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    Summary
    EudraCT Number:2020-000451-12
    Sponsor's Protocol Code Number:BNT122-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-12-10
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-000451-12
    A.3Full title of the trial
    A multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457 versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A global study to evaluate efficacy of cancer vaccine RO7198457 versus watchful waiting in a population of patients with colorectal cancer who are at a higher risk of disease progression.
    A.4.1Sponsor's protocol code numberBNT122-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04486378
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1250-5294
    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 SponsorBioNTech SE
    B.1.3.4CountryGermany
    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 supportBioNTech SE
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioNTech SE
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address An der Goldgrube 12
    B.5.3.2Town/ city Mainz
    B.5.3.3Post code 55131
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 (0)6131 9084 – 0
    B.5.5Fax number+49 (0)6131 9084 – 392010
    B.5.6E-mailchirag.patel@biontech.us
    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 nameRO7198457
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNn/a
    D.3.9.1CAS number 2365453-34-3
    D.3.9.2Current sponsor codeRO7198457
    D.3.9.3Other descriptive nameautogene cevumeran
    D.3.9.4EV Substance CodeSUB188166
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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 No
    D.3.11.3.2Gene therapy medical product Yes
    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 numberGene therapy medicinal product (EMA/608944/2018)
    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 Yes
    D.3.11.13.1Other medicinal product typeRO7198457 is an individualized neoantigen specific immunotherapy that uses a single-stranded RNA molecule encoding cancer neoantigens encapsulated in a lipoplex formulation (RNA-Lipoplex)
    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
    Colorectal cancer (Stage II [high risk] and Stage III)
    E.1.1.1Medical condition in easily understood language
    Patient with a high risk form of cancer affecting the colon and rectum.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10010034
    E.1.2Term Colorectal cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10010033
    E.1.2Term Colorectal cancer stage II
    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 demonstrate superiority of RO7198457 compared to “watchful waiting” in terms of Disease Free Survival (DFS) (i.e., prolonged DFS time) in chemotherapy pretreated patients.
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of RO7198457 compared to “watchful waiting” in terms of relapse-free survival (RFS), time to recurrence (TTR) time to treatment failure (TTF), and overall survival (OS).
    -To assess anti-tumor efficacy.
    -To assess the safety and tolerability of RO7198457.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must be a man or woman of at least 18 years of age.
    2. Patients must have given informed consent indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial.
    3. Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per AJCC 2017 that has been surgically totally resected (R0 confirmed by pathology report).
    4. Patients must have detectable ctDNA prior to start of AdCTx (except for the Biomarker Cohort), detected with the Avenio Oncology Assay (AOA) Surveillance Test.
    5. Patients must have an ECOG Performance Status of 0-1.
    6. Patients must have organ and bone marrow function, in line with the criteria further detailed in the protocol.
    E.4Principal exclusion criteria
    1. Patients with uncontrolled intercurrent illness, including any of but not limited to the criteria outlined in the protocol.
    2. Diagnosed Microsatellite instability (MSI) high tumors.
    3. Prior therapy with any of the medications further detailed in the protocol.
    4. Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
    5. Patients who are breastfeeding at screening visits 2 or 3, or who plan to breastfeed during the trial, starting after the start of treatment with RO7198457 and continuously until at least 90 d after receiving the last dose of RO7198457, further detailed in the protocol
    6. Patients who have had prior splenectomy.
    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival (DFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the time from randomization to occurrence of any of the following events, whichever occurs first:

    -Locoregional recurrence or distant metastases as determined by an independent central radiology assessment.
    -Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment.
    -Death from any cause.
    -Loss to follow-up is censored.
    E.5.2Secondary end point(s)
    -Relapse Free Survival (RFS)
    -Time to recurrence (TTR)
    -Time to treatment failure (TTF)
    -Overall survival (OS)
    -Change of Circulating tumor DNA (ctDNA) status
    -Occurrence of treatment emergent adverse events (TEAEs), including Grade 3+, serious, fatal TEAEs by relationship.
    -Occurrence of dose reduction and discontinuation of R07198457 due to a TEAE
    E.5.2.1Timepoint(s) of evaluation of this end point
    From randomization to occurrence of any of the following events, whichever occurs first:

    Locoregional recurrence or distant metastases as determined by the investigator
    Death from any cause (RFS, OS)
    Death from same cancer (TTR)
    Death from any cause except non-cancer related death (TTF)
    Occurrence of second primary (same or other) cancer as determined by the investigator is ignored (RFS, TTR)
    Occurrence of second primary (same or other) cancer as determined by the investigator (TTF)
    Loss to follow-up is censored (RFS)
    Loss to follow-up and deaths from other cancer, non-cancer-related deaths, treatment-related deaths are censored (TTR)
    Loss to follow-up and non–cancer-related deaths are censored (TTF)

    ctDNA status: every 3 months.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3.1Comparator description
    "Watchful waiting" control arm
    E.8.2.4Number of treatment arms in the trial3
    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 concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    United States
    Belgium
    Germany
    Spain
    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
    The end of the trial will be declared at the time at which:

    -All patients have discontinued RO7198457 treatment; and
    -All patients have completed safety follow-up assessment at day 90 subsequent to last dose; and
    -The primary analyses are mature to be performed (i.e., at least 124 events have occurred); and
    -All patients have been followed-up for at least 48 months subsequent to first dose/randomization, are lost to follow-up or have died.
    or
    -The sponsor discontinues the trial.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months10
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 136
    F.4.2.2In the whole clinical trial 199
    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)
    Patients will receive standard of care following the trial; no treatment with RO7198457 is planned after the end of the trial.
    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 Decision2020-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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