A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Participants With Metastatic Solid Malignancies
A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Participants With Metastatic Solid Malignancies
This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic).
The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer.
This is a multi-cohort study.
Inclusion Criteria
Participants must have
Metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without known targetable EGFR, ALK, ROS1, or BRAF mutations) who either
Relapsed/refractory metastatic cutaneous melanoma (regardless of mutation status) with progression on a PD-1 inhibitor
Metastatic head and neck squamous cell carcinoma (HNSCC) who have not yet received frontline therapy for metastatic disease and without prior exposure to a PD-1/PD-L1 inhibitor.
Cohorts 1-4 only: Melanoma participants must be currently on PD-1 checkpoint inhibitor (CPI) therapy (e.g. nivolumab or pembrolizumab) or had their last dose of PD-1 CPI containing therapy as the last previous line of therapy within 90 days prior to enrollment; PD-1 CPI therapy must be the immediate prior line of treatment.
Cohorts 1-4 only: Participants must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other CPIs or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria.
Have received at least 2 doses of an approved PD-1 inhibitor.
Have demonstrated disease progression (PD) after a PD-1 inhibitor as defined by RECIST v1.1.
Tumor tissue sample obtained within 3 months prior to enrollment is required, and no systemic anticancer therapy given after the sample was obtained.
An Eastern Cooperative Oncology Group (ECOG) Performance Status score of equal or less than 1
Exclusion Criteria
Encinitas, California 92024, United States
Fresno, California 93720, United States
Los Angeles, California 90025, United States
Los Angeles, California 90048, United States
San Marcos, California 92069, United States
Santa Monica, California 90404, United States
Aurora, Colorado 80045, United States
Aurora, Colorado 80045, United States
Blacksburg, Virginia 24060, United States
Richmond, Virginia 23298, United States
Roanoke, Virginia 24014, United States
Salem, Virginia 24153, United States
Wytheville, Virginia 24382, United States