Spots Global Cancer Trial Database for Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)

Study Description

Brief Summary: 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.

Detailed Description: This is a single-arm, open-label phase 2 study to evaluate the safety and efficacy of single agent balstilimab in participants with relapsed/refractory lymphoma. The study will enroll participants with relapsed/refractory classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma. The participants will receive balstilimab (BAL) 300 mg IV every 3 weeks. BAL infusions will be administered within 30 minutes (± 5 min) using an infusion pump. The total estimated maximum time of study participation for each patient is approximately 49 months across 3 periods: * Screening Period: approximately 28 days * Treatment Period: up to 24 months, or until any criterion for stopping the study drug or withdrawal from the study occurs * Follow-up Period: up to 24 months from last dose of study treatment for every patient who is alive Study Duration * Recruitment: 2 years * Treatment: 2 years * Follow-up: 2 years

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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