EUCTR2017-002544-32-GB
Active, not recruiting
Phase 1
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 - ANIMATE
niversity College London0 sites120 target enrollmentJanuary 26, 2018
DrugsOpdivo
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College London
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for registration
- •Age 16 or over
- •Primary refractory classical Hodgkin lymphoma or classical Hodgkin lymphoma in first relapse
- •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
- •Inclusion criteria – trial treatment
- •Has received 2 cycles of first line or second line salvage chemotherapy (4 cycles if being 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)
Exclusion Criteria
- •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 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
Outcomes
Primary Outcomes
Not specified
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