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

• ClinicalTrials.gov Identifier: NCT04693234
• Recruitment Status: Active, not recruiting
• First Posted: January 5, 2021
• Last Update Posted: July 28, 2022
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

Tracking Information

• First Submitted Date: December 22, 2020
• First Posted Date: January 5, 2021
• Last Update Posted Date: July 28, 2022
• Actual Study Start Date: February 15, 2021
• Actual Primary Completion Date: June 16, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 30, 2020): Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) per RECIST v1.1 for Cohort 1 [ Time Frame: approximately 3 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 1, 2021)

• Objective Response Rate (ORR) assessed by investigator's review per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 for Cohort 1 [ Time Frame: approximately 3 years ]
• Objective Response Rate (ORR) assessed by both IRC and investigator's review per RECIST v1.1 for Cohort 2 [ Time Frame: approximately 3 years ]
• Duration of Response (DOR) assessed by both IRC and investigator's review [ Time Frame: approximately 3 years ]
• Progression Free Survival (PFS) assessed by both IRC and investigator's review [ Time Frame: Date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, approximately 3 years ]
• Time to Response (TTR) assessed by both IRC and investigator's review [ Time Frame: date of first dose of study drug to first documentation of response, approximately 3 years ]
• Disease Control Rate (DCR) assessed by both IRC and investigator's review [ Time Frame: the proportion of patients who achieve CR, PR, or stable disease (SD) approximately 3 years ]
• Clinical Benefit Rate (CBR) assessed by both IRC and investigator's review [ Time Frame: the proportion of patients who achieve CR, PR, or durable SD (SD ≥ 24 weeks), approximately 3 years ]
• Overall Survival (OS) assessed by both IRC and investigator's review [ Time Frame: Date of first dose of study drug until the date of death from any cause for Cohorts 1 and 2, approximately 3 years ]
• Health-related quality of life (HRQoL) [ Time Frame: approximately 3 years ]
  Assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
• Adverse events (AEs) and serious adverse events (SAEs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0 for Cohorts 1 and 2 [ Time Frame: approximately 3 years ]
• Serum BGB-A1217 and tislelizumab concentrations at specified timepoints [ Time Frame: specified timepoints up to 30 (±7) days after last dose, approximately 3 years ]
• Immunogenic responses to BGB-A1217 and tislelizumab, evaluated through the detection of antidrug antibodies (ADAs) [ Time Frame: date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, approximately 3 years ]
• Health-related quality of life (HRQoL) [ Time Frame: approximately 3 years ]
  Assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ-CX24)

Original Secondary Outcome Measures (submitted: December 30, 2020)

• Objective Response Rate (ORR) assessed by investigator's review per RECIST v1.1 for Cohort 1 [ Time Frame: approximately 3 years ]
• Objective Response Rate (ORR) assessed by both IRC and investigator's review per RECIST v1.1 for Cohort 2 [ Time Frame: approximately 3 years ]
• Duration of Response (DOR) assessed by both IRC and investigator' review [ Time Frame: approximately 3 years ]
• Progression Free Survival (PFS) assessed by Independent Review Committee (IRC) and Investigator's review [ Time Frame: ate of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, approximately 3 years ]
• Time to Response (TTR) assessed by Independent Review Committee (IRC) and Investigator [ Time Frame: date of first dose of study drug to first documentation of response, approximately 3 years ]
• Disease Control Rate (DCR) assessed by Independent Review Committee (IRC) and Investigator [ Time Frame: the proportion of patients who achieve CR, PR, or stable disease (SD) approximately 3 years ]
• Clinical Benefit Rate (CBR) assessed by Independent Review Committee (IRC) and Investigator [ Time Frame: the proportion of patients who achieve CR, PR, or durable SD (SD ≥ 24 weeks), approximately 3 years ]
• Overall Survival (OS) [ Time Frame: Date of first dose of study drug until the date of death from any cause for Cohorts 1 and 2, approximately 3 years ]
• Health-related quality of life (HRQoL) [ Time Frame: approximately 3 years ]
  assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
• Adverse events (AEs) and serious adverse events (SAEs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0 for Cohorts 1 and 2 [ Time Frame: approximately 3 years ]
• Serum BGB-A1217 and tislelizumab concentrations at specified timepoints [ Time Frame: specified timepoints up to 30 (±7) days after last dose, approximately 3 years ]
• immunogenic responses to BGB-A1217 and tislelizumab, evaluated through the detection of antidrug antibodies (ADAs) [ Time Frame: date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first, approximately 3 years ]
• Health-related quality of life (HRQoL) [ Time Frame: approximately 3 years ]
  assessment of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: 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
• Brief Summary: This is an open-label, 2-cohort, multicenter, Phase 2 study to evaluate the efficacy and safety of tislelizumab combined with or without ociperlimab (BGB-A1217) in participants with previously treated recurrent or metastatic cervical cancer.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cervical Cancer

Intervention

• Drug: Tislelizumab
  Administered as specified in the treatment arm
• Drug: Ociperlimab
  Administered as specified in the treatment arm
  Other Name: BGB-A1217

Study Arms

• Tislelizumab and Ociperlimab (BGB-A1217) Combination (Cohort 1)
  Participants will receive tislelizumab 200 milligrams (mg) on Day 1 followed by the administration of ociperlimab (BGB-A1217) 900 mg of each 21-day cycle.
  Interventions:

  • Drug: Tislelizumab
  • Drug: Ociperlimab
• Tislelizumab Monotherapy (Cohort 2)
  Tislelizumab 200 mg will be administered on Day 1 of each 21-day cycle
  Intervention: Drug: Tislelizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 30, 2020): 167
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2023
• Actual Primary Completion Date: June 16, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, China, Korea, Republic of, Poland, Russian Federation, Taiwan, Thailand, Ukraine

Administrative Information

• NCT Number: NCT04693234
• Other Study ID Numbers: BGB-A317-A1217-202; 2020-004657-77 ( EudraCT Number ); AdvanTIG-202 ( Other Identifier: BeiGene )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: BeiGene
• Original Responsible Party: Same as current
• Current Study Sponsor: BeiGene
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Xiyan Mu; BeiGene

• PRS Account: BeiGene
• Verification Date: July 2022