Pembrolizumab with Chemotherapy for Frail Hodgkin Lymphoma Patients
This study is for patients with newly diagnosed Hodgkin lymphoma who are not able to receive standard treatments due to their health. It tests a combination of pembrolizumab, an immunotherapy drug that helps your immune system fight cancer, with chemotherapy drugs like gemcitabine, brentuximab vedotin, and dacarbazine. Pembrolizumab is a monoclonal antibody, which means it's a lab-made protein designed to attach to specific targets on cancer cells. Brentuximab vedotin is an antibody-drug conjugate, combining an antibody with a chemotherapy drug to deliver it directly to cancer cells. Researchers want to see how many patients have a complete metabolic response (CMR), meaning their cancer activity significantly decreases, after receiving these treatments. The study plans to enroll 23 participants and is currently unclear on its recruitment status.
- Study design
- This is an interventional study, but the phase is not specified. It aims to enroll 23 participants.
- What's involved
- You would undergo blood sample collection, PET/CT scans, and echocardiography tests. You would receive pembrolizumab and gemcitabine intravenously (IV) on day 1 of each 21-day cycle, for up to 8 cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, complete metabolic response, is measured during or after cycles 1-8 of treatment, before further therapy.
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NCT07275216
Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment
Recruiting
PHASE2Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~23 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBrentuximab VedotinComputed TomographyDacarbazineEchocardiography TestGemcitabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete metabolic response (CMR) to pembrolizumab and gemcitabine (P-G)
Measured over During/after cycles 1-8 of P-G (cycle length = 21 days), before initiation of salvage or maintenance therapy or non-protocol lymphoma therapy
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Matthew Mei · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants
Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative) OR
If seropositive for HBV or HCV, nucleic acid quantitation must be performed. Viral load must be undetectable. Patients with occult or prior HBV infection (defined as negative hepatitis B virus surface antigen \[HBsAg\] and positive hepatitis B core antibody \[HBcAb\]) may be included if HBV DNA is undetectable, if they are willing to undergo DNA testing on day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
A male participant must agree to use a contraception during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least (X days/weeks \[corresponding to time needed to eliminate any study treatment(s)\] \[pembrolizumab and/or any active comparator/combination\] plus 30 days \[a menstruation cycle\] for study treatments with risk of genotoxicity) after the last dose of study treatment
TO PROCEED WITH SALVAGE TREATMENT: ECOG ≤ 2
TO PROCEED WITH SALVAGE TREATMENT: Resolution of treatment-related adverse events (AEs) to baseline or grade 1, whichever is higher
TO PROCEED WITH SALVAGE TREATMENT: Measurable disease (at least one non-bony FDG-avid lesion ≥ 1.5 cm in long axis)
TO PROCEED WITH SALVAGE TREATMENT: Peripheral neuropathy ≤ grade 2
TO PROCEED WITH SALVAGE TREATMENT: ANC ≥ 1,000/mm\^3
NOTE: Growth factors are permitted
TO PROCEED WITH SALVAGE TREATMENT: Platelets ≥ 50,000/mm\^3
NOTE: Platelet transfusions are permitted
TO PROCEED WITH SALVAGE TREATMENT: Hemoglobin ≥ 8 g/dL (no transfusion allowed within 3 days prior to screening)
TO PROCEED WITH SALVAGE TREATMENT: Total bilirubin ≤ 2 x ULN or direct bilirubin ≤ 2 x ULN for patients with Gilbert's disease
TO PROCEED WITH SALVAGE TREATMENT: AST ≤ 3 x ULN, or less then 5 x ULN for patients with liver involvement by lymphoma
TO PROCEED WITH SALVAGE TREATMENT: ALT ≤ 3 x ULN, or less then 5 x ULN for patients with liver involvement by lymphoma
TO PROCEED WITH SALVAGE TREATMENT: Creatinine clearance of ≥ 30 mL/min per 24-hour urine test or the Cockcroft-Gault formula
Exclusion
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
Conditions not expected to recur in the absence of an external trigger (such exceptions should be discussed with the study PI)
Active history of:
Hepatitis B (HBV) or C (HCV) infection. Patients with past HBV infection (defined as negative HBsAg and positive hepatitis B core antibody \[HBcAb\]) are eligible if HBV DNA is undetectable. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV RNA
HIV positive
History of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association class III-IV within 6 months prior to day 1 of protocol therapy
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Complete metabolic response (CMR) to pembrolizumab and gemcitabine (P-G)During/after cycles 1-8 of P-G (cycle length = 21 days), before initiation of salvage or maintenance therapy or non-protocol lymphoma therapy
Will be estimated by the proportion of response-evaluable patients achieving a best response of CMR, along with the 95% exact binomial confidence interval.