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

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BeiGene

Status and phase

Invitation-only
Phase 3

Conditions

Advanced Malignancies

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04164199
2019-002554-23 (EudraCT Number)
BGB-A317-290-LTE1

Details and patient eligibility

About

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).

Full description

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).

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

300 participants in 11 patient groups

Tislelizumab monotherapy
Experimental group
Treatment:
Drug: Tislelizumab
Pamiparib Monotherapy
Experimental group
Treatment:
Drug: Pamiparib
Tislelizumab and Pamiparib Combination Therapy
Experimental group
Treatment:
Drug: Pamiparib
Drug: Tislelizumab
Tislelizumab and Pemetrexed Combination Therapy
Experimental group
Treatment:
Drug: Pemetrexed 500 mg/m² IV
Drug: Tislelizumab
Tislelizumab and Capecitabine Combination Therapy
Experimental group
Treatment:
Drug: Capecitabine 1000 mg/m² PO BID
Drug: Tislelizumab
Pamiparib and temozolomide Combination Therapy
Experimental group
Treatment:
Drug: Pamiparib
Drug: Temozolomide 120, 80, 40 or 20 mg PO Once Daily (QD)
Sitravatinib Monotherapy
Experimental group
Treatment:
Drug: Sitravatinib
Tislelizumab and Sitravatinib Combination Therapy
Experimental group
Treatment:
Drug: Tislelizumab
Drug: Sitravatinib
Tislelizumab and Ociperlimab Combination Therapy
Experimental group
Treatment:
Drug: Ociperlimab
Drug: Tislelizumab
Tislelizumab and BAT1706 Combination Therapy
Experimental group
Treatment:
Drug: BAT1706
Drug: Tislelizumab
Tislelizumab and Fruquintinib Combination Therapy
Experimental group
Treatment:
Drug: Fruquintinib
Drug: Tislelizumab

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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