Pembrolizumab for Bladder Cancer In Situ

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bladder Cancer In Situ+5 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

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.