Actively Recruiting
Pembrolizumab Monotherapy as Maintenance Therapy Following Bladder-Preserving Tri-modality Treatment in Patients With Muscle-Invasive Bladder Cancer
Led by Peking University First Hospital · Updated on 2022-01-10
54
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate pembrolizumab as a maintenance therapy for patients with muscle-invasive bladder cancer (MIBC) who have received maximal transurethral resection of bladder tumor (TURBT) and tri-modality treatment (TMT), achieving complete response (CR). This Phase II study explores the potential benefits of pembrolizumab monotherapy following bladder-preserving treatments, as distant metastasis remains a concern after TMT and there is no consensus on adjuvant therapy. The study is sponsored by Peking University First Hospital and builds on evidence supporting PD-(L)1 inhibitors in urothelial carcinoma treatment. Participants will receive pembrolizumab at a dose of 200 mg every 21 days for up to 17 cycles or until disease progression or death. This single-arm, open-label study offers pembrolizumab monotherapy as maintenance treatment after successful tri-modality therapy. The treatment period continues with regular dosing every three weeks, aiming to assess progression-free survival over three years. During the study, participants will undergo evaluations to monitor disease status and treatment safety, including assessments based on RECIST 1.1 criteria and measurement of tumor lesions. Organ function and performance status will be regularly checked, and adverse events monitored throughout treatment. The primary outcome measured is progression-free survival at three years. Participants will remain in the study until disease progression, death, or withdrawal, with close safety monitoring provided throughout the trial duration.
CONDITIONS
Brief 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 (>50%) according to AJCC 8th edition
- Received maximum TURBT followed by tri-modality therapy
- Achieved complete response after tri-modality therapy within 28-90 days
- 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 positive pregnancy test within 72 hours before study
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Patients unsuitable for radical cystectomy or with pN+ or T4b disease or distant metastases
- Received systemic anti-cancer therapy or investigational agents within 4 weeks before study
- Received radiotherapy within 2 weeks before study unless recovered and no corticosteroids needed
- Received live vaccines within 30 days before first dose (except killed virus vaccines like seasonal influenza injection)
- Participation in investigational agent or device study within 4 weeks before first dose
- Diagnosis of immunodeficiency or recent systemic steroid or immunosuppressive therapy
- Known progressing malignancy requiring treatment in past 3 years (with exceptions)
- Severe hypersensitivity to pembrolizumab or its excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis needing steroids
- Active infection requiring systemic therapy
- Known history of HIV, active Hepatitis B or C infection
- Conditions or therapies interfering with study participation
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or expecting to conceive or father children during study and 120 days after last dose
- History of allogeneic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 17 cycles administered every 21 days until disease progression or death
Participants receive pembrolizumab monotherapy as maintenance therapy following bladder-preserving tri-modality treatment.
Visits every 3 weeks for up to 17 cycles
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here