Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male/female participants who are at least 18 years of age on the day of signing informed consent.
Based on AJCC 8th edition: stage cT2-4N0M0，Urothelial carcinoma >50% and
Requires definitive local therapy
Has received maximum TURBT followed by tri-modality therapy
Disqualifiers
A WOCBP who has a positive urine pregnancy test within 72 hours prior to. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Patients judged not to be candidates for radical cystectomy; patients with pN+ or T4b disease are considered to have unresectable disease; Has any distant metastases.
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab
Drugpembrolizumab 200 mg Q3W
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: arm 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PFS
PFS is defined as the time from first dose of pembrolizumab to any of the following events: recurrent MIBC, nodal or distant metastases or death due to any cause.
Time frame
three yearsSponsors and contacts
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Source ClinicalTrials.gov