Study Summary
This trial is testing whether adding the immunotherapy drug pembrolizumab to the chemotherapy drug gemcitabine can help to treat patients with bladder cancer that has not responded to treatment with Bacillus Calmette-Guerin (BCG).
Eligible Conditions
- Bladder Cancer In Situ
- Bladder Cancer
- Stage 0 Bladder Cancer
- Stage I Bladder Cancer
- Stage 0a Bladder Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 6 Secondary · Reporting Duration: Up to 5 years post treatment
Month 6
Complete response rate in the carcinoma in situ (CIS) subpopulation
Year 5
Overall survival (OS)
From the date of study registration to the date of cystectomy for all patients
Cystectomy-free survival
Year 5
Progression-free survival (PFS)
Month 18
Event-free survival at 18 months
Year 5
Recurrence free survival (RFS)
Year 5
Duration of response (DOR)
Year 5
Incidence of adverse events
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
Trial Design
1 Treatment Group
Treatment (pembrolizumab, gemcitabine hydrochloride)
1 of 1
Experimental Treatment
161 Total Participants · 1 Treatment Group
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
Treatment (pembrolizumab, gemcitabine hydrochloride)Experimental Group · 2 Interventions: Gemcitabine Hydrochloride, Pembrolizumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Pembrolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years post treatment
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,070 Previous Clinical Trials
41,128,661 Total Patients Enrolled
Michael E WoodsPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have high grade urothelial carcinoma of the bladder.
You have a history of TB disease recurrence within 9 months of the last BCG instillation.
Patients who are disease free at 6 months after starting BCG but have high grade recurrence (T1, Ta, CIS) while on maintenance therapy would be eligible.
You are registered for BCG within 12 months of last maintenance BCG instillation.
You are not deemed unfit for radical cystectomy by the treating physician.
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Conditions
Cancer Related
Treatments