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Immunotherapy + Radiotherapy for Bladder Cancer

Phase 1

Recruiting

Led By John Christodouleas, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No clinical evidence of residual or recurrent disease within 3 months of consent

Radical cystectomy and pelvic lymph node dissection within the prior 48 weeks

Must not have

Subtotal surgical resection with residual disease

Prior partial or complete small bowel obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 18 weeks from start of radiation therapy

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to determine if combining immunotherapy with radiation therapy is safe for treating urothelial bladder cancer."

Who is the study for?

This trial is for individuals with urothelial bladder cancer. Specific eligibility details are not provided, but typically participants would need to meet certain health standards and have a confirmed diagnosis of the condition being studied.

What is being tested?

The study is testing the safety of combining immunotherapy with radiation therapy as an additional treatment (adjuvant therapy) after primary treatment for bladder cancer.

What are the potential side effects?

While specific side effects are not listed, generally, immunotherapy can cause immune-related reactions and radiation may lead to localized skin irritation, fatigue, 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 have shown no signs of cancer returning in the last 3 months.

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I had bladder removal surgery and lymph node dissection within the last year.

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My cancer is at least stage T3 but has not spread to distant organs.

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I am currently on a checkpoint inhibitor as part of my cancer treatment.

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I can take care of myself and am up and about more than half of the day.

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I am 18 years old or older.

Exclusion Criteria

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

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I had surgery for my condition but some of the disease remains.

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I have had a blockage in my small intestine before.

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I have a surgically created bladder replacement.

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I have had radiation therapy to my pelvis under certain conditions.

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I have experienced severe GI issues from surgery or nivolumab before joining.

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I have a history of inflammatory bowel disease.

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I will be receiving chemotherapy or other new drugs with my radiation therapy.

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I have or had another type of cancer besides the one being treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 18 weeks from start of radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 18 weeks from start of radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 18 weeks from start of radiation therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety of concurrent adjuvant immunotherapy and radiation therapy

Side effects data

From 2023 Phase 3 trial • 1460 Patients • NCT04145219

58%

Oral pruritus

55%

Throat irritation

33%

Ear pruritus

33%

Abdominal pain upper

25%

Nasopharyngitis

21%

Lip swelling

20%

Glossodynia

19%

Nausea

17%

Taste disorder

14%

Mouth swelling

14%

Swollen tongue

13%

Diarrhoea

13%

Mouth ulceration

Pharyngeal swelling

Tongue ulceration

Vomiting

Tooth loss

Pharyngitis

Bronchitis

COVID-19

Upper respiratory tract infection

Asthma

100%

80%

60%

40%

20%

Study treatment Arm

HDM SLIT-tablet (12 SQ-HDM)

Placebo SLIT-tablet

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: Concurrent Immunotherapy and Radiation TherapyExperimental Treatment1 Intervention

Subjects will receive the standard of care procedures and follow-up for immunotherapy and radiation therapy. The part of this study that is research is receiving both of these treatments at the same time.

0 / 14Eligibility criteria met