 weeks on day 1 of each cycle. Postdose was collected within 30 minutes after the end of infusion.
Number of Participants Who Developed Anti-drug Antibodies (ADAs) to Tislelizumab	19 Participants	7 Participants	—	—

Adverse Events

Cohort 1: Ociperlimab + Tislelizumab

Serious events: 61 serious events

Other events: 128 other events

Deaths: 79 deaths

Cohort 2: Tislelizumab

Serious events: 17 serious events

Other events: 37 other events

Deaths: 19 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

BeiGene

Phone: +1-877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights
Publication restrictions are in place

Restriction type: OTHER