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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)

Must not have

Major surgery within the last 30 days (with the exception of TURBT).

Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 30 days, except for TURBT.

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I am not currently on any cancer treatments like chemotherapy.

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I have received IV therapy for bladder cancer.

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My scans show cancer has spread to my lymph nodes or other areas.

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I have had radiation therapy to my pelvic area before.

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I have had an organ or stem-cell transplant.

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I am breastfeeding and not willing to stop during and for a month after treatment.

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I am currently on IV antibiotics for an infection.

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I do not have serious heart problems or a recent stroke or heart attack.

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My bladder biopsy shows small cell cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete clinical response rate

Secondary study objectives

Locoregional recurrence rate

Metastases-free survival

Overall Survival

+2 more

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848

17%

Musculoskeletal and connective tissue disorders

11%

Injury, poisoning and procedural complications

Endocrine disorders

General disorders and administration site conditions

Metabolism and nutrition disorders

Nervous system disorders

Investigations

Cardiac disorders

Gastrointestinal disorders

Infections and infestations

Immune system disorders

Blood and lymphatic system disorders

Neoplasms benign, malignant and unspecified

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

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

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

2017

Completed Phase 2

~2440

Radiation

2003

Completed Phase 2

~780