Study of MEDI4736 With or Without Tremelimumab Versus Standard of Care Chem... | Recruiting
Study of MEDI4736 With or Without T... | Recruiting
Study of MEDI4736 With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

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Medical Conditions
  • Urothelial Cancer
Primary Contact Details
AstraZeneca Clinical Study Information Center
1-877-240-9479
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02516241
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer
Research Details
  • This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of MEDI4736 monotherapy and MEDI4736 in combination with tremelimumab versus SoC (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) first-line chemotherapy in treatment-naïve patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) and to allow sufficient flexibility for Investigators and patients to select the agents that reflect their normal clinical practice and national guidelines. The patients enrolled in the study will be randomized 1:1:1 to receive treatment with combination therapy, monotherapy, or SoC (cisplatin + gemcitabine or carboplatin + gemcitabine, based on cisplatin eligibility). Patients will be treated with MEDI4736 or MEDI4736 with tremelimumab, or treated with SoC until progressive disease (PD) is confirmed, unacceptable toxicity occurs, withdrawal of consent, or another discontinuation criterion is met. Patients will be followed for up to 2 years.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : MEDI4736, Drug : Tremelimumab, Drug : Cisplatin, Drug : Carboplatin, Drug : Gemcitabine

Study Arm Groups : Combination Therapy, Monotherapy, Combination Therapy, Standard of Care, Standard of Care, Standard of Care

Intervention Type
See Interventions above
Primary Outcome Measures
    The efficacy of MEDI4736 + tremelimumab combination therapy compared to Standard of Care (SoC) in terms of Progression-Free Survival (PFS) and Overall Survival (OS) in patients with Urothelial Cancer (UC); Up to 4 years
Secondary Outcome Measures
    The efficacy of MEDI4736 monotherapy compared to SoC in terms of PFS and OS in patients with UC; 4 years; Health related quality of life (HRQoL) in patients treated with MEDI4736 + tremelimumab or MEDI4736 compared to SoC using the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-BL) questionnaire; 4 years; The pharmacokinetics (PK) - Peak concentration (Cmax) of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy; up to 6 months; The pharmacokinetics (PK) - Trough concentration (Ctrough) of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy; up to 6 months; The immunogenicity of MEDI4736 and tremelimumab combination therapy and MEDI4736 monotherapy; 4 years; The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Objective Response Rate (ORR); 4 years; The efficacy of MEDI4736 monotherapy compared to SoC in terms of ORR; 4 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - 130 Years
Who Can Participate
Patients
Number of Participants
1005
Participant Inclusion Criteria
    Inclusion Criteria:

    - 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.

    - Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: • 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 • Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss • CTCAE Grade ≥2 peripheral neuropathy • New York Heart Association ≥Class III heart failure.

    - Tumor PD-L1 status, with Immunohistochemical (IHC) assay confirmed by a reference laboratory, must be known prior to randomization.

    Exclusion Criteria:

    - Prior exposure to immune-mediated therapy, including but not limited to, other anti cytotoxic T-lymphocyte-associated protein 4 (CTLA 4), anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment.

    - History of allogenic organ transplantation that requires use of immunosuppressive agents.

    - Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion: • Patients with vitiligo or alopecia • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement • Any chronic skin condition that does not require systemic therapy • Patients without active disease in the last 3 years may be included but only after consultation with AstraZeneca • Patients with celiac disease controlled by diet alone may be included but only after consultation with AstraZeneca.

    - Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids for at least 14 days prior to the start of study treatment. Patients with suspected or known brain metastases at screening should have an MRI (preferred)/CT, preferably with IV contrast to access baseline disease status.

    - Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

    - Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection) • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).

    - Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Southampton General Hospital
Southampton
England
SO16 6YD
London
EC1A 7BE
GSK Investigational Site
Cambridge
CB2 0QQ
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Guy's Hospital
London
SE1 9RT
Sheffield
S10 2SJ
Glasgow
G12 0YN
The Clatterbridge Cancer Centre NHS Foundation Trust
Birkenhead
CH63 4JY
Research Site
Cardiff.
CF14 2TL
Trial Contact(s)
Primary Trial Contact
AstraZeneca Clinical Study Information Center
1-877-240-9479
Other Trial Contacts
AstraZeneca Cancer Study Locator Service
1-877-400-4656
Countries Recruiting
Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
D419BC00001
Sponsor(s)
AstraZeneca
Key Dates

Recruitment Start Date

Nov 2015

Recruitment End Date

Apr 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

13 Jul 2015

Date updated in source

16 Aug 2017