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Pembrolizumab

Immunoglobulins

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Immune Checkpoint Inhibitors

Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles

The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.

Eric Jacobsen, MD

This research study is studying a drug called pembrolizumab as a possible treatment for aggressive lymphoma or a histiocyte or dendritic cell neoplasm.

The drug involved in this study is:

-Pembrolizumab

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for this specific disease but it has been approved for other uses.

The study drug is an antibody that targets a molecule called programmed cell death protein 1 (PD-1). PD-1 is used to turn down the immune system. In general, this is used by the body to prevent the immune system from being too active. However, several cancers appear to use this pathway to prevent the immune system from attacking them. The theory behind this study is that by blocking PD-1, we may be able to prevent the cancer from hiding from the immune system and allow the immune system to attack the cancer more effectively. There is evidence that the type of lymphoma the participant have may use PD-1 to escape the immune system.

Pembrolizumab in Neoplasms or Lymphomas

A Phase 2 Study of Pembrolizumab in Patients With Histiocyte/Dendritic Cell Neoplasms and Biologically Selected Subtypes of Relapsed/Refractory Aggressive Lymphomas

The number of subjects with partial response (PR) or complete response (CR) by PET/CT scan

Per Lugano criteria, CR is defined as positron emission tomography-computed tomography (PET-CT), score 1, 2, or 3 with or without a residual mass on 5 point scale (5PS) OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi). PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in the sum of the products of the longest perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites.

The number of patients with complete response (CR)

Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with or without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi.

The number of patients with an adverse event of any grade that has definite, probable, or possible attribution to study treatment.

Length of first complete (CR) or partial response (PR) until progression (PD)

Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with/without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites. PD is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new fluoro-2-deoxy-D-glucose (FDG)-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new/clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR new node \>1.5 cm in any axis or new extranodal site \>1.0 cm in any axis or be unequivocal and attributable to lymphoma. AND/OR new/recurrent involvement of the bone marrow

Time from study registration until the earlier of first progression or death from any cause, censored for patients alive without progression or lost to follow-up without documented progression.

Per Lugano criteria, progression is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new or clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR a new node \>1.5 cm in any axis or a new extranodal site \>1.0 cm in any axis or be unequivocal and must be attributable to lymphoma. AND/OR new or recurrent involvement of the bone marrow

The length of first complete response (CR) until progression (PD)

Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with or without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. PD is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new or clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR a new node \>1.5 cm in any axis or a new extranodal site \>1.0 cm in any axis or be unequivocal and must be attributable to lymphoma. AND/OR new or recurrent involvement of the bone marrow

Time from study registration until death from any cause, censored for patients still alive or lost to follow-up

Merck Sharp & Dohme LLC

Dana-Farber Cancer Institute

Principal Investigator

Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles

Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.

Spots Global Cancer Trial Database for follicular dendritic cell sarcoma