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Anti-tumor antibiotic

Immunotherapy + Chemotherapy for Bladder Cancer (NILE Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Patients who have not been previously treated with first-line chemotherapy

World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment

Must not have

No severe concomitant condition that requires immunosuppression medication

Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is studying if adding the drugs durvalumab and tremelimumab to standard chemotherapy can help to control transitional cell carcinoma of the urothelium that has spread to other parts of the body and cannot be removed by surgery.

Who is the study for?

This trial is for adults with advanced urothelial cancer that can't be surgically removed. They should not have had first-line chemotherapy but may have had other treatments if their disease worsened after a year. Participants need to be relatively healthy, able to perform daily activities with ease or some limitation, and women must not be pregnant.

What is being tested?

The study tests the effectiveness of Durvalumab alone or combined with Tremelimumab alongside standard chemotherapy (Cisplatin + Gemcitabine or Carboplatin + Gemcitabine) versus just the chemotherapy. It's randomized and open-label, meaning patients are assigned treatment by chance and everyone knows which treatment they're getting.

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in various organs, infusion reactions from the drugs being administered into the vein, fatigue, nausea from chemo drugs, blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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I have not received first-line chemotherapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have at least one cancer lesion that has not been treated with radiation.

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I am post-menopausal or not currently pregnant.

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My cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

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

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I am not on strong medication to suppress my immune system.

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My cancer has spread to my brain or its coverings and hasn't been treated.

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I am not allergic to platinum-based chemotherapy or any study drug ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Alive and Progression Free Survival at 12 months (APF12)

Disease Control Rate (DCR)

Duration of Response (DoR)

+6 more

Other study objectives

To assess immunogenicity of Durvalumab and Tremelimumab

To assess pharmacokinetics of Durvalumab and Tremelimumab

To assess safety using a summary of adverse events.

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Durvalumab in Combination with Tremelimumab+SoC ChemotherapyExperimental Treatment4 Interventions

Durvalumab and Tremelimumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks Tremelimumab will be provided for 4 cycles. All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: * cisplatin+ gemcitabine * If the patient is cisplatin-ineligible, carboplatin + gemcitabine

Group II: Durvalumab in Combination with SoC ChemotherapyExperimental Treatment3 Interventions

Durvalumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks. All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: * cisplatin+ gemcitabine * If the patient is cisplatin-ineligible, carboplatin + gemcitabine

Group III: SoC ChemotherapyActive Control2 Interventions

Patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: * cisplatin+ gemcitabine * If the patient is cisplatin-ineligible, carboplatin + gemcitabine

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Tremelimumab

2017

Completed Phase 2

~3070