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Hodgkin LymphomaPhase 2AVENuENCT03617666

Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study

A Phase 2 study testing Avelumab in people with Hodgkin Lymphoma, run by University College, London at 11 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase II, non-randomised, multicentre study to assess the safety and efficacy of the PD-L1 inhibitor, avelumab, in a previously untreated fit population of high risk stage II, stage III and stage IV classical Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Avelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
11 sitesin 2 countries
Study dates
27 Sep 2019to 30 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Previously untreated classical Hodgkin lymphoma
  • High risk stage II (defined as stage IIB, presence of bulky disease, 3 or more sites of disease), stage III or IV as assessed by FDG-PET/CT
  • ECOG performance status 0-1
  • Adequate bone marrow function (Hb >80g/l, Platelets >75 x 10^9/l, neutrophils >1.0 x 10^9/l)
  • Adequate liver function tests (ALT/AST <2.5 x ULN, total serum bilirubin level <1.5 x ULN)
  • Creatinine clearance >50ml/min calculated by Cockroft-Gault formula
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  • Written informed consent
  • Willing to comply with the contraceptive requirements of the trial
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Who cannot join

  • Nodular lymphocyte predominant Hodgkin lymphoma
  • Compressive symptoms due to disease (which may or may not be bulky). If there is evidence of compression of vital structures radiologically but the patient is asymptomatic, the case must be discussed with the TMG.
  • 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 excluding patients with vitiligo, diabetes mellitus type 1, hypo- and hyperthyroidism, coeliac disease not requiring immunosuppressive therapy
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  • Immunosuppressive therapy within the last 2 months, apart from inhaled, intranasal, topical corticosteroids or systemic corticosteroids at low doses (≤10mg prednisolone per day or equivalent - see steroid exception below)
  • Prior history of solid organ or allogeneic haematopoietic stem cell transplant
  • Positive serology for hepatitis B or C (unless due to vaccination), or hepatitis C RNA negative if hepatitis C antibody positive
  • Known HIV infection
  • Administration of a live vaccine within 30 days prior to study entry
  • History of allergy to monoclonal antibodies, anaphylaxis or uncontrolled allergy
  • Chemo- or radiotherapy within 15 days prior to registration. Corticosteroids permitted for disease control but must be weaned down to ≤10mg prednisolone per day or equivalent at least 7 days prior to starting avelumab - steroids may only be started for disease control after the baseline PET-CT
  • Persisting toxicity (of >grade 1) related to prior therapy, however, alopecia, sensory neuropathy Grade <2, or other grade <2 not constituting a safety risk based on investigator's judgement are acceptable
  • Major surgery within 4 weeks prior to registration
  • Active infection requiring systemic therapy
  • 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)
  • 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

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United Kingdom10 sites

  • Heartlands Hospital

    Birmingham

  • Beatson Hospital

    Glasgow

  • Leicester Royal Infirmary

    Leicester

  • St George's Hospital

    London

  • Christie Hospital

    Manchester

  • Norfolk and Norwich University Hospital

    Norwich

  • Churchill Hospital

    Oxford

  • Derriford Hospital

    Plymouth

  • Royal Stoke University Hospital

    Stoke

  • The Royal Marsden Hospital, Sutton

    Sutton

Other trials in United Kingdom

Australia1 site

  • Austin Health

    Heidelberg, Victoria

Other trials in Australia

About this study

Official title: AVENuE - Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study

This is a phase II, non-randomised, multicentre study to assess the safety and efficacy of the PD-L1 inhibitor, avelumab, in a previously untreated fit population of high risk stage II, stage III and stage IV classical Hodgkin lymphoma.

Read the detailed description

This phase II study investigates the safety and efficacy of the PD-L1 inhibitor, avelumab, in a previously untreated fit population of high risk stage II, stage III and stage IV classical Hodgkin lymphoma.

Patients with newly diagnosed high risk stage II, stage III or stage IV cHL staged by 18FDG-PET/CT will receive 4 doses of single agent avelumab every 2 weeks. After the 4th dose of avelumab patients will have a PET-CT scan. All patients will then receive 2 cycles of ABVD followed by a PET-CT scan and further treatment will be guided in a risk-adapted manner based on the results of the RATHL. That is, patients who achieve PET CMR (defined as Deauville score 1-3) will receive 4 cycles of AVD and will undergo a CT scan. Patients with Deauville score 4-5 will receive 4 cycles of BEACOPP-14 or 3 cycles of escalated BEACOPP (at Investigators discretion and as per standard local policy) and will then undergo a further PET scan. Patients who are Deauville score 1-3 at this point will receive 2 further cycles of BEACOPP-14 or 1 cycle of escalated BEACOPP (at Investigators discretion and as per standard local policy). Patients who are Deauville score 4-5 at this point will receive further treatment at Investigators discretion and as per standard local policy. Radiotherapy to sites of residual avidity, initial bulk or as part of salvage treatment, is recommended (but not mandated).

Being tested
Avelumab
Keywords
avelumab
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvelumabDrug

    Also called Bavencio

    Patients with newly diagnosed cHL will receive 4 doses of single agent avelumab 10 mg/kg intravenously given every 2 weeks.

Study groups in NCT03617666
Study groupRoleWhat they receive
AvelumabExperimentalPatients with newly diagnosed cHL will receive single agent avelumab in 2 cycles
Receives: Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    Overall response rate (complete metabolic response (CMR) and partial metabolic response (PMR)) after 2 months (4 doses) of single agent avelumab treatment

    Measured: 2 months (after first dose of avelumab)

Secondary outcomes (7)

  1. Progression free survival

    Progression free survival will be calculated from the date of registration until the date of progression.

    Measured: 1 year and 3 years (from date of registration)

  2. Overall survival

    Overall survival time will be calculated from the date of registration until the date of death.

    Measured: 1 year and 3 years (from date of registration)

  3. Rates of adverse events with avelumab

    Safety and toxicity of avelumab, particularly autoimmune toxicity, as assessed by CTCAE v5.0

    Measured: 3 months (after first dose of avelumab)

  4. Rates of adverse events with ABVD/BEACOPP

    Safety and toxicity of subsequent ABVD/BEACOPP based chemotherapy, as assessed by CTCAE v5.0

    Measured: 7 months (after commencing ABVD/BEACOPP)

  5. Complete metabolic response rate

    Complete metabolic response rate following 2 cycles of ABVD

    Measured: 2 months (after commencing ABVD)

  6. Partial metabolic response rate

    Partial metabolic response rate following 2 cycles of ABVD

    Measured: 2 months (after commencing ABVD)

  7. Treatment compliance

    Proportion of patients completing chemotherapy without delays/dose modifications and proportion of patients who have chemotherapy dose delay/modification.

    Measured: 9 months (from the date of registration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start27 Sep 2019
  3. Primary completion4 Jul 2022
  4. Study completion30 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03617666
Sponsor's protocol ID
UCL /17/0192
Other IDs
2018-002227-42, 2018
Acronym
AVENuE
Status last verified
Dec 2023
First submitted
20 Jul 2018
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avelumab in people with Hodgkin Lymphoma, run by University College, London at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 2 months (after first dose of avelumab)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03617666.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.

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