Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced … (NCT04164199) | Clinical Trial Compass
CompletedPhase 3
Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies
United States, Australia, China404 participantsStarted 2019-12-19
Plain-language summary
This is an open-label, multicenter, extension study to evaluate the long-term safety and efficacy of BeiGene or BeOne investigational drugs in participants with advanced malignancies who participated in a prior BeiGene- or BeOne-sponsored clinical study (parent study).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Currently participating in a BeiGene- or BeOne-sponsored eligible parent study
. Fulfills treatment criteria specified in the parent study protocol
. In the opinion of the investigator, the participant 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:
. "Treatment interruption" is an unplanned pause in study treatment (eg, due to adverse event). Restarting study treatment beyond the interruption period allowed by the parent study will be determined by the investigator and the sponsor.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Immune-Mediated Adverse Events, Serious Adverse Events, and Adverse Events Grade 3 or Higher
. 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 prior to the start of the extension study
. Have a 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 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