Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Re… (NCT04052997) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
United States117 participantsStarted 2019-09-13
Plain-language summary
The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Written informed consent must be obtained prior to any procedures.
✓. Male or female participant aged 18 years or older. (16 years or older at US based sites)
✓. Pathologic diagnosis of classical Hodgkin lymphoma (cHL).
✓. Patients with relapsed or refractory cHL, who have received at least 3 prior lines of systemic therapy (or at least 2 prior lines in HSCT ineligible patients) including brentuximab vedotin and a checkpoint inhibitor approved for cHL (e.g., nivolumab or pembrolizumab). Note 1: Receipt of HSCT to be included in the number of prior therapies needed to meet eligibility.
✓. Measurable disease as defined by the 2014 Lugano Classification.
✓. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available).
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
✓. Adequate organ function as defined by Screening laboratory values within the following parameters:
Exclusion criteria
✕. Previous treatment with Camidanlumab Tesirine.
✕. Participation in another investigational interventional study. Being in follow-up of another investigational study is allowed.
✕. Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a CD25 antibody.
✕. Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary.
✕. History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]) (subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled).