An Open-Label, Multicenter, Long-Term Extension Study of Treatment With Tislelizumab, Pamiparib, and Other Investigational Agents in Patients With Advanced Malignancies

BeOne Medicines214 sites in 3 countries404 target enrollmentDecember 19, 2019

Overview

Phase: Phase 3
Intervention: Temozolomide
Conditions: Not specified
Sponsor: BeOne Medicines
Enrollment: 404
Locations: 214
Primary Endpoint: Number of Participants with Immune-Mediated Adverse Events, Serious Adverse Events, and Adverse Events Grade 3 or Higher
Status: Active, Not Recruiting
Last Updated: 18 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Detailed Description

For the purposes of this study, "study treatment" will refer to all investigational agents. A parent study is defined as the original BeiGene- or BeOne-sponsored clinical trial in which the participant was initially enrolled and received BeiGene or BeOne investigational drugs (with or without other treatments). Note: Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Registry

clinicaltrials.gov

Start Date

December 19, 2019

End Date

July 1, 2026

Last Updated

18 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

BeOne Medicines

Responsible Party

Sponsor

Eligibility Criteria

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
•Pregnant or lactating women
•NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.