Actively Recruiting
Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer
Led by Peking University First Hospital · Updated on 2022-01-10
54
Participants Needed
1
Research Sites
412 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II, single-arm, study of pembrolizumab as maintenance therapy in muscle-invasive bladder cancer (MIBC) participants who have received maximum TURBT and tri-modality treatment (TMT) and achieved CR. All participants will receive pembrolizumab monotherapy per 21 days no longer than 17 cycles until disease progression or death.
CONDITIONS
Official Title
Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Diagnosed with stage cT2-4N0M0 urothelial carcinoma over 50% based on AJCC 8th edition
- Have received maximum TURBT followed by tri-modality therapy and achieved complete response within 28 to 90 days after treatment
- Tumor located on one side of the bladder wall
- Provide written informed consent
- Have measurable disease based on RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function before starting study intervention
You will not qualify if you...
- Women of childbearing potential with a positive urine or serum pregnancy test prior to study
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Not candidates for radical cystectomy, presence of pN+ or T4b disease, or distant metastases
- Received systemic anti-cancer therapy or investigational agents within 4 weeks prior to study
- Received radiotherapy within 2 weeks before study intervention without recovery from toxicities
- Received live vaccines within 30 days before first dose (except killed virus vaccines like seasonal influenza injection)
- Participation in other investigational agent or device studies within 4 weeks prior to first dose
- Immunodeficiency diagnosis or receiving systemic steroid or immunosuppressive therapy within 7 days prior to first dose
- Active or progressing additional malignancies requiring treatment within past 3 years (except certain skin or carcinoma in situ cancers)
- Severe hypersensitivity to pembrolizumab or its excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known HIV, active Hepatitis B or C infection
- Conditions, therapies, or abnormalities interfering with study participation or results
- Psychiatric or substance abuse disorders affecting study cooperation
- Pregnant, breastfeeding, or planning conception during study and 120 days thereafter
- History of allogeneic tissue or solid organ transplant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
S
Shang-Bin Qin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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