The goal of this study is to see if the drug balstilimab is safe and effective in participants with relapsed/refractory lymphomas.
Participants will receive balstilimab every 3 weeks and their outcomes will be assessed periodically.
Voluntarily agree to participate by giving written informed consent
≥ 18 years of age
Have a histologically confirmed diagnosis of a relapsed/refractory classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) for which no standard therapy is available or standard therapy has failed or the patient does not have access to it.
Has a life expectancy of at least 3 months and an ECOG performance status of ≤1 as determined by study Investigator
Received systemic cytotoxic chemotherapy within 3 weeks before initiation of study treatment
Received biological therapy or investigational therapy within 4 weeks or 5 circulating halve-lives, whichever is shorter
Received small molecule/tyrosine kinase inhibitors within 2 weeks or 5 circulating half-lives, whichever is shorter
Received radiation therapy within 3 weeks before initiation of study treatment, except for palliative radiation therapy, which can be received 2 weeks prior to initiation of study treatment
Single group
Balstilimab
DrugAn anti-programmed death (ligand) 1 \[PD-(L)1\] monoclonal antibody
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) assessed per the Lugano criteria
Duration of Response (DOR)
DOR is defined as time from first observation of response to first observation of documented disease progression per the Lugano criteria or death within 12 weeks of last tumor assessment
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who have achieved complete response, partial response or stable disease per the Lugano criteria
Duration of Stable Disease (SD)
Duration of SD is measured from the start of treatment until the criteria for progression are met, per the Lugano criteria
Time to Response
Time to Response is defined as the time from the first dose date to first observation of confirmed response per the Lugano criteria
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Immune Oncology Research Institute
Lead sponsor
Agenus Inc.
Collaborator