Study of Tislelizumab and/or Pamiparib Containing Treatments in Participants With Advanced Malignancies

Study Overview
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Brief Summary
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This is an open-label, multicenter, extension study to evaluate the long-term safety of tislelizumab or pamiparib given either as monotherapy or in combination with each other or with other agents in participants with advanced malignancies who participated in a prior BeiGene sponsored clinical study (parent study).

Detailed Description
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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 tislelizumab or pamiparib treatment or both (with or without other treatments).

Official Title
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An Open Label, Multicentre, Long-Term Extension Study of Tislelizumab- Containing Treatment and/or Pamiparib-Containing Treatment in Patients With Advanced Malignancies

Conditions
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Advanced Malignancies

Intervention / Treatment
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* Drug: Tislelizumab
* Drug: Pamiparib
* Drug: Pemetrexed 500 mg/m² IV
* Drug: Capecitabine 1000 mg/m² PO BID
* Drug: Temozolomide 120, 80, 40 or 20 mg PO Once Daily (QD)
* Drug: Sitravatinib
* Drug: Ociperlimab
* Drug: BAT1706
* Drug: Fruquintinib


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 tislelizumab and pamiparib treatment as monotherapy or in combination. Note: For patients with GBM, continuation on single agent pamiparib or single agent temozolomide will not be permitted. Note: For patients with solid tumors (other than GBM), receiving single agent pamiparib is allowed if deemed clinically appropriate by the investigator. Continued treatment with single agent temozolomide will not be permitted. The first dose of study treatment in the LTE study will be received within the treatment interruption period allowed by the parent study: For tislelizumab monotherapy or in combination with chemotherapies, the interruption period is no more than 12 weeks For pamiparib monotherapy, interruption period is no more than 21 consecutive days due to toxicities other than anaemia and no more than 56 consecutive days for investigational drug-related anaemia For pamiparib in combination with tislelizumab, the interruption period is no more than 21 consecutive days for pamiparib and no more than 42 consecutive days for tislelizumab For pamiparib in combination with low dose temozolomide, the interruption period is no more than 28 consecutive days due to toxicities other than anaemia and no more than 56 consecutive days for investigational drug-related anaemia If the interruption period is beyond the period allowed by the parent study, the acceptable length of interruption will depend on an agreement between the investigator and the medical monitor of the LTE study Specific Inclusion Criteria for Participants Who Continue Survival Follow-up Only in the Extension Study: Signed informed consent obtained prior to enrolling in this LTE study Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion following tislelizumab-containing therapy Key Exclusion Criteria: Permanently discontinued from either tislelizumab and/or pamiparib treatment in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent. Participants who were treated with pamiparib or tislelizumab in combination with other agents and are still receiving pamiparib or tislelizumab but have discontinued the other agent(s) are eligible with the exception of patients with GBM receiving the combination of pamiparib and low-dose temozolomide 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 tislelizumab or pamiparib, 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tislelizumab monotherapy<br> | Drug: Tislelizumab<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>|
| Experimental: Pamiparib Monotherapy<br> | Drug: Pamiparib<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>|
| Experimental: Tislelizumab and Pamiparib Combination Therapy<br> | Drug: Tislelizumab<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>Drug: Pamiparib<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>|
| Experimental: Tislelizumab and Pemetrexed Combination Therapy<br> | Drug: Tislelizumab<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>Drug: Pemetrexed 500 mg/m² IV<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>|
| Experimental: Tislelizumab and Capecitabine Combination Therapy<br> | Drug: Tislelizumab<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>Drug: Capecitabine 1000 mg/m² PO BID<br>* Day 1 to Day 15 of each 21 day cycle, to be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>|
| Experimental: Pamiparib and temozolomide Combination Therapy<br> | Drug: Pamiparib<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>Drug: Temozolomide 120, 80, 40 or 20 mg PO Once Daily (QD)<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>|
| Experimental: Sitravatinib Monotherapy<br> | Drug: Sitravatinib<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>|
| Experimental: Tislelizumab and Sitravatinib Combination Therapy<br> | Drug: Tislelizumab<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>Drug: Sitravatinib<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>|
| Experimental: Tislelizumab and Ociperlimab Combination Therapy<br> | Drug: Tislelizumab<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>Drug: Ociperlimab<br>* Participants will receive tislelizumab followed by the administration of ociperlimab on Day 1 of each 21-day cycle (ie, once every 3 weeks)<br>|
| Experimental: Tislelizumab and BAT1706 Combination Therapy<br> | Drug: Tislelizumab<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>Drug: BAT1706<br>* Participants will receive tislelizumab followed by the administration of BAT1706 on Day 1 of each 21-day cycle (ie, once every 3 weeks). If applicable, ociperlimab will be administered after completion of the BAT1706 infusion<br>|
| Experimental: Tislelizumab and Fruquintinib Combination Therapy<br> | Drug: Tislelizumab<br>* To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.<br>Drug: Fruquintinib<br>* Fruquintinib will be self-administered orally once daily for 21 days, followed by 7 days off in 28-day cycles with or without food.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all adverse events | Safety as assessed by incidence of all adverse events of special interest, Grade 3, 4, or 5 adverse events, Grade 2 adverse events that affect vital organs (eg, heart, liver), nonserious adverse events that lead to dose modification or drug discontinuation or withdrawal from the trial, and serious adverse events of any severity. | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival defined as the time from start of treatment in parent study (or randomization date for a randomized study) until the date of death from any cause. | up to 5 years |