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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 : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
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

Detailed Description:
For the purposes of this study, "study treatment" will refer to the investigational agents, tislelizumab and/or pamiparib. 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).

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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 16, 2021
Estimated Study Completion Date : December 16, 2021

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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 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.

  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. For tislelizumab monotherapy or in combination with chemotherapies, the interruption period is no more than 12 weeks
    2. 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
    3. 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
    4. 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
    5. 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:

  1. Signed informed consent obtained prior to enrolling in this LTE study
  2. Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion following tislelizumab-containing therapy

Key Exclusion Criteria:

  1. 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
  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 tislelizumab or pamiparib, 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.


Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Andong Nkobena, Pharm. D. BeiGene
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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: June 9, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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