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    Summary
    EudraCT Number:2019-001138-32
    Sponsor's Protocol Code Number:208887
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-11
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-001138-32
    A.3Full title of the trial
    A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study GSK2857916 as Monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) – DREAMM 5
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Platform Study of GSK2857916 as monotherapy and in combination with anti-cancer treatmentsin participants with RRMM
    A.4.1Sponsor's protocol code number208887
    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 SponsorGlaxoSmithKline Research & Development 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 supportGlaxoSmithKline, Research and Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0800 783 9733
    B.5.5Fax numberNot Applicable
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1925
    D.3 Description of the IMP
    D.3.1Product nameGSK2857916
    D.3.2Product code GSK2857916
    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 INNbelantamab mafodotin
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGSK2857916
    D.3.9.3Other descriptive nameGSK2857916
    D.3.9.4EV Substance CodeSUB130430
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeGSK2857916 is a Humanized afucosylated, maleimidocaproyl monomethyl auristatin phenylalanine (mcMMAF) conjugated IgG1 antibody.
    D.IMP: 2
    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 nameGSK3174998
    D.3.2Product code GSK3174998
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNGSK3174998
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGSK3174998
    D.3.9.3Other descriptive nameGSK3174998
    D.3.9.4EV Substance CodeSUB178364
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number8 to 24
    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.IMP: 3
    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 nameGSK3359609
    D.3.2Product code GSK3359609
    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 INNGSK3359609
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGSK3359609
    D.3.9.3Other descriptive nameGSK3359609
    D.3.9.4EV Substance CodeSUB181939
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number8 to 80
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized, engineered IgG4 monoclonal antibody
    D.IMP: 4
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2214
    D.3 Description of the IMP
    D.3.1Product nameNirogacestat
    D.3.2Product code PF-03084014
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIROGACESTAT
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codePF-03084014
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeSUB188628
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    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) 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
    Relapsed/Refractory Multiple Myeloma
    E.1.1.1Medical condition in easily understood language
    Relapsed/Refractory Multiple Myeloma
    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 LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of GSK’916 (belantamab mafodotin) in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each combination treatment to explore in the CE Phase

    Cohort Expansion
    To assess the clinical activity of GSK’916 (belantamab mafodotin) at the RP2D in combination with anti-cancer treatments compared to GSK’916 (belantamab mafodotin) monotherapy in participants with RRMM
    E.2.2Secondary objectives of the trial
    DE Key Secondary
    To evaluate the clinical measures of efficacy of GSK'916 (belantamab mafodotin) and combination treatments in participants with RRMM

    Secondary
    To further evaluate the clinical measures of efficacy of GSK’916 (belantamab mafodotin) and combination treatments in each sub-study in participants with RRMM

    CE
    Secondary
    To further assess clinical activity of combination treatments with GSK'916 (belantamab mafodotin) at the RP2D compared with monotherapy in participants with RRMM

    Refer to the protocol for remaining Dose Exploration & Cohort Expansion secondary points.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SUB-STUDY 1 – GSK’916 (BELANTAMAB MAFODOTIN) AND GSK’998 (AOX40) (GSK3174998)

    SUB-STUDY 2 – GSK’916 (BELANTAMAB MAFODOTIN) AND GSK’609 (AICOS) (GSK3359609)

    SUB-STUDY 3 – GSK’916 (BELANTAMAB MAFODOTIN) AND NIROGACESTAT
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the criteria in Section 5.1 and Section 5.2 apply. In addition, participants must fulfil additional inclusion/exclusion criteria for at least 1 partner combination sub-study. Criteria for each individual substudy can be found in the respective sub-study protocol sections, starting in Section 11.

    Age
    1. Participant must be 18 years of age inclusive or older, at the time of signing the informed consent.

    Type of Participant and Disease Characteristics
    2. Participants who have histologically or cytologically confirmed diagnosis of MM,as defined by the International Myeloma Working Group(IMWG, [Rajkumar, 2014]).

    3. Participants who have been treated with at least 3 prior lines of anti-myeloma treatments including an IMID (eg. lenalidomide), a proteasome inhibitor (eg. bortezomib) and an anti-CD38 monoclonal antibody. Lines of therapy are defined by consensus panel of the International Myeloma Workshop [Rajkumar, 2011a].

    4. Participants with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met:
    a. transplant was >100 days prior to screening
    b. no active infection(s)

    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

    6. Measurable disease defined as at least 1 of the following:
    • Serum M-protein ≥0.5 g/dL (≥5 g/L)
    • Urine M-protein ≥200 mg/24 hours
    • Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)

    7. Have organ system functions as defined by the laboratory assessments in Table 13:

    8. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI -CTCAE], version 5.0, 2017) must be Grade ≤1 at the time of screening except for alopecia (any grade), neuropathy (Grade ≤2), or endocrinopathy managed with replacement therapy (any grade).

    Sex
    9. Male or female
    Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see Appendix 7,Section 17.7 for further details).

    a. Male Participants:
    Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in the clinical studies.
    Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm:
    Refrain from donating sperm
    PLUS either:
    • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
    OR
    • Must agree to use contraception/barrier as detailed below
    • Agree to use a male condom,even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant

    b. Female Participants:
    a. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    • Is not a woman of childbearing potential (WOCBP)
    OR
    • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, as described in Appendix 7 during the intervention period and for 9 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
    • A WOCBP must have a negative highly sensitive pregnancy test [urine or serum] as required by local regulations) within 72 hours before the first dose of study intervention and agree to use effective contraception during the study and for 9 months after the last dose of study medication.
    • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy

    Informed Consent
    10. Capable of giving signed written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:

    Medical Conditions
    1. Symptomatic amyloidosis, active ‘polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes’ (POEMS) syndrome, active plasma cell leukemia at the time of screening.

    2. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant’s safety, obtaining informed consent, or compliance with study procedures.

    3. Current corneal epithelial disease except mild punctate keratopathy

    4. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert’s syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria.

    5. Malignancies other than disease under study are excluded, except for any other malignancy from which the participant has been disease-free for more than 2 years and, in the opinion of the principal investigators and GSK Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (MM).
    • Participants with curatively treated non-melanoma skin cancer are not excluded.

    6. Evidence of cardiovascular risk including any of the following:
    a. QTcF interval ≥480 msecs (the QT interval values must be corrected for heart rate by Fridericia’s formula [QTcF])
    b. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobiz Type II) or 3rd degree atrioventricular (AV) block.
    c. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting or bypass grafting, all within three months of Screening.
    d.Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
    e. Uncontrolled hypertension
    f. Recent (within the past 6 months) history of symptomatic pericarditis.

    7. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK’916 (belantamab mafodotin) or any of the components of the study treatment. History of severe hypersensitivity to other mAbs.

    8. Active infection requiring antibiotic, antiviral, or antifungal treatment.

    9. Known HIV infection.

    10. Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.

    11. Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment

    12. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
    Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing

    Prior/Concomitant Therapy

    13. Patients who have received prior therapy with GSK’916 (belantamab mafodotin) are excluded. Patients previously treated with other BCMA-targeting agents, such as CAR-T cells or bispecific antibodies, are permitted only during the DE phase.

    14. Other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within <14 days of first dose of study drug.

    15. Prior radiotherapy within 2 weeks of start of study therapy. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.

    16. Plasmapheresis within 7 days prior to the first dose of study drug

    17. Prior allogeneic transplant is prohibited

    18. Patients who have received prior CAR-T therapy with lymphodepletion with chemotherapy within 3 months of screening.

    19. Any major surgery (other than bone-stabilizing surgery) within 30 days of screening.

    20. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs, or treatment with an investigational agent or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter.

    For 'Other Exclusions' please refer to the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Dose Exploration
    - Percentage (number) of participants with dose limiting toxicities (DLTs)
    - Percent of subjects with AEs, changes in clinical signs and laboratory parameters

    Cohort Expansion
    Overall Response Rate (ORR), according to the International Myeloma Working Group (IMWG) Response Criteria [Kumar, 2016].
    E.5.1.1Timepoint(s) of evaluation of this end point
    From when the first participant initiated treatment until the last participant has received 3 cycles of study drug(s).

    Cohort Expansion: 6 months after the last participant is dosed for each sub-study.
    E.5.2Secondary end point(s)
    Dose Exploration
    -Clinical activity measured as Overall Response Rate (ORR) according to the International Myeloma Working Group (IMWG) Response Criteria [Kumar, 2016].
    Rates of:
    - Partial Response (PR);
    -Very Good Partial Response (VGPR);
    - Complete Response (CR);
    - stringent Complete Response (sCR)
    -GSK’916 observed concentration
    -Anti-cancer combination treatment’s observed concentration
    -Incidence and titers of ADAs against GSK’916 (belantamab mafodotin) and combination treatments, when measured.
    • AEs of special interest for GSK’916 (belantamab mafodotin)
    • AEs of special interest for combination treatments
    • Ocular findings on ophthalmic exam

    Cohort Expansion
    Assess the Clinical Benefit Rate (CBR) [Kumar, 2016]
    - PFS
    - DoR
    - TTR
    -Rates of: PR, VGPR; CR, sCR)
    - OS
    - Number (%) of adverse events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation or dose reduction/delay, changes in clinical signs, ECGs, and laboratory parameters
    - AEs of special interest for GSK’916 (belantamab mafodotin)
    - AESIs for the individual partner for each sub-study
    - Number (%) of adverse events (AEs), Serious Adverse Events (SAEs), AEs
    - Ocular findings on ophthalmic exam for GSK’916 (belantamab mafodotin)
    -GSK’916 (belantamab mafodotin) and combination treatment’s plasma concentrations.
    -Incidence and titers of ADAs against GSK’916 (belantamab mafodotin) and combination treatments, when measured.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From when the first participant initiated treatment until the last participant has received 3 cycles of study drug(s).

    Cohort Expansion: 6 months after the last participant is dosed for each sub-study.
    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 No
    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 Yes
    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 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Netherlands
    Spain
    Sweden
    United States
    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 years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 421
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 83
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 504
    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 Investigator is responsible for ensuring that consideration has been given to the post-study care of the participant’s medical condition.
    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 Decision2019-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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