Study of Tislelizumab and/or Pamiparib Containing Treatments in Participants With Advanced Malignancies
EU CTIS ID: 2023-508883-31-00
What this study is testing
To evaluate the long-term safety of BeiGene investigational drugs in patients with advanced malignancies
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Currently participating in a BeiGene-sponsored eligible parent study
- Fulfills treatment criteria specified in the parent study protocol
- In the opinion of the investigator, the patient will continue to benefit from and tolerate any of the parent study treatments
- 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
- 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 L for contraception methods. More details on treatment-specific requirements can be found in the relevant appendices.
- 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 L 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 treatmentspecific requirements can be found in the relevant appendices.
You likely can't join if
- Permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent.
- 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
- 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
- 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
- Pregnant or lactating women
- Inability to comply with study procedures
See the full eligibility criteria
- Currently participating in a BeiGene-sponsored eligible parent study
- Fulfills treatment criteria specified in the parent study protocol
- In the opinion of the investigator, the patient will continue to benefit from and tolerate any of the parent study treatments
- 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
- 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 L for contraception methods. More details on treatment-specific requirements can be found in the relevant appendices.
- 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 L 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 treatmentspecific requirements can be found in the relevant appendices.
- A signed informed consent form obtained before enrolling in this LTE study and receiving study treatment
- Permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent.
- 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
- 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
- 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
- Pregnant or lactating women
- Inability to comply with study procedures
- Concurrent participation in another therapeutic clinical trial
- Are participating in the follow-up phase in a parent study for which there is no planned survival analysis
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Taiwan
- Japan
- Turkey
- Korea, Republic of
- New Zealand
- China
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Taiwan; Japan; Turkey; Korea, Republic of; New Zealand and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.