18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Number of Participants Experiencing an Unacceptable Level of Toxicity as Defined BelowPrimary· 12 weeks of study treatment
Unacceptable toxicity was predefined as fitting one of the following categories.
* Grade 3 or worse adverse event per CTCAE V 5.0 (excluding urinary adverse events Grade 3 and Grade 4)
* Cisplatin is withheld for 2 or more doses
* Cisplatin is withheld or dose reduced such that \<66% of the intended total cisplatin dose is delivered
* Radiation therapy extended beyond 7 weeks
* Any single pembrolizumab dose is delayed for \>6 weeks
Complete Response Rate at Week 19 of the Trial (12 Weeks Post Completion of Chemoradiotherapy).Secondary· Week 19 (12 weeks post chemotherapy)
Complete response defined at this time point by fulfillment of all of the following criteria:
i) the bi-manual examination under anesthesia is negative (performed at the time of cystoscopy) ii) All biopsies are negative for any tumor at the site(s) of pre-treatment tumor(s) iii) There is an absence of metastatic disease on most recently performed imaging of chest/abdomen and pelvis
Group
Value
95% CI
Pembrolizumab
90
70 – 99
The Complete Response Rate Assessed at Week 31 of the Trial (24 Weeks Post Completion of Chemoradiotherapy).Secondary· Week 31 of the trial (24 weeks post completion of chemoradiotherapy)
Complete response defined at this time point by fulfillment of all of the following criteria:
i) the bi-manual examination under anesthesia is negative (performed at the time of cystoscopy) ii) All biopsies are negative for any tumor at the site(s) of pre-treatment tumor(s) iii) There is an absence of metastatic disease on most recently performed imaging of chest/abdomen and pelvis
Group
Value
95% CI
Pembrolizumab
88
70 – 98
Estimated Median Overall SurvivalSecondary· median follow up 39 months
Estimation after characterization with a Kaplan Meier curve
Group
Value
95% CI
Pembrolizumab
39
17 – NA
Overall Survival at 12 Months Post Study EntrySecondary· 12 months post study entry
Overall survival timepoint estimated after characterization on a Kaplan Meier curve
Group
Value
95% CI
Pembrolizumab
92
72 – 98
Distant Metastasis Free Survival (DMFS) at 12 MonthsSecondary· At 12 months post study entry
End point was characterized using a Kaplan Meier curve and 12 month time point assessed.
Group
Value
95% CI
Pembrolizumab
85
64 – 94
Local Disease Free Survival (LRPFS) at 12 MonthsSecondary· 12 months post therapy commencement
Local recurrence was defined as recurrence in the bladder or a nodal recurrence in the pelvis
Group
Value
95% CI
Pembrolizumab
88
68 – 98
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months.
Reporting threshold: 3.5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pembrolizumab
Serious: 13/28 (46%)
Deaths: 8/28
Serious adverse events (20 terms)
Reaction
System
Pembrolizumab
Urinary tract infection
Infections and infestations
—
Haematuria
Renal and urinary disorders
—
Fever
General disorders
—
Renal and urinary discorders (other)
Renal and urinary disorders
—
Musculoskeletal and Conncective tissue disorder (other)
This study will enrol patients with maximally resected (via transurethral resection (TURBT) non-metastatic muscle invasive bladder cancer, who either wish to attempt bladder preservation therapy or are ineligible for cystectomy. Patients must have adequate organ function and performance status to receive cisplatin based chemoradiotherapy, and no contraindications to the use of pembrolizumab. The study will enrol 30 patients to be treated with pembrolizumab and radiotherapy.
All patients will be planned to be treated with 64Gy of radiation therapy in 32 fractions over 6 weeks and 2 days. All patients will receive cisplatin 35mg/m2 IV concurrently weekly with radiation therapy for 6 doses total. Pembrolizumab will commence concurrently with radiation and be given 200mg IV every 21 days, continuing until the 12 week cystoscopy and assessment.
Surveillance cystoscopy will be performed 12 weeks after the commencement of chemoradiotherapy, and assess the rate of complete response to therapy. A safety follow up visit will occur 4 and 12 weeks post cystoscopy. From week 31 survival follow up will commence with clinical assessment, cystoscopy and CT staging performed at intervals until 5 years.
The objective of the study is to assess the safety and feasibility of combining pembrolizumab with chemoradiotherapy. The primary endpoint assessed will be safety, as defined by a satisfactorily low rate of unacceptable toxicity (G3-4 adverse events or failure of completion of planned chemotherapy and radiotherapy according to defined parameters). The secondary endpoint will be efficacy, as assessed by complete response rate of the primary tumour at first post chemoradiotherapy cystoscopic assessment. Exploratory analysis will include assessment of tumour histopathological, molecular, genetic and immunological parameters.
It is expected that it will take two years to accrue the required 30 patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
Other recruiting trials for Bladder Cancer
Currently open trials in the same condition.
NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
· Phase 3
· recruiting
NCT03392428 — A Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Last refreshed: 27 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02662062.