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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

Tracking Information
First Submitted Date  ICMJE November 14, 2019
First Posted Date  ICMJE November 15, 2019
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE December 19, 2019
Estimated Primary Completion Date December 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tislelizumab and/or Pamiparib Containing Treatments in Participants With Advanced Malignancies
Official Title  ICMJE An Open Label, Multicentre, Long-Term Extension Study of Tislelizumab- Containing Treatment and/or Pamiparib-Containing Treatment in Patients With Advanced Malignancies
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).
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Malignancies
Intervention  ICMJE
  • 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: 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: 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Tislelizumab monotherapy
    Intervention: Drug: Tislelizumab 200 mg, IV
  • Experimental: Pamiparib Monotherapy
    Intervention: Drug: Pamiparib 20, 40, 60 mg PO Twice Daily (BID)
  • Experimental: Tislelizumab and Pamiparib Combination Therapy
    Intervention: Drug: Tislelizumab 200 mg, IV
  • Experimental: Tislelizumab and Pemetrexed Combination Therapy
    Interventions:
    • Drug: Tislelizumab 200 mg, IV
    • Drug: Pemetrexed 500 mg/m² IV
  • Experimental: Tislelizumab and Capecitabine Combination Therapy
    Interventions:
    • Drug: Tislelizumab 200 mg, IV
    • Drug: Capecitabine 1000 mg/m² PO BID
  • Experimental: Experimental: Pamiparib and temozolomide
    Interventions:
    • Drug: Pamiparib 20, 40, 60 mg PO Twice Daily (BID)
    • Drug: Temozolomide 120, 80, 40 or 20 mg PO Once Daily (QD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 14, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 16, 2021
Estimated Primary Completion Date December 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   China,   New Zealand,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04164199
Other Study ID Numbers  ICMJE BGB-A317-290-LTE1
2019-002554-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andong Nkobena, Pharm. D. BeiGene
PRS Account BeiGene
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP