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    Summary
    EudraCT Number:2012-000871-17
    Sponsor's Protocol Code Number:AGS-003-007
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-02-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-000871-17
    A.3Full title of the trial
    An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Personalized immune therapy (AGS-003) plus standard treatment for advanced kidney cancer
    A.3.2Name or abbreviated title of the trial where available
    ADAPT
    A.4.1Sponsor's protocol code numberAGS-003-007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01582672
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorArgos Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportArgos Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace GmbH
    B.5.2Functional name of contact pointMedpace Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressGmunder Strasse 53
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81379
    B.5.3.4CountryGermany
    B.5.4Telephone number004989895571860
    B.5.5Fax number0049898955718160
    B.5.6E-mailv.iassonidou@medpace.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAGS-003
    D.3.2Product code AGS-003
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberSomatic cell therapy medicinal product EMA/CAT/511419/2011
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Renal cell carcinoma (RCC)
    E.1.1.1Medical condition in easily understood language
    Kidney cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10038414
    E.1.2Term Renal cell carcinoma stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare overall survival (OS) between study arms in subjects treated with AGS-003 in combination with standard treatment (combination arm) versus active control of standard treatment alone (control arm).
    E.2.2Secondary objectives of the trial
    Safety
    • To compare safety assessments between study arms
    Efficacy
    • To compare progression free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST)1.1 between study arms
    • To compare tumor responses based on RECIST 1.1 between study arms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Advanced disease, histologically assessed as RCC, with a component of clear cell histology
    3. Measurable metastatic disease that can be monitored throughout the course of the study participation per RECIST 1.1
    4. Subjects who are candidates for a first-line therapy initiating with sunitinib
    5. Time from diagnosis to treatment <1 year
    6. Karnofsky Performance Status (KPS) ≥ 80%
    7. Life expectancy of 6 months or greater
    8. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade ≤ 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
    9. Adequate hematologic function, as defined by the following criteria (per the central lab):
    a. Absolute neutrophil count (ANC) ≥ LLN
    b. Platelets ≥ LLN
    c. Hemoglobin (Hgb) ≥ 9.0 g/dL
    10. Adequate renal and hepatic function, as defined by the following criteria:
    a. Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
    − or, if serum creatinine > 1.5 x ULN, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
    b. Total serum bilirubin ≤ 1.5 x ULN
    c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    − or, AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
    11. Adequate coagulation function as defined by the following criteria:
    a. Corrected calcium ≤ 11.5 mg/dL
    b. Activated partial thromboplastin time (PTT) < 1.5 x ULN
    12. Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
    13. Normal ECG or clinically non-significant finding(s) at Screening
    14. Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
    15. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
    16. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
    E.4Principal exclusion criteria
    1. Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy
    2. Prior history of malignancy other than RCC within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer
    3. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
    4. Patients will be excluded if they have 5 or more of the following risk factors at Screening:
    a. Time from diagnosis to treatment <1 year
    b. Hgb < LLN
    c. Corrected calcium > 10.0 mg/dL
    d. KPS < 80%
    e. Neutrophils > ULN
    f. Platelets > ULN
    − Note: Per inclusion criteria, eligible subjects will have a time from diagnosis to treatment of < 1 year and must have good performance status (eg., KPS ≥ 80%).
    5. Planned or elective surgical treatment or radiation therapy post-nephrectomy within 28 days before Visit 1 (Day 0)
    − NOTE: Palliative radiotherapy to metastatic lesion(s) is permitted if it is completed > 28 days before Visit 1 (Day 0) and provided there is at least one measurable lesion that has not been irradiated.
    6. NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)
    7. Clinically significant cardiovascular conditions within 3 months prior to Randomization, including:
    a. Cardiac angioplasty
    b. Myocardial infarction
    c. Unstable angina
    d. Coronary artery by-pass graft or stenting
    e. Class III or IV congestive heart failure (CHF)
    f. Symptomatic peripheral vascular disease
    g. Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
    h. Pulmonary embolism or deep vein thrombosis (DVT)
    i. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥ 2, atrial fibrillation of any grade, or prolongation of the QTc for males > 450 msec and for females > 470 msec as corrected by either the Fridericia or Bazett formula
    j. Left ventricular ejection fraction (LVEF) < LLN as assessed by either echocardiography or multiple gated acquisition (MUGA) scan
    k. Poorly controlled hypertension, defined as a systolic blood pressure (SBP) ≥ 150 mm Hg or diastolic blood pressure (DBP) ≥ 90 mm Hg
    − NOTE: Initiation of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on 2 occasions separated by at least 1 hour. The mean SBP/DBP values must be < 150/90 for a subject to be eligible.
    l. Ongoing treatment with therapeutic doses of warfarin (oral low-dose warfarin up to 2 mg daily for DVT prophylaxis is allowed)
    m. Evidence of active bleeding or a bleeding diathesis at Screening
    8. Significant gastrointestinal abnormalities:
    a. Any history of major resection of the stomach or small bowel
    b. Malabsorption syndrome with active symptoms within 3 months prior to Randomization
    c. Active peptic ulcer within 3 months prior to Randomization
    d. Intra-luminal bleeding lesions within 3 months prior to Randomization
    e. History of abdominal fistula or intra-abdominal abscess within 3 months prior to Randomization
    9. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
    10. Active autoimmune disease or condition requiring chronic immunosuppressive therapy
    − NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary.
    11. Clinically significant infections, including human immunodeficiency virus (HIV), syphilis, and active hepatitis B or C
    12. Current treatment with an investigational therapy on another clinical trial
    13. Pregnancy or breastfeeding
    14. Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    • Overall Survival (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the date of initial subject randomization until 290 deaths have accrued.
    E.5.2Secondary end point(s)
    Safety:
    • Treatment emergent adverse events (AEs)
    • Changes from Baseline values in clinical laboratory tests (hematology, biochemistry, urinalysis)
    • Changes in vital signs, physical examinations, and ECGs
    • Treatment-emergent changes in autoimmunity evaluations as measured by clinical signs and symptoms and laboratory assessments
    Efficacy:
    • Progression-Free Survival (PFS)
    − Progression-free survival from the date of subject randomization as assessed by the investigator per RECIST 1.1.
    − Radiological evidence of progression
    • Stable Disease and Tumor Response
    − The clinical efficacy of AGS-003 in combination with standard treatment will be assessed based on tumor responses per RECIST 1.1 to determine the following:
    o Overall response rate (ORR)
    o Duration of overall response (DR)
    o Disease control rate (DCR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety:
    The safety of multiple administrations of AGS-003 in combination with standard treatment will be assessed by monitoring the following for all study subjects, starting at Visit 2 (Week 6), as this is the first dose of AGS-003 (for subjects randomized to the combination arm)
    Radiological evidence of progression at baseline (Screening) and restaging scans at Weeks 8, 16, 24, 30, 36, 48, then every 12 weeks.
    Efficacy
    Overall survival from day of randomization
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard treatment initiating with Sunitinib
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Germany
    Israel
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Until 290 deaths have accrued
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 315
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    subjects incable of giving consent
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 450
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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