Status:
ACTIVE_NOT_RECRUITING
ANIMATE: Phase II Study of Nivolumab Monotherapy for Relapsed/Refractory Hodgkin Lymphoma
Lead Sponsor:
University College, London
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
This is a single-arm, phase II, multi-centre study of the safety and efficacy of the PD-1 inhibitor, nivolumab, as second-line or third-line salvage therapy as a bridge to stem cell transplant (SCT) i...
Detailed Description
This is a single-arm, phase II, multi-centre study of the safety and efficacy of the programmed cell death protein 1 (PD-1) inhibitor, nivolumab, as second-line or third-line salvage therapy, and in p...
Eligibility Criteria
Inclusion
- Inclusion criteria for study registration:
- Age 16 or over
- Primary refractory classical Hodgkin lymphoma or classical Hodgkin lymphoma in first relapse
- About to receive or receiving first or second line salvage therapy (up to a maximum of 14 days after last treatment)
- Fit for autologous stem cell transplantation
- Written informed consent
- Willing to comply with the contraceptive requirements of the trial
- Exclusion criteria for study registration:
- Nodular lymphocyte predominant Hodgkin lymphoma
- Women who are pregnant or breastfeeding
- History of colitis, inflammatory bowel disease or pneumonitis
- Patients with autoimmune disorders, except patients with vitiligo, diabetes mellitus type 1, hypo- and hyperthyroidism not requiring immunosuppressive therapy
- Known history of hepatitis B or C infection
- Known HIV infection
- History of allergy (including severe/life threatening skin reaction) to monoclonal antibodies, 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 (with some exceptions - listed in protocol)
- Inclusion criteria for trial treatment:
- Has received 2 cycles of first or second line salvage chemotherapy
- PET positive (Deauville score 4 or 5) after first or second line salvage chemotherapy
- Fit for further salvage chemotherapy
- ECOG performance status 0-1
- Creatinine clearance \>30ml/min calculated by Cockcroft-Gault formula
- Bilirubin \<1.5 x ULN, ALT/AST \<2.5 x ULN
- Adequate bone marrow function (Hb \>80g/l, Platelets \>50 x 10\^9/l, neutrophils \>1.0 x 10\^9/l)
- Exclusion criteria for trial treatment:
- Deauville score 1-3 after first or second line salvage chemotherapy
- Positive serology for hepatitis B or C (some exclusions apply - see protocol)
- Active infection requiring systemic therapy
- Ongoing requirement for immunosuppressive therapy, apart from inhaled, intranasal, topical corticosteroids or systemic corticosteroids at low doses (≤10mg prednisolone per day, or the equivalent)
- Corticosteroids at a dose of more than 10mg per day prednisolone or equivalent within 7 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
Exclusion
Key Trial Info
Start Date :
December 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT03337919
Start Date
December 3 2018
End Date
February 28 2026
Last Update
May 10 2024
Active Locations (10)
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1
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom, TR1 3LQ
2
Norfolk & Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
3
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
4
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW