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New treatment option for MSI-H/dMMR Solid Tumors
Official title Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
ClinicalTrials.gov ID: NCT03736889
What this study is testing
What is Tislelizumab (BGB-A317)?
Tislelizumab (BGB-A317) is an investigational medicine, being studied as a potential treatment for msi-h/dmmr solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
You likely can't join if
- 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...
- 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
- Any active malignancy
- Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive...
See the full eligibility criteria
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function Key
- 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
- Any active malignancy
- Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug
- Having a history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, or uncontrolled systemic diseases (including but not limited to diabetes, hypertension, etc.)
- Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management
- Having severe chronic or active infections
- A known history of human immunodeficiency virus infection
- Child - Pugh B or greater cirrhosis
- Any major surgical procedure ≤ 28 days before the first dose of study drug
- Prior allogeneic stem cell transplantation or organ transplantation NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Huizhou, Guangdong, China
- Meizhou, Guangdong, China
- Hechi, Guangxi, China
- Baoding, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Weifang, Shandong, China
- Shanghai, Shanghai Municipality, China
- Yibin, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Huizhou, Guangdong, China and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.