ClinicalTrials.gov

History of Changes for Study: NCT04164199
Study of Tislelizumab and/or Pamiparib Containing Treatments in Patients With Advanced Malignancies
Latest version (submitted March 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 14, 2019 None (earliest Version on record)
2 December 3, 2019 Oversight and Study Status
3 December 20, 2019 Recruitment Status, Study Status, Arms and Interventions, Contacts/Locations, Eligibility, Study Description and Study Identification
4 February 7, 2020 Study Status and Contacts/Locations
5 February 25, 2020 Contacts/Locations and Study Status
6 March 23, 2020 Study Status and Contacts/Locations
7 April 27, 2020 Study Status
8 June 10, 2020 Study Status and Contacts/Locations
9 June 18, 2020 Study Status
10 June 24, 2020 Study Status
11 July 21, 2020 Contacts/Locations, Study Description and Study Status
12 August 3, 2020 Study Status
13 August 12, 2020 Study Status
14 August 19, 2020 Study Status
15 August 24, 2020 Study Status
16 September 16, 2020 Contacts/Locations, Arms and Interventions, Study Status and Eligibility
17 October 21, 2020 Study Status
18 October 21, 2020 Contacts/Locations and Study Status
19 March 4, 2021 Study Status and Contacts/Locations
20 June 8, 2021 Study Status
21 June 16, 2021 Study Status
22 March 4, 2022 Study Status
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Study NCT04164199
Submitted Date:  November 14, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: BGB-A317-290-LTE1
Brief Title: Study of Tislelizumab and/or Pamiparib Containing Treatments in Patients With Advanced Malignancies
Official Title: An Open Label, Multicentre, Long-Term Extension Study of Tislelizumab- Containing Treatment and/or Pamiparib-Containing Treatment in Patients With Advanced Malignancies
Secondary IDs: 2019-002554-23 [EudraCT Number]
Open or close this module Study Status
Record Verification: November 2019
Overall Status: Not yet recruiting
Study Start: December 16, 2019
Primary Completion: December 16, 2024 [Anticipated]
Study Completion: December 16, 2024 [Anticipated]
First Submitted: November 14, 2019
First Submitted that
Met QC Criteria:
November 14, 2019
First Posted: November 15, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
November 14, 2019
Last Update Posted: November 15, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BeiGene
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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 patients with advanced malignancies who participated in a prior BeiGene sponsored clinical study (parent study). 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 patient was initially enrolled and received tislelizumab or pamiparib treatment or both (with or without other treatments).
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Malignancies
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 5
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 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.
Drug: Pamiparib 20 or 40 mg PO 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 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.
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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 patient will continue to benefit from tislelizumab and/or pamiparib treatment
  4. The first dose of study treatment in the extension study will be received within the treatment interruption period allowed by the parent study:
    1. For tislelizumab monotherapy or in combination with chemotherapies, 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 anemia and no more than 56 consecutive days for investigational drug-related anemia
    3. For pamiparib in combination with tislelizumab, interruption period is no more than 21 consecutive days for pamiparib and no more than 42 consecutive days for tislelizumab
    4. 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 extension study

Specific Inclusion Criteria for Patients Who Continue Survival Follow-up Only in the Extension Study:

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

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. Patients 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
  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 patient'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 extension study
  5. Pregnant or lactating women

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Open or close this module Contacts/Locations
Central Contact Person: BeiGene
Telephone: +1-877-828-5568
Email: clinicaltrials@beigene.com
Study Officials: Jingxia Chen, MD
Study Director
BeiGene
Locations: Australia
Chris O'Brien Lifehouse
Camperdown, Australia, NSW 2050
Monash Health
Clayton, Australia, VIC 3168
Peter MacCallum Cancel Centre
East Melbourne, Australia
Prince of Wales Hospital
Randwick, Australia, NSW 2031
New Zealand
Auckland City Hospital
Auckland, New Zealand
Wellington Hospital
Newtown, New Zealand
Open or close this module IPDSharing
Plan to Share IPD: Yes
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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