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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

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Tislelizumab Drug: Ociperlimab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 15, 2021
Actual Primary Completion Date : June 16, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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.
Drug: Tislelizumab
Administered as specified in the treatment arm

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

Tislelizumab Monotherapy (Cohort 2)
Tislelizumab 200 mg will be administered on Day 1 of each 21-day cycle
Drug: Tislelizumab
Administered as specified in the treatment arm




Primary Outcome Measures :
  1. Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) per RECIST v1.1 for Cohort 1 [ Time Frame: approximately 3 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Objective Response Rate (ORR) assessed by both IRC and investigator's review per RECIST v1.1 for Cohort 2 [ Time Frame: approximately 3 years ]
  3. Duration of Response (DOR) assessed by both IRC and investigator's review [ Time Frame: approximately 3 years ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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)

  10. 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 ]
  11. Serum BGB-A1217 and tislelizumab concentrations at specified timepoints [ Time Frame: specified timepoints up to 30 (±7) days after last dose, approximately 3 years ]
  12. 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 ]
  13. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693234


Locations
Show Show 31 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Xiyan Mu BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04693234    
Other Study ID Numbers: BGB-A317-A1217-202
2020-004657-77 ( EudraCT Number )
AdvanTIG-202 ( Other Identifier: BeiGene )
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases