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Monoclonal Antibodies
Avelumab + Radiation for Bladder Cancer
Phase 2
Recruiting
Led By Kent Mouw, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of child-bearing age must have a negative serum pregnancy test at screening.
ECOG performance status ≤2 or Karnofsky score ≥60% (see Appendix A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing if adding avelumab to radiation therapy can help treat bladder cancer.
Who is the study for?
Adults with muscle-invasive bladder cancer who can't receive cisplatin chemotherapy due to certain health issues or personal choice. They must have normal organ/marrow function, not be pregnant, agree to use contraception if there's a risk of conception, and have no history of severe allergies to monoclonal antibodies or other exclusion criteria like active infections.Check my eligibility
What is being tested?
The trial is testing the combination of Avelumab (an immunotherapy drug) with standard radiation therapy for treating muscle-invasive urothelial carcinoma. The goal is to see if adding Avelumab improves treatment outcomes compared to radiation alone.See study design
What are the potential side effects?
Avelumab may cause immune-related side effects such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, and increased risk of infections. Radiation can lead to skin irritation at the treatment site and potential damage to nearby organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am of child-bearing age and my pregnancy test was negative.
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I can take care of myself but might not be able to do active work.
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My organs and bone marrow are functioning normally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete clinical response rate
Secondary outcome measures
Locoregional recurrence rate
Metastases-free survival
Overall Survival
+2 moreSide effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Investigations
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
Infections and infestations
6%
Endocrine disorders
6%
Nervous system disorders
6%
General disorders and administration site conditions
6%
Metabolism and nutrition disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Avelumab and Bladder-Directed RadiationExperimental Treatment2 Interventions
Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Radiation
2003
Completed Phase 3
~1010
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
341,031 Total Patients Enrolled
PfizerIndustry Sponsor
4,575 Previous Clinical Trials
10,923,078 Total Patients Enrolled
Kent Mouw, MD, PhDPrincipal Investigator - Brigham and Women's Hospital
Dana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 30 days, except for TURBT.My bladder cancer has spread into the muscle layer.I am not currently on any cancer treatments like chemotherapy.I have received IV therapy for bladder cancer.You have had a severe allergic reaction to the study drug or any of its ingredients in the past.My scans show cancer has spread to my lymph nodes or other areas.You tested positive for hepatitis B or hepatitis C virus at screening.I can start the study treatment within 1-8 weeks after my last bladder tumor surgery.I have side effects from past treatments, but they are mild and not dangerous.I have had radiation therapy to my pelvic area before.I have had an organ or stem-cell transplant.I am breastfeeding and not willing to stop during and for a month after treatment.I am of child-bearing age and my pregnancy test was negative.I am not on strong immune-suppressing drugs, except for low-dose steroids or specific exceptions.You have serious medical conditions like immune colitis, inflammatory bowel disease, or lung problems, or psychiatric conditions like recent thoughts of self-harm, or abnormal lab results that could make participating in the study risky.I am 18 years old or older.I am not willing to stop taking herbal remedies that may affect the immune system during the study.I haven't had cancer, except for certain types, in the last 5 years.I have an autoimmune disease but it's not severe and doesn't require immunosuppressive treatment.I am currently on IV antibiotics for an infection.You are expected to live for more than 1 year.I cannot have cisplatin chemotherapy due to kidney issues, physical condition, hearing loss, heart problems, severe nerve pain, or personal choice.I do not have serious heart problems or a recent stroke or heart attack.I can take care of myself but might not be able to do active work.I have not received any vaccines within 4 weeks before starting avelumab, except for inactivated ones.My bladder biopsy shows small cell cancer.Your kidney function, as measured by the Cockcroft-Gault formula, is better than a certain level.You have tested positive for HIV or have AIDS.My organs and bone marrow are functioning normally.
Research Study Groups:
This trial has the following groups:- Group 1: Avelumab and Bladder-Directed Radiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor presently taking on new participants?
"Based on the latest information posted to clinicaltrials.gov, this research project is actively recruiting participants. It was first advertised on December 13th 2018 and has had its details revised as recently as April 18th 2022."
Answered by AI
How many participants are being monitored in this clinical research?
"Affirmative. According to clinicaltrials.gov, this experiment is currently looking for volunteers that meet the criteria and began on December 13th 2018. It was recently updated on April 18th 2022, with 24 participants needed from two sites."
Answered by AI
Is this an unprecedented attempt to explore a new medical solution?
"Presently, 112 trials are being conducted worldwide utilizing Avelumab on a global scale that span 1024 cities across 52 nations. This drug was first tested in 2014 when EMD Serono Research & Development Institute sponsored its Phase 2 trial involving 204 participants; since then, 116 studies have concluded their research protocol."
Answered by AI
Has Avelumab been granted regulatory approval by the FDA?
"Our team at Power rated avelumab's safety as 2 due to the limited clinical support of its efficacy, though there is evidence affirming its security."
Answered by AI
Are there prior investigations with Avelumab that have yielded encouraging results?
"Currently, there are 112 trials researching the efficacy of Avelumab. Of those studies, 10 have reached Phase 3 status. While Barcelona and South dakota act as major hubs for this research, a total of 3685 clinical trial sites across the globe are offering participants treatment with Avelumab."
Answered by AI
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