The purpose of this study is to test the safety and efficacy of magrolimab in combination with pembrolizumab in patients with Hodgkin lymphoma.
Primary Objectives: \- To assess the complete remission (CR) rate of magrolimab in combination with pembrolizumab in adult subjects with relapsed or refractory cHL Secondary Objectives: * To assess the safety and tolerability of magrolimab in combination with pembrolizumab in adult subjects with relapsed or refractory cHL * To assess the overall response rate (ORR)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion
200 mg IV infusion
Scan
Stanford University
Stanford, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Complete Response (CR)
Each participant's response to treatment will be assessed per the Lugano criteria. The criteria are: * Complete Response (CR): Complete disappearance of all lesions, evidence, and effects of disease * Partial Response (PR): ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease * Stable disease (SD): less than PR. * Progressive disease (PD): sum of the product of dimensions (SPD) of lesions increased ≥50% from smallest value The outcome will be reported as the number of participants with a CR after 4 and 8 cycles of treatment (4 and 8 months), and if CR is achieved anytime within 2 years ("overall").
Time frame: 2 years
Magrolimab related Adverse Events
Magrolimab safety and tolerability will be assessed on the basis of magrolimab related adverse events occurring within 4 cycles of treatment (4 months). The outcome will be reported as the number of magrolimab related adverse events judged mild (Grade 1), moderate (Grade 2), severe (Grade 3), life threatening (Grade 4), or fatal (Grade 5), numbers without dispersion.
Time frame: 4 months
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