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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights
NILE Trial 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.Check my eligibility
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.See study design
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.
NILE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
NILE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Alive and Progression Free Survival at 12 months (APF12)
Disease Control Rate (DCR)
Duration of Response (DoR)
+6 moreOther outcome measures
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 • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
NILE 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
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,604,038 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on strong medication to suppress my immune system.I may undergo or am considering major surgery as part of my treatment plan.I have not received first-line chemotherapy.I am fully active or restricted in physically strenuous activity but can do light work.I have at least one cancer lesion that has not been treated with radiation.I am post-menopausal or not currently pregnant.I have been treated with immune therapy before, but not Bacillus Calmette-Guerin.My cancer is advanced and cannot be removed by surgery.My organs and bone marrow are working well.My cancer has spread to my brain or its coverings and hasn't been treated.I am not allergic to platinum-based chemotherapy or any study drug ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: SoC Chemotherapy
- Group 2: Durvalumab in Combination with SoC Chemotherapy
- Group 3: Durvalumab in Combination with Tremelimumab+SoC Chemotherapy
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some possible side effects of Durvalumab?
"Durvalumab's safety is estimated to be a 3."
Answered by AI
Can subjects of any age participate in this research?
"According to the eligibility requirements, patients that enroll in this trial must be aged 18-130. In contrast, there are 125 trials for those under 18 and 1614 for elderly patients above 65 years old."
Answered by AI
Are there any patients needed for this clinical trial at the moment?
"The latest information on clinicaltrials.gov suggests that this clinical trial is still recruiting patients. This research was originally posted on September 27th, 2018 and has since been updated on September 16th, 2020."
Answered by AI
What are some key benefits of Durvalumab?
"Durvalumab is most commonly used as a first-line treatment. It can also help patients who have undergone adjuvant anthracycline-containing therapy, or those with advanced endometrial cancer manage their disease."
Answered by AI
Who meets the eligibility requirements for this clinical trial?
"This study is looking for 1292 patients with metastatic urothelial cancer, between the ages of 18 and 130, who have not yet received first-line chemotherapy. Additionally, these patients must meet the following requirements: They must have progressed to locally advanced or metastatic disease more than 12 months after their last treatment [for chemoradiation and adjuvant treatment] or surgery [for neoadjuvant treatment], a World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment, and At least 1 lesion that qualifies as a RECIST"
Answered by AI
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