Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma

Required: CD30 overexpression (>1% by IHC)

Presence of CD30 (>1%) by IHC on a previous biopsy sample

Must have received: systemic therapy

Relapsed/refractory disease having failed at least one prior systemic therapy

Cannot have received: anti-PD-1 therapy

Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent

Cannot have received: co-inhibitory T-cell receptor therapy (CTLA-4, OX 40, CD137)

agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)

Cannot have received: systemic anti-cancer therapy

Exception: concurrent use of bexarotene or vorinostat (dose stable for 8 weeks prior to initiating therapy on trial) is permitted for CTCL; concurrent use of topical steroids or therapies for CTCL is allowed

Has received prior systemic anti-cancer therapy including investigational agents ≤ 4 weeks prior to first dose of study treatment

Cannot have received: radiation therapy

Exception: 1-week washout permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease

Has received radiotherapy within 2 weeks of start of study treatment

Cannot have received: live vaccine

Exception: killed vaccines allowed

Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug

Cannot have received: allogeneic stem cell transplant

Prior allogeneic stem cell transplant within last 5 years or active graft vs. host disease (GVHD)

Cannot have received: Brentuximab vedotin (Brentuximab vedotin)

Exception: Single agent Brentuximab could have been a prior line of therapy EXCEPT those with ≥ grade 2 side effects leading to treatment discontinuation or those refractory to Brentuximab

Single agent Brentuximab could have been a prior line of therapy EXCEPT those with ≥ grade 2 side effects leading to treatment discontinuation or those refractory to Brentuximab