A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL

• Status: Withdrawn
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Safety run-in (part 1): Relapsed or refractory B-cell Non-Hodgkin lymphoma (NHL)

Main study (part 2): Relapsed or refractory diffuse large B-cell lymphoma

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Royal Marsden NHS Foundation Trust
• Collaborators: Merck Sharp & Dohme Corp.; Mundipharma-EDO GmbH
• Treatments: Pembrolizumab; Rituximab

Criteria

Inclusion Criteria:

• Histologically proven CD20+ DLBCL (including transformed lymphoma)

• Previous treatment with at least 1 line of standard therapy

• Age 18 or over

• ECOG performance status 0/1 Measurable disease on cross-sectional imaging that is at least 1.5 cm in the longest diameter and measureable in two perpendicular dimensions

• Adequate organ function

• Resolution of prior systemic therapy related non-haematological AEs to grade (G) ≤ 1. Participants with ≤ G 2 neuropathy may be eligible.

• Consent to provide fresh tumour tissue during screening and treatment

Exclusion Criteria:

• CNS or leptomeningeal involvement

• Autologous stem cell transplant (ASCT) within 12 weeks or other anticancer treatment within 3 weeks of commencing therapy

• Prior allogeneic transplant

• Known HIV, or active Hepatitis B/C infection

• Active systemic autoimmune disease

• No previous therapy with agents targeting immune checkpoint proteins