ANIMATE: Phase II Study of Nivolumab Monotherapy for Relapsed/Refractory Hodgkin Lymphoma

NCT03337919 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: UCL/15/0515CA-209-4452017-002544-32
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 10

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) in relapsed/ refractory classical Hodgkin lymphoma patients not achieving a complete metabolic response (CMR) on FDG-PET-CT scan after first or second line salvage therapy.

Conditions

Hodgkin Lymphoma

Keywords

Nivolumab

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) by PET-CT scan following 4-8 cycles of nivolumab

  Rate of patients achieving complete metabolic response (CMR) on PET-CT scan following 4 or 8 cycles of nivolumab

  4 months

Secondary Outcomes (6)

• Progression-free survival

  1 year

• Overall survival

  1 year

• Proportion of patients progressing to stem cell transplant

  1 year

• Adverse events [Safety and toxicity of nivolumab]

  3 years

• Transplant-related mortality

  3 years

Other Outcomes (3)

• Biopsy-negative PMR rate

  4 months

• Serological biomarkers of response to nivolumab

  5 months

• Immunological biomarkers of response to treatment

  4 months

Study Arms (1)

Nivolumab

EXPERIMENTAL

Up to 8 x 2-weekly cycles of nivolumab 240mg IV. Interim PET-CT scan to be performed after 4 cycles, and centrally reviewed. Patients will stop treatment after 4 cycles if they have complete metabolic response or progressive metabolic disease. If they have partial metabolic response or stable disease, they will continue to 8 cycles.

Drug: Nivolumab

Interventions

Nivolumab DRUG

Up to 8 cycles of nivolumab

Also known as: Opdivo®

Nivolumab

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University College, London: lead
• Bristol-Myers Squibb: collaborator

Study Sites (10)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LQ, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

The Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Related Links

• CR UK \& UCL Cancer Trials Centre

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Graham Collins

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, phase II, multi-centre study. It will use an Ahern single stage design with independent trials steering committee review to monitor for safety and efficacy.

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 9, 2017
• Study Start: December 3, 2018
• Primary Completion: March 1, 2023
• Study Completion: February 28, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (10)