BGB-A317-290-LTE1

JRCT ID: jRCT2031230161

Registered date:24/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced Malignancies
• Date of first enrollment: 28/12/2022
• Target sample size: 2
• Countries of recruitment: Australia,Japan,New Zealand,Japan,China,Japan,Taiwan,Japan,Italy,Japan,France,Japan,Canada,Japan,USA,Japan,UK,Japan,Spain,Japan,Switzerland,Japan,Netherlands,Japan,Korea,Japan
• Study type: Other

Outcome(s)

Primary Outcome

To evaluate the long-term safety of BeiGene investigational drugs in patients with advanced
malignancies

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable

Include 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 patient 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 J 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 J for contraception methods. Nonsterile males receiving investigational drugs or other genotoxic chemotherapeutic treatment must avoid sperm donation for the duration of the study and 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

Exclude 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

Related Information

• Primary Sponsor: IQVIA Services Japan G.K. jRCT Inquiry Contact