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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
ANIMATE Protocol version history 1.0 Current 25/09/2020
ANIMATE Protocol_v4.0 28.05.20204.0 Current 28/05/2020
ANIMATE Protocol_v4.0 28.05.2020 tracked4.0 Current 28/05/2020
ANIMATE Protocol version history1.0 Historic 02/05/2018
ANIMATE protocol_v1.1 21.02.18 Clean_superseded1.1 Historic 21/02/2018
ANIMATE protocol_v1.1 21.02.18 Tracked_superseded1.1 Historic 21/02/2018
ANIMATE protocol_v2.0 10.04.18_superseded2.0 Historic 10/04/2018
ANIMATE protocol_v2.0 10.04.18_tracked_superseded2.0 Historic 10/04/2018
ANIMATE protocol_v2.1 12.06.2018_superseded2.1 Historic 12/06/2018
ANIMATE protocol_v2.1 21.02.18 Tracked changes2.1 Historic 21/02/2018
ANIMATE protocol_v3.0 10.12.2019_superseded3.0 Historic 10/12/2019
ANIMATE protocol_v3.0 10.12.2019_tracked_superseded3.0 Historic 10/12/2019
Trial documents
NameTypeVersionCurrent versRelease dateDownload
1 ANIMATE Registration Case Report FormCRF2.0 Current 17/12/2019
10 ANIMATE Disease Progression FormCRF1.0 Current 22/11/2018
11 ANIMATE Death FormCRF1.0 Current 22/11/2018
12 ANIMATE Lost to follow up FormCRF1.0 Current 22/11/2018
13 ANIMATE Transfer of Care FormCRF1.0 Current 22/11/2018
14 ANIMATE New Treatment FormCRF1.0 Current 22/11/2018
15 ANIMATE Adverse Event FormCRF1.0 Current 22/11/2018
16 ANIMATE Normal Range Form CRF2.0 Current 10/02/2020
2 ANIMATE Post-Salvage Case Report FormCRF2.0 Current 17/12/2019
3 ANIMATE Treatment FormCRF2.0 Current 17/12/2019
4 ANIMATE Treatment Summary FormCRF1.0 Current 22/11/2018
5 ANIMATE Follow Up Form - nivolumabCRF2.0 Current 17/12/2019
6 ANIMATE Annual Follow Up Form NIVOLUMABCRF1.0 Current 22/11/2018
7 ANIMATE Follow Up Form - No Trial TreatmentCRF1.0 Current 22/11/2018
8 ANIMATE Transplant FormCRF1.0 Current 22/11/2018
9 ANIMATE Post-Allogeneic Transplant FormCRF1.0 Current 22/11/2018
ANIMATE 24_10_18_ mNCA_V2.1_UCL-[site name][date]-TEMPLATEOtherN/A Current 24/10/2018
ANIMATE Amendments LogAmendmentN/A Current 09/10/2020
ANIMATE Biological Sample collection form v1.0 15.08.18Collection1.0 Current 15/08/2018
ANIMATE BMS Drug Request form updated 13MAY2020OtherN/A Current 13/05/2020
ANIMATE Cancer Trials Centre Contact List v2.1 28.04.2020Other2.1 Current 28/04/2020
ANIMATE GP Letter v2.0 10.12.2019GPletter2.0 Current 10/12/2019
ANIMATE GP Letter v2.0 10.12.2019_trackedGPletter2.0 Current 10/12/2019
ANIMATE HRA SA6 approval letter 10.07.20AmendmentN/A Current 10/07/2020
ANIMATE HRA SA6 Categorisation email 18.06.20AmendmentN/A Current 18/06/2020
ANIMATE Investigator Site File Index v1 22.10.2018Other1.0 Current 22/10/2018
ANIMATE Investigator Site File Index v1 22.10.2018Other1.0 Current 22/10/2018
ANIMATE lab manual version 2.0 28.03.19GuidanceDdocument2.0 Current 28/03/2019
ANIMATE MHRA NoSA6 form 28.05.2020AmendmentN/A Current 28/05/2020
ANIMATE MHRA SA6 approval letter 10.06.2020AmendmentN/A Current 10/06/2020
ANIMATE MHRA SA6 Cover letter 28.05.2020AmendmentN/A Current 28/05/2020
ANIMATE Nivolumab Accountability Patient Log v1.1 15.06.2018TrialsLog1.1 Current 15/06/2018
ANIMATE Nivolumab Accountability Patient Log v1.1 15.06.2018TrialsLog1.1 Current 15/06/2018
ANIMATE Nivolumab balance log v1.1 15.06.2018TrialsLog1.1 Current 15/06/2018
ANIMATE Nivolumab Balance log v1.1 15.06.2018TrialsLog1.1 Current 15/06/2018
ANIMATE Patient Information Version History LogTrialsLog1.0 Current 21/07/2020
ANIMATE Patient Screening Log v3.0 10.11.2020TrialsLog3.0 Current 10/11/2020
ANIMATE Pharmacy Site File Index v1 22.10.2018Other1.0 Current 22/10/2018
ANIMATE PIS v5 28.05.2020PatientInformationSheet5.0 Current 28/05/2020
ANIMATE PIS v5 28.05.2020 trackedPatientInformationSheet5.0 Current 28/05/2020
ANIMATE PMIS (Partner) v2.0 12.06.2018PatientInformationSheet2.0 Current 12/06/2018
ANIMATE PMIS (Partner) v2.0 12.06.2018 trackedPatientInformationSheet2.0 Current 12/06/2018
ANIMATE PMIS (Patient) v1 28.05.2020 trackedPatientInformationSheet1.0 Current 28/05/2020
ANIMATE PMIS (Patient) v1.0 28.05.2020PatientInformationSheet1.0 Current 28/05/2020
ANIMATE Pregnancy Report Form CRF1.1 Current 15/08/2018
ANIMATE Pt Contact Card v1.0 04.01.2018PatientInformation1.0 Current 04/01/2018
ANIMATE REC NoSA6 form 28.05.2020AmendmentN/A Current 28/05/2020
ANIMATE REC SA6 approval letter 07.07.2020AmendmentN/A Current 07/07/2020
ANIMATE REC SA6 cover letter 28.05.2020AmendmentN/A Current 28/05/2020
ANIMATE SAE guidanceSAEform1.0 Current 20/08/2018
ANIMATE SAE guidance v1.0 20.08.18SAEform1.0 Current 20/08/2018
ANIMATE SAE Report FormSAEform2.0 Current 04/01/2019
ANIMATE SAE Report Form v2.0 04.01.19SAEform2.0 Current 04/01/2019
ANIMATE Sample Tracking Website Manual version 1.0 22.11.18GuidanceDdocument1.0 Current 22/11/2018
ANIMATE schedule-events non-PET v2.0 21.03.18Other2.0 Current 21/03/2018
ANIMATE schedule-events PET v4.0 21.03.18Other4.0 Current 21/03/2018
ANIMATE Site_Delegation_Log_v2 29.07.2020Other2.0 Current 29/07/2020
ANIMATE Source Data Form v2 29.07.2020Other2.0 Current 29/07/2020
ANIMATE statement of activities (non-PET) 04.01.2018Other1.0 Current 04/01/2018
ANIMATE statement of activities PET sites 04.01.2018Other1.0 Current 04/01/2018
ANIMATE Summary of drug arrangements v1.0 18.10.2018Other1.0 Current 18/10/2018
ANIMATE Summary of drug arrangements v1.0 18.10.2018GuidanceDdocument1.0 Current 18/10/2018
ANIMATE UCL CTC Pharmacy Procedure for Reporting Temp Excursions v1.0 21.08.2018GuidanceDdocument1.0 Current 21/08/2018
ANIMATE UK Site Registration Form v2 11.02.2020Other2.0 Current 11/02/2020
ANIMATE Wales study checks email 19.04.18Other0 Current 19/04/2018
ANIMATE_MIMcloud_PET_Upload_manual_v1.1GuidanceDdocument1.1 Current 01/05/2019
ANIMATE_PET-CT_Manual_V4.0_13.10.2020GuidanceDdocument4.0 Current 13/10/2020
BMS Nivolumab IB v19 addendum01GuidanceDdocument19 Current 16/10/2020
BMS Nivolumab IB v19_tracked changesGuidanceDdocument19 Current 29/06/2020
CTC Incident Report template v3_31Jul18Other3.0 Current 31/07/2018
UCL Clinical Trials Insurance policy note 2020-21Other08.2020 - 07.2021 Current 29/07/2020
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
ANIMATE - Full set - v1.0 22.11.2018_18032019_0.pdfCRF1.0 Historic 22/11/2018
ANIMATE amended CTA - amendment 2 - 13.04.2018_22062018_0.pdfAmendment2 Historic 13/04/2018
ANIMATE GP Letter v1.0 04.01.2018GPletter1..0 Historic 04/01/2018
ANIMATE ICF v1.0 04.01.18_supersededInformedConsentForm1.0 Historic 04/01/2018
ANIMATE ICF v2.0 10.04.18 tracked_supersededInformedConsentForm2.0 Historic 10/04/2018
ANIMATE ICF v2.0 10.04.18_supersededInformedConsentForm2.0 Historic 10/04/2018
ANIMATE ICF v3.0 12.06.18 tracked_supersededInformedConsentForm3.0 Historic 12/06/2018
ANIMATE ICF v3.0 12.06.18_supersededInformedConsentForm3.0 Historic 12/06/2018
ANIMATE PET-CT manual v1.0 05.01.18GuidanceDdocument1.0 Historic 05/01/2018
ANIMATE PIS v1.0 04.01.18_supersededPatientInformationSheet1.0 Historic 04/01/2018
ANIMATE PIS v2.0 10.04.2018 supersededPatientInformationSheet2.0 Historic 10/04/2018
ANIMATE PIS v2.0 10.04.2018 tracked supersededPatientInformationSheet2.0 Historic 10/04/2018
ANIMATE PIS v3.0 12.06.18 supersededPatientInformationSheet3.0 Historic 12/06/2018
ANIMATE PIS v3.0 12.06.18 tracked_supersededPatientInformationSheet3.0 Historic 12/06/2018
ANIMATE PIS v4 10.12.2019 supersededPatientInformationSheet4.0 Historic 10/12/2019
ANIMATE PIS v4 10.12.2019 tracked_supersededPatientInformationSheet4.0 Historic 10/12/2019
ANIMATE PMIS (Partner) v1.0 04.01.2018 supersededPatientInformationSheet1.0 Historic 04/01/2018
ANIMATE Site Delegation Log & Site Contacts Form- v1 26.04.2018TrialsLog1.0 Historic 26/04/2018
ANIMATE_ Cancer Trials Centre Contact List v1.0 26.04.2018GuidanceDdocument1.0 Historic 26/04/2018
BMS Nivolumab IB v16GuidanceDdocument16 Historic 23/06/2017
BMS Nivolumab IB v17_Track changesGuidanceDdocument17 Historic 27/06/2018
BMS Nivolumab IB v18_tracked changesGuidanceDdocument18 Historic 25/06/2019
UCL Clinical trials insurance policy note 2017-18Other08.2017 - 07.2018 Historic 24/07/2017
UCL Clinical Trials Insurance policy note 2018-19Other08.2018 - 07.2019 Historic 06/11/2018
UCL Clinical Trials Insurance policy note 2019-20Other08.2019 - 07.2020 Historic 04/02/2020
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