Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
03/12/2018
Funder:
Bristol-Meyers Squibb
Sponsor:
UCL
Chief Investigator:
Dr Graham Collins
Recruitment target:
120
EudraCT number:
2017-002544-32
Contact details:
ctc.animate@ucl.ac.uk
Lay summary:
ANIMATE
A phase II study of nivolumab monotherapy in patients with relapsed/refractory Hodgkin lymphoma, fit for autologous stem cell transplant, who fail to reach complete metabolic remission after first or second line salvage therapy
Description
Design: Single-arm, open label, multicentre phase IItrial.
Treatment:

Patients can be consented and registered at any time before, during or within 14 days after completing two cycles of first line or second line salvage therapy (4 cycles if being treated with brentuximab vedotin).

A PET-CT scan will be performed under trial conditions following 2 cycles of first line or second salvage (4 cycles if being treated with brentuximab vedotin) to determine eligibility for trial treatment.

  • Patients who are PET-negative (Deauville 1-3) will not be eligible for trial treatment.They will enter follow up for the purpose of the trial, and any further treatment will be at their treating clinician’s discretion.

  • Patients who are PET-positive (Deauville 4-5) after first line salvage chemotherapy will receive 4 x 14-day cycles of nivolumab.

    A further PET-CT scan will then be performed:

  • Patients who are PET negative (Deauville 1-3) will stop trial treatment and enter followup.

Patients who are PET positive (Deauville 4-5) will have a further 4  x 14-day cycles of nivolumab, unless there is evidence of progressive disease
Key inclusion/exclusion criteria:

Inclusion criteria for registration

  • Age 16 or over

  • Primary refractory classical Hodgkin lymphoma or classical Hodgkin lymphoma in firstrelapse

  • About to receive, receiving or within 14 days of first 2 cycles of first or second line salvage therapy (4 cycles if receiving treatment with brentuximab vedotin)

  • Fit for autologous stem cell transplantation

  • Written informed consent

  • Willing to comply with the contraceptive requirements of the trial

    Exclusion criteria for registration

  • Nodular lymphocyte predominant Hodgkin lymphoma

  • Women who are pregnant or breastfeeding

  • History of colitis, inflammatory bowel disease or pneumonitis

  • Patients with autoimmune disorders excluding patients with vitiligo, diabetes mellitustype 1, hypo- and hyperthyroidism not requiring immunosuppressive therapy

  • Known active hepatitis B or C infection

  • Known HIV infection

  • History of allergy (including severe/life threatening skin reaction) to monoclonalantibodies, anaphylaxis or uncontrolled allergy

  • Major surgery within 4 weeks prior to registration

  • Myocardial infarction, unstable angina, coronary artery bypass graft, cerebrovascular accident or transient ischaemic attack within the past 6 months

  • Non-haematological malignancy within the past 3 years (some exceptions apply – see trial protocol)

    Inclusion criteria – trial treatment

  • Has received 2 cycles of first line or second line salvage chemotherapy (4 cycles ifbeing treated with brentuximab vedotin)

  • PET positive (Deauville score 4 or 5) after 2 cycles of first or second line salvage chemotherapy (4 cycles if being treated with brentuximab vedotin)

  • Fit for further salvage chemotherapy

  • ECOG performance status 0-1

  • Creatinine clearance >30ml/min calculated by Cockroft-Gault formula

  • Bilirubin

  • Adequate bone marrow function (Hb >80g/l, Platelets >50 x 109/l,neutrophils >1.0 x 109/l

    Exclusion criteria for trial treatment

  • Deauville score 1-3 after 2 cycles of first or second line salvage chemotherapy (4 cycles if being treated with brentuximab vedotin)

  • Positive serology for hepatitis B or C (some exceptions apply – see trial protocol)

  • Active infection requiring systemic therapy

  • Ongoing immunosuppressive therapy, apart from inhaled, intranasal, topical corticosteroids or systemic corticosteroids at low doses (≤10mg prednisolone or equivalent per day).

  • Chemo-or radiotherapy or corticosteroids at a dose of more than 10mg/day prednisolone or equivalent within 14 days prior to response PET-CT. NOTE: corticosteroids can be used AFTER a positive PET-CT scan for symptomatic disease but must be weaned to a dose of prednisolone ≤10mg/day or less (or equivalent) at least 7 days prior to starting nivolumab.

  • Treatment with any investigational agent within 28 days prior to planned start of nivolumab

  • Ongoing grade 2-4 non-haematological toxicities related to prior Hodgkin lymphoma treatments, with the exception of alopecia and grade 2 fatigue

  • Pregnant or breastfeeding women

Duration of recruitment: 3 years.
Aim
To assess the efficacy of nivolumab as a second or third line salvage therapy in relapsed/refractory classical Hodgkin lymphoma patients, particularly as a bridge to stem cell transplant.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
NameVersionCurrent versRelease dateDownload
001 Animate protocol v2.0 10.04.18_22062018_0.pdf2.0 Current 10/04/2018
002 Animate protocol v2.0 10.04.18 Tracked_22062018_0.pdf2.0 Current 10/04/2018
005 ANIMATE Protocol version history v2.0 02.05.18_22062018_0.pdf2.0 Current 02/05/2018
003 Animate protocol v1.1 21.02.18 Clean_superseded_22062018_0.pdf1.1 Historic 21/02/2018
004 Animate protocol v1.1 21.02.18 Tracked_superseded_22062018_0.pdf1.1 Historic 21/02/2018
Trial documents
NameTypeVersionCurrent versRelease dateDownload
006 ANIMATE PIS v2.0 10.04.2018_22062018_0.pdfPatientInformationSheet2.0 Current 10/04/2018
007 ANIMATE PIS v2.0 10.04.2018_22062018_0.docxPatientInformationSheet2.0 Current 10/04/2018
008 ANIMATE PIS v2.0 10.04.2018 tracked_22062018_0.pdfPatientInformationSheet2.0 Current 10/04/2018
010 Animate ICF v2.0 10.04.18_22062018_0.pdfInformedConsentForm2.0 Current 10/04/2018
011 ANIMATE ICF v2.0 10.04.18_22062018_0.docxInformedConsentForm2.0 Current 10/04/2018
012 Animate ICF v2.0 10.04.18 tracked_22062018_0.pdfInformedConsentForm2.0 Current 10/04/2018
014 ANIMATE PMIS (Partner) v1.0 04.01.2018_22062018_0.pdfPatientInformationSheet1.0 Current 04/01/2018
015 ANIMATE PMIS (Partner) v1.0 04.01.2018 clean_22062018_0.docPatientInformationSheet1.0 Current 04/01/2018
016 ANIMATE PMICF (Partner) v1.0 04.01.2018_22062018_0.pdfInformedConsentForm1.0 Current 04/01/2018
017 ANIMATE PMICF (Partner) v1.0 04.01.2018 clean_22062018_0.docPatientInformationSheet1.0 Current 04/01/2018
018 ANIMATE Pt Contact Card v1.0 04.01.2018_22062018_0.pdfPatientInformation1.0 Current 04/01/2018
019 ANIMATE GP Letter v1.0 04.01.2018_22062018_0.pdfGPletter1..0 Current 04/01/2018
020 ANIMATE GP Letter v1.0 04.01.2018_22062018_0.docxGPletter1.0 Current 04/01/2018
023 BMS_Nivolumab_IB_v16_22062018_0.pdfGuidanceDdocument16.0 Current 23/06/2017
047 ANIMATE statement of activities PET sites 04.01.2018_22062018_0.pdfOther1.0 Current 04/01/2018
048 ANIMATE statement of activities (non-PET) 04.01.2018_22062018_0.pdfOther1.0 Current 04/01/2018
049 ANIMATE schedule-events PET v4.0 21.03.18_22062018_0.xlsOther4.0 Current 21/03/2018
050 ANIMATE schedule-events non-PET v2.0 21.03.18_22062018_0.xlsOther2.0 Current 21/03/2018
051 CTC CTSA_ANIMATE_13-07-18-[site name] [date]_25072018_0.pdfOthern/a Current 13/07/2018
052 UCL_clinical trials insurance policy note Aug2017_July 2018_22062018_0.pdfOther08.2017 - 07.2018 Current 24/07/2017
053 ANIMATE Wales study checks email 19.04.18_22062018_0.pdfOther0 Current 19/04/2018
054 ANIMATE - Summary of drug arrangements v1.0 DRAFT 21.06.2018_22062018_0.pdfGuidanceDdocument1.0 draft Current 21/06/2018
055 Animate PET-CT manual v1.0 05.01.18_22062018_0.pdfGuidanceDdocument1.0 Current 05/01/2018
056 ANIMATE -nivolumab balance log v1.1 15.06.2018_22062018_0.pdfTrialsLog1.1 Current 15/06/2018
057 ANIMATE Nivolumab Accountability Patient Log v1.1 15.06.2018_22062018_0.pdfTrialsLog1.1 Current 15/06/2018
058 ANIMATE Site Delegation Log & Site Contacts Form- v1 26.04.2018_22062018_0.docxTrialsLog1.0 Current 26/04/2018
059 ANIMATE_ Cancer Trials Centre Contact List v1.0 26.04.2018_22062018_0.pdfGuidanceDdocument1.0 Current 26/04/2018
009 ANIMATE PIS v1.0 04.01.18_superseded_22062018_0.pdfPatientInformationSheet1.0 Historic 04/01/2018
013 Animate ICF v1.0 04.01.18_superseded_22062018_0.pdfInformedConsentForm1.0 Historic 04/01/2018
021 ANIMATE amended CTA - amendment 2 - 13.04.2018_22062018_0.pdfAmendment2 Historic 13/04/2018
022 ANIMATE initial CTA form Signed 23.01.18_22062018_0.pdfOther0 Historic 23/01/2018
024 ANIMATE HRA Approval SA2 08.05.18_22062018_0.pdfAmendment2 Historic 08/05/2018
025 ANIMATE - Amendment 2 - REC cover letter - 13.04.2018_22062018_0.pdfAmendment2 Historic 13/04/2018
026 ANIMATE REC approval SA2 30.04.2018_22062018_0.pdfAmendment2 Historic 30/04/2018
027 ANIMATE SA 2 MHRA Cover Letter 13.04.2018_22062018_0.pdfAmendment2 Historic 13/04/2018
028 ANIMATE MHRA SA2 approval letter 20.04.2018_22062018_0.pdfAmendment2 Historic 20/04/2018
029 ANIMATE Amendment 2 SA form 13.04.2018_22062018_0.pdfAmendment2 Historic 13/04/2018
030 ANIMATE HRA Approval SA1 17.04.18_22062018_0.pdfAmendment1 Historic 17/04/2018
031 ANIMATE - Amendment 1 REC cover letter - 13.03.2018_22062018_0.pdfAmendment1 Historic 13/03/2018
032 ANIMATE REC approval SA1 10Apr18_22062018_0.pdfAmendment1 Historic 10/04/2018
033 ANIMATE - Amendment 1 SA form 13.03.2018_22062018_0.pdfAmendment1 Historic 13/03/2018
034 ANIMATE HRA Approval Letter 13.04.2018_22062018_0.pdfAmendment1 Historic 13/04/2018
035 ANIMATE HRA Initial Assessment Letter 09.03.2018_22062018_0.pdfOther0 Historic 09/03/2018
036 ANIMATE REC cover letter 11.01.18 + IDMC + Insurance + Stats_22062018_0.pdfOther0 Historic 11/01/2018
037 ANIMATE REC initial approval letter 01.03.2018_22062018_0.pdfOther0 Historic 01/03/2018
038 ANIMATE CTA Cover letter 23.01.18 + initial QP declaration_22062018_0.pdfOther0 Historic 23/01/2018
039 ANIMATE NoticeofNon-Acceptance 09.02.18_22062018_0.pdfOther0 Historic 09/02/2018
040 ANIMATE response to GNA 22.02.18 + nivo GP declaration_22062018_0.pdfOther0 Historic 22/02/2018
041 ANIMATE MHRA CTA approval letter 27.02.2018_22062018_0.pdfOther0 Historic 27/02/2018
042 ANIMATE IRAS form submitted 11.01.18_22062018_0.pdfOther0 Historic 11/01/2018
043 ANIMATE UCL Insurance Confirmation Letter re-issued 06.11.2017_22062018_0.pdfOther0 Historic 06/11/2017
044 ANIMATE nivo labelling form v3.0 30.11.17_22062018_0.pdfOther3.0 Historic 30/11/2017
045 ANIMATE_ARSAC_Approval_11.04.2018_22062018_0.pdfOther0 Historic 11/01/2018
046 ANIMATE_ARSAC_PRA_Form_07.03.2018_22062018_0.pdfOther0 Historic 07/03/2018
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