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Checkpoint Inhibitor

Immunotherapy + Radiation for Bladder Cancer

Phase 2

Waitlist Available

Led By Himanshu Nagar

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from randomization until disease progression as assessed by the treating physician using recist 1.1 or death due to any cause, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding radiation therapy to atezolizumab helps people with urothelial cancer live longer compared to atezolizumab alone.

Who is the study for?

This trial is for adults with metastatic urothelial cancer who've had prior platinum-based chemotherapy, can provide tissue for PD-L1 testing or agree to a biopsy, and have at least one measurable tumor. They should not have severe peripheral neuropathy, advanced heart failure, or impaired kidney function. An ECOG performance status of >2 (which means they are quite ill) also disqualifies them.

What is being tested?

The study is examining if adding Stereotactic Body Radiation Therapy (SBRT), which precisely targets tumors with high-energy X-rays in fewer doses, to the immunotherapy drug Atezolizumab improves outcomes compared to Atezolizumab alone in patients with spreading urothelial cancer.

What are the potential side effects?

Potential side effects include those from Atezolizumab like immune-related inflammation of organs and infusion reactions. SBRT may cause localized skin irritation and fatigue. The combination could potentially increase these risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from randomization until disease progression as assessed by the treating physician using recist 1.1 or death due to any cause, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from randomization until disease progression as assessed by the treating physician using recist 1.1 or death due to any cause, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization until disease progression as assessed by the treating physician using recist 1.1 or death due to any cause, assessed up to 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

Neoplasms

Secondary study objectives

Incidence of adverse events

Overall survival

Progression-free survival

+1 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

87%

Fatigue

53%

Nausea

33%

Cough

27%

Pain

27%

Anemia

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

20%

Chills

20%

Edema limbs

20%

Dizziness

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

13%

Skin infection

13%

Dysesthesia

13%

Edema

13%

Insomnia

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Myalgia

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Anxiety

Headaches

Oral lesions

Weakness (facial)

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Hearing impaired

Hypernatremia

Hypertension

Neutrophil count decreased

Headache

Creatinine increased

Fever

Pleural effusion

Death NOS

Gait disturbance

Nasal congestion

Tremor

Urinary urgency

Amnesia

Photophobia

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Allergy (seasonal)

Muscle weakness

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Hypoxic respiratory failure

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (pembrolizumab, SBRT)Experimental Treatment8 Interventions

Patients receive pembrolizumab as in Arm A. Patients also undergo SBRT QD every other day for 3 fractions over 2 weeks that must be completed before 12 weeks after the first dose of pembrolizumab in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, bone scan, and/or PET scan, as well as optional urine and blood sample collection throughout the study.

Group II: Arm A (pembrolizumab)Experimental Treatment7 Interventions

Patients receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, bone scan and/or PET scan, as well as optional urine and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Pembrolizumab

2017

Completed Phase 3

~3150