Advanced Malignancies
Conditions
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.
Interventions
DRUGTislelizumab
Administered intravenously.
DRUGPamiparib
Administered orally.
DRUGTemozolomide
Administered orally.
DRUGSitravatinib
Administered orally.
DRUGOciperlimab
Administered intravenously.
DRUGBAT1706
Administered intravenously.
DRUGFruquintinib
Administered orally.
DRUGBGB-15025
Administered orally.
DRUGZanidatamab
Administered intravenously.
DRUGBGB-A445
Administered intravenously.
DRUGSurzebiclimab
Administered intravenously.
DRUGLenvatinib
Administered orally.
DRUGLBL-007
Administered intravenously.
Sponsors
BeOne Medicines
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Currently participating in a BeiGene- or BeOne-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" 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. 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 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Immune-Mediated Adverse Events, Serious Adverse Events, and Adverse Events Grade 3 or Higher | up to 7 years | Safety as assessed by the number of participants with immune-mediated adverse events (imAEs), ≥ Grade 3 adverse events, and serious adverse events. |
Countries
Australia, China, France, Italy, Japan, Malaysia, New Zealand, Poland, South Korea, Taiwan, Thailand, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed