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Avelumab Combinations for Bladder Cancer

Phase 2
Recruiting
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants without progressive disease as per RECIST v1.1 guidelines following completion of 4 to 6 cycles of 1L chemotherapy
Participants with histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma. Transitional cell carcinoma must be the predominant histology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 51 months
Awards & highlights

Study Summary

This trial will study if the immunotherapy drug avelumab is safe and effective when used with other cancer treatments to help maintain remission in patients with bladder cancer.

Who is the study for?
This trial is for adults with advanced bladder cancer who've completed initial chemotherapy without disease progression. They must have a good performance status, meaning they're relatively active and can care for themselves. Participants need proper organ function and an expected lifespan of at least 3 months. Those previously treated with certain immunotherapies or systemic therapies within the last year are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Avelumab in combination with other anti-cancer drugs as maintenance therapy for bladder cancer patients post-chemotherapy. It aims to see if these combinations help control the disease better than current treatments.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that may affect organs, infusion-related symptoms, fatigue, blood abnormalities, liver issues, kidney problems, and increased risk of infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer did not worsen after 4-6 rounds of initial chemotherapy.
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My bladder cancer cannot be removed by surgery and has spread.
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I am fully active or can carry out light work.
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My cancer was at Stage IIIA/IIIB with N1-N3, or Stage IV when I started chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 51 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 51 months 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 with Treatment Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, and AEs of Special Interest (AESIs) as per Qualitative Toxicity Scale [National Cancer Institute-Common Terminology Criteria for Adverse Events 5.0]
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Secondary outcome measures
Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator
Number of Participants with Positive Anti-Drug Antibody (ADA) of Avelumab, M6223, Sacituzumab govitecan and NKTR-255
+3 more

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Investigations
6%
Metabolism and nutrition disorders
6%
General disorders and administration site conditions
6%
Gastrointestinal disorders
6%
Nervous system disorders
6%
Cardiac disorders
6%
Infections and infestations
6%
Endocrine 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

4Treatment groups
Experimental Treatment
Group I: Group D: Avelumab + NKTR-255Experimental Treatment2 Interventions
Group II: Group C: Avelumab + M6223Experimental Treatment2 Interventions
Group III: Group B: Avelumab + Sacituzumab GovitecanExperimental Treatment2 Interventions
Group IV: Group A: AvelumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
M6223
2020
Completed Phase 1
~60
NKTR-255
2020
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar TherapeuticsUNKNOWN
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,608 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,723 Total Patients Enrolled

Media Library

Avelumab Clinical Trial Eligibility Overview. Trial Name: NCT05327530 — Phase 2
Urothelial Carcinoma Research Study Groups: Group A: Avelumab, Group B: Avelumab + Sacituzumab Govitecan, Group D: Avelumab + NKTR-255, Group C: Avelumab + M6223
Urothelial Carcinoma Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT05327530 — Phase 2
Avelumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327530 — Phase 2

Frequently Asked Questions

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

What is the regulatory status of Avelumab in the United States?

"Avelumab's safety rating is a 2. While there is some evidence backing its safety, no Phase 2 trials have been run to test for efficacy."

Answered by AI

Are there any vacancies in this research project for trial participants?

"The clinical study, which was originally advertised on August 17th, is still looking for volunteers. The listing was updated as recently as October 4th."

Answered by AI

Could you tell me how many research facilities are participating in this project?

"The current list of 8 clinical trial locations for this study include: Rush University Medical Center (Chicago, Illinois), Washington University (Saint Louis, Missouri), and University of Wisconsin Cancer Center (Madison, Wisconsin)."

Answered by AI

How many enrollees does this research project have?

"In order to properly conduct this study, 252 individuals that fit the pre-determined inclusion criteria are required. These patients can come from various locations, such as Rush University Medical Center located in Chicago, Illinois or Washington University situated in Saint Louis, Missouri."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
2022. "A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327530.
~70 spots leftby Jan 2025
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