E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Previously Treated Recurrent or Metastatic Cervical Cancer |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008229 |
E.1.2 | Term | Cervical cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008231 |
E.1.2 | Term | Cervical cancer recurrent |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of BGB-A1217 combined with tislelizumab as measured by ORR according to RECIST v1.1, by Independent Review Committee (IRC) in patients who had previously treated recurrent or metastatic cervical cancer. |
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E.2.2 | Secondary objectives of the trial |
•To evaluate the efficacy of BGB-A1217 combined with tislelizumab as assessed by ORR by investigator review •To evaluate the efficacy of tislelizumab monotherapy as assessed by ORR by both IRC and investigator review •To evaluate the efficacy of BGB-A1217 combined with tislelizumab and tislelizumab monotherapy as measured by DOR, PFS, time to response (TTR), disease control rate (DCR), and clinical benefit rate (CBR) by both IRC and investigator review •To evaluate the efficacy of BGB-A1217 combined with tislelizumab and tislelizumab monotherapy as measured by OS •To evaluate Health Related Quality of Life (HRQoL) via cancer-specific patient-reported outcomes (PROs) in patients treated with BGB-A1217 combined with tislelizumab and tislelizumab monotherapy •To evaluate the safety and tolerability of BGB-A1217 combined with tislelizumab and tislelizumab monotherapy •To characterize the PK of BGB-A1217 and tislelizumab •To assess host immunogenicity to BGB-A1217 and tislelizumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult patients (≥ 18 years of age or the legal age of consent, at the time of voluntarily signing of informed consent) with histologically or cytologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix and who had progression on or after one or more lines of chemotherapy for management of recurrent or metastatic disease and are not amenable to curative treatment are eligible. Patients must submit qualified archival tumor tissue with an associated pathology report or agree to a tumor biopsy for determination of PD-L1 expression and other biomarker analyses. Patients must have an ECOG PS of ≤ 1 and life expectancy ≥ 12 weeks with adequate organ functions. Patients must have ≥ 1 measurable lesion as defined per RECIST v1.1. |
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E.4 | Principal exclusion criteria |
Patients who have received 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 are excluded. |
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E.5 End points |
E.5.1 | Primary end point(s) |
ORR, defined as the proportion of patients who had complete response (CR) or partial response (PR) assessed by IRC per RECIST v1.1 for Cohort 1 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• ORR, defined as above assessed by investigator’s review per RECIST v1.1 for Cohort 1 • ORR, defined as above assessed by both IRC and investigator’s review per RECIST v1.1 for Cohort 2 • DOR, defined as the time from the first confirmed objective response until the first documentation of progression or death, whichever comes first, assessed by both IRC and investigator’s review according to RECIST v1.1 for Cohorts 1 and 2 • Other efficacy endpoints (PFS, TTR, DCR, and CBR) that need tumor assessments by both IRC and investigator’s review per RECIST v1.1 for Cohorts 1 and 2 - PFS, 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 occurs first - TTR, defined as the time from the date of first dose of study drug to first documentation of response - DCR, defined as the proportion of patients who achieve CR, PR, or stable disease (SD) - CBR, defined as the proportion of patients who achieve CR, PR, or durable SD (SD ≥ 24 weeks) • OS, defined as the time from the date of first dose of study drug until the date of death from any cause for Cohorts 1 and 2 • HRQoL, defined as assessment of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module (EORTC QLQ-CX24) for Cohorts 1 and 2 • Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (as graded by National Cancer Institute – Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0), timing, seriousness, and relationship to study drugs, physical examinations, electrocardiograms (ECGs), and laboratory assessments for Cohorts 1 and 2 • Serum BGB-A1217 and tislelizumab concentrations at specified timepoints • Immunogenic responses to BGB-A1217 and tislelizumab, evaluated through the detection of antidrug antibodies (ADAs) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Information not present in EudraCT |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
China |
Korea, Republic of |
Taiwan |
Thailand |
Poland |
Bulgaria |
Russian Federation |
Ukraine |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is defined as the timepoint when the final data point is collected from the last patient in the study. This is when the last patient dies, withdraws consent, completes all study assessments, or is lost to follow-up. Alternatively, the end of study is when the sponsor decides to terminate the study.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |