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Platinum-containing compounds

Durvalumab + Chemo/Radiation for Bladder Cancer

Phase 2

Waitlist Available

Led By Monika Joshi

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patient must not have received any previous radiation therapy to the pelvic area

Adequate renal function as evidenced by calculated (Cockcroft's formula) creatinine clearance or 24 hours actual creatinine clearance >= 30mL/min

Must not have

Patient must not have clinically significant liver disease

Patient with active or prior documented inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding the immunotherapy drug durvalumab to standard chemotherapy and radiation therapy helps treat bladder cancer that has spread to the lymph nodes better than standard chemotherapy and radiation therapy alone.

Who is the study for?

This trial is for adults with bladder cancer that has spread to lymph nodes but not elsewhere. They must have good physical function, no prior pelvic radiation, and acceptable blood counts and organ function. HIV-positive patients on effective therapy can join. Those with a history of certain cancers or autoimmune diseases, active infections like tuberculosis or hepatitis, or who are pregnant cannot participate.

What is being tested?

The INSPIRE study is testing if adding the immunotherapy drug Durvalumab to standard chemotherapy (Cisplatin) and radiation improves treatment response in bladder cancer that's reached lymph nodes. The goal is to see if this combination helps shrink tumors better than chemo and radiation alone.

What are the potential side effects?

Durvalumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver issues, fatigue, infusion reactions, potential worsening of pre-existing autoimmune conditions, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had radiation therapy to my pelvic area.

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My kidneys work well enough, with a creatinine clearance of at least 30 mL/min.

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My cancer has spread to the lymph nodes but not to distant parts of the body.

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My tests after initial treatment show no advanced bladder cancer.

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My bladder cancer is confirmed to be urothelial type.

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I can care for myself and am up and about more than 50% of my waking hours.

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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 do not have serious liver disease.

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I have or had inflammatory bowel disease.

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I have a history of cancer.

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I have had or currently have pneumonitis.

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I don't have lasting side effects from cancer treatment.

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I do not have an active infection like TB or Hepatitis B/C.

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I do not have active tumors in my upper urinary tract or urethra.

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I have had a condition where my lymphocytes grow abnormally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Clinical complete response (CR)

Secondary study objectives

Bladder cancer specific survival

Bladder-intact event-free survival (BI-EFS)

Complete response duration

+5 more

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

Active Control

Group I: Step 2, Arm E (durvalumab)Experimental Treatment6 Interventions

Patients previously randomized to Arm C (chemoradiation and durvalumab) who achieve clinical CR or clinical benefit receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bladder biopsy on study, cystoscopy on study and during follow-up, as well as CT or MRI throughout the trial. Patients may also undergo tumor tissue and blood sample collection on study.

Group II: Step 1, Arm C (durvalumab, radiation therapy, chemotherapy)Experimental Treatment11 Interventions

Patients undergo radiation therapy for 6.5-8 weeks. Beginning 4 days before or after starting radiation therapy, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning 4 days before or after starting radiation therapy, patients also receive gemcitabine hydrochloride IV over 30-60 minutes BIW for 6 weeks; or cisplatin IV over 30-60 minutes QW for 6 weeks; or mitomycin IV over 30 minutes on day 1 of radiation and fluorouracil IV continuous infusion on days 1-5 and 16-20 of radiation in the absence of disease progression or unacceptable toxicity. Patients also undergo bladder biopsy on study, cystoscopy on study and during follow-up, as well as CT or MRI throughout the trial. Patients may also undergo tumor tissue and blood sample collection on study.

Group III: Step 1, Arm D (radiation therapy, chemotherapy)Active Control10 Interventions

Patients undergo radiation therapy for 6.5-8 weeks. Beginning 4 days before or after starting radiation therapy, patients also receive gemcitabine hydrochloride IV over 30-60 minutes BIW for 6 weeks; or cisplatin IV over 30-60 minutes QW for 6 weeks; or mitomycin IV over 30 minutes on day 1 of radiation and fluorouracil IV continuous infusion on days 1-5 and 16-20 of radiation in the absence of disease progression or unacceptable toxicity. Patients also undergo bladder biopsy on study, cystoscopy on study and during follow-up, as well as CT or MRI throughout the trial. Patients may also undergo tumor tissue and blood sample collection on study.

Group IV: Step 2, Arm F (observation)Active Control6 Interventions

Patients previously randomized to Arm D (chemoradiation) who achieve clinical CR or clinical benefit undergo observation undergo observation. Patients also undergo bladder biopsy on study, cystoscopy on study and during follow-up, as well as CT or MRI throughout the trial. Patients may also undergo tumor tissue and blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mitomycin

2009

Completed Phase 3

~410

Biospecimen Collection

2004

Completed Phase 3

~2020