NCT03617666

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_2

Geographic Reach
2 countries

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 27, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2022

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

2.8 years

First QC Date

July 20, 2018

Last Update Submit

December 5, 2023

Conditions

Hodgkin Lymphoma

Keywords

avelumab

Outcome Measures

Primary Outcomes (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

    2 months (after first dose of avelumab)

Secondary Outcomes (7)

  • Progression free survival

    1 year and 3 years (from date of registration)

  • Overall survival

    1 year and 3 years (from date of registration)

  • Rates of adverse events with avelumab

    3 months (after first dose of avelumab)

  • Rates of adverse events with ABVD/BEACOPP

    7 months (after commencing ABVD/BEACOPP)

  • Complete metabolic response rate

    2 months (after commencing ABVD)

  • +2 more secondary outcomes

Other Outcomes (3)

  • Correlate PET positive disease

    End of trial (3 years)

  • Correlate disease response

    End of trial (3 years)

  • Correlation between response to avelumab and biological parameter

    End of trial (3 years)

Study Arms (1)

Avelumab

EXPERIMENTAL

Patients with newly diagnosed cHL will receive single agent avelumab in 2 cycles

Drug: Avelumab

Interventions

AvelumabDRUG

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

Also known as: Bavencio
Avelumab

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Austin Health

Heidelberg, Victoria, Australia

Location

Heartlands Hospital

Birmingham, United Kingdom

Location

Beatson Hospital

Glasgow, United Kingdom

Location

Leicester Royal Infirmary

Leicester, United Kingdom

Location

St George's Hospital

London, United Kingdom

Location

Christie Hospital

Manchester, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Location

Churchill Hospital

Oxford, United Kingdom

Location

Derriford Hospital

Plymouth, United Kingdom

Location

Royal Stoke University Hospital

Stoke, United Kingdom

Location

The Royal Marsden Hospital, Sutton

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

avelumab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Graham Collins

    Churchill Hospital

    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

Study Record Dates

First Submitted

July 20, 2018

First Posted

August 6, 2018

Study Start

September 27, 2019

Primary Completion

July 4, 2022

Study Completion

May 30, 2025

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)GB(10)