This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical
activity, and predictive biomarkers of durvalumab in combination with R-CHOP or R2-CHOP,
followed by durvalumab consolidation therapy in previously untreated subjects with
high-risk diffuse large B-cell lymphoma (DLBCL). Induction treatment with R-CHOP (±
lenalidomide) will last for a total of up to 6 to 8 treatment cycles (21 day cycles), and
the total time on study treatment, including durvalumab consolidation, will last up to 12
months.
On 05-Sep-2017, the US FDA has issued a Partial Clinical Hold on this study resulting in
the discontinuation of enrollment into Arm B (Durvalumab + Lenalidomide + R-CHOP). After
the US FDA Partial Clinical Hold, new eligible participants have been enrolled in Arm A
(Durvalumab + R-CHOP).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03003520.
This research study is conducted in participants with previously untreated, high-risk
diffuse large B-cell lymphoma (DLBCL). Patients with high-risk DLBCL typically have
insufficient therapeutic outcomes. Therefore, the addition of novel agents to the
currently used induction therapy (R-CHOP) is a rational approach to improve therapeutic
outcomes in this disease setting.
Based on pre-clinical and clinical observations, it is hypothesized that durvalumab will
have activity in DLBCL because the PD 1/PD L1 pathway is involved in the pathophysiology
of DLBCL. In particular, the addition of durvalumab may augment the anti-tumor activity
of R-CHOP against high-risk DLBCL sub-types.
The safety of durvalumab has already been explored. However, as there is limited clinical
experience with durvalumab in DLBCL, the study is divided into two stages:
- A Safety Run-in Stage to evaluate the safety of the treatment combinations until at
least 10 subjects are included in each of the two treatment arms
- An Expansion Stage to analyze the clinical activity of the treatment combinations
Results posted following Primary Outcome Completion date are based on a database cut-off
of August 2, 2018.
Lead OrganizationCelgene Corporation
