This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment.
The names of the study drugs involved in this study are:
\- Pembrolizumab
Standard treatment will include:
* CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel) * Cyclophosphamide * Fludarabine
Histologically confirmed diagnosis of PMBCL, EBV+ DLBCL or THRLBCL at one of the participating institutions.
Availability of archival or freshly collected tumor tissue before study enrollment. If archival tissue is unavailable or is determined to be inadequate, tumor tissue must be obtained from a biopsy performed at screening, unless an exception is given after consultation with the sponsor-investigator.
Eligible for standard of care CAR T-cell therapy with progression after at least two prior lines of therapy OR refractory to initial chemoimmunotherapy OR relapse within 12 months of front-line chemoimmunotherapy OR one prior line of therapy and not fit for HSCT.
ECOG Performance Status of 0 or 1.
Patients in urgent need of cytoreductive therapy.
Participants who are receiving any other investigational agents.
Malignancy treated medically or surgically with curative intent and with no known active disease present for ≥2 years before study registration
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Jennifer Crombie, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Merck Sharp & Dohme LLC
Collaborator