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 tislelizumab and pamiparib given as monotherapy or in combination with each other or with other agents in patients with advanced malignancies |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of tislelizumab and pamiparib given as monotherapy or in combination with each other or other agents 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 tislelizumab and/or pamiparib treatment 4. The first dose of study treatment in the extension study will be received within the treatment interruption period allowed by the parent study: a. For tislelizumab monotherapy or in combination with chemotherapies, interruption period is no more than 12 weeks b. For pamiparib monotherapy, interruption period is no more than 21 consecutive days due to toxicities other than anemia and no more than 56 consecutive days for investigational drug-related anemia c. For pamiparib in combination with tislelizumab, interruption period is no more than 21 consecutive days for pamiparib and no more than 42 consecutive days for tislelizumab d. If the interruption period is beyond the period allowed by the parent study, the acceptable length of interruption will depend on an agreement between the investigator and the medical monitor of the extension study
Specific Inclusion Criteria for Participants Who Continue Survival Follow-up Only in the Extension Study: 1. Signed informed consent obtained prior to enrolling in this long-term extension study 2. Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion following tislelizumab-containing therapy |
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E.4 | Principal exclusion criteria |
1. Permanently discontinued from either tislelizumab and/or pamiparib treatment in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent. Participants who were treated with pamiparib or tislelizumab in combination with other agents and are still receiving pamiparib or tislelizumab but have discontinued the other agent(s) are eligible 2. Have uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy prior to the start of the extension study 3. Have a life-threatening illness, medical condition, or organ system dysfunction that in the investigator’s opinion, could compromise the participant’s safety, interfere with the absorption or metabolism of tislelizumab or pamiparib, 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 extension study 5. Pregnant or lactating women |
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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 | 5 |
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 | 6 |
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 |
France |
Italy |
New Zealand |
Spain |
Taiwan |
United States |
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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 |