Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
Pfizer Limited
Chief Investigator:
Graham Collins
Recruitment target:
EudraCT number:
Contact details:
Note: For enquiries only. DO NOT use for clinical referrals.
Lay summary:
Avelumab in the frontline treatment of advanced classical Hodgkin lymphoma - a window study
Design: AVENuE is a non-randomised, single arm Phase II trial investigating how patients with newly diagnosed, untreated advanced classical Hodgkin lymphoma respond to treatment with the monocolonal antibody, avelumab. 


All patients will start treatment by receiving 2 cycles of the monoclonal antibody, avelumab, this will last about 2 months. Patients will have a PET-CT scan after these 2 cycles to assess their response to treatment. 

Patients will then go on to receive standard treatment for Hodgkin lymphoma which is a response adapted approach whereby all patients receive 2 cycles of ABVD chemotherapy followed by an interim PET scan. For those with a negative PET result (which shows the patient has responded well to treatment), 4 cycles of AVD chemotherapy are given. Patients with a positive PET result (which shows the patients has not responded as well to treatment) go on to receive BEACOPP chemotherapy. 

Key inclusion/exclusion criteria:

Key Inclusion Criteria

• Aged 16-60 (inclusive)

• Previously untreated classical Hodgkin lymphoma

• High risk stage II, stage III or IV disease

• ECOG performance status 0-1

• Adequate bone marrow and liver function 

Key Exclusion Criteria

• Nodular lymphocyte predominant Hodgkin lymphoma

• Requirement for urgent treatment due to life-threatening complications of the disease

• Women who are pregnant or breastfeeding

• History of colitis, inflammatory bowel disease or pneumonitis

• Patients with autoimmune disorders (some exclusions apply)

• Positive serology for hepatitis B or C 

• Known HIV infection

• Major surgery within 4 weeks prior to registration

• Active infection requiring systemic therapy

• Non-haematological malignancy within the past 3 years 

• Previously treated haematological malignancy

• Any uncontrolled medical condition which can impair delivery of planned immunochemotherapy

• Patient not deemed suitable for ABVD/AVD/escalated-BEACOPP/BEACOPP-14

Duration of recruitment: 1 year
To determine the overall response rate to single agent avelumab in a previously untreated fit population of advanced classical Hodgkin lymphoma.
To establish the safety of delivering an ABVD-based regimen following single agent avelumab.
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.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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