Status:
WITHDRAWN
A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Mundipharma-EDO GmbH
Conditions:
Relapsed or Refractory Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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
Detailed Description
The primary objective of the safety run-in phase (part 1) is to assess the safety and tolerability of pembrolizumab in combination with R-tinostamustineand to recommend a safe and tolerated dose of ti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04279938
Start Date
September 1 2018
End Date
January 1 2021
Last Update
February 21 2020
Active Locations (1)
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1
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT