Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies

BeiGene

Status and phase: Invitation-only; Phase 3

Conditions: Advanced Malignancies

Treatments: Drug: Fruquintinib; Drug: Tislelizumab; Drug: Ociperlimab; Drug: LBL-007; Drug: Pamiparib; Drug: Surzebiclimab; Drug: BGB-15025; Drug: Lenvatinib; Drug: Sitravatinib; Drug: BAT1706; Drug: Zanidatamab; Drug: Temozolomide; Drug: BGB-A445

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 and efficacy of BeiGene investigational drugs 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 BeiGene investigational drugs (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:

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 and tolerate any of the parent study treatments.

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. "Treatment interruption" (unplanned pause in study treatment) and "treatment break" (planned stop of study therapy) are not interchangeable. Restarting study treatment beyond the interruption period allowed by the parent study or after a treatment break will be determined by the investigator and the sponsor. Participants who have not restarted treatment within 1 year of starting a treatment break must discontinue treatment.

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

1. Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion
2. Parent study plans to have survival analysis

Key Exclusion Criteria:

1. Permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent
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 investigational drugs, 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 18 patient groups

A - Tislelizumab Monotherapy

Experimental group

Treatment:

Drug: Tislelizumab

B - Pamiparib Monotherapy

Experimental group

Treatment:

Drug: Pamiparib

C - Sitravatinib Monotherapy

Experimental group

Treatment:

Drug: Sitravatinib

D - BGB-15025 Monotherapy

Experimental group

Treatment:

Drug: BGB-15025

E - Zanidatamab Monotherapy

Experimental group

Treatment:

Drug: Zanidatamab

F - Pamiparib and Temozolomide Combination Therapy

Experimental group

Treatment:

Drug: Temozolomide

Drug: Pamiparib

G - Tislelizumab and Pamiparib Combination Therapy

Experimental group

Treatment:

Drug: Pamiparib

Drug: Tislelizumab

H - Tislelizumab and Sitravatinib Combination Therapy

Experimental group

Treatment:

Drug: Sitravatinib

Drug: Tislelizumab

I - Tislelizumab and Ociperlimab Combination Therapy

Experimental group

Treatment:

Drug: Ociperlimab

Drug: Tislelizumab

J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy

Experimental group

Treatment:

Drug: BAT1706

Drug: Tislelizumab

K - Tislelizumab and Fruquintinib Combination Therapy

Experimental group

Treatment:

Drug: Tislelizumab

Drug: Fruquintinib

L - Tislelizumab and BGB-A445 Combination Therapy

Experimental group

Treatment:

Drug: BGB-A445

Drug: Tislelizumab

M - Tislelizumab and Surzebiclimab Combination Therapy

Experimental group

Treatment:

Drug: Surzebiclimab

Drug: Tislelizumab

N - Tislelizumab and BGB-15025 Combination Therapy

Experimental group

Treatment:

Drug: BGB-15025

Drug: Tislelizumab

O - Tislelizumab and Lenvatinib Combination Therapy

Experimental group

Treatment:

Drug: Lenvatinib

Drug: Tislelizumab

P - Tislelizumab and Zanidatamab Combination Therapy

Experimental group

Treatment:

Drug: Zanidatamab

Drug: Tislelizumab

Q - Tislelizumab and LBL-007 Combination Therapy

Experimental group

Treatment:

Drug: LBL-007

Drug: Tislelizumab

R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy

Experimental group

Treatment:

Drug: Surzebiclimab

Drug: LBL-007

Drug: Tislelizumab