Locally Advanced Bladder Urothelial CarcinomaPhase 2NCT04848519
Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma
A Phase 2 study testing Pembrolizumab, Propranolol Hydrochloride and Nivolumab in people with Locally Advanced Bladder Urothelial Carcinoma and Locally Advanced Renal Pelvis Urothelial Carcinoma, run by Emory University at 1 site in United States.
Trial summary
This research study is an open label study designed to evaluate the safety and translational correlative changes of the combination of propranolol hydrochloride and immune checkpoint inhibitors (ICI) in subjects with urothelial carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma
- What is being tested?
- Pembrolizumab, Propranolol Hydrochloride and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 4 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- Age ≥18 years
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must have histologically confirmed urothelial carcinoma planned for treatment with any of the following at the genitourinary oncology clinics of Emory University's Winship Cancer Institute under the list FDA approved indications:
- Pembrolizumab: first line for locally advanced or metastatic urothelial carcinoma who are not eligible for platinum-based chemotherapy; or second line for locally advanced or metastatic urothelial carcinoma after progression on platinum-based chemotherapy)
- Avelumab: maintenance treatment in locally advanced or metastatic urothelial carcinoma following no progression on first-line platinum-containing chemotherapy
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- Nivolumab: adjuvant treatment of urothelial carcinoma in high risk of disease recurrence after undergoing radical resection. High risk disease as defined in Checkmate 274: pathological stage of pT3, pT4a, or pN+ and patient not eligible for or declined adjuvant cisplatin-based combination chemotherapy for patients who had not received neoadjuvant cisplatin-based chemotherapy and pathological stage of ypT2 to ypT4a or ypN+ for patients who received neoadjuvant cisplatin
- Patients must have adequate organ and marrow function, within 28 days of Cycle 1 Day 1, at the discretion of the investigator.
- The effects of study drugs on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy.
- FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 3 months after completion of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥ 4 weeks before the start of study therapy.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification (Appendix B). To be eligible for this trial, patients should be class IIB or better.
- Patients without existing cardiac disease that raise the risk of complications who consent for the trial will proceed with trial participation.
- Patients with existing cardiac disease that could raise the risk of complications will be referred at the discretion of the investigator to a cardio-oncologist who is a co-investigator on the trial (or general cardiologist) for cardiac optimization prior to starting propranolol.
- Life expectancy > 12 weeks as determined by the Investigator.
- Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities > Grade 2).
- Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.
- Contraindication to ICI per investigator discretion.
- Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy.
- Contraindication to a beta blocker: cardiac conditions that significantly raise the risk of cardiopulmonary complications, including unstable angina, uncontrolled heart failure, symptomatic bradycardia, and severe asthma.
- Current use of an oral or intravenous beta blocker (e.g. atenolol, bisoprolol, carvedilol, labetalol, metoprolol, nadolol, sotalol, among other beta blockers) with inability to safely switch to a non-beta blocker agent. The washout for current users should be at least 14 days with enough transition period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
This research study is an open label study designed to evaluate the safety and translational correlative changes of the combination of propranolol hydrochloride and immune checkpoint inhibitors (ICI) in subjects with urothelial carcinoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety of the combination of propranolol hydrochloride and immune checkpoint inhibitors in urothelial cancer as measured by the incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
SECONDARY OBJECTIVE:
- To describe response and survival outcomes for ICI plus or minus propranolol in patients with urothelial cancer as measured by ORR per RECIST 1.1 (only for subjects receiving avelumab and pembrolizumab as ICI), profession free survival (PFS) and overall survival (OS).
TERTIARY/EXPLORATORY OBJECTIVE:
- To measure overall response rate (ORR) along with correlative changes in peripheral T-cell subsets, myeloid derived suppressor cells (MDSC), blood inflammatory markers and blood cytokines before and after treatment for patients receiving ICI plus propranolol vs. ICI alone. Available archival tissue will also be collected for tissue-based assays.
OUTLINE:
Patients who meet eligibility criteria and consent for enrollment in the trial will be on one of the two study cohorts. Assignment to cohorts will be sequentially, in a 1:1 fashion, starting with the ICI plus propranolol cohort. The specific ICI that the subject would receive will be dependent on the clinical need and associated FDA approval.
ICI PLUS PROPRANOLOL COHORT:
- Propranolol: Participants will remain on propranolol 30mg twice daily for the duration of the trial unless unacceptable toxicity or withdrawal of consent. Patients who develop toxicity and stop propranolol will remain on trial for endpoint measurement.
PLUS
Pembrolizumab: Participants will receive 200mg IV on Day 1, every 3 weeks. Pembrolizumab would be continued for up to 2 years in the absence of disease progression or unacceptable toxicity.
OR
Avelumab: Participants will receive Avelumab at a dose of 10 mg per kilogram of body weight, IV on Day 1 every 2 weeks until disease progression or unacceptable toxicity.
OR
Nivolumab: Participants will receive Nivolumab (480mg) IV on every 4 weeks for up to 1 year or until disease recurrence or discontinuation from the trial.
ICI ALONE COHORT:
Pembrolizumab: Participants will receive 200mg IV on Day 1, every 3 weeks. Pembrolizumab would be continued for up to 2 years in the absence of disease progression or unacceptable toxicity.
OR
Avelumab: Participants will receive Avelumab at a dose of 10 mg per kilogram of body weight, IV on Day 1 every 2 weeks until disease progression or unacceptable toxicity
OR
Nivolumab: Participants will receive Nivolumab (480mg) IV on every 4 weeks for up to 1 year or until disease recurrence or discontinuation from the trial.
After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for up to 2 years.
- Conditions
- Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma, Locally Advanced Urethral Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma
- Being tested
- Pembrolizumab, Propranolol Hydrochloride, Nivolumab, Avelumab
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Ureteral Neoplasms, Urethral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475
Given IV as first line for locally advanced or metastatic urothelial carcinoma who are not eligible for platinum-based chemotherapy; or second line for locally advanced or metastatic urothelial carcinoma after progression on platinum-based chemotherapy
Propranolol HydrochlorideDrug
Also called Inderal
Given PO for patients on the ICI plus propranolol arm
NivolumabDrug
Given IV as adjuvant treatment of urothelial carcinoma in high risk of disease recurrence after undergoing radical resection
AvelumabDrug
Given IV as maintenance treatment in locally advanced or metastatic urothelial carcinoma following no progression on first-line platinum-containing chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (propranolol hydrochloride, immune checkpoint inhibitor) | Experimental | The specific ICI that the subject would receive will be dependent on the clinical need and associated FDA approval. Receives: Drug: Pembrolizumab; Drug: Propranolol Hydrochloride; Drug: Nivolumab; Drug: Avelumab |
| Treatment (immune checkpoint inhibitor) | Other | The specific ICI that the subject would receive will be dependent on the clinical need and associated FDA approval. Receives: Drug: Pembrolizumab; Drug: Nivolumab; Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Assessed according to the Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be used to summarize the toxicity profile of the intervention. Toxicities will be tabulated by grade, association, and cycle number.
Measured: 2 years
Secondary outcomes (3)
Progression free survival (PFS)
Kaplan-Meier methods will be used to estimate median survival time or time-specific survival rate with 95% confidence interval for PFS.
Measured: 2 years
Overall survival (OS)
Kaplan-Meier methods will be used to estimate median survival time or time-specific survival rate with 95% confidence interval for OS.
Measured: 2 years
Objective Response Rate (ORR)
Defined as the proportion of subjects only receiving avelumab and pembrolizumab as ICI.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start20 May 2021
- Primary completion15 Oct 2025
- Study completion4 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jacqueline Brown, Emory University
- Investigators
- Jacqueline Brown, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848519
- Sponsor's protocol ID
- STUDY00002186
- Other IDs
- NCI-2021-00437, WINSHIP5200-20, P30CA138292
- Status last verified
- Feb 2026
- First submitted
- 14 Apr 2021
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04848519
- Acronym / sponsor ID
- STUDY00002186
- Conditions
- Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma, Locally Advanced Urethral Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 4 Dec 2026 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is an open label study designed to evaluate the safety and translational correlative changes of the combination of propranolol hydrochloride and immune checkpoint inhibitors (ICI) in subjects with urothelial carcinoma.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety of the combination of propranolol hydrochloride and immune checkpoint inhibitors in urothelial cancer as measured by the incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
SECONDARY OBJECTIVE:
- To describe response and survival outcomes for ICI plus or minus propranolol in patients with urothelial cancer as measured by ORR per RECIST 1.1 (only for subjects receiving avelumab and pembrolizumab as ICI), profession free survival (PFS) and overall survival (OS).
TERTIARY/EXPLORATORY OBJECTIVE:
- To measure overall response rate (ORR) along with correlative changes in peripheral T-cell subsets, myeloid derived suppressor cells (MDSC), blood inflammatory markers and blood cytokines before and after treatment for patients receiving ICI plus propranolol vs. ICI alone. Available archival tissue will also be collected for tissue-based assays.
OUTLINE:
Patients who meet eligibility criteria and consent for enrollment in the trial will be on one of the two study cohorts. Assignment to cohorts will be sequentially, in a 1:1 fashion, starting with the ICI plus propranolol cohort. The specific ICI that the subject would receive will be dependent on the clinical need and associated FDA approval.
ICI PLUS PROPRANOLOL COHORT:
- Propranolol: Participants will remain on propranolol 30mg twice daily for the duration of the trial unless unacceptable toxicity or withdrawal of consent. Patients who develop toxicity and stop propranolol will remain on trial for endpoint measurement.
PLUS
Pembrolizumab: Participants will receive 200mg IV on Day 1, every 3 weeks. Pembrolizumab would be continued for up to 2 years in the absence of disease progression or unacceptable toxicity.
OR
Avelumab: Participants will receive Avelumab at a dose of 10 mg per kilogram of body weight, IV on Day 1 every 2 weeks until disease progression or unacceptable toxicity.
OR
Nivolumab: Participants will receive Nivolumab (480mg) IV on every 4 weeks for up to 1 year or until disease recurrence or discontinuation from the trial.
ICI ALONE COHORT:
Pembrolizumab: Participants will receive 200mg IV on Day 1, every 3 weeks. Pembrolizumab would be continued for up to 2 years in the absence of disease progression or unacceptable toxicity.
OR
Avelumab: Participants will receive Avelumab at a dose of 10 mg per kilogram of body weight, IV on Day 1 every 2 weeks until disease progression or unacceptable toxicity
OR
Nivolumab: Participants will receive Nivolumab (480mg) IV on every 4 weeks for up to 1 year or until disease recurrence or discontinuation from the trial.
After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (propranolol hydrochloride, immune checkpoint inhibitor) | Experimental | Drug: Pembrolizumab, Drug: Propranolol Hydrochloride, Drug: Nivolumab, Drug: AvelumabThe specific ICI that the subject would receive will be dependent on the clinical need and associated FDA approval. |
| Treatment (immune checkpoint inhibitor) | Other | Drug: Pembrolizumab, Drug: Nivolumab, Drug: AvelumabThe specific ICI that the subject would receive will be dependent on the clinical need and associated FDA approval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or Female
- Age ≥18 years
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must have histologically confirmed urothelial carcinoma planned for treatment with any of the following at the genitourinary oncology clinics of Emory University's Winship Cancer Institute under the list FDA approved indications:
- Patients must have adequate organ and marrow function, within 28 days of Cycle 1 Day 1, at the discretion of the investigator.
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities > Grade 2).
- Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.
- Contraindication to ICI per investigator discretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: Keytruda, Lambrolizumab, MK-3475, SCH 900475Given IV as first line for locally advanced or metastatic urothelial carcinoma who are not eligible for platinum-based chemotherapy; or second line for locally advanced or metastatic urothelial carcinoma after progression on platinum-based chemotherapy | Drug | Treatment (immune checkpoint inhibitor), Treatment (propranolol hydrochloride, immune checkpoint inhibitor) |
| Propranolol HydrochlorideAlso: InderalGiven PO for patients on the ICI plus propranolol arm | Drug | Treatment (propranolol hydrochloride, immune checkpoint inhibitor) |
| NivolumabGiven IV as adjuvant treatment of urothelial carcinoma in high risk of disease recurrence after undergoing radical resection | Drug | Treatment (immune checkpoint inhibitor), Treatment (propranolol hydrochloride, immune checkpoint inhibitor) |
| AvelumabGiven IV as maintenance treatment in locally advanced or metastatic urothelial carcinoma following no progression on first-line platinum-containing chemotherapy | Drug | Treatment (immune checkpoint inhibitor), Treatment (propranolol hydrochloride, immune checkpoint inhibitor) |
Primary outcome
Incidence of adverse events
Time frame: 2 years
Assessed according to the Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be used to summarize the toxicity profile of the intervention. Toxicities will be tabulated by grade, association, and cycle number.
3 secondary outcomes
Progression free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Objective Response Rate (ORR)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Brown, MD principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Propranolol Hydrochloride and Nivolumab in people with Locally Advanced Bladder Urothelial Carcinoma and Locally Advanced Renal Pelvis Urothelial Carcinoma, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.