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AdvanTIG-203: Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT04732494
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) visually estimated combined positive score (vCPS) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Tislelizumab Drug: Ociperlimab Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody BGB-A1217 Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 vCPS ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Tislelizumab plus Ociperlimab
Participants will receive tislelizumab (200 milligrams [mg]) plus ociperlimab (900 mg) intravenously once every 3 weeks.
 Drug: Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Other Name: BGB-A317

Drug: Ociperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Other Name: BGB-A1217
Placebo Comparator: Arm B: Tislelizumab plus Placebo
Participants will receive tislelizumab (200 mg) plus placebo intravenously once every 3 weeks.
 Drug: Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Other Name: BGB-A317

Drug: Placebo
Ociperlimab placebo injection is a sterile, preservative-free solution for infusion formulated in the same buffer as ociperlimab active drug.
Other Name: Ociperlimab placebo


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) Assessed By The Investigator's Review Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 [ Time Frame: Approximately 17 months ]
    The objective response rate will be defined as the proportion of participants who have complete response or partial response.

  2. Overall Survival [ Time Frame: Approximately 32 months ]
    Overall survival will be defined as the time from the date of randomization until the date of death due to any cause in all randomized participants.


Secondary Outcome Measures :
  1. Progression-free Survival Assessed By The IRC And The Investigator Per RECIST v1.1 [ Time Frame: Approximately 32 months ]
    Progression-free survival will be defined as the time from the date of randomization to the date of first documentation of PD assessed by both the IRC and the investigator per RECIST v1.1 or death, whichever occurs first.

  2. Duration Of Response Assessed By The IRC And The Investigator Per RECIST v1.1 [ Time Frame: Approximately 32 months ]
    Duration of response will be defined as the time from the first determination of an objective response until the first documentation of PD as assessed by both the IRC and the investigator per RECIST v1.1, or death, whichever comes first.

  3. Disease Control Rate Assessed By The IRC And The Investigator Per RECIST v1.1 [ Time Frame: Approximately 32 months ]
    Disease Control Rate will be defined as the proportion of participants who have CR, PR, and stable disease assessed by both the IRC and the investigator per RECIST v1.

  4. Clinical Benefit Rate [ Time Frame: Approximately 32 months ]
    The clinical benefit rate will be defined as the proportion of participants who achieve complete response, partial response, and durable stable disease (stable disease ≥ 24 weeks).

  5. Health -related Quality Of Life (HRQoL): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: 30 days (±7) after last dose ]
    The HRQoL will be assessed by scores in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-30) :

  6. HRQoL: Dysphagia, Eating, Reflux and Pain Scales of EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) [ Time Frame: 30 days (±7) after last dose ]
    The HRQoL will be assessed by scores in the EORTC QLQ-OES18.

  7. Incidence of Adverse Events And Serious Adverse Events [ Time Frame: 90 days (±14) after last dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Histologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.
  2. Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
  3. Have measurable disease as assessed by RECIST v1.1.
  4. Have confirmed PD-L1 vCPS ≥ 10% in tumor tissues tested by the central lab.
  5. Eastern Cooperative Oncology Group Performance Status score of 0 or 1.

Key Exclusion Criteria:

  1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
  2. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta).
  3. Evidence of complete esophageal obstruction not amenable to treatment.
  4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).
  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.

Contacts and Locations
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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): NCT04732494


Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Yang Haiyang BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04732494    
Other Study ID Numbers: BGB-A317-A1217-203
2020-004658-32 ( EudraCT Number )
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
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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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases