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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

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

Tracking Information
First Submitted Date  ICMJE December 22, 2020
First Posted Date  ICMJE January 5, 2021
Last Update Posted Date July 28, 2022
Actual Study Start Date  ICMJE February 15, 2021
Actual Primary Completion Date June 16, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Drug: Tislelizumab
    Administered as specified in the treatment arm
  • Drug: Ociperlimab
    Administered as specified in the treatment arm
    Other Name: BGB-A1217
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 30, 2020)
167
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Actual Primary Completion Date June 16, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   China,   Korea, Republic of,   Poland,   Russian Federation,   Taiwan,   Thailand,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04693234
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Yes
Current Responsible Party BeiGene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BeiGene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xiyan Mu BeiGene
PRS Account BeiGene
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP