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    Summary
    EudraCT Number:2018-002872-42
    Sponsor's Protocol Code Number:D9100C00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-01-28
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-002872-42
    A.3Full title of the trial
    A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer (CALLA).
    Globalne, randomizowane, wieloośrodkowe badanie fazy III prowadzone metodą podwójnie ślepej próby, mające na celu określenie skuteczności i bezpieczeństwa stosowania durwalumabu w skojarzeniu z chemioradioterapią oraz po chemioradioterapii w porównaniu z samą chemioradioterapią u pacjentek z miejscowo zaawansowanym rakiem szyjki macicy (CALLA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Durvalumab + Chemoradiotherapy or Chemoradiotherapy Alone for Women with Locally Advanced Cervical Cancer (CALLA).
    Badanie oceniające zastosowanie durwalumabu w skojarzeniu z chemioradioterapią lub samej chemioradioterapii u kobiet z miejscowo zaawansowanym rakiem szyjki macicy (CALLA)
    A.3.2Name or abbreviated title of the trial where available
    CALLA
    A.4.1Sponsor's protocol code numberD9100C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressSödertälje
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE 151 85
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patient with FIGO (2009) Stages IB2 to IIB Node+ and IIIA to IVA with
    any node. Patients must not have previously received any definitive
    surgical, radiation, or systemic therapy for cervical cancer and must be
    immunotherapy-naïve.
    Pacjentki z rakiem szyjki macicy w stadium od IB2 do IIB N+ i od IIIA do IVA przy dowolnym N według klasyfikacji Międzynarodowej Federacji Ginekologii i Położnictwa (FIGO) 2009. Pacjentki nie mogą wcześniej być poddane żadnemu radykalnemu leczeniu chirurgicznemu, radioterapii ani terapii ogólnoustrojowej z powodu raka szyjki macicy ani nie mogą wcześniej otrzymywać immunoterapii.
    E.1.1.1Medical condition in easily understood language
    Treatment naive patients with cervical cancer
    Pacjentki z rakiem szyjki macicy nie poddane uprzedniemu leczeniu.
    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 assess the efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of Progression-Free Survival (PFS)
    Ocena skuteczności durwalumabu + standardowe leczenie jednoczasową chemioradioterapią (SoC CCRT) w porównaniu z placebo + SoC CCRT pod względem czasu przeżycia bez progresji choroby (PFS)
    E.2.2Secondary objectives of the trial
    1. To further assess the efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of overall survival(OS), PFS and OS in PD-L1 positive patients, objective response rate(ORR), complete response (CR) rate, progression-free at 3 years (PFS 3 year), and DoR in Patients with CR.
    2. To assess the effect of durvalumab + SoC CCRT compared with placebo + SoC CCRT on the incidence of local progression, distant disease progression, and secondary malignancy as the first documented progression event.
    3. To assess disease-related symptoms and health-related quality of life (HRQoL) in patients with cervical cancer treated with durvalumab + SoC CCRT compared with placebo + SoC CCRT using the core quality of life questionnaire (EORTC QLQ-C30) and core quality of life questionnaire cervical cancer module (CX24).
    4. To assess the PK of durvalumab when in combination with CCRT.
    5. To investigate the immunogenicity of durvalumab in both arms in combination with CCRT.
    1.Dalsza ocena skuteczności durwalumabu + SoC CCRT vs placebo + SoC CCRT pod względem całkowitego czasu przeżycia (OS), PFS i OS u pacjentek z dodatnim PD L1, wskaźnika odsetka odpowiedzi obiektywnych (ORR), odpowiedzi całkowitej (CR), czasu przeżycie bez progresji choroby po 3 latach (PFS 3) i czasu trwania odpowiedzi (DoR) u pacjentek z CR;
    2.Ocena wpływu durwalumabu + SoC CCRT vs placebo + SoC CCRT na częstość występowania miejscowej progresji, progresji choroby odległej i wtórnego nowotworu złośliwego jako 1. udokumentowanego zdarzenia związanego z progresją;
    3.Ocena objawów związanych z chorobą i jakości życia uwarunkowanej stanem zdrowia (HRQoL) u pacjentek z rakiem szyjki macicy leczonych durwalumabem + SoC CCRT vs placebo + SoC CCRT z wykorzystaniem kwestionariusza EORTC QLQ C30 i modułu raka szyjki macicy kwestionariusza CX24;
    4.Ocena PK durwalumabu stosowanego w skojarzeniu z CCRT;
    5.Ocena immunogenności durwalumabu w obu ramionach stosowanego w skojarzeniu z CCRT .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female
    2. Aged at least 18 years
    3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any nodal status.
    4. No prior chemotherapy or radiotherapy for cervical cancer
    5. WHO/ECOG performance status of 0-1
    6. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.
    1. Kobiety
    2. Wiek ≥18 lat
    3. Potwierdzony histologicznie gruczolakorak szyjki macicy lub rak płaskonabłonkowy szyjki macicy w stadium wg FIGO (2009) od IB2 do IIB z zajęciem węzłów chłonnych (N≥1) -albo- stadium wg FIGO (2009) od IIIA do IVA z dowolnym statusem N (N≥0);
    4. Pacjentki z rakiem szyjki macicy wcześniej niepoddane leczeniu z zastosowaniem chemioterpii lub radioterapii;
    5. Stan sprawności (PS) równy 0 lub 1 w skali Światowej Organizacji Zdrowia (WHO)/ECOG;
    6. Co najmniej 1 zmiana, która nie była wcześniej naświetlana i którą można uznać za zmianę wybraną do oceny zgodnie z kryteriami RECIST 1.1 podczas oceny wyjściowej.
    E.4Principal exclusion criteria
    1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer
    2. Intent to administer a fertility-sparing treatment regimen
    3. Undergone a previous hysterectomy
    4. Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body, in the inguinal region or outside the planned radiation field.
    5. History of allogeneic organ transplantation
    6. Active or prior documented autoimmune or inflammatory disorders
    7. Uncontrolled intercurrent illness
    8. History of another primary malignancy and active primary immunodeficiency
    1. Rozpoznanie raka szyjki macicy o typie histologicznym drobnokomórkowym
    (neuroendokrynnym) lub gruczolakoraka śluzowego szyjki macicy;
    2. Zamiar zastosowania schematu leczenia oszczędzającego płodność
    3. Pacjentki, u których w przeszłości wykonano histerektomię
    4. Oznaki występowania choroby przerzutowej zgodnie z kryteriami RECIST 1.1, w tym obecność węzłów chłonnych o średnicy ≥15 mm (w osi krótkiej) powyżej trzonu kręgu L1, w okolicy pachwinowej, bądź poza planowanym polem napromieniania;
    5. Stan po allogenicznym przeszczepieniu narządu
    6. Udokumentowane aktywne lub wcześniej przebyte choroby autoimmunologiczne lub zapalne;
    7. Niekontrolowane choroby współistniejące;
    8. Inny pierwotny nowotwór złośliwy i aktywny pierwotny niedobór immunologiczny w wywiadzie
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) per RECIST 1.1 or histopathologic confirmation of local tumor progression
    Czas przeżycia bez progresji choroby (PFS) według kryteriów RECIST 1.1 lub potwierdzenie histopatologiczne miejscowej progresji nowotworu.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Estimated to be from the time of randomization up to 4.5 years
    Zakładany okres ewaluacji – od daty randomizacji do 4,5 roku
    E.5.2Secondary end point(s)
    1. Overall Survival (OS)
    2. Objective Response Rate (ORR)
    3. Complete Response (CR) rate
    4. Duration of Response (DoR) in patients with a Complete Response (CR)
    5. Health-related quality of life (HRQoL) measured by EORTC QLQ-C30 and core quality of life questionnaire cervical cancer module (CX24).
    6. PK and ADA of durvalumab in both arms in combination with CCRT
    7. Progression-free Survival(PFS) and Overall Survival (OS) in PD-L1 high patients
    8. Proportion of patients alive and progression-free at 3 years
    9. Incidence of Local Progression, Distant Disease Progression, and Secondary Malignancy: Number and percentage of patients who develop local progression, distant disease recurrence, or secondary malignancy
    1.całkowity czas przeżycia (OS);
    2.odsetek odpowiedzi obiektywnych (ORR);
    3.odsetek odpowiedzi całkowitej (CR);
    4.czas trwania odpowiedzi (DoR) u pacjentek z odpowiedzią całkowitą (CR);
    5.objawy związane z chorobą i jakość życia uwarunkowane stanem zdrowia (HRQoL) z wykorzystaniem kwestionariusza jakości życia (EORTC QLQ C30) i modułu raka szyjki macicy podstawowego kwestionariusza jakości życia (CX24);
    6.farmakokinetyka oraz obecność przeciwciał przeciwko lekowi (ADA) durwalumab, w obu ramionach, w skojarzeniu z jednoczasową chemioradioterapią (CCRT);
    7.czas przeżycia bez progresji choroby (PFS) i całkowity czas przeżycia (OS) u pacjentek z wysokim PD-L1;
    8.odsetek pacjentów żyjących oraz wolnych od progresji choroby po 3 latach;
    9.przypadki wystąpienie miejscowej progresji, progresji choroby odległej oraz wtórnego nowotworu złośliwego: liczba i odsetek pacjentów, u których doszło do miejscowej progresji, progresji choroby odległej oraz wtórnego nowotworu złośliwego.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During treatment and through to study completion, up to
    approximately 4 years.
    2. During treatment and through to database lock, up to approximately
    3.5 years.
    3. During treatment and through to database lock, up to approximately
    5 months.
    4. During treatment and through to database lock, up to approximately
    3.5 years.
    5. During treatment and through to database lock, up to approximately
    3.5 years.
    6. During treatment and through to 180 days after last dose of
    investigational product.
    7. During treatment and through to database lock, up to approximately
    3.5 years.
    8. During treatment and through to database lock, up to approximately 3.5 years.
    9. During treatment and through to database lock, up to approximately 3.5 years
    1. Podczas leczenia aż do zakończenia badania, przez około 4 lat;
    2. Podczas leczenia do czasu zamknięcia bazy danych, przez około 3,5 roku;
    3. Podczas leczenia do czasu zamknięcia bazy danych, przez około 5 miesięcy;
    4. Podczas leczenia do czasu zamknięcia bazy danych, przez około 3,5 roku;
    5. Podczas leczenia do czasu zamknięcia bazy danych, przez około 3,5 roku;
    6. Podczas leczenia do ok. 180 dni po podaniu ostatniej dawki badanego produktu;
    7. Podczas leczenia do czasu zamknięcia bazy danych, przez około 3,5 roku.
    8. Podczas leczenia do czasu zamknięcia bazy danych, przez około 3,5 roku.
    9. Podczas leczenia do czasu zamknięcia bazy danych, przez około 3,5 roku.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Brazil
    Chile
    China
    India
    Japan
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Russian Federation
    South Africa
    Taiwan
    United States
    Hungary
    Poland
    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 Subject Last Visit(LSLV)
    Last Subject Last Visit(LSLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    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: 571
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 143
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients or their legally authorized representative will be required to sign a statement of informed consent that meets the requirements
    Zgodnie z obowiązującymi przepisami pacjentka lub jej prawny przedstawiciel będą musieli wyrazić zgodę na udział w badaniu.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 714
    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)
    After the final analysis, AstraZeneca will continue to supply open-label study medication to patients who had not completed 24 doses of study therapy up to the time that they discontinue the treatment for whatever reason.
    Po finalnej analizie , AstraZeneca będzie kontynuowała dostawy leków w ramach badania otwartego (open-label) pacjentkom, które nie zakończyły terapii 24 dawek leku badanego, aż do momentu zaprzestania leczenia z jakiegokolwiek powodu.
    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 Decision2019-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-03
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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