Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001346-34
    Sponsor's Protocol Code Number:IMM-101-015
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-04-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-001346-34
    A.3Full title of the trial
    A Study of the Safety and Efficacy of IMM-101 in Combination with Checkpoint Inhibitor Therapy in Patients with Advanced Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immune Therapy in Combination with Checkpoint Inhibitor Treatment
    A.3.2Name or abbreviated title of the trial where available
    IMM-101 in Combination with Checkpoint Inhibitor Therapy
    A.4.1Sponsor's protocol code numberIMM-101-015
    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 SponsorImmodulon Therapeutics Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportImmodulon Therapeutics Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmodulon Therapeutics Ltd
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address6-9 The Square
    B.5.3.2Town/ cityStockley Park, Uxbridge
    B.5.3.3Post codeUB11 1FW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440203137 6346
    B.5.5Fax number00440208929 9283
    B.5.6E-mailinfo@immodulon.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 nameHeat-killed whole cell Mycobacterium obuense
    D.3.2Product code IMM-101
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMM-101
    D.3.9.3Other descriptive nameIMM-101
    D.3.9.4EV Substance CodeSUB33966
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 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
    Unresectable, Stage III or Stage IV metastatic melanoma who are either previously untreated (cohort A), or whose disease has progressed during PD-1 blockade (cohort B).
    E.1.1.1Medical condition in easily understood language
    Metastatic melanoma that cannot be completely removed through surgery, either previously untreated (cohort A), or whose disease has progressed during treatment with a PD-1 inhibitor (cohort B).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10028980
    E.1.2Term Neoplasm
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    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 evaluate Overall Response Rate (ORR) after a maximum of 18 months treatment, in patients with advanced melanoma receiving IMM-101 plus nivolumab. ORR in both previously untreated patients (cohort A) and in patients whose disease has progressed during PD-1 blockade (cohort B) will be evaluated using RECIST 1.1. ORR will also be assessed for subgroups based on PD-L1 status (positive or negative/undetermined) in cohort A patients.
    • To evaluate the safety and tolerability of the combination of IMM-101 plus nivolumab in patients with advanced melanoma by examining the profile of adverse events experienced.
    E.2.2Secondary objectives of the trial
    • To evaluate Progression-free Survival (PFS) after a maximum of 18 months treatment in patients with advanced melanoma receiving IMM-101 plus nivolumab for both cohort A and cohort B, assessed by RECIST 1.1
    • To evaluate Overall Survival (OS) and OS at 1 year in patients with advanced melanoma for both cohort A and cohort B
    • To evaluate changes in laboratory parameters
    • To evaluate local tolerability (injection site reactions).

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must have a histologically-confirmed diagnosis of advanced (unresectable Stage III) or metastatic (Stage IV) melanoma excluding uveal/ocular melanoma. Patients with unknown primary melanoma are eligible.
    2. Patient has at least one measurable lesion by CT or MRI, according to RECIST 1.1.
    3. Patient must have known BRAF V600 mutation status or consent to BRAF V600 mutation testing during the Screening Period.
    4. Patients who have had prior radiotherapy must have completed this at least 2 weeks prior to study drug administration (Week 0, Visit 1). Prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to enrolment (Week 0, Visit 1), and all related adverse events have resolved or stabilised.
    5. Patient is considered suitable for treatment with nivolumab.
    6. Patient provides signed informed consent for participation in the study.
    7. Patient has an Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) Performance Status of ≤1 at Day 0.
    8. Patient has Screening laboratory values meeting the following criteria. These should be obtained within 14 days prior to first dose on study:
    • Haemoglobin (Hb) ≥9.0g/dL, absolute neutrophil count ≥1.5 x 109/L, platelets ≥100 x 109/L and White Blood Cells (WBC) ≥ 2.0 x 109/L (blood transfusion to achieve these levels are not permitted within 2 weeks of this assessment)
    • Total bilirubin ≤1.5 x upper limit of normal (ULN), excluding cases where elevated bilirubin can be attributed to Gilbert's Syndrome
    • Aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and alanine transaminase (ALT; serum glutamate pyruvate transaminase [SGPT]) each ≤2.5 x ULN or ≤5 x ULN in presence of liver metastases
    • Creatinine ≤1.5 x ULN
    • Serum albumin ≥30g/L
    9. Patient is aged ≥18 years.

    For cohort A, the following inclusion criteria must also be met for a patient to be eligible to participate in this study:
    1. Patient is treatment-naive (i.e. no prior systemic anticancer therapy for unresectable or metastatic melanoma).
    2. Patient must have a tumour sample (archived tissue in the last 3 months or newly obtained biopsy) that is adequate for PD-L1 assessment prior to enrolment.

    For cohort B, the following inclusion criteria must also be met for a patient to be eligible to participate in this study:
    1. Patient is either currently on (or has previously received) treatment with an anti-PD-1 therapy (monotherapy or in combination) for advanced melanoma and has progressive disease by RECIST 1.1 after at least 3 doses of anti-PD-1 given as monotherapy or at least 2 doses of anti-PD-1 given in combination regimes, and has not received any further therapy since for advanced melanoma. The last dose of PD-1 targeted therapy must have been received no more than 12 weeks prior to the start of Screening but more than 6 weeks prior to first IMM-101 administration. For all patients in cohort B, progression must have occurred during the PD-1 targeted treatment and the investigator has deemed it appropriate to continue/start treatment with nivolumab beyond disease progression.
    2. Patients must have recovered from any AEs related to prior anti-PD-1 containing regime to Grade 1 or have resolved.
    3. Patients with a BRAF mutation must have taken BRAF- and/or MEK-targeted therapy, unless patients are not candidates for, or have refused, these therapies. Anti-PD-1 therapy must be the current or last treatment for advanced melanoma prior to study entry.
    E.4Principal exclusion criteria
    1. Patient has uveal/ocular melanoma. .
    2. Patient has active brain metastases or leptomeningeal metastases. Patients with brain metastases are eligible for cohort B of the study only, if these have been treated and there is no MRI evidence of progression for at least 8 weeks after treatment is complete and within 21 days prior to first dose of study treatment administration.
    3. Patient has previously received treatment with IMM-101.
    4. Patient is either receiving concomitant treatment with another investigational product or has received such treatment within the 3 weeks prior to first IMM-101 administration.
    5. Patient has any serious or uncontrolled medical disorder or co existing active infection that, in the opinion of the Investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate.
    6. Patient has any previous or concurrent malignancy. Patients will not be excluded if they have had adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non melanoma skin cancer, or if previous malignancy was more than 5 years prior to Screening and there are no signs of recurrence.
    7. Patient has previously experienced an allergic reaction to any mycobacterial product or any monoclonal antibody.

    For cohort A, patients meeting any of the following criteria are also ineligible to participate in this study:
    1. Patient has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD ligand-1 (PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) agent.

    For cohort B, patients meeting any of the following criteria are also ineligible to participate in this study:
    1. Patient has previously experienced an AE related to anti-PD-1 therapy which, in the investigator's opinion, makes them unsuitable for further treatment with nivolumab.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is:
    • Overall Response Rate (ORR) calculated from the Best Overall Response (BOR) of patients as assessed by RECIST 1.1. For cohort B, ORR will apply to BOR from tumour assessments during IMM-101 plus nivolumab treatment only. ORR and BOR will also be assessed for subgroups based on PD-L1 status (positive or negative/undetermined) in cohort A patients.

    The primary safety endpoint is:
    • Incidence, frequency and severity of AEs, SAEs, treatment related AEs, and immune-related AEs assessed during treatment with IMM-101 plus nivolumab study for both cohorts.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary efficacy and safety endpoints:
    • Assessed when all patients have had the opportunity for a maximum of 18 months study treatment in each cohort or when all patients have withdrawn, if this is sooner. The final analysis may be conducted for each cohort separately or together, depending on recruitment rates.
    • Cohort interim data reviews will be conducted for ORR and incidence, frequency and severity of AEs, when all patients have had the opportunity for 1 year on study (cohort A) and after 6 months on study (cohort B).

    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    • Progression-free survival (PFS) assessed by RECIST 1.1 in patients receiving IMM-101 plus nivolumab.
    • Overall survival (OS) and OS at 1 year for cohort A and B. The median OS (if applicable) and OS rate will be estimated.

    The secondary safety endpoints are:
    • Incidence and frequency of laboratory parameter abnormalities
    • Change from baseline values in laboratory parameter values
    • Incidence and frequency of local injection site reactions
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy and safety endpoints:
    • Assessed when all patients have had the opportunity for a maximum of 18 months study treatment in each cohort or when all patients have withdrawn, if this is sooner. The final analysis may be conducted for each cohort separately or together, depending on recruitment rates.
    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 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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 16
    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 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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 26
    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 will continue until all patients have either withdrawn from the study or completed 18 months’ of treatment with IMM-101. At the end of the study, surviving patients will be treated according to best clinical practice and current hospital protocols. Patients will also be offered the opportunity for continued treatment under a compassionate use or EAP scheme.
    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 Decision2018-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun Apr 28 14:58:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA