Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04164199

Patient View

This open-label, multicenter extension study evaluates the long-term safety and efficacy of BeiGene investigational drugs in participants from a prior BeiGene-sponsored study. Eligible participants must meet treatment criteria and benefit from ongoing treatment. Interventions include intravenous and oral administration of drugs like Tislelizumab, Pamiparib, and others.

Patient Parameters

Program Overview

This is an open-label, multicenter, extension study to evaluate the long-term safety and efficacy of BeiGene investigational drugs in participants with advanced malignancies who participated in a prior BeiGene-sponsored clinical study (parent study).

Description

For the purposes of this study, "study treatment" will refer to all investigational agents. A parent study is defined as the original BeiGene-sponsored clinical trial in which the participant was initially enrolled and received BeiGene investigational drugs (with or without other treatments).

Eligibility Criteria

Inclusion 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 participant will continue to benefit from and 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:

    1. "Treatment interruption" (unplanned pause in study treatment) and "treatment break" (planned stop of study therapy) are not interchangeable. Restarting study treatment beyond the interruption period allowed by the parent study or after a treatment break will be determined by the investigator and the sponsor. Participants who have not restarted treatment within 1 year of starting a treatment break must discontinue treatment.

Specific Inclusion Criteria for Participants Who Continue Survival Follow-up Only in the Extension Study:

  1. Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion
  2. Parent study plans to have survival analysis

Key

Exclusion 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 prior to the start of the extension study
  3. Have a life-threatening illness, 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
  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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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