Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies
- Registration Number
- NCT04164199
- Lead Sponsor
- BeiGene
- Brief Summary
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).
- 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-sponsored clinical trial in which the participant was initially enrolled and received BeiGene investigational drugs (with or without other treatments).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 430
-
Currently participating in a BeiGene-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" (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:
- Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion
- Parent study plans to have survival analysis
Key
- 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 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A - Tislelizumab Monotherapy Tislelizumab - F - Pamiparib and Temozolomide Combination Therapy Temozolomide - B - Pamiparib Monotherapy Pamiparib - C - Sitravatinib Monotherapy Sitravatinib - E - Zanidatamab Monotherapy Zanidatamab - F - Pamiparib and Temozolomide Combination Therapy Pamiparib - G - Tislelizumab and Pamiparib Combination Therapy Pamiparib - G - Tislelizumab and Pamiparib Combination Therapy Tislelizumab - I - Tislelizumab and Ociperlimab Combination Therapy Tislelizumab - J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy Tislelizumab - J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy BAT1706 - K - Tislelizumab and Fruquintinib Combination Therapy Tislelizumab - H - Tislelizumab and Sitravatinib Combination Therapy Tislelizumab - H - Tislelizumab and Sitravatinib Combination Therapy Sitravatinib - K - Tislelizumab and Fruquintinib Combination Therapy Fruquintinib - L - Tislelizumab and BGB-A445 Combination Therapy Tislelizumab - L - Tislelizumab and BGB-A445 Combination Therapy BGB-A445 - M - Tislelizumab and Surzebiclimab Combination Therapy Tislelizumab - N - Tislelizumab and BGB-15025 Combination Therapy Tislelizumab - O - Tislelizumab and Lenvatinib Combination Therapy Lenvatinib - Q - Tislelizumab and LBL-007 Combination Therapy Tislelizumab - M - Tislelizumab and Surzebiclimab Combination Therapy Surzebiclimab - O - Tislelizumab and Lenvatinib Combination Therapy Tislelizumab - P - Tislelizumab and Zanidatamab Combination Therapy Tislelizumab - P - Tislelizumab and Zanidatamab Combination Therapy Zanidatamab - R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy Tislelizumab - R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy Surzebiclimab - N - Tislelizumab and BGB-15025 Combination Therapy BGB-15025 - Q - Tislelizumab and LBL-007 Combination Therapy LBL-007 - R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy LBL-007 - I - Tislelizumab and Ociperlimab Combination Therapy Ociperlimab - D - BGB-15025 Monotherapy BGB-15025 -
- Primary Outcome Measures
Name Time Method Number of Participants with Immune-Mediated Adverse Events up to 7 years Safety as assessed by the number of participants with immune-mediated adverse events related to immunotherapy as assessed by the investigator, \> Grade 3 adverse events, Grade 2 adverse events that affect key organs (eg, heart, liver, brain, lung, kidney, eye), nonserious adverse events that lead to dose modification or drug discontinuation or withdrawal from the trial, and serious adverse events.
- Secondary Outcome Measures
Name Time Method Overall survival up to 7 years Overall survival defined as the time from start of treatment in the parent study (or randomization date for a randomized parent study) until the date of death from any cause.
Trial Locations
- Locations (106)
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Memorial Sloan Kettering Cancer Center Mskcc
🇺🇸New York, New York, United States
Tennessee Oncology, Pllc Nashville
🇺🇸Nashville, Tennessee, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Northern Cancer Institute
🇦🇺St Leonards, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
Icon Cancer Centre South Brisbane
🇦🇺South Brisbane, Queensland, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Scroll for more (96 remaining)Mount Sinai Comprehensive Cancer Center🇺🇸Miami Beach, Florida, United States