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Checkpoint Inhibitor

Immune Checkpoint Inhibitors + Propranolol Hydrochloride for Urothelial Carcinoma

Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Targeting 13 different conditionsPembrolizumab +3 morePhase 2RecruitingLed by Bassel Nazha, MD, MPHResearch Sponsored by Emory University

Study Summary

This trial studies the effect of propranolol hydrochloride and pembrolizumab in treating patients with urothelial cancer that has come back or has spread to other places in the body.

Eligible Conditions
  • Renal Pelvis Cancer
  • Urethral Cancer
  • Ureter Cancer
  • Urothelial Carcinoma
  • Bladder Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You are able to perform daily activities with some difficulty, but it does not greatly affect your ability to function.
Select...
You have been diagnosed with urothelial carcinoma and are planning to be treated with specific FDA-approved drugs like Pembrolizumab, Avelumab, or Nivolumab.
Select...
You are expected to live for at least 12 more weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Objective Response Rate (ORR)
Overall survival (OS)
Progression free survival (PFS)
Other outcome measures
Immune profile and changes in selected biomarkers and cell subsets

Side effects data

From 2021 Phase 3 trial • 453 Patients • NCT03066778
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%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Nasopharyngitis
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment (propranolol hydrochloride, immune checkpoint inhibitor)Experimental Treatment4 Interventions
The specific ICI that the subject would receive will be dependent on the clinical need and associated FDA approval.
Group II: Treatment (immune checkpoint inhibitor)Experimental Treatment3 Interventions
The specific ICI that the subject would receive will be dependent on the clinical need and associated FDA approval.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2030
Propranolol Hydrochloride
2021
Completed Phase 3
~130
Nivolumab
2014
Completed Phase 3
~4120
Avelumab
2017
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,604 Previous Clinical Trials
2,885,500 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,492 Previous Clinical Trials
41,267,560 Total Patients Enrolled
Bassel Nazha, MD, MPHPrincipal Investigator - Emory University Hospital/Winship Cancer Institute
Emory University
3 Previous Clinical Trials
76 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04848519 — Phase 2
Renal Pelvis Cancer Research Study Groups: Treatment (propranolol hydrochloride, immune checkpoint inhibitor), Treatment (immune checkpoint inhibitor)
Renal Pelvis Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04848519 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04848519 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents for the use of Pembrolizumab in clinical trials?

"Currently, a thousand clinical trials are being conducted to assess the efficacy of Pembrolizumab. Of these studies, 127 have progressed to Phase 3. While most of these research initiatives are located in Melbourne, Victoria; there is an expansive global network running tests with this drug - 35804 sites in total."

Answered by AI

Are there vacancies available for participants of this trial?

"Yes, according to information on clinicaltrials.gov the study is still open for enrollment and was initially published on May 20th 2021. The most recent update occurred on June 8th 2022 and 25 people are being recruited from a single medical facility."

Answered by AI

For what medical ailments is Pembrolizumab regularly prescribed?

"Pembrolizumab is frequently employed to treat malignant neoplasms, but it can also be a beneficial treatment for unresectable melanoma, microsatellite instability high, and adrenergic alpha-antagonists."

Answered by AI

How many participants are included in this clinical experiment?

"Indeed, clinicaltrials.gov reflects that this study is currently enrolling volunteers. It was first posted on May 20th 2021 and has been recently revised as of June 8th 2022. 25 individuals are being sought out from a single site."

Answered by AI

What is the Food and Drug Administration's stance on Pembrolizumab?

"Our team at Power has rated the safety of Pembrolizumab a 2 due to its clinical trial phase. This medication is in Phase 2, indicating that while there are some studies backing up its security and tolerability, efficacy data still needs to be collected."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma
Bassel Nazha 2021. "Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04848519.
~0 spots leftby Jan 2024
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