Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment

Recruiting now · Phase 2

Conditions studied: Classic Hodgkin Lymphoma

In brief

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.

Key facts

Study ID: NCT07275216
Run by: City of Hope Medical Center
People needed: 23
Starts: 2026-07-01
Expected to finish: 2029-10-20
Last updated by the study team: 2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Meets at least one of the following criteria indicating unsuitability for conventional anthracycline-based frontline chemotherapy, as determined by the investigator:
Age ≥ 75 years
Eastern Cooperative Oncology Group (ECOG) 2-4
Left ventricular ejection fraction (LVEF) < 50%
Creatinine clearance < 60 mL/min, using Cockcroft-Gault formula or equivalent
Pulmonary function impairment: forced expiratory volume in 1 second (FEV1) < 50% and/or diffusion capacity of the lung for carbon monoxide (DLCO) < 50%
ECOG ≤ 2
Age ≥ 18 years
Histologically confirmed new diagnosis of classical Hodgkin lymphoma (excluding nodular lymphocyte predominant Hodgkin lymphoma) according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution
No prior systemic treatment for classical Hodgkin lymphoma with the following exceptions: a course of systemic corticosteroids for palliation of symptoms related to the classical Hodgkin lymphoma is allowed but must be stopped by cycle 1 day 1 (C1D1) as well as prior treatment with P-G as part of this clinical trial for patients will receive P-BV-D
Measurable disease (at least one non-bone fludeoxyglucose F-18 [FDG]-avid lesion ≥ 1.5 cm in long axis)
Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement
Platelets ≥ 50,000/mm\^3
NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement
Total bilirubin ≤ 2 × upper limit of normal (ULN) or direct bilirubin ≤ 2 × ULN for patients with Gilbert's disease
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
AST and ALT ≤ 3 x ULN unless there is liver involvement by lymphoma in which case AST and ALT < 5 x ULN
For patients for whom P-BV-D therapy is planned, creatinine clearance of ≥ 30 mL/min per 24-hour urine test or the Cockcroft-Gault formula
If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN
If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants

You may not qualify if…

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
Known active central nervous system (CNS) involvement by lymphoma including parenchymal and/or lymphomatous meningitis
History of prior ≥ grade 3 hypersensitivity to either brentuximab vedotin or pembrolizumab
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
History of another primary malignancy that has been in remission for fewer than 3 years, with the following exceptions:
Non-melanoma skin cancer treated with curative intent
In situ cervical cancer
If the malignancy is expected to not require any systemic treatment for at least 2 years (this exception should be discussed with the study PI)
Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Exceptions are:
Inhaled or topical steroids and
Adrenal replacement doses > 10 mg daily prednisone equivalents in the absence of active autoimmune disease
Up to 7 days of 20 mg daily prednisone equivalent after C1D1 for management of lymphoma-related symptoms
History of progressive multifocal leukoencephalopathy (PML)
Active pneumonitis or interstitial lung disease
Prior solid organ or allogeneic stem cell transplantation
History of known or suspected hemophagocytic lymphohistiocytosis (HLH)
Active, known or suspected autoimmune disease. The following are exceptions:
Vitiligo
Psoriasis not requiring systemic treatment
Hemolytic anemia associated with the lymphoma
Type I diabetes mellitus, if adequately controlled with therapy
Thyroid disease, if adequately controlled with therapy

Where it is running

City of Hope Medical Center — Duarte, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.