E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
solid tumors and hematological malignancies |
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E.1.1.1 | Medical condition in easily understood language |
cancerous tumors not containing any liquid or cysts and cancer in the blood-forming tissue, or in the immune system |
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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 | 10065147 |
E.1.2 | Term | Malignant solid tumor |
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 | 10066481 |
E.1.2 | Term | Hematological malignancy |
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 long-term safety of BeiGene investigational drugs in patients with advanced malignancies. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of BeiGene investigational drugs by following patients for overall survival. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Currently participating in a BeiGene-sponsored eligible parent study 2. Fulfills treatment criteria specified in the parent study protocol 3. In the opinion of the investigator, the participant will continue to benefit from, and/or tolerate any of the parent study treatments 4. The first dose of study treatment in the LTE study will be received within the treatment interruption period allowed by the parent study. Details for treatment-specific requirements can be found in the relevant appendices, • The terms "treatment interruption" and "treatment break" are not interchangeable. Treatment interruption is an unplanned pause in study treatment (eg, due to adverse event). If the interruption is beyond the period allowed by the parent study, the acceptability of restarting study treatment will depend on an agreement between the investigator and the medical monitor of the LTE study • Treatment break is a planned stop of study therapy for a patient who has been treated for significant period of time and derived treatment benefits. For a patient who is on a treatment break with confirmed CR, PR, or SD after 2 years of tislelizumab containing treatment, and who has evidence of PD within 1 year of start of treatment break, the investigator can consider restarting the study treatment defined in parent study after discussion with the sponsor, contingent on the continued availability of study medications 5. Female patients of childbearing potential and female partners of nonsterile males must practice highly effective methods of birth control initiated before the first dose of study treatment, for the duration of the study, and after the last dose of study treatment. See Appendix I for contraception methods. More details on treatment-specific requirements can be found in the relevant appendices. 6. Male patients are eligible if abstinent or vasectomized or if they agree to use contraception for the duration of the study, and after the last dose of study treatment. See Appendix I for contraception methods. More details on treatment-specific requirements can be found in the relevant appendices. Nonsterile males receiving investigational drugs or other genotoxic chemotherapeutic treatment must avoid sperm donation for the duration of the study and for at least 6 months after the last dose of study treatment. More details on treatment-specific requirements can be found in the relevant appendices. 7. A signed informed consent form obtained before enrolling in this LTE study and receiving study treatment
Specific Inclusion Criteria for Patients Who Continue Survival Follow-up Only in the LTE Study 1. A signed informed consent form obtained before enrolling in this LTE study 2. Currently participating in a BeiGene-sponsored eligible parent study in the survival follow up period. 3. Parent study plans to have survival analysis
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E.4 | Principal exclusion criteria |
Patients are not eligible to participate in this study if they meet any of the following exclusion criteria: 1. Permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent. 2. Have uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy 14 days before the planned first dose of treatment in the LTE study 3. Have a life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of investigational drugs or put the study outcomes at undue risk 4. Underwent treatment with any systemic anticancer treatment (other than treatment permitted in the parent study) during the time between the last treatment in the parent study and the first dose of study treatment in the LTE study 5. Pregnant or lactating women 6. Inability to comply with study procedures 7. Concurrent participation in another therapeutic clinical trial
Specific Exclusion Criteria for Patients Who Continue Survival Follow-up Only in the LTE Study There are no specific exclusion criteria for patients who continue survival follow-up only in the LTE study. Patients in the survival followup should not be transferred to the LTE if there is no plan for survival analysis in the parent study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety as assessed by incidence of all adverse events of special interest, Grade 3, 4, or 5 adverse events, Grade 2 adverse events that affect vital organs (eg, heart, liver), nonserious adverse events that lead to dose modification or drug discontinuation or withdrawal from the trial, and serious adverse events of any severity. |
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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) |
Overall survival defined as the time from the start of treatment in parent study (or randomization date for a randomized study) until the date of death from any cause. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 7 |
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 |
Australia |
Canada |
China |
New Zealand |
United States |
France |
Italy |
Poland |
Taiwan |
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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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |