Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced … (NCT04164199) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies
United States, Australia404 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 range18 Years
SexALL
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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
✕. 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
What they're measuring
1
Number of Participants with Immune-Mediated Adverse Events, Serious Adverse Events, and Adverse Events Grade 3 or Higher