US-based Seattle Genetics and Bristol-Myers Squibb have initiated a new trial assessing Adcetris (brentuximab vedotin) in combination with Opdivo (nivolumab).
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The phase 1/2 open-label, multi-center, clinical trial is for patients with CD30-expressing relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL), including diffuse large B-cell lymphoma (DLBCL), peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
The antibody-drug conjugate (ADC) Adcetris is directed to CD30 and causes immunogenic cell death of tumor cells, providing rationale for combination with Opdivo.
Seattle Genetics research and development chief medical officer and executive vice-president Jonathan Drachman said: "This is the second corporate-sponsored clinical trial to evaluate Adcetris combined with a checkpoint inhibitor to determine if the combination can improve patient outcomes.
"This study is a part of a broad development program that includes more than 70 ongoing clinical trials evaluating Adcetris in multiple lines of therapy for Hodgkin and non-Hodgkin lymphoma and as part of novel combinations that could result in improved clinical benefit with manageable safety profiles."
The latest trial, which is the second of two trials being conducted under a clinical trial collaboration agreement announced previously between the companies, has been designed to assess the safety, tolerability and antitumor activity of Adcetris.
The study comprises a phase 1 dose evaluation portion.
This is followed by a single-arm phase 2 portion that will expand enrollment to treat disease-specific cohorts with relapsed or refractory DLBCL, PTCL or CTCL at the recommended dose level.
Adcetris is also being evaluated in over 70 ongoing clinical trials and is not currently approved for frontline treatment or for the treatment of NHL other than relapsed systemic anaplastic large cell lymphoma (sALCL).
Image: A Bristol-Myers Squibb R&D facility at Lawrence Township, US. Photo: courtesy of Coolcaesar