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Checkpoint Inhibitor

Immune Checkpoint Inhibitors + Propranolol for Bladder Cancer

Phase 2
Recruiting
Led By Bassel Nazha, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Female of child-bearing potential (FCBP) must have a negative pregnancy test and agree to use adequate contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.

Who is the study for?
Adults with urothelial carcinoma eligible for Pembrolizumab, Avelumab, or Nivolumab treatment can join. They should be relatively healthy (ECOG ≤2), have a life expectancy over 12 weeks, and proper organ/marrow function. Women must test negative for pregnancy and use birth control. Participants need to have finished previous cancer treatments at least 4 weeks prior and not have severe heart issues or other illnesses that could interfere with the trial.Check my eligibility
What is being tested?
The study is testing if adding Propranolol Hydrochloride to immune checkpoint inhibitors like Pembrolizumab, Avelumab, or Nivolumab improves outcomes in urothelial carcinoma patients. It's an open-label trial where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Possible side effects include typical reactions to immune checkpoint inhibitors such as fatigue, skin reactions, inflammation of organs; plus those related to Propranolol like low blood pressure, slow heartbeat, dizziness and potential breathing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am a woman who can have children, not pregnant, and agree to use birth control.
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I finished all my cancer treatments more than 4 weeks ago.
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I have urothelial carcinoma and am planned to be treated with Pembrolizumab, Avelumab, or Nivolumab.
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I can care for myself but may not be able to do active work.

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 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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
Nivolumab
2014
Completed Phase 3
~4750
Avelumab
2018
Completed Phase 2
~2450
Pembrolizumab
2017
Completed Phase 2
~2010
Propranolol Hydrochloride
2021
Completed Phase 3
~130

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,508 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,049 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
Ureter Cancer Research Study Groups: Treatment (propranolol hydrochloride, immune checkpoint inhibitor), Treatment (immune checkpoint inhibitor)
Ureter 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.
~6 spots leftby Apr 2025
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