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Platinum-based chemotherapy

Durvalumab +/- Tremelimumab for Bladder Cancer

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
Tumor PD-L1 status, with Immunohistochemical (IHC) assay confirmed by a reference laboratory, must be known prior to randomization
Patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium who have not been previously treated with first-line chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. assessed up to the data cut-off date (01nov2017, a maximum of 3 years).
Awards & highlights

Study Summary

This trial is testing a new immunotherapy drug, MEDI4736, to see if it can improve survival in patients with stage IV urothelial cancer.

Who is the study for?
This trial is for adults with Stage IV bladder cancer who haven't had first-line chemotherapy. They must know their tumor PD-L1 status and can be eligible or ineligible for cisplatin-based chemo due to certain health conditions. People with prior immune therapy, autoimmune/inflammatory disorders, brain metastases not stable off steroids, active infections like TB/HIV, recent live vaccines, or current immunosuppressants (with some exceptions) cannot join.Check my eligibility
What is being tested?
The study tests Durvalumab alone or combined with Tremelimumab against standard chemo drugs (Gemcitabine with Cisplatin or Carboplatin). It's a Phase III trial where patients are randomly assigned to one of these treatments to compare effectiveness as a first-line treatment in advanced bladder cancer.See study design
What are the potential side effects?
Durvalumab and Tremelimumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems like thyroid issues. Standard chemo can lead to nausea, hair loss, fatigue and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tumor's PD-L1 status has been confirmed by a lab test.
Select...
I have Stage IV bladder cancer that hasn't been treated with first-line chemotherapy.
Select...
I am either eligible or not for cisplatin chemotherapy based on specific health conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. assessed up to the data cut-off date (01nov2017, a maximum of 3 years).
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. assessed up to the data cut-off date (01nov2017, a maximum of 3 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set
To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set
Secondary outcome measures
Alive and Progression-free at 12 Months (APF12), Full Analysis Set
Alive and Progression-free at 12 Months (APF12), PD-L1-High Analysis Set
Alive and Progression-free at 12 Months (APF12), PD-L1-Low/Negative Analysis Set
+35 more

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471
26%
Asthenia
20%
Anaemia
20%
Constipation
17%
Decreased appetite
16%
Diarrhoea
15%
Nausea
13%
Pruritus
10%
Urinary tract infection
10%
Cough
10%
Fatigue
9%
Vomiting
9%
Dyspnoea
9%
Back pain
9%
Oedema peripheral
9%
Pyrexia
7%
Haematuria
7%
Abdominal pain
7%
Arthralgia
7%
Hypothyroidism
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Pneumonia
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Death
1%
Acute kidney injury
1%
Pyelonephritis
1%
Device related infection
1%
Urosepsis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: MonotherapyExperimental Treatment1 Intervention
MEDI4736 (Durvalumab)
Group II: Combination TherapyExperimental Treatment2 Interventions
MEDI4736 (Durvalumab) + Tremelimumab
Group III: Standard of CareActive Control3 Interventions
Standard of Care Chemotherapy Treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI4736 (Durvalumab)
2017
Completed Phase 3
~940
Tremelimumab
2017
Completed Phase 2
~3380

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,470,295 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02516241 — Phase 3
Bladder Cancer Research Study Groups: Monotherapy, Standard of Care, Combination Therapy
Bladder Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02516241 — Phase 3
Carboplatin (Platinum-based chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02516241 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any known dangers associated with MEDI4736 (Durvalumab)?

"MEDI4736 (Durvalumab) has been evaluated for safety and given a score of 3."

Answered by AI

If a person is below a certain age, can they not participate in this research?

"In order to participate in this study, patients must between 18-130 years old. Out of the 2,887 total clinical trials, 125 are for patients under 18 and 1637 are for patients over 65."

Answered by AI

For what purpose is MEDI4736 (Durvalumab) most often administered?

"MEDI4736 (Durvalumab) can be used to treat patients that have yet to receive treatment, those that have received adjuvant anthracycline-based therapy, and patients with active disease."

Answered by AI

Are there many case studies of MEDI4736 (Durvalumab)'s efficacy?

"MEDI4736 (Durvalumab) was first studied over two decades ago in 1997. Since then, there have been a total of 2345 completed trials. At the moment, 1695 clinical trials are ongoing, a significant number of which are based in Halifax, Nova Scotia."

Answered by AI

Are there different sites where I can participate in this trial?

"There are 27 sites running this study currently. Locations include Halifax, Calgary, Vancouver and a few other places. If you enroll, it may be helpful to choose the site nearest you to cut down on travel."

Answered by AI

Are there any patients who have yet to join this trial?

"This particular clinical trial is no longer seeking patients. The trial was initially posted on November 2nd, 2015 and had its last update on November 2nd, 2022. For individuals interested in other trials, 31 different studies are actively recruiting patients with urothelial cancer and 1695 studies are actively admitting patients for MEDI4736 (Durvalumab)."

Answered by AI

Could I participate in this research project if I qualify?

"This study is looking for 1126 participants of all ages who currently have urothelial cancer. In order to be eligible, patients must meet the following criteria: histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium and have not been previously treated with first-line chemotherapy; patients eligible or ineligible for cisplatin-based chemotherapy; creatinine clearance (calculated or measured) <60 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection for determination; CTCAE Grade ≥2 audiometric"

Answered by AI
~121 spots leftby Mar 2025