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    Summary
    EudraCT Number:2014-003673-42
    Sponsor's Protocol Code Number:MM-121-01-02-09
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-09-10
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-003673-42
    A.3Full title of the trial
    SHERLOC: A Phase 2 Study of MM-121 in Combination with Docetaxel versus Docetaxel Alone in Patients with Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SHERLOC: A Phase 2 Study of MM-121 in Combination with Chemotherapy versus Chemotherapy Alone in Patients with Heregulin Positive Non-Small Cell Lung Cancer.
    A.4.1Sponsor's protocol code numberMM-121-01-02-09
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02387216
    A.5.4Other Identifiers
    Name:INDNumber:129253
    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 SponsorMerrimack Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportMerrimack Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerrimack Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMM121 Clinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressOne Kendall Square, Suite B7201
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016174411020
    B.5.5Fax number0016174941011
    B.5.6E-mailMM_121_01_02_09_study@merrimack.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 nameSeribantumab
    D.3.2Product code MM-121
    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 INNSeribantumab
    D.3.9.2Current sponsor codeMM-121
    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
    Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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 PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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
    The primary objective of this study is to determine whether the
    combination of MM-121 plus docetaxel is more effective than docetaxel
    alone based on investigator assessed Progression-Free Survival (PFS)
    according to RECIST 1.1 in HRG positive patients (defined as HRG ISH
    score of ≥1+).
    E.2.2Secondary objectives of the trial
    • To determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in HRG positive patients (defined as HRG ISH score of ≥1+) for the following clinical outcome parameters:
    - Overall Survival (OS)
    - Objective Response Rate (ORR) based on RECIST v 1.1
    - Time to Progression (TTP)
    • To describe the safety profile of MM-121 in combination with docetaxel
    • To characterize the pharmacokinetic (PK) profile of MM-121 when
    given in combination with docetaxel and of docetaxel when given in combination with MM-121
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for participation in the study, patients must meet the following criteria. Patients who are assessed to be HRG negative do not complete any screening procedures beyond HRG assessment.
    • Patients with cytologically or histologically documented NSCLC classified as adenocarcinoma that is presenting as either:
    o Stage IV (metastatic disease) or
    o Stage IIIB or IIIC disease not amenable to surgery with curative intent or
    o Recurrent or progressive disease following multimodal therapy (chemotherapy, radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced or metastatic disease)
    • Disease progression or evidence of recurrent disease during or after the last systemic therapy as documented by radiographic assessment
    • Received one prior platinum-based regimen for management of primary or recurrent disease
    • Received nivolumab, pembrolizumab, or other anti-PD-1 or anti-PD-L1 therapy, where available and clinically indicated
    • Clinically eligible for treatment with docetaxel once every three weeks per the investigator's judgment
    • Must have at least one lesion amenable to collection of tissue
    • A positive in-situ hybridization (ISH) test for heregulin with a score of ≥1+, as determined by centralized testing
    • ECOG performance status (PS) of 0 or 1
    • Screening ECG without clinically significant abnormalities
    • Women of childbearing potential, as well as fertile men and their partners, must be willing to abstain from sexual intercourse or to use an effective form of contraception (an effective form of contraception is an oral contraceptive or a double barrier method or as defined by country specific guidelines) during the study and for 6 months, in males and
    females, following the last dose of study drug(s), or greater, as in accordance with the label requirements or institutional guidelines for docetaxel
    • ≥ 18 years of age
    • Able to provide informed consent, or have a legal representative able and willing to do so
    • Patients who have experienced a venous thromboembolic event within 60 days of signing the main consent form should have been treated with anti-coagulants for at least 7 days prior to beginning treatment and for
    the duration of treatment on this study
    E.4Principal exclusion criteria
    To be eligible for randomization, patients must not meet any of the following criteria:
    • Known Anaplastic Lymphoma Kinase (ALK) gene rearrangement
    • Presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene
    • Pregnant or lactating
    • Prior radiation therapy to >25% of bone marrow-bearing areas
    • Received >2 prior lines of systemic anti-cancer drug regimens for locally advanced and/or metastatic disease
    o Any type of maintenance therapy, e.g. pemetrexed maintenance following first line treatment with cisplatin and pemetrexed, is not considered a separate line of therapy
    • Prior treatment with an anti-ErbB3 antibody
    • Prior treatment with docetaxel for advanced/ metastatic disease
    • Received other recent antitumor therapy including:
    o Investigational therapy administered within the 28 days or 5 half-lives, whichever is shorter, prior to the first scheduled day of dosing in this study
    o Radiation or other standard systemic therapy within 14 days prior to the first scheduled dose in this study, including, in addition (if necessary), the timeframe for resolution of any actual or anticipated toxicities from such radiation
    • CTCAE grade 3 or higher peripheral neuropathy
    • Presence of an unexplained fever > 38.5°C during screening visits that does not resolve prior to the first day of dosing. If the fever and active infection have resolved prior to randomization, the patient will be eligible. At the discretion of the investigator, patients with tumor fever may be enrolled.
    • Clinically active CNS metastasis
    • Use of strong CYP3A4 inhibitors
    • Any other active malignancy requiring systemic therapy
    • Known hypersensitivity to any of the components of MM-121 or previous CTCAE grade 3 or higher hypersensitivity reactions to fully human monoclonal antibodies
    • History of severe hypersensitivity reactions to docetaxel
    • Known hypersensitivity to polysorbate (Tween) 80 or arginine
    • Inadequate bone marrow reserve as evidenced by:
    o ANC < 1,500/μl or
    o Platelet count < 100,000/μl or
    o Hemoglobin < 9 g/dL (5.59 mmol/L)
    • Serum/plasma creatinine > 1.5 x ULN
    • Inadequate hepatic function as evidenced by:
    o Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 x ULN concomitant with Alkaline phosphatase (AP) > 2.5 x ULN
    o Serum/plasma total bilirubin > ULN
    • Clinically significant cardiac disease, including: symptomatic congestive heart failure, unstable angina, acute myocardial infarction within 12 months of planned first dose, or unstable cardiac arrhythmia requiring therapy (including torsades de pointes)
    • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; or active human immunodeficiency virus (HIV) infection, active hepatitis B infection or active hepatitis C infection
    • Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is Progression-Free Survival (PFS) based on investigator assessment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS, based on investigator assessment is the primary endpoint of the study. PFS is defined as the time from randomization to the first documented radiographical progression of disease using RECIST 1.1, or death from any cause, whichever comes first.
    E.5.2Secondary end point(s)
    To determine whether the combination of MM-121 plus docetaxel is more
    effective than docetaxel alone in HRG positive patients (defined as HRG
    ISH score of > 1+) for the following clinical outcome parameters:
    o Overall Survival (OS)
    o Objective Response Rate (ORR) based on RECISTv1.1
    o Time to Progression (TTP)
    • To describe the safety profile of MM-121 in combination with docetaxel
    • To characterize the pharmacokinetic (PK) profile of MM-121 when
    given in combination with docetaxel and of docetaxel when given in
    combination with MM-121
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall Survival (OS) is defined as the time from the date of
    randomization to the date of death from any cause. The Kaplan-Meier
    method will be used to estimate median OS for each treatment group.
    Objective response rate (ORR) is determined by RECIST v1.1 (CR+PR).
    An estimate of the ORR and its 95% CI will be calculated.
    TTP is defined as the time from the date of randomization to the date of
    objective tumor progression. Those patients without objective tumor
    progression will be censored at the date of last tumor assessment
    documenting no objective.
    All secondary endpoints will be evaluated as defined in the study protocol.
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker analysis and MM-121 Anti-Immunogenicity
    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 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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Australia
    Canada
    France
    Germany
    Hungary
    Korea, Republic of
    Poland
    Spain
    Taiwan
    Thailand
    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
    It is intended that patients will be treated until radiographic disease
    progression per RECIST 1.1, death or intolerable toxicity, as assessed
    by the investigator. The primary analysis will be event driven. It is
    estimated that the accrual will be approximately 5-6 patients per
    month over an approximately 15 month period.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 135
    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 PFS analysis has been completed, ongoing patients that were randomized to the MM-121 containing treatment arm may continue to receive MM-121 at the discretion of the investigator if the patient is deriving benefit. Merrimack Pharmaceuticals will continue to supply MM-121.
    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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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