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    The EU Clinical Trials Register currently displays   44138   clinical trials with a EudraCT protocol, of which   7324   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-000662-38
    Sponsor's Protocol Code Number:D419NC00001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-06
    Trial results View 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 ConcernedFrance - ANSM
    A.2EudraCT number2016-000662-38
    A.3Full title of the trial
    A Phase 1 Study of Durvalumab and IPH2201 in Adult Subjects with Select
    Advanced Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the study drugs Durvalumab and IPH2201 for use in
    patients with cancer.
    A.4.1Sponsor's protocol code numberD419NC00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02671435
    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 SponsorMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    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 supportMedimmune LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedimmune LLC
    B.5.2Functional name of contact pointAstraZeneca Study Info. Center
    B.5.3 Address:
    B.5.3.1Street AddressOne Medimmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18772409479
    B.5.5Fax number+18772409479
    B.5.6E-mailinformation.center@astrazeneca.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 nameDurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMedi4736
    D.3.9.3Other descriptive nameImmunoglobulin G1, anti-human CD antigen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 No
    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 Yes
    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.IMP: 2
    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 nameIPH2201
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMonalizumab
    D.3.9.3Other descriptive nameIPH2201
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 No
    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 Yes
    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
    Advanced solid tumor
    E.1.1.1Medical condition in easily understood language
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    To assess safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose level in the absence of establishing an MTD of durvalumab in combination with IPH2201 in subjects with advanced solid tumors.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    1. To determine the preliminary antitumor activity of durvalumab in combination with IPH2201 based on Response Evaluation criteria in Solid Tumors (RECIST) v1.1
    2. To describe the pharmacokinetics (PK) of durvalumab in combination with IPH2201 and the PK of IPH2201 in combination with durvalumab
    3. To describe the immunogenicity of durvalumab in combination with IPH2201 and the immunogenicity of IPH2201 in combination with durvalumab
    4. To characterize the association between clinical outcomes to durvalumab in combination with IPH2201 and/or expression of PD-L1 and human leukocyte antigen (HLA-E) within the tumor microenvironment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must have received and have progressed or are refractory to at least one line of standard systemic therapy in the recurrent/metastatic setting, appropriate for the specific tumor type. In addition, subjects must meet all of the tumor specific criteria specified in the protocol, with documented progression from previous therapy at study entry. Interval progression between two lines of therapy defines separate lines of therapy. Both standard and investigational treatments will count as lines of therapy when determining eligibility.
    2. Subjects must have at least one lesion that is measurable by RECIST v1.1 (Eisenhauer et al, 2009).
    3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
    4. As of Week 1 Day 1, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic and meet the following:
    a. No concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids
    b. At least 28 days after CNS treatment, clinically stable with no symptoms of CNS metastasis or sequelae of radiation and at least 14 days since last dose of corticosteroids
    NOTE: Subjects with clinical symptoms or cord compression or with leptomeningeal disease are excluded from the study
    5. Adequate organ function as determined by:
    a. Hematological (criteria i – iii cannot be met with recent blood transfusions or require ongoing growth factor support within 2 weeks of starting study treatment):
    i. Absolute neutrophil count ≥ 1.5 × 109/L (1,500/mm3)
    ii. Platelet count ≥ 100 × 109/L (100,000/mm3)
    iii. Hemoglobin ≥ 9.0 g/dL within first 2 weeks prior to first dose
    b. Renal: Calculated creatinine clearance* (CrCl) or 24 hour urine CrCl > 50 mL/min
    c. Hepatic:
    i. TBL ≤ 1.5 × ULN; for subjects with documented/suspected Gilbert's disease, bilirubin ≤ 3 × ULN
    ii. AST and ALT ≤ 2.5 × ULN (AST/ALT can be up to 5 × ULN in the presence of liver metastasis, but cannot be associated with elevated bilirubin)
    E.4Principal exclusion criteria
    1. Prior treatment with immunotherapy agents including, but not limited to tumor necrosis factor receptor superfamily agonists or checkpoint inhibitors or NK cell inhibitors including agents targeting KIR, PD-1, PDL1, CTLA-4, OX40, CD27, CD137 (4-1BB), CD357 (GITR), and CD40. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
    2. Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint havenot yet been completed
    3. Known allergic reaction to any component of durvalumab or IPH2201
    4. Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study
    5. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of durvalumab and IPH2201
    6. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for noncancer- related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable. Local treatment (eg, by local
    surgery or radiotherapy) of isolated lesions for palliative intent is acceptable beyond the DLT evaluation period with prior consultation and in agreement with the medical monitor.
    7. Receipt of live attenuated vaccines within 30 days prior to the first dose of investigational products. Subjects, if enrolled, should not receive live or live attenuated vaccine during the study and 30 days after the last dose of investigational products.
    8. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be
    exacerbated by the study drug may be included (eg, hearing loss) after consultation with the medical monitor
    9. Current or prior use of immunosuppressive medication within 14 days before the first dose. The following are exceptions to this criterion:
    a. Intranasal, inhaled, topical steroids or local steroid injections (eg, intra-articular injection), OR
    b. systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent, OR
    c. steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication)
    10. History of primary immunodeficiency or allogeneic transplantation
    11. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease, Wegner syndrome) within the past 2 years. Subjects with vitiligo, alopecia, Grave's disease, hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded
    12. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from durvalumab and IPH2201, or compromise the ability of the subject to give written informed consent
    13. Major surgery (as defined by the investigator) within 28 days prior to first dose of durvalumab and IPH2201 or still recovering from prior surgery. Local surgery of isolated lesions for palliative intent is acceptable.
    14. Positive test results for human immunodeficiency virus, acute hepatitis A, active hepatitis B, or C
    15. Females who are pregnant, lactating, or intend to become pregnant during their participation in this study
    16. Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured. Subjects with localized malignancy that was treated with curative intent (eg, localized breast cancer, prostate cancer) and who remain disease free and are considered of low likelihood for recurrence may be enrolled on a case by case basis with prior discussion and in agreement with the sponsor's medical monitor.
    17. Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is safety as assessed by presence of AEs, SAEs, DLTs, abnormal laboratory parameters, vital signs, and electrocardiogram (ECG) results. AEs will be graded according to the NCI CTCAE v4.03.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    E.5.2Secondary end point(s)
    1. The endpoints for assessment of antitumor activity based on RECIST v1.1 will include objective response (OR), disease control (DC), duration of response (DoR), progression-free survival (PFS), and OS.
    2. The endpoints for assessment of PK of durvalumab and IPH2201 include individual subject concentrations in serum at different time points after administration of both agents. PK parameters that may be modeled on this data include, but are not limited to, peak concentration (Cmax), area under the concentration-time curve (AUC), clearance (CL), and terminal elimination half-life (t1/2).
    3. The endpoints for assessment of immunogenicity of durvalumab and IPH2201 include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
    4. The endpoints for assessment of biomarkers predicting subject clinical outcomes will include expression of PD-L1 and HLA-E in tumor biopsies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First Administration to cancer subjects
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    France
    Hungary
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    5 years after the final subject is enrolled or the date the study is closed
    by the sponsor, whichever occurs first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 190
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 42
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 208
    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)
    The study treatment will be provided until unacceptable toxicity, documentation of confirmed progressive disease, or subject withdrawal for another reason.
    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 Decision2017-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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