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Checkpoint Inhibitor

Immunotherapy for Bladder Cancer

Phase 2
Waitlist Available
Led By Moshe Ornstein, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 weeks from end of treatment, an average of 24 weeks
Awards & highlights

Study Summary

This trial is testing if immunotherapy is safe and works well when given off and on instead of continuously.

Who is the study for?
Adults over 18 with advanced bladder cancer that's measurable by certain criteria, who've had at least 24 weeks of standard checkpoint inhibitor therapy. They must have a good performance status (able to carry out daily activities), adequate organ function, and no severe allergies to monoclonal antibodies. Excluded are those with HIV/AIDS, recent major surgery, need for high-dose steroids or immunosuppressants, conditions increasing risk or affecting results interpretation, and pregnant or breastfeeding women.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of intermittent doses of checkpoint inhibitors like Pembrolizumab in patients with advanced bladder cancer. It aims to find better dosing schedules and identify when patients can pause treatment while maintaining disease control.See study design
What are the potential side effects?
Checkpoint inhibitors may cause immune-related side effects such as inflammation in various organs including the intestines and lungs, skin reactions, hormone gland problems (like thyroid issues), fatigue, infusion reactions (like fever or chills during drug administration), and potential harm to a fetus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 weeks from end of treatment, an average of 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 weeks from end of treatment, an average of 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants that sustain a response post CPI suspension
Secondary outcome measures
Median Treatment Free Interval (TFI) in months
Overall Survival (OS)
Overall response rate (ORR)
+1 more

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

1Treatment groups
Experimental Treatment
Group I: CPI therapyExperimental Treatment5 Interventions
Patients will be treated with CPI therapy for at least 24 weeks (+/- 4 weeks) as per standard of care (SOC), at which time those with a tumor burden reduction of 10% or greater will suspend CPI therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Atezolizumab
2017
Completed Phase 3
~5860
Durvalumab
2017
Completed Phase 2
~3870
Nivolumab
2014
Completed Phase 3
~4750
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,906 Total Patients Enrolled
Moshe Ornstein, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
1 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04322643 — Phase 2
Bladder Cancer Research Study Groups: CPI therapy
Bladder Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04322643 — Phase 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04322643 — 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 dangerous side effects associated with Pembrolizumab?

"While there is some data suggesting that Pembrolizumab is safe, it only received a score of 2 because there is no clinical evidence yet supporting its efficacy."

Answered by AI

Have other research teams looked into this topic before?

"Pembrolizumab has been under investigation since 2008 when the first clinical study was completed. This initial trial, which had 720 participants, was sponsored by Hoffmann-La Roche. Pembrolizumab received Phase 2 drug approval following this first study in 2008 and today there are 2462 active studies involving 4248 cities across 79 countries."

Answered by AI

How many people are being asked to participate in this clinical trial?

"The website clinicaltrials.gov has the most recent information on this topic, which indicates that the trial is actively recruiting patients as of the latest update on May 27th, 2022. The study was first posted on March 23rd, 2020 and is looking for 20 more participants at a single site."

Answered by AI

What patients does Pembrolizumab help the most?

"Pembrolizumab is a medication that can be used to treat various conditions, including cancer. It is most commonly used for the treatment of malignant neoplasms, but it can also be prescribed to treat other conditions such as unresectable melanoma and microsatellite instability high."

Answered by AI

Are we still able to sign new patients up for this research project?

"The trial is presently recruiting patients, with the most recent update having been on 5/27/2022. The clinical trial was initially posted on 3/23/2020."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma
2020. "Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04322643.
~1 spots leftby Apr 2025
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