Study of Avelumab in pts with previously treated Hodgkin’s Lymphoma
Research type
Research Study
Full title
A Phase 1 Pharmacokinetic (PK)-Pharmacodynamic (PD) Study of Avelumab (MSB0010718C) in Patients with Previously Treated Advanced Stage Classical Hodgkin’s Lymphoma – Javelin Hodgkin’s
IRAS ID
198831
Contact name
John Radford
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2015-002636-41
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Hodgkin’s lymphoma is a B cell malignancy and is a lymphoma involving peripheral lymph nodes, which may also impact organs including liver, lung as well as bone marrow. It affects about 9,000 new patients each year. There are two main types of Hodgkin’s lymphoma, classical Hodgkin’s lymphoma (cHL) and nodular lymphocyte predominant Hodgkin’s lymphoma. cHL accounts for most (~95%) Hodgkin’s Lymphoma diagnosed and it can be broken down further into subtypes. People diagnosed with classical Hodgkin’s lymphoma have large, abnormal cells called Reed-Sternberg cells in their lymph nodes.
The standard initial treatment for patients with newly diagnosed cHL includes chemotherapy or combined modality therapy, followed by restaging with PET/CT to assess treatment. While patients with cHL commonly respond well to initial therapy, a subset of patients (~25%) continues to experience relapsed disease and have very poor prognosis.
The primary purpose of this Clinical Trial is to learn about the safety of the study drug, avelumab, and how it is absorbed, distributed, broken down, and removed from the body. The study will look into whether a particular dose of avelumab alone could be used to treat advanced stage classical Hodgkin’s lymphoma. There will be two parts in this study; a “lead-in phase” and a “dose expansion phase”.
Approximately 66 patients will be taking part in this study. In the lead-in phase, there will be up to 30 patients divided into 5 dose groups. For the dose expansion phase, up to 12 additional patients will be enrolled in each of the 3 dose groups. The study is being done at approximately 20 different research sites around the world.
If the patient is accepted in the study, they will be assigned to either lead-in phase or dose expansion phase and to a 2-week or a 3-week dosing schedule with avelumab. They will have some tests and procedures or assessments during this study. In addition to the visits listed in the protocol, the study doctor may also ask them to come in for an extra visit if necessary to protect their well-being.
The duration of participation in this study can be up to a maximum of 2 years but will depend on ability to safely tolerate the treatment, how cancer responds to treatment, and study doctor’s decision to continue study treatment. If complete the maximum number of treatment cycles per month on avelumab and if cancer responds well to treatment with less side effects, and if willing to continue receiving avelumab, will be given the opportunity to continue treatment upon agreement between the study doctor and the Sponsor.
Participants are required to attend the screening visit when the study doctor will determine if they meet all requirements to be eligible for study enrollment. The screening period will take up to 28 days. During the lead-in phase or the dose expansion phase, if patients are selected for the 2 week dosing schedule, they will visit the research site at least 3 times (Days 1, 2, and 7) during the first 2 treatment cycles. After this, they will visit the research site at least once every 14 days (Day 1 of each every 2-week schedule) from Cycle 3 and for all other cycles until the end of treatment. If they are selected for the 3 week dosing schedule, they will visit the research site at least 4 times (Days 1, 2, 7, and 14) during the first 2 treatment cycles. After this, they will visit the research site at least once every 21 days (Day 1 of each every 3-week schedule) from Cycle 3 and for all other cycles until end of treatment.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0086
Date of REC Opinion
8 Mar 2016
REC opinion
Further Information Favourable Opinion