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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2021-001181-38
    Sponsor's Protocol Code Number:AuspiCiOus
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-26
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-001181-38
    A.3Full title of the trial
    Anti-PD-1, Capecitabine, and Oxaliplatin for the first-line treatment of dMMR esophagogastric cancer (AuspiCiOus-dMMR): a proof-of-principle study
    Anti-PD-1, Capecitabine en Oxaliplatin voor de eerstelijnsbehandeling van dMMR oesofagogastrische kanker (AuspiCiOus-dMMR): een proof-of-principle studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the treatment of patients with gastroesophageal cancer with chemotherapy and immunotherapy based on a non-functioning DNA mismatch repair mechanism in the tumour cells
    Onderzoek naar de behandeling van patiënten met maag-/slokdarmkanker met chemotherapie en immunotherapie op basis van een niet werkend DNA mismatch herstel mechanisme in de tumorcellen
    A.3.2Name or abbreviated title of the trial where available
    AuspiCiOus
    AuspiCiOus
    A.4.1Sponsor's protocol code numberAuspiCiOus
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIncyte
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointStudy Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailmedonc-uppergi@amsterdamumc.nl
    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 nameRetifanlimab
    D.3.2Product code INCMGA00012
    D.3.4Pharmaceutical form 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 INNNot available
    D.3.9.1CAS number 2079108-44-2
    D.3.9.2Current sponsor codeINCMGA00012
    D.3.9.3Other descriptive nameMGA012, retifanlimab
    D.3.9.4EV Substance CodeSUB191459
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Gastroesophageal cancer
    Oesophagus- en maagcarcinoom
    E.1.1.1Medical condition in easily understood language
    Gastroesophageal cancer
    Slokdarm- en maagkanker
    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
    To investigate the effects of the combination of two chemotherapies followed by immunostimulants on the interferon gamma expression and infiltration of cytotoxic T cells in the tumour microenvironment
    Onderzoeken welk effecten de combinatie van twee chemokuren gevolgd door immuunstimulerende middelen heeft op de interferon gamma expressie en infiltratie van cytotoxische T cellen in the tumor microenvironment
    E.2.2Secondary objectives of the trial
    Secondary objectives
    - Overall survival and compare with a propensity score matched cohort from the Dutch randomized phase 2 LyRICX study and Dutch Cancer Registry
    - Progression free survival and compare with a propensity score matched cohort
    - Response rate according to RECIST 1.1
    - Adverse events according to NCI CTCAE version 5.0
    - Quality of life
    - Percentage of patients proceeding to subsequent lines of treatment after progression and describe the types of treatment
    - Reasons for forgoing subsequent treatment after progression

    Exploratory endpoints:
    1 Explore the impact of cytotoxic therapy on the tumor immune microenvironment
    2 Identify candidate markers of response to PD-1 pathway inhibitors and potential aetiologies of de novo or acquired resistance
    3 Explore whether 1 and 2 are related to response to treatment and survival
    4 Patient derived tumor organoids and autologous immune cell co-culturing to asses markers of response to treatment and identify resistance pathways
    Secundaire eindpunten:
    - Algehele overleving en vergelijken met een propensity score gematched cohort uit de Nederlandse gerandomiseerde fase 2 LyRICX studie en de Nederlandse Kanker registratie
    - Progressievrije overleving en vergelijking met een propensity score gematched cohort
    - Response rate volgens RECIST 1.1
    - Bijwerkingen volgens NCI CTC versie 5.0
    - Kwaliteit van leven
    - Percentage patiënten dat aan een volgende lijn behandeling start en de inhoud van die behandelingen
    - Redenen voor het starten van de volgende lijnen van behandeling

    Exploratieve eindpunten:
    1 Bepalen van het effect van cytotoxische therapie op de tumor immuun micro-omgeving
    2 Identificeren van kandidaat-markers van respons op PD-1 pathway remmers
    3 Bepalen of 1 en 2 gerelateerd zijn aan respons op behandeling en overleving
    4 Maken van tumororganoïden van patienten en autologe immuun co-culturen om markers van respons op behandeling te bepalen en resistentiepathways te identificeren
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female adult patients (> 18 years)
    - Primaire tumor or metastasis accessible for repeat fresh histological biopsies
    - dMMR identified by IHC of mismatch repair proteins MLH1, PMS2, MSH2, and MSH6
    - Patients with histologically confirmed diagnosis of metastatic or irresectable HER2 negative adenocarcinoma of the stomach or oesophagus; patients with HER2 positive disease are eligble when treatment with trastuzumab is contraindicated. If histology cannot be obtained, cytology is acceptable to prove metastatic disease
    - Patients with metastatic or irresectable adenocarcinoma of the stomach or oesophagus not pre-treated with chemotherapy or radiotherapy for irresectable or metastatic disease. Palliative radiotherapy on the primary tumor or a metastatic lesion is allowed if other untreated lesions eligble for evaluation are present
    - Measurable disease as assessed by RECIST 1.1
    - ECOG (WHO) performace status 0-2
    - Patient has adequate hepatic, renal and hematological function
    - Volwassen patienten (> 18 jaar)
    - Primaire tumor of metastase beschikbaar voor meerdere biopten
    - dMMR geidentificeerd door IHC of mismatch repair proteins MLH1, PMS2, MSH2, en MSH6
    - Histologisch bewezen gemetastaseerd of irresectabel HER 2 negatief adenocarcinoom van slokdarm of maag
    - Meetbare ziekte volgens RECIST 1.1
    - ECOG (WHO) performance status 2.0
    - Patienten met gemetastaseerd of irresectabel HER 2 negatief adenocarcinoom van slokdarm of de maag di enog niet behandeld zijn met chemotherapie of radiotherapie voor irresectabele of gemetastaseerde ziekte. Palliatieve radiotherapie van de primaire tumor is toegestaan als andere niet behandelde leasies evalueerbaar zijn
    - Patient heeft adequate lever, nier en been merg functies
    E.4Principal exclusion criteria
    - Past or current malginancy other than entry diagnosis interfering with prognosis of metastatic esophagogastric cancer
    - de aanwezigheid van een andere maligniteit die interfereert met de prognose van de slokdarm-maagkanker
    E.5 End points
    E.5.1Primary end point(s)
    Interferon gamma expression and number of infiltrating cytotoxic T cells
    Interferon gamma expressie en aantal infiltrerende cytotoxische T cellen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Fresh tumor biopsies, faeces and blood in week 0, week 6, week 14.
    Extra blood sample in week 7.
    Tumor biopten, bloed en faecus in week 0, week 6 en week 14.
    Extra bloed sample in week 7.
    E.5.2Secondary end point(s)
    - overall survival
    - progression free survival
    - response rate according to RECIST 1.1
    - Adverse events according to NCI CTCAE version 5.0
    - Quality of life
    - Percentage of patients proceeding to subsequent lines of treatment after progression and describe the types of subsequent treatments
    - Reasons for forgoing subsequent treatment after progression
    - Overall survival
    - Response rate volgens RECIST 1.1
    - Bijwerkingen volgens NCI CTC versie 5.0
    - Kwaliteit van leven
    - Percentage van patienten die met een volgende lijn behandeld worden en het beschrijven van die behandeling
    - Redenen voor het doorgaan met een andere lijn na progressie
    E.5.2.1Timepoint(s) of evaluation of this end point
    - CT scan in week 0, week 6, week 14, and every 12th week until progression
    - Laboratory assessment at start of each cycle
    - questionnaire neurotoxicity every 3 weeks, up until week 9
    - questionnaire quality of life every 12 weeks
    - CT scan in week 1, week 6, week 14, en elke 12e week tot progressie
    - Onderzoek van bloed aan het begin van elke cyclus
    - vragenlijst neurotoxiciteit elke 3 weken, tot week 9
    - vragenlijst kwaliteit van leven elke 12 weken
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) 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 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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last visit of the last subject
    Laatste bezoek van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    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 with incurable disease
    Patienten met een ongeneeslijke ziekte
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    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
    geen
    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 Decision2021-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
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