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Urinary Bladder NeoplasmsPhase 1/2TACBIN-01NCT04922047

Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients (TACBIN-01)

A Phase 1/2 study testing tislelizumab and BCG in people with Urinary Bladder Neoplasms and Urologic Neoplasms, run by RenJi Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a single-arm, open-label, single-center study to assess the safety of tislelizumab with BCG, and to obtain the preliminary efficacy results in subjects who have been diagnosed with high-risk NMIBC without prior BCG treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
tislelizumab and BCG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
Jun 2021to Aug 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult man and women, 18-75 years old ECOG PS 0-1
  • Life expectancy ≥1year
  • Any high risk non muscle invasive urothelial carcinoma histologically confirmed defined on the TURBT within 6weeks as any of the following :
  • T1 tumor and/or
  • High grade (WHO 2004) and/or Grade 3 (WHO1973) and/or
  • Carcinoma in situ (CIS)
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  • Underwent TURBT to remove all resectable disease (residual CIS acceptable) within 6 weeks before recruitment and confirm absence of muscle invasion. The restagingTURBT is acceptable, but the interval between the two TURBTs is 2-6 weeks;
  • Absence of metastasis in pelvis, abdomen, or chest, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan no more than 3m prior to the first study treatment
  • BCG-naïve defined as：
  • Chemotherapy failure but BCG naïve: patients who have received at least six of eight induction doses of chemotherapy（including immediate single instillation）have a high risk of recurrence within 1 year; but have not received BCG perfusion in the bladder;
  • Treatment-naïve: patients who have not received prior intravesical chemotherapy or BCG, but who previously received but stopped chemotherapy or BCG more than 3 years before study entry are eligible
  • Adequate hematologic and organ function, as defined by the following laboratory results obtained within 14 days prior to the first dose:
  • white blood cell (WBC) counts ≥ 3.0× 109/L
  • absolute neutrophil count (ANC) ≥1.5 ×109/L
  • Platelet count ≥ 75 ×109/L
  • Hemoglobin ≥ 9.0 g/dL
  • Serum albumin ≥ 30g/L
  • aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase(ALP) ≤2.5 × the upper limit of normal (ULN)
  • Serum bilirubin ≤1.0 × ULN
  • Partial thromboplastin time (PTT)/Prothrombin Time (PT) ≤1.5 × ULN or international normalized ratio (INR) <1.7 × ULN
  • Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
  • Female participants of childbearing potential have a negative urine or serum pregnancy test before recruitment. Female or male must be willing to use an adequate method of contraception during the treatment period and for at least 5 months after the last dose of tislelizumab
  • Patient is willing and able to sign a written informed consent document and comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.

Who cannot join

  • Muscle-invasive, locally advanced non-resectable, or lymph node positive, or metastatic urothelial carcinoma; previous or accompanied by upper urinary tract urothelial carcinoma (UTUC)
  • There are pathological variants or non-urothelial cancer components in the very high risk of NMIBC
  • T1 high-grade (HG/G3) combined with urothelial carcinoma of the prostate urethra
  • Pathological tissue specimens with lymphovascular infiltration or special type of urothelial carcinoma after TURBT*
  • Special types of urothelial carcinoma: adenoid differentiation, squamous differentiation, neuroendocrine differentiation, plasma cell-like changes and micropapillary changes, etc.
  • Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
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  • The diagnosis of HR NMIBC was followed by induction intravesical chemotherapy, but immediate single instillation (within 24 hours after surgery) was allowed before the pathological results were not clear. The drugs include mitomycin, pirarubicin, doxorubicin, epirubicin, CHPT or gemcitabine;
  • Treatment with anti-cancer therapy including systemic immunostimulatory agents (including but not limited to INF, IL-2any), chemotherapy, radiation therapy, or hormonal therapy or any other investigational agent.
  • Any unresolved toxicity (CTCAE grade 2 or above) from previous anti-cancer therapy.
  • Active autoimmune disease that has required systemic treatment in the past 2 years, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease and so on.
  • Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before first dose. The use of inhaled or low-dose (e.g., ≤10 mg/day prednisone) corticosteroids is allowed.
  • Known HIV, active Hepatitis B or C infection or tuberculosis.
  • Infections ≥ 3 grade within 4 weeks, including but not limited to severe urinary tract infection, severe pneumonia, infectious complications, bacteremia intravenous antibiotic therapy or hospitalization patients receiving therapeutic oral or IV antibiotics within 1 weeks prior to the first dose are not eligible.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Allergy or hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the tislelizumab or BCG formulation
  • Prior allogeneic stem cell or solid organ transplant
  • Major surgical procedure other than for diagnosis within 4 weeks prior to the first dose or anticipation of need for a major surgical procedure during the study
  • Patients who have any of the following cardiac conditions:
  • Poorly controlled diabetes (after treatment with glycosylated hemoglobin [HbA1c]> 8%);
  • Poorly controlled High blood pressure evaluated by the investigator (blood pressure >160mmHg/100mmHg);
  • Cardiac insufficiency (including left ventricular ejection fraction [LVEF] <50%), myocardial infarction within the past 6 months, arrhythmia or unstable angina that cannot be well controlled by medication.
  • Pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease or clinically significant lung function test abnormalities; oother conditions that the treating physicians believe may endanger the health of the patients by their participation in this clinical trial.
  • Administration of a live, attenuated vaccine within 4 weeks prior to first dose, during treatment or within 8 weeks following the last dose of tislelizumab Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed.
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, in situ cervical cancer, prostate cancer without evidence of PSA progression or carcinoma in situ such as the following: gastric, prostate, cervix, colon, melanoma, or breast for example.
  • Have a mental illness, restricted or incapable of civil conduct, and a known history of psychotropic drug abuse. It may increase the risk of participating in the research, or interfere with the results of the research, and patients who the researcher believes are not suitable for participating in this research.

Trial locations and contacts

1 site in 1 country.

Ruiyun Zhang, MD, MSc contact

008613681687457

zhangruiyun4337@163.com

China1 site, 1 recruiting

  • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200127

    Ruiyun Zhang, MD, MSc, 008613681687457, zhangruiyun4337@163.com

    Wei Xue, MD, PHD

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy Study of Tislelizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Patients, a Prospective Open Single-site Trial（TACBIN-01）

This study is a single-arm, open-label, single-center study to assess the safety of tislelizumab with BCG, and to obtain the preliminary efficacy results in subjects who have been diagnosed with high-risk NMIBC without prior BCG treatment.

Read the detailed description

An estimated 130,000 new cases were diagnosed with bladder cancer in China each year. About 75-85% of them are NMIBC. The standard care for high risk (HR) NMIBC is intravesicular BCG instillation. Despite BCG treatment, 40% of patients will eventually experience a recurrence, which is associated with a poorer prognosis.

This is a single center Phase I safety and efficacy study of tislelizumab with BCG treatment. The study will determine the safety of administering tislelizumab at 200mg iv q3w in conjunction with intravesicular BCG treatment in HR NMIBC patients who was treatment-naïve or BCG naïve, but underwent TURBT to remove all resectable disease (residual CIS acceptable) within 6 weeks and confirm absence of muscle invasion.

BCG installation was the stander treatment for HR NMIBC. Despite BCG treatment, 40% of patients will eventually experience a recurrence, which is associated with a poorer prognosis. It was reported that BCG increased antigen expression and cytokine release from tumor cells, leading to immune cell (e.g. CD4+ and CD8+T cells, NK, macrophages) recruitment and immune-mediated cytotoxicity (indirect effect). PD-L1 expression intravesicular is found to be extremely abundant in the tumor tissue in patients failing BCG treatment. Which may inhibit the T cell to eliminate cancer cells. Based on these data, a combination of tislelizumab with BCG may be effective in preventing recurrence of NMIBC.

The 6 subjects will be treated at a dose of 200 mg tislelizumab with 120 mg BCG to explode safety for the combination though observing DLT within 28days. If no safety issues are present, we will carry out multi-cohort Phase II study（TACBIN-02）

Being tested
tislelizumab and BCG
Keywords
bladder carcinoma, BCG, PD-1
Medical subject headings
Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Urinary Bladder Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tislelizumab and BCGDrug

    Tislelizumab 200 mg administered by intravenous infusion every 3 weeks in first year and continue to second year based on physician choose. BCG 120 mg induction therapy administered via intravesical instillation (once weekly for 6 weeks). BCG induction therapy is followed by maintenance therapy (once weekly for 3 weeks at months 3, 6, 12, 18, 24m).

Study groups in NCT04922047
Study groupRoleWhat they receive
Experimental: Intravenous tislelizumab / Intravesical BCGExperimentalDrug: tislelizumab / BCG Tislelizumab 200 mg administered by intravenous infusion every 3 weeks in first year and continue to second year based on physician choose. BCG 120 mg induction therapy administered via intravesical instillation (once weekly for 6 weeks). BCG induction therapy is followed by maintenance therapy (once weekly for 3 weeks at months 3, 6, 12, 18, 24m). Other Name: BGB-A317
Receives: Drug: tislelizumab and BCG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    Safety

    Measured: 28 days of single infusion

Secondary outcomes (3)

  1. Event Free Survival (EFS) rate at 24 months

    efficacy

    Measured: approximately 24 months

  2. Progression free survival (PFS) rate at 36 months

    efficacy

    Measured: approximately 36 months

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Safety

    Measured: approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study startJun 2021 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04922047
Sponsor's protocol ID
KY2021-041
Other IDs
BGB-A317-2002-IIT
Acronym
TACBIN-01
Status last verified
Jun 2021
First submitted
6 Jun 2021
Last updated
11 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing tislelizumab and BCG in people with Urinary Bladder Neoplasms and Urologic Neoplasms, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ruiyun Zhang, MD, MSc (008613681687457, zhangruiyun4337@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: 28 days of single infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04922047.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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