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    Summary
    EudraCT Number:2021-002630-17
    Sponsor's Protocol Code Number:NBK132/2/2021
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-11-30
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-002630-17
    A.3Full title of the trial
    Treatment of nivolumab (N) followed by chemotherapy: bendamustine, gemcitabine and
    Dexamethasone (BGD) with autologous bone marrow transplantation in lymphoma patients
    Hodgkin resistant to treatment of 1 line.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of nivolumab (N) followed by chemotherapy: bendamustine, gemcitabine and
    Dexamethasone (BGD) with autologous bone marrow transplantation in lymphoma patients
    Hodgkin resistant to treatment of 1 line.
    A.4.1Sponsor's protocol code numberNBK132/2/2021
    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 SponsorMedical Unicersity of Gdansk
    B.1.3.4CountryPoland
    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 supportMedical Research Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Gdansk
    B.5.2Functional name of contact pointJan Maciej Zaucha
    B.5.3 Address:
    B.5.3.1Street AddressSmoluchowskiego 17
    B.5.3.2Town/ cityGdańsk
    B.5.3.3Post code80-214
    B.5.3.4CountryPoland
    B.5.4Telephone number0048585844340
    B.5.6E-mailjzaucha@gumed.edu.pl
    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 Yes
    D.2.1.1.1Trade name OPDIVO
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNivolumab
    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 INNNivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    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
    Refractory / relapsed Hodgkin's lymphoma
    Oporny/nawrotowy chłoniak Hodgkina
    E.1.1.1Medical condition in easily understood language
    Refractory / relapsed Hodgkin's lymphoma
    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 evaluate the efficacy and safety of the intervention based on early initiation of second-line treatment (Nivolumab) in patients with Hodgkin's lymphoma resistant to previously administered treatment, followed by BGD chemotherapy (2 cycles) and consolidation with autologous transplantation of hematopoietic stem cells (aHCT). Additionally, the predictive value of circulating free DNA of Hodgkin's lymphoma cells measured before autologous transplantation will be assessed.
    1. Complete Metabolic Remission (CMR) rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab (N).
    2. PFS, which is the time from N treatment initiation to progression (PD) or death, regardless of cause.
    E.2.2Secondary objectives of the trial
    Percentage of all complete and partial metabolic responses (overall metabolic response rate, OMRR = CMR + CSF after N, BGD, and aHCT treatment.
    Overall Survival (OS) from the time of initiation of Nivolumab treatment to the time of death from any cause.
    Percentage of patients among whom aHCT was successfully performed.
    Tolerance of N-BGD treatment defined as the frequency of adverse events (AEs) with a toxicity level greater than two based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
    The number of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with recurrence of previously confirmed histopathologically confirmed classical Hodgkin's lymphoma based on the local pathology report according to the WHO 2016 classification, after the first line of treatment initially diagnosed in stage IIA but with a large metabolic tumor volume or the presence of a massive lesion (>10cm) or diagnosed in stage IIB- IV
    OR
    Patients with primary refractory classical Hodgkin's lymphoma in stage IIA with a large metabolic tumor volume (>147 ml) or the presence of a massive lesion (>10 cm) or in stage IIB-IV. Primary resistance to treatment will be defined by a positive iPET2 test (Deauville scale scores 4 and 5) performed after the 2nd cycle of first-line chemotherapy; and in patients with a negative iPET2 test result (Deauville scale scores 1, 2, 3) the occurrence of active disease confirmed by PET-CT within three months of the end of first-line chemotherapy.
    2. Evaluation of disease advancement by PET examination at diagnosis.
    3. Age ≥18 years old
    4. ECOG 0-2
    5. Presence of at least one measurable change
    6. Consent to effective contraception during the study using contraception for 14 months for women and 11 months for men after the last dose of immuno-chemotherapy
    7. In women of childbearing age, a negative serum pregnancy test result at screening and consent to use highly effective methods of contraception during the study and for 14 months after the last dose of chemotherapy (except for patients over 50 years of age with natural amenorrhea for a period of at least 12 months or after bilateral salpingoophorectomy or hysterectomy).
    8. Signing consent to participate in the clinical trial
    E.4Principal exclusion criteria
    1. Non-classical form of Hodgkin's lymphoma,
    2. Performance status according to ECOG>2
    3. Failure to perform PET scans during induction treatment in accordance with the inclusion criteria
    Fig. 4. Transformation of Hodgkin's lymphoma into another lymphoma
    5. Central nervous system involvement,
    6. Medical contraindications or patient's refusal to consolidate BGD rescue treatment with aHCT
    7. Other cancer - active form or less than 5 years from cure,
    8. Uncontrolled diabetes
    9. Heart failure NYHA>2 or LVEF<45%
    10. Liver failure (bilirubin 1.5 x ULN, SGOT > 5 x ULN) if unrelated to lymphoma, and Gilbert's syndrome
    11. HIV infection, active HBV, HCV, CMV infection. In the case of hepatitis B infection and the presence of abHBc, it is necessary to evaluate the PCR DNA of the virus and start prophylactic treatment in accordance with the advice of an infectious disease doctor.
    12. Pregnancy or breastfeeding,
    13. Known hypersensitivity to any of the drugs used in the treatment.
    14. The patient is unable to sign the informed consent form to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    1. Complete Metabolic Remission (CMR) rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab (N).
    2. PFS, which is the time from N treatment initiation to progression (PD) or death, regardless of cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During follow-up after the end of treatment
    E.5.2Secondary end point(s)
    3. Percentage of all complete and partial metabolic responses (overall metabolic response rate, OMRR = CMR + CSF after N, BGD, and aHCT treatment.
    4. Overall Survival (OS) from the time of initiation of Nivolumab treatment to the time of death from any cause.
    5. Percentage of patients among whom aHCT was successfully performed.
    6. Tolerance of N-BGD treatment defined as the frequency of adverse events (AEs) with a toxicity level greater than two based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
    7. The number of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Positive and negative predictive value of circulating free DNA of Hodgkin's lymphoma cells measured before autologous transplantation compared to PET / CT scan performed at the same time.
    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 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 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 concerned7
    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
    LSLV
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 74
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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)
    None
    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 Decision2022-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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