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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02625961




Registration number
NCT02625961
Ethics application status
Date submitted
7/12/2015
Date registered
9/12/2015
Date last updated
17/04/2020

Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)
Scientific title
A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects With High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy
Secondary ID [1] 0 0
2014-004026-17
Secondary ID [2] 0 0
3475-057
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - pembrolizumab

Experimental: Pembrolizumab - Participants receive pembrolizumab, 200 mg, intravenously, every 3 weeks (Q3W) for up to 24 months.


Other interventions: pembrolizumab


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete Response Rate
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
Disease Free Survival Rate
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Duration of Response
Timepoint [1] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
- Histologically-confirmed diagnosis of high risk non-muscle-invasive (T1, high grade Ta
and / or carcinoma in situ [CIS]) transitional cell carcinoma of the bladder (mixed
histology tumors allowed if transitional cell histology is predominant histology).

- Fully resected disease at study entry (residual CIS acceptable)

- BCG-unresponsive high risk non-muscle-invasive bladder cancer after treatment with
adequate BCG therapy

- Ineligible for radical cystectomy or refusal of radical cystectomy

- Available tissue from a newly obtained core biopsy of a tumor lesion not previously
irradiated

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Adequate organ function

- Female participants of childbearing potential have a negative urine or serum pregnancy
test and must be willing to use an adequate method of contraception

- Male participants must be willing to use an adequate method of contraception
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma
(i.e., T2, T3, T4, and / or stage IV)

- Concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis) non-muscle invasive
transitional cell carcinoma of the urothelium

- Currently participating or has participated in a study of an investigational agent and
received study therapy or received investigational device within 4 weeks prior to the
first dose of study treatment

- Received intervening intravesical chemotherapy or immunotherapy from the time of most
recent cystoscopy / Transurethral Resection of Bladder Tumor (TURBT) to starting study
treatment

- Received prior chemotherapy, targeted small molecule therapy, or radiation therapy
within 2 weeks prior to starting study treatment or not recovered from adverse events
due to a previously administered agent

- Known additional malignancy that is progressing or requires active treatment excepting
basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has
undergone potentially curative therapy or in situ cervical cancer. A history of
prostate cancer that was treated with definitive intent (surgically or through
radiation therapy) is acceptable provided that the following criteria are met: Stage
T2N0M0 or lower; Gleason score =7 and prostatic-specific antigen (PSA) undetectable
for at least 1 year while off androgen deprivation therapy that was either treated
with definitive intent or untreated in active surveillance that has been stable for
the past year prior to study allocation

- Active autoimmune disease that has required systemic treatment in the past 2 years

- Evidence of interstitial lung disease or active non-infectious pneumonitis

- Active infection requiring systemic therapy

- Pregnant or breastfeeding, or expecting to conceive within the projected duration of
the trial through 120 days after the last dose of study treatment

- Prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-ligand 2 (L2)
agent, or with an agent directed to another co-inhibitory T-cell receptor

- Known human immunodeficiency virus (HIV)

- Known active Hepatitis B or C infection

- Received a live virus vaccine within 30 days of planned start of study treatment

- Has had an allogeneic tissue/solid organ transplant

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Merck Sharp & Dohme - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Finland
State/province [13] 0 0
Espoo
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
Greece
State/province [15] 0 0
Alimos
Country [16] 0 0
Italy
State/province [16] 0 0
Rome
Country [17] 0 0
Japan
State/province [17] 0 0
Chiyoda-Ku, Tokyo
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Netherlands
State/province [19] 0 0
Haarlem
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Moscow
Country [21] 0 0
Sweden
State/province [21] 0 0
Stockholm
Country [22] 0 0
Turkey
State/province [22] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC)
unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for
or have refused to undergo radical cystectomy, will receive pembrolizumab therapy. The
primary study hypothesis is that treatment with pembrolizumab will result in a clinically
meaningful response.
Trial website
https://clinicaltrials.gov/show/NCT02625961
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02625961