This study is designed to determine the recommended phase 2 dose (RP2D), and the safety,
and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide
and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with
lymphoma or chronic lymphocytic leukemia (CLL).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02733042.
The study was to consist of 3 parts: dose-finding, dose-confirmation, and dose-expansion.
In this study, 4 treatment arms were to be investigated:
- Arm A: durvalumab and lenalidomide ± rituximab
- Arm B: durvalumab and ibrutinib
- Arm C: durvalumab and rituximab ± bendamustine
- Arm D: durvalumab (monotherapy)
The study was to start with 3 dose-finding cohorts (Arms A, B, and C) and 1
dose-confirmation cohort (Arm D) in parallel. All treatment arms were to be open for
enrollment at study start except in the US, where Arm D was to enroll depending on the
availability of treatment slots and following the completion of assessment of responses
from the combination therapy arms. For Arms A and C, prior to enrolling participants to
receive all 3 drugs, the doublet combinations were to be evaluated. Once the doublet
combinations were deemed tolerable, the eventual triplet combinations were to be tested.
On 05 September 2017, the US FDA issued a Partial Clinical Hold on the study Arm A.
Following this Partial Clinical Hold no more participants were enrolled into study Arm A.
Participants already enrolled and treated in Arm A who were receiving clinical benefit,
based on the discretion of the investigator, could continue study treatment after being
reconsented. Arm B and C completed dose confirmation. The dose expansion part of the
study was not opened.
Lead OrganizationCelgene Corporation