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Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors

ConditionMSI-H/dMMR Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeiGene

About this trial

In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) will be treated with anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Having histological confirmed diagnosis of malignancy

Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR

Having received prior cancer therapy regimen(s) for advanced disease.

At least 1 measurable lesion as defined per RECIST Version (v) 1.1

Disqualifiers

Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Active leptomeningeal disease or uncontrolled brain metastasis.

Clinically significant pleural effusion, pericardial effusion or ascites

Active autoimmune diseases or history of autoimmune diseases that may relapse

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab (BGB-A317)

    Drug

    Anti-PD-1 Antibody

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Tislelizumab (BGB-A317) InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1

Time frame
Up to 2 years

Secondary outcomes

1

Duration of response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

Time frame
Up to 2 years
2

Time to response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

Time frame
Up to 2 years
3

Progression-free survival assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

Time frame
Up to 2 years
4

Disease control rate assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeiGene

Lead sponsor

Source ClinicalTrials.gov
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