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Avelumab Combinations for Bladder Cancer

Phase 2
Waitlist Available
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
Must not have
Participants with active infection 48 hours before randomization requiring systemic therapy
Participants with prior immunotherapy with Interleukin-2 (IL-2), IL-15, interferon alfa (IFN-α), or certain antibodies targeting immune checkpoint pathways
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an infection that needed treatment within the last 48 hours.
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I have previously received immunotherapy treatments like IL-2 or interferon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2017
Completed Phase 2
~2440
Sacituzumab Govitecan
2019
Completed Early Phase 1
~30
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
85 Previous Clinical Trials
22,477 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
300 Previous Clinical Trials
60,923 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
~0 spots leftby Jan 2025
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