E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
solid tumors and hematological malignancies |
tumori solidi e neoplasie ematologiche |
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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 |
tumori cancerosi che non contengono alcun liquido o cisti e tumori nel tessuto che forma il sangue o nel sistema immunitario |
|
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 |
Valutare la sicurezza a lungo termine di tislelizumab e pamiparib somministrati in monoterapia o in combinazione tra loro o con altri agenti in pazienti con tumori maligni in stadio avanzato |
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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 |
Valutare l’efficacia di tislelizumab e pamiparib somministrati in monoterapia o in combinazione tra loro o con altri agenti monitorando la sopravvivenza complessiva dei pazienti |
|
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 Followup 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 |
1. Attuale partecipazione a uno studio originario idoneo sponsorizzato da BeiGene 2. Soddisfacimento dei criteri di trattamento specificati nel protocollo dello studio originario 3. In base al giudizio dello sperimentatore, il paziente continuerà a trarre beneficio dal trattamento con tislelizumab e/o pamiparib 4. La prima dose del trattamento in studio nello studio di estensione sarà somministrata entro il periodo di interruzione del trattamento consentito dallo studio originario: a. Per tislelizumab in monoterapia o in combinazione con chemioterapici, il periodo di interruzione non supera 12 settimane b. Per pamiparib in monoterapia, il periodo di interruzione non supera 21 giorni consecutivi in caso di tossicità diverse da anemia e non 56 giorni consecutivi in caso di anemia correlata al farmaco sperimentale c. Per pamiparib in combinazione con tislelizumab, il periodo di interruzione non supera 21 giorni consecutivi per pamiparib e 42 giorni consecutivi per tislelizumab d. Se il periodo di interruzione è superiore al periodo consentito dallo studio originario, la durata accettabile dell’interruzione dipenderà da un accordo tra lo sperimentatore e il monitor medico dello studio di estensione
Criteri specifici per i pazienti che continuano il follow-up di sopravvivenza solo nello studio di estensione: 1. Acquisizione del consenso informato firmato prima dell’arruolamento in questo studio di estensione a lungo termine 2. Attuale partecipazione a uno studio originario idoneo sponsorizzato da BeiGene nella porzione di follow-up di sopravvivenza dopo la terapia contenente tislelizumab |
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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 |
1. Interruzione permanente del trattamento con tislelizumab e/o pamiparib nello studio originario a causa di tossicità inaccettabile, mancata aderenza alle procedure dello studio o ritiro del consenso. I pazienti che sono stati trattati con pamiparib o tislelizumab in combinazione con altri agenti e stanno ancora ricevendo pamiparib o tislelizumab avendo però interrotto l’assunzione dell’altro/degli altri agente/i sono idonei 2. Attuale infezione sistemica attiva non controllata o recente infezione che richieda una terapia antimicrobica per via parenterale. 3. Presenza di una malattia, condizione medica o disfunzione di organo pericolosa per la vita che, a giudizio dello sperimentatore, potrebbe compromettere la sicurezza del paziente, interferire con l’assorbimento o il metabolismo di tislelizumab or pamiparib o esporre gli esiti dello studio a un rischio eccessivo 4. Precedente trattamento con qualsiasi terapia antitumorale sistemica durante il periodo di tempo compreso tra l’ultimo trattamento nello studio originario e la prima dose del trattamento in studio nello studio di estensione 5. Donne in stato di gravidanza o allattamento al seno |
|
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. |
Sicurezza valutata in base all’incidenza di eventi avversi di interesse speciale, eventi avversi di grado 3, 4 o 5, eventi avversi di grado 2 che interessano organi vitali (ad es., cuore, fegato), eventi avversi non seri che comportano una modifica della dose, interruzione del farmaco o ritiro dalla sperimentazione, ed eventi avversi seri di qualsiasi gravità. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
up to 5 years |
fino a 5 anni |
|
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. |
• Sopravvivenza complessiva definita come l’intervallo di tempo intercorso tra l’inizio del trattamento nello studio originario (o la data della randomizzazione per uno studio randomizzato) e la data del decesso per qualsiasi causa. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
up to 5 years |
fino a 5 anni |
|
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 | No |
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 | 3 |
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 | Information not present in EudraCT |
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 |
|
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
|
|
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 |