The CTC offices will be closed for refurbishment from the 11th June 2021 to the 29th August 2021 inclusive. Access to trial TMFs and patient records will be limited during this period. We will still be able to receive post during this time, but there may be a small delay in responding to this. Our fax lines may also be subject to disruption. Where possible, please direct all correspondence via email to trial-specific email addresses. We appreciate your patience and understanding.

Due to COVID-19 and current government guidance, UCL CTC staff continue to work remotely with limited access to the office. Please continue to email the trial specific mailbox with any urgent queries. For paper CRF trials, please continue to copy and scan CRFs to the trial inboxes (remove all patient identifiers except Trial Number and Initials) until further notice.

 
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 II trial.
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 version history1.0 Historic 02/05/2018
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 Amendments LogAmendmentN/A Current 09/10/2020
ANIMATE Biological Sample collection form v1.0 15.08.18Collection1.0 Current 15/08/2018
ANIMATE Cancer Trials Centre Contact List v2.1 28.04.2020Other2.1 Current 28/04/2020
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 MHRA NoSA6 form 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 Pregnancy Report Form CRF1.1 Current 15/08/2018
ANIMATE Pt Contact Card v1.0 04.01.2018PatientInformation1.0 Current 04/01/2018
ANIMATE SAE guidance v1.0 20.08.18SAEform1.0 Current 20/08/2018
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 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 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
CTC Incident Report template v3_31Jul18Other3.0 Current 31/07/2018
ANIMATE - Full set - v1.0 22.11.2018_18032019_0.pdfCRF1.0 Historic 22/11/2018
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
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

View map
Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

Copyright © 2021 UCL | Disclaimer | Freedom of Information | Accessibility | Privacy | Cookies | Contact Us