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An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies. (STRONG)

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ClinicalTrials.gov Identifier: NCT03084471
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
To evaluate the safety, tolerability, and anti-tumor activity of the combination of durvalumab + tremelimumab or durvalumab alone in different solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Malignancies Biological: MEDI4736 (Durvalumab) Biological: MEDI4736 (Durvalumab) + Tremelimumab Phase 3

Detailed Description:

This is an open-label, multi-center, study to determine the short and long term safety of fixed doses of durvalumab 1500 mg + tremelimumab 75 mg combination therapy or durvalumab 1500 mg monotherapy in patients with advanced solid malignancies. This study is modular in design, one or more of the modules will be opened in a given country / region based on local patient population prevalence, and results of feasibility studies. The total number of patients to be enrolled overall and in each module will depend on the types and number of tumor modules added to the main study and country-specific ancillary studies. The number of patients and sites to be involved in individual countries will be dependent on each module or ancillary study. This study consisted of a screening period, a treatment period, a 90 day safety follow-up period and a survival follow-up period. Patients will receive the investigation product (IP) via intravenous (IV) infusion once every 4 weeks (Q4W) in combination therapy or monotherapy as mentioned below - Combination therapy: Durvalumab 1,500 mg + tremelimumab 75 mg on Week 0, for up to a maximum of 4 doses (or cycles) followed by durvalumab 1,500 mg starting 4 weeks after the last infusion of the combination or discontinuation of tremelimumab.

Monotherapy: Durvalumab 1,500 mg on week 0.

Patients will attend a safety follow-up visit 90 days after study treatment discontinuation. Thereafter, patients will be contacted by phone or electronic communication every 3 months for survival status up to 5 years following date of first patient treatment initiation. All patients will be followed for a minimum of 6 months following enrolment of last patient. It is anticipated that the total enrolment period for the overall study will be approximately 2 to 3 years, with an overall duration of approximately 5 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : March 26, 2023
Estimated Study Completion Date : March 26, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Combination therapy

Combination therapy (durvalumab + tremelimumab) : Patients will receive the combination therapy followed by monotherapy via intravenous (IV) infusion once Q4W:

  • Durvalumab 1,500 mg + tremelimumab 75 mg on Week 0, for up to a maximum of 4 doses (or cycles) and
  • Durvalumab 1,500 mg starting 4 weeks after the last infusion of the combination or discontinuation of tremelimumab.
Biological: MEDI4736 (Durvalumab)
A human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on immune cells (IC).

Biological: MEDI4736 (Durvalumab) + Tremelimumab

Durvalumab: A human mAb of IgG 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on IC.

Tremelimumab: A human Ig G2 mAb that completely blocks the interaction of human CTLA-4 (cluster of differentiation [CD]152) with CD80 and CD86 and increase release of cytokines (interleukin [IL]-2 and interferon [IFN]-γ) from human T cells, peripheral blood mononuclear cells and whole blood.


Experimental: Monotherapy
Monotherapy (Durvalumab 1,500 mg): Patients will receive durvalumab 1,500 mg via IV infusion Q4W on Week 0.
Biological: MEDI4736 (Durvalumab)
A human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on immune cells (IC).




Primary Outcome Measures :
  1. Safety: Number of patients with adverse events of special interest (AESIs). [ Time Frame: From screening to safety follow up visit (90 days after last dose). ]
    To assess the AESIs as a criteria of safety and tolerability variables.


Secondary Outcome Measures :
  1. Safety: Number of patients with treatment-emergent adverse events (TEAEs). [ Time Frame: From screening to safety follow up visit (90 days after last dose). ]
    To assess the incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of TEAEs (including serious adverse events [SAEs])

  2. Safety: Number of patients who discontinued treatment due to TEAEs (including SAEs). [ Time Frame: From screening to safety follow up visit (90 days after last dose). ]
    To assess the incidence and frequency of durvalumab ± tremelimumab discontinuation due to TEAEs (including SAEs)

  3. Safety: Number of patients who had treatment interrupted due to TEAEs (including SAEs). [ Time Frame: From screening to safety follow up visit (90 days after last dose). ]
    To assess the incidence and frequency of durvalumab ± tremelimumab interruption due to TEAEs (including SAEs).

  4. Efficacy: Overall survival (OS) rate [ Time Frame: Up to 5 years following date of first patient treatment initiation. ]
    Overall survival was defined as the time from the first date of treatment until death due to any cause. To assess OS of durvalumab + tremelimumab combination therapy or durvalumab monotherapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must have a life expectancy of at least 12 weeks.
  2. Age ≥ 18 years at the time of screening. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative
  3. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  4. Disease not amendable to curative surgery
  5. Eastern Cooperative Oncology Group (ECOG) performance status as defined in the specific module.
  6. Body weight >30 kg.
  7. No prior exposure to anti-programmed death (PD) 1 or anti-PD-ligand (L) 1.
  8. Adequate organ and marrow function.
  9. Female patients of childbearing potential (i.e., not surgically sterile or post-menopausal) who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy.
  10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:

    • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
    • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  11. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after receipt of the final dose of durvalumab + tremelimumab combination therapy or 90 days after receipt of the final dose of durvalumab monotherapy.

For inclusion in the Module A of the study patients should fulfill the following criteria:

  1. Histologically or cytologicaly confirmed locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract (including the urinary bladder, ureter, urethra and renal pelvis)
  2. Disease that has progressed during or after at least one previous platinum or nonplatinum based chemotherapy, either for metastatic disease or progressive disease less than 12 months after adjuvant or neo-adjuvant chemotherapy
  3. ECOG performance status 0-2

Exclusion Criteria:

  1. Involvement in the planning and/or conduct of the study.
  2. Previous IP assignment in the present study.
  3. Concurrent enrollment in another clinical study or another sub-study of this protocol, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  4. Participation in another clinical study with an IP and receipt of any investigational anticancer therapy during the last / within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
  5. Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment.
  6. Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy).
  7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
  8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
  9. History of allogenic organ transplantation.
  10. Uncontrolled intercurrent illness (ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  11. History of another primary malignancy, leptomeningeal carcinomatosis and active primary immunodeficiency.
  12. Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on baseline brain imaging (please refer to RECIST for details on the imaging modality) obtained during the screening period or identified prior to signing the ICF. Brain metastases will not be recorded as RECIST Target Lesions at baseline.
  13. Active infection including tuberculosis, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (positive HIV ½ antibodies).

14. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab.

15. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).

16) Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.

17) Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic composition to the study drug(s), or any of the study drug excipients.

18) Any unresolved NCI CTCAE Grade ≥2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia, and the laboratory values defined in the inclusion criteria.

19) Pregnant or breastfeeding women or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy.

20) Prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084471


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Locations
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United States, Alaska
Research Site Recruiting
Anchorage, Alaska, United States, 99503
Research Site Not yet recruiting
Anchorage, Alaska, United States, 99508
United States, Arizona
Research Site Withdrawn
Chandler, Arizona, United States, 85224
United States, California
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Escondido, California, United States, 92025
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Los Angeles, California, United States, 90073
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Los Angeles, California, United States, 90095
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Mather, California, United States, 95655
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San Diego, California, United States, 92130-3318
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Santa Rosa, California, United States, 95403
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Whittier, California, United States, 90603
United States, Connecticut
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New Haven, Connecticut, United States, 06510
United States, Delaware
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Newark, Delaware, United States, 19713
United States, District of Columbia
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Washington, District of Columbia, United States, 20007
United States, Florida
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Fort Myers, Florida, United States, 33901
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Miami Lakes, Florida, United States, 33014
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Miami, Florida, United States, 33136
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Orlando, Florida, United States, 32804
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West Palm Beach, Florida, United States, 33401
United States, Georgia
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Athens, Georgia, United States, 30607
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Atlanta, Georgia, United States, 30342
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Decatur, Georgia, United States, 30033-4004
United States, Illinois
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Skokie, Illinois, United States, 60077
Research Site Not yet recruiting
Tinley Park, Illinois, United States, 60487
United States, Iowa
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Ames, Iowa, United States, 50010
United States, Maryland
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Baltimore, Maryland, United States, 21218
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Hagerstown, Maryland, United States, 21742
United States, Michigan
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Ann Arbor, Michigan, United States, 48109
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Lansing, Michigan, United States, 48912
United States, Minnesota
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Minneapolis, Minnesota, United States, 55414
United States, Missouri
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Kansas City, Missouri, United States, 64128
United States, Montana
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Billings, Montana, United States, 59102
United States, Nebraska
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Omaha, Nebraska, United States, 68130
United States, New Jersey
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Hackensack, New Jersey, United States, 07601
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Summit, New Jersey, United States, 07901-3533
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Voorhees, New Jersey, United States, 08043
United States, New York
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East Setauket, New York, United States, 11733
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Lake Success, New York, United States, 11042
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New Hyde Park, New York, United States, 11042
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White Plains, New York, United States, 10601
United States, North Carolina
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Charlotte, North Carolina, United States, 28226
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Greenville, North Carolina, United States, 27834
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Salisbury, North Carolina, United States, 28144
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Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
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Portland, Oregon, United States, 97227-1191
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
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Providence, Rhode Island, United States, 02903
United States, South Carolina
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Greenville, South Carolina, United States, 29607
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Rock Hill, South Carolina, United States, 29732
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Seneca, South Carolina, United States, 29672-9495
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
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Knoxville, Tennessee, United States, 37920
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Nashville, Tennessee, United States, 37203
United States, Texas
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77090
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Tyler, Texas, United States, 75701
United States, Virginia
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Blacksburg, Virginia, United States, 24060
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Chesapeake, Virginia, United States, 23454
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Fairfax, Virginia, United States, 22031
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Fort Belvoir, Virginia, United States, 22060
United States, Washington
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Lacey, Washington, United States, 98503
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Olympia, Washington, United States, 98502
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Spokane, Washington, United States, 99208-1129
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
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Brampton, Ontario, Canada, L6R 3J7
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Hamilton, Ontario, Canada, L8V 5C2
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Kingston, Ontario, Canada, K7L 5P9
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London, Ontario, Canada, N6A 4L6
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Newmarket, Ontario, Canada, L3Y 2P9
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Oshawa, Ontario, Canada, L1G 2B9
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H3G 1A4
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Montreal, Quebec, Canada, H4A 3T2
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Sherbrooke, Quebec, Canada, J1H 5N4
Canada
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Quebec, Canada, G1R 2J6
France
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Besançon Cedex, France, 25030
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Bordeaux Cedex, France, 33075
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Bordeaux, France, 33000
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Brest, France, 29609
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Dijon, France, 21079
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Lille, France, 59000
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Lyon Cedex 08, France, 69373
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Marseille, France, 13005
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Montpellier, France, 34298
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Nice, France, 6189
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Nimes, France, 30029
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Paris, France, 75010
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Pierre Benite, France, 69495
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Poitiers Cedex, France, 86021
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Rouen, France, 76031
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Saint Herblain Cedex, France, 44805
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Strasbourg Cedex, France, 67091
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Toulouse, France, 31059
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Tours CEDEX, France, 37044
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Villejuif, France, 94805
Germany
Research Site Withdrawn
Berlin, Germany, 13125
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Berlin, Germany, 13585
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Bielefeld, Germany, 33611
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Dresden, Germany, 01307
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Duisburg, Germany, 47179
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Düsseldorf, Germany, 40225
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Erlangen, Germany, 91054
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Essen, Germany, 45136
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Guetersloh, Germany, 33332
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Hamburg, Germany, 20246
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Jena, Germany, 07747
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Kiel, Germany, 24116
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Lübeck, Germany, 23538
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Muenster, Germany, 48149
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Münster, Germany, 48149
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Rostock, Germany, 18057
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Stuttgart, Germany, 70174
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Tübingen, Germany, 72076
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Wiesbaden, Germany, 65199
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Würzburg, Germany, 97080
Italy
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Alba, Italy, 15100
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Ancona, Italy, 60126
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Arezzo, Italy, 52100
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Avellino, Italy, 83100
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Bari, Italy, 70124
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Catania, Italy, 95126
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Genova, Italy, 16132
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Lecce, Italy, 73100
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Meldola, Italy, 47014
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Milano, Italy, 20141
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Modena, Italy, 41124
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Padova, Italy, 35128
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Pavia, Italy, 27100
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Perugia, Italy, 06156
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Pisa, Italy, 56126
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Ravenna, Italy, 48100
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Roma, Italy, 00128
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Roma, Italy, 00152
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Rozzano, Italy, 20089
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Udine, Italy, 33100
Korea, Republic of
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Goyang-si, Korea, Republic of, 10408
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Seo-Gu, Korea, Republic of, 49241
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Seoul, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 135-710
Netherlands
Research Site Not yet recruiting
Leeuwarden, Netherlands, 8934 AD
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Leiden, Netherlands, 2333 ZA
Research Site Withdrawn
Tilburg, Netherlands, 5042AD
Switzerland
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Basel, Switzerland, CH-5405
Research Site Withdrawn
Bern, Switzerland, 3010
Research Site Recruiting
Genolier, Switzerland, 1272
United Kingdom
Research Site Not yet recruiting
Glasgow, United Kingdom, G12 0YH
Research Site Recruiting
London, United Kingdom, EC1A 7BE
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London, United Kingdom, SW3 6JJ
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London, United Kingdom, W1G 6AD
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London, United Kingdom, W6 8RF
Research Site Recruiting
Newcastle, United Kingdom, NE7 7DN
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Plymouth, United Kingdom, PL6 8DH
Research Site Withdrawn
Preston, United Kingdom, PR2 9HT
Research Site Recruiting
Sheffield, United Kingdom, S10 2SJ
Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03084471     History of Changes
Other Study ID Numbers: D4191C00068
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AstraZeneca:
Programmed death ligand 1 (PD-L1)
Cytotoxic T-lymphocyte antigen-4 (CTLA-4)
Durvalumab in combination with tremelimumab
Additional relevant MeSH terms:
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Neoplasms
Durvalumab
Tremelimumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs