Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study (AVENuE)
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|ClinicalTrials.gov Identifier: NCT03617666|
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: Avelumab||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AVENuE - Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||October 2022|
Patients with newly diagnosed cHL will receive single agent avelumab in 2 cycles
Patients with newly diagnosed cHL will receive 4 doses of single agent avelumab intravenously given every 2 weeks.
- Overall response rate [ Time Frame: 2 months (after first dose of avelumab) ]Overall response rate (complete metabolic response (CMR) and partial metabolic response (PMR)) after 2 months (4 doses) of single agent avelumab treatment
- Progression free survival [ Time Frame: 1 year (from date of registration) ]Progression free survival will be calculated from the date of registration until the date of progression.
- Overall survival [ Time Frame: 1 year (from date of registration) ]Overall survival time will be calculated from the date of registration until the date of death.
- Rates of adverse events with avelumab [ Time Frame: 3 months (after first dose of avelumab) ]Safety and toxicity of avelumab, particularly autoimmune toxicity, as assessed by CTCAE v5.0
- Rates of adverse events with ABVD/BEACOPP [ Time Frame: 7 months (after commencing ABVD/BEACOPP) ]Safety and toxicity of subsequent ABVD/BEACOPP based chemotherapy, as assessed by CTCAE v5.0
- Complete metabolic response rate [ Time Frame: 2 months (after commencing ABVD) ]Complete metabolic response rate following 2 cycles of ABVD
- Partial metabolic response rate [ Time Frame: 2 months (after commencing ABVD) ]Partial metabolic response rate following 2 cycles of ABVD
- Treatment compliance [ Time Frame: 9 months (from the date of registration) ]Proportion of patients completing chemotherapy without delays/dose modifications and proportion of patients who have chemotherapy dose delay/modification.
- Correlate PET positive disease [ Time Frame: End of trial (3 years) ]Correlate PET positive disease with histological evidence of disease on biopsy to establish biopsy negative PMR rate (subject to patient consent)
- Correlate disease response [ Time Frame: End of trial (3 years) ]Correlate disease response, as assessed by FDG-PET and histology, with serological markers, including serum TARC
- Correlation between response to avelumab and biological parameter [ Time Frame: End of trial (3 years) ]Evaluate the correlation between response to avelumab and biological parameters e.g. PD-1 expression on Reed Sternberg cells
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617666
|Contact: Bojana Selinsek||+44 (0)207 679 email@example.com|
|Contact: Ellice Marwood||+44 (0)207 679 firstname.lastname@example.org|
|Principal Investigator:||Graham Collins||Churchill Hospital|