This phase II trial tests how well pembrolizumab in addition to chemotherapy (gemcitabine, brentuximab vedotin, and dacarbazine) works in treating frail patients with newly diagnosed Hodgkin lymphoma who aren't candidates for standard anthracycline-based treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Dacarbazine is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells and slow down or stop cancer growth. Pembrolizumab in combination chemotherapy may be a safe and effective alternative treatment option for frail patients with Hodgkin lymphoma who can't receive standard anthracycline-based treatment.
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Concomitant investigational therapy
Live vaccine within 30 days prior to day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacille Calmette Guerin [BCG], oral polio vaccine, and oral typhoid)
Grade ≥ 2 peripheral neuropathy
Requirement for hemodialysis or peritoneal dialysis. Estimated glomerular filtration rate (EGFR) > 30 for pembrolizumab + BV + dacarbazine
Single group
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Brentuximab Vedotin
DrugGiven IV
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Dacarbazine
DrugGiven IV
Echocardiography Test
Procedure/SurgeryUndergo ECHO
Gemcitabine
DrugGiven IV
Pembrolizumab
Biological/VaccineGiven IV
Physical Performance Testing
Other interventionAncillary studies
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Pulmonary Function Test
Procedure/SurgeryAncillary studies
Complete metabolic response (CMR) to pembrolizumab and gemcitabine (P-G)
Will be estimated by the proportion of response-evaluable patients achieving a best response of CMR, along with the 95% exact binomial confidence interval.
CMR
Will be estimated by the proportion of response-evaluable patients achieving a best response of CMR, along with the 95% exact binomial confidence interval.
Overall response (OR)
Will be estimated by the proportion of response-evaluable patients achieving a best response of CMR or partial metabolic response (PMR), along with the 95% exact binomial confidence interval.
Progression-free survival (PFS)
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median value will be estimated when available.
Duration of response (DOR)
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median value will be estimated when available.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
