Prolgolimab is an anti-PD-1 inhibitor that has previously been shown to be effective and safe for the treatment of patients with melanoma. Given the mechanism of action, it is expected to be effective in patients with classical Hodgkin lymphoma (cHL). The use of PD-1 inhibitors in 2nd line treatment, as part of PET-adapted monotherapy/combination therapy, has already demonstrated a favorable toxicity profile, as well as a high efficacy, which may lead to increased survival of patients with r/r cHL. It has been demonstrated that long-term disease remission can be achieved after PD-1 inhibitor therapy, even in a group of heavily pretreated patients with relapsed/refractory cHL. The use of prolgolimab as part of PET-adapted therapy strategy in this study may allow to achieve a prolonged remission in patients with cHL who are highly sensitive to immunotherapy while omitting the autologous stem cell transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Prolgolimab monotherapy 1 mg/kg IV every 2 weeks up to a maximum of 24 cycles
Prolgolimab 1 mg/kg IV D1,15; Bendamustine 90 mg/m2 IV D1,2, 28-day cycle, maximum of 3 cycles;
St. Petersburg State Pavlov Medical University
Saint Petersburg, Russia
RECRUITINGN.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia
RECRUITINGOverall response rate during prolgolimab monotherapy
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano and LYRIC criteria
Time frame: 12 months
Frequency of grade 3 or higher treatment-related adverse events during prolgolimab monotherapy
Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0)
Time frame: 12 months
Frequency of grade 3 or higher treatment-related adverse events during combination therapy (prolgolimab+bendamustine)
Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0)
Time frame: 24 months
Overall response rate during combination therapy (prolgolimab+bendamustine)
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano and LYRIC criteria
Time frame: 24 months
1-year and 2-year overall survival
Overall survival defined as the time from the protocol therapy initiation to death from any reason
Time frame: 24 months
1-year and 2-year progression-free survival
Progression-free survival defined as the time from the protocol therapy initiation to disease progression, relapse or death from any reason.
Time frame: 24 months
Duration of response
Duration of response was defined as the time from response achievement to disease progression, relapse or death from any reason
Time frame: 24 months
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