Study of Tislelizumab and/or Pamiparib Containing Treatments in Participants With Advanced Malignancies
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ClinicalTrials.gov Identifier: NCT04164199 |
Recruitment Status :
Enrolling by invitation
First Posted : November 15, 2019
Last Update Posted : March 8, 2022
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Condition or disease | Intervention/treatment | Phase |
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Advanced Malignancies | Drug: Tislelizumab 200 mg, IV Drug: Pamiparib 20, 40, 60 mg PO Twice Daily (BID) 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) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label, Multicentre, Long-Term Extension Study of Tislelizumab- Containing Treatment and/or Pamiparib-Containing Treatment in Patients With Advanced Malignancies |
Actual Study Start Date : | December 19, 2019 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
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Experimental: Tislelizumab monotherapy |
Drug: Tislelizumab 200 mg, IV
Day 1 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. |
Experimental: Pamiparib Monotherapy |
Drug: Pamiparib 20, 40, 60 mg PO Twice Daily (BID)
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. |
Experimental: Tislelizumab and Pamiparib Combination Therapy |
Drug: Tislelizumab 200 mg, IV
Day 1 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. |
Experimental: Tislelizumab and Pemetrexed Combination Therapy |
Drug: Tislelizumab 200 mg, IV
Day 1 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. Drug: Pemetrexed 500 mg/m² IV 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. |
Experimental: Tislelizumab and Capecitabine Combination Therapy |
Drug: Tislelizumab 200 mg, IV
Day 1 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. Drug: Capecitabine 1000 mg/m² PO BID 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. |
Experimental: Experimental: Pamiparib and temozolomide |
Drug: Pamiparib 20, 40, 60 mg PO Twice Daily (BID)
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. Drug: Temozolomide 120, 80, 40 or 20 mg PO Once Daily (QD) 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. |
- Incidence of all adverse events [ Time Frame: up to 5 years ]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.
- Overall survival [ Time Frame: up to 5 years ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Currently participating in a BeiGene-sponsored eligible parent study
- Fulfills treatment criteria specified in the parent study protocol
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In the opinion of the investigator, the participant will continue to benefit from tislelizumab and/or 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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164199

Study Director: | Andong Nkobena, Pharm. D. | BeiGene |
Responsible Party: | BeiGene |
ClinicalTrials.gov Identifier: | NCT04164199 |
Other Study ID Numbers: |
BGB-A317-290-LTE1 2019-002554-23 ( EudraCT Number ) |
First Posted: | November 15, 2019 Key Record Dates |
Last Update Posted: | March 8, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms Capecitabine Pemetrexed Temozolomide Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Alkylating Alkylating Agents |