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).
Additional locations may be listed on ClinicalTrials.gov for NCT02733042.
See trial information on ClinicalTrials.gov for a list of participating sites.
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