Classic Hodgkin LymphomaPhase 2NCT07275216
Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment
A Phase 2 study testing Biospecimen Collection, Brentuximab Vedotin and Computed Tomography in people with Classic Hodgkin Lymphoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classic Hodgkin Lymphoma
- What is being tested?
- Biospecimen Collection, Brentuximab Vedotin and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 20 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Matthew Mei, 626-218-2405, mamei@coh.org
Matthew Mei
About this study
Official title: Phase 2 Study of Pembrolizumab With Chemotherapy in Frail Patients With Newly Diagnosed Classical Hodgkin Lymphoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Estimate the best complete metabolic response (CMR) rate for frail patients with classical Hodgkin lymphoma (cHL) who receive pembrolizumab and gemcitabine (P-G).
SECONDARY OBJECTIVES:
- Estimate CMR rate, overall response rate (ORR), progression-free-survival (PFS), duration of response (DOR), and overall response (OS) among patients who receive P-G (± pembrolizumab maintenance).
II. Estimate CMR, overall response, PFS, DOR, and OS among patients who receive pembrolizumab, brentuximab vedotin, and dacarbazine (P-BV-D).
III. Evaluate the toxicity of P-G, pembrolizumab maintenance, and P-BV-D.
EXPLORATORY OBJECTIVES:
- Explore association between geriatric assessment measures (Cancer and Aging Research Group [CARG] geriatric assessment) and toxicity and efficacy in the elderly patients enrolled on this trial.
II. Assess functional trajectory determined by short physical performance battery (SPPB) change score in the elderly patients enrolled on this trial.
III. Explore the association between clinical outcomes and pathological tumor characteristics.
OUTLINE:
CYCLES 1-8: Patients receive pembrolizumab intravenously (IV) over 30 minutes and gemcitabine IV on day 1 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients without progressive disease during or at the completion of 8 cycles of P-G proceed to maintenance therapy. Patients with progressive disease during or at the completion of 8 cycles of P-G proceed to salvage therapy.
MAINTENANCE THERAPY: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 4 cycles (cycles 9-12) in the absence of disease progression or unacceptable toxicity.
SALVAGE THERAPY: Patients receive pembrolizumab IV over 30 minutes, brentuximab vedotin IV over 30 minutes, and dacarbazine IV on day 1 of each cycle. Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Patients undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the trial and may undergo echocardiography (ECHO) at screening if indicated.
After completion of study treatment, patients are followed up at 30 days and at 12, 18 (salvage patients), and 24 months.
- Conditions
- Classic Hodgkin Lymphoma
- Being tested
- Biospecimen Collection, Brentuximab Vedotin, Computed Tomography, Dacarbazine, Echocardiography Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
Brentuximab VedotinDrug
Also called ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
DacarbazineDrug
Also called 4-(Dimethyltriazeno)imidazole-5-carboxamide, 5-(Dimethyltriazeno)imidazole-4-carboxamide, Asercit, Biocarbazine
Given IV
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo ECHO
GemcitabineDrug
Also called dFdC, dFdCyd, Difluorodeoxycytidine
Given IV
PembrolizumabBiological
Also called BCD-201, GME 751, GME751, Keytruda
Given IV
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Ancillary studies
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
Pulmonary Function TestProcedure or surgery
Also called lung function test, PFT, Pulmonary Function Testing, Pulmonary Function Tests
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (P-G, P-BV-D) | Experimental | See Detailed Description. Receives: Procedure: Biospecimen Collection; Drug: Brentuximab Vedotin; Procedure: Computed Tomography; Drug: Dacarbazine; Procedure: Echocardiography Test; Drug: Gemcitabine; Biological: Pembrolizumab; Other: Physical Performance Testing; Procedure: Positron Emission Tomography; Procedure: Pulmonary Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During/after cycles 1-8 of P-G (cycle length = 21 days), before initiation of salvage or maintenance therapy or non-protocol lymphoma therapy
Secondary outcomes (12)
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.
Measured: During/after cycles 1-8 of P-G (cycle length = 21 days) or cycles 1-4 of pembrolizumab maintenance (cycle length = 42 days), before initiation of non-protocol lymphoma therapy
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.
Measured: During/after cycles 1-8 of P-G (cycle length = 21 days) or cycles 1-4 of pembrolizumab maintenance (cycle length = 42 days), before initiation of non-protocol lymphoma therapy
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.
Measured: From start of P-G treatment to time of disease relapse/progression or death, assessed up to 24 months
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.
Measured: From first achievement of CMR or PMR during/after cycles 1-8 of P-G (cycle length = 21 days) or cycles 1-4 of pembrolizumab maintenance (cycle length = 42 days) to disease relapse/progression or death, assessed up to 24 months
Overall survival (OS)
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.
Measured: From start of P-G treatment to time of death, assessed up to 24 months
Incidence of adverse events
Toxicities will be coded and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version (v) 5.0. Observed toxicities of study therapy will be summarized by type (organ affected or laboratory determination such as absolute neutrophil count), severity, and attribution.
Measured: Up to 24 months
CMR (for patients who receive salvage 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.
Measured: During/after cycles 1-12 of pembrolizumab, brentuximab vedotin, and dacarbazine (P-BV-D) (cycle length = 21 days), before initiation of non-protocol lymphoma therapy
OR (for patients who receive salvage therapy)
Will be estimated by the proportion of response-evaluable patients achieving a best response of CMR or PMR, along with the 95% exact binomial confidence interval.
Measured: During/after cycles 1-12 of P-BV-D (cycle length = 21 days), before initiation of non-protocol lymphoma therapy
PFS (for patients who receive salvage therapy)
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.
Measured: From start of P-BV-D treatment to time of disease relapse/progression or death, assessed up to 24 months
DOR (for patients who receive salvage therapy)
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.
Measured: From first achievement of CMR or PMR during/after cycles 1-12 of P-BV-D (cycle length = 21 days) to disease relapse/progression or death, assessed up to 24 months
OS (for patients who receive salvage therapy)
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.
Measured: From start of P-BV-D treatment to time of death, assessed up to 24 months
Incidence of adverse events (for patients who receive salvage therapy)
Toxicities will be coded and graded using the NCI CTCAE v 5.0. Observed toxicities of study therapy will be summarized by type (organ affected or laboratory determination such as absolute neutrophil count), severity, and attribution.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Oct 2026 (estimated)
- Primary completion20 Oct 2029 (estimated)
- Study completion20 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matthew Mei, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275216
- Sponsor's protocol ID
- 24081
- Other IDs
- NCI-2025-08524, 24081, P30CA033572
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Pembrolizumab With Chemotherapy in Frail Patients With Newly Diagnosed Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07275216
- Acronym / sponsor ID
- 24081
- Conditions
- Classic Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2029 (estimated)
- Study completion
- 20 Oct 2029 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- Estimate the best complete metabolic response (CMR) rate for frail patients with classical Hodgkin lymphoma (cHL) who receive pembrolizumab and gemcitabine (P-G).
SECONDARY OBJECTIVES:
- Estimate CMR rate, overall response rate (ORR), progression-free-survival (PFS), duration of response (DOR), and overall response (OS) among patients who receive P-G (± pembrolizumab maintenance).
II. Estimate CMR, overall response, PFS, DOR, and OS among patients who receive pembrolizumab, brentuximab vedotin, and dacarbazine (P-BV-D).
III. Evaluate the toxicity of P-G, pembrolizumab maintenance, and P-BV-D.
EXPLORATORY OBJECTIVES:
- Explore association between geriatric assessment measures (Cancer and Aging Research Group [CARG] geriatric assessment) and toxicity and efficacy in the elderly patients enrolled on this trial.
II. Assess functional trajectory determined by short physical performance battery (SPPB) change score in the elderly patients enrolled on this trial.
III. Explore the association between clinical outcomes and pathological tumor characteristics.
OUTLINE:
CYCLES 1-8: Patients receive pembrolizumab intravenously (IV) over 30 minutes and gemcitabine IV on day 1 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients without progressive disease during or at the completion of 8 cycles of P-G proceed to maintenance therapy. Patients with progressive disease during or at the completion of 8 cycles of P-G proceed to salvage therapy.
MAINTENANCE THERAPY: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 4 cycles (cycles 9-12) in the absence of disease progression or unacceptable toxicity.
SALVAGE THERAPY: Patients receive pembrolizumab IV over 30 minutes, brentuximab vedotin IV over 30 minutes, and dacarbazine IV on day 1 of each cycle. Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Patients undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the trial and may undergo echocardiography (ECHO) at screening if indicated.
After completion of study treatment, patients are followed up at 30 days and at 12, 18 (salvage patients), and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (P-G, P-BV-D) | Experimental | Procedure: Biospecimen Collection, Drug: Brentuximab Vedotin, Procedure: Computed Tomography, Drug: Dacarbazine, Procedure: Echocardiography Test, Drug: Gemcitabine, Biological: Pembrolizumab, Other: Physical Performance Testing, Procedure: Positron Emission Tomography, Procedure: Pulmonary Function TestSee Detailed Description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (48 listed)
- Documented informed consent of the participant and/or legally authorized representative
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- Meets at least one of the following criteria indicating unsuitability for conventional anthracycline-based frontline chemotherapy, as determined by the investigator:
- ECOG ≤ 2
- Age ≥ 18 years
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Treatment (P-G, P-BV-D) |
| Brentuximab VedotinAlso: ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35Given IV | Drug | Treatment (P-G, P-BV-D) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Treatment (P-G, P-BV-D) |
| DacarbazineAlso: 4-(Dimethyltriazeno)imidazole-5-carboxamide, 5-(Dimethyltriazeno)imidazole-4-carboxamide, Asercit, BiocarbazineGiven IV | Drug | Treatment (P-G, P-BV-D) |
| Echocardiography TestAlso: EC, EchocardiographyUndergo ECHO | Procedure or surgery | Treatment (P-G, P-BV-D) |
| GemcitabineAlso: dFdC, dFdCyd, DifluorodeoxycytidineGiven IV | Drug | Treatment (P-G, P-BV-D) |
| PembrolizumabAlso: BCD-201, GME 751, GME751, KeytrudaGiven IV | Biological | Treatment (P-G, P-BV-D) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingAncillary studies | Other | Treatment (P-G, P-BV-D) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Treatment (P-G, P-BV-D) |
| Pulmonary Function TestAlso: lung function test, PFT, Pulmonary Function Testing, Pulmonary Function TestsAncillary studies | Procedure or surgery | Treatment (P-G, P-BV-D) |
Primary outcome
Complete metabolic response (CMR) to pembrolizumab and gemcitabine (P-G)
Time frame: 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.
12 secondary outcomes
CMR
Time frame: During/after cycles 1-8 of P-G (cycle length = 21 days) or cycles 1-4 of pembrolizumab maintenance (cycle length = 42 days), before initiation of non-protocol lymphoma therapy
Overall response (OR)
Time frame: During/after cycles 1-8 of P-G (cycle length = 21 days) or cycles 1-4 of pembrolizumab maintenance (cycle length = 42 days), before initiation of non-protocol lymphoma therapy
Progression-free survival (PFS)
Time frame: From start of P-G treatment to time of disease relapse/progression or death, assessed up to 24 months
Duration of response (DOR)
Time frame: From first achievement of CMR or PMR during/after cycles 1-8 of P-G (cycle length = 21 days) or cycles 1-4 of pembrolizumab maintenance (cycle length = 42 days) to disease relapse/progression or death, assessed up to 24 months
Overall survival (OS)
Time frame: From start of P-G treatment to time of death, assessed up to 24 months
Incidence of adverse events
Time frame: Up to 24 months
CMR (for patients who receive salvage therapy)
Time frame: During/after cycles 1-12 of pembrolizumab, brentuximab vedotin, and dacarbazine (P-BV-D) (cycle length = 21 days), before initiation of non-protocol lymphoma therapy
OR (for patients who receive salvage therapy)
Time frame: During/after cycles 1-12 of P-BV-D (cycle length = 21 days), before initiation of non-protocol lymphoma therapy
PFS (for patients who receive salvage therapy)
Time frame: From start of P-BV-D treatment to time of disease relapse/progression or death, assessed up to 24 months
DOR (for patients who receive salvage therapy)
Time frame: From first achievement of CMR or PMR during/after cycles 1-12 of P-BV-D (cycle length = 21 days) to disease relapse/progression or death, assessed up to 24 months
OS (for patients who receive salvage therapy)
Time frame: From start of P-BV-D treatment to time of death, assessed up to 24 months
Incidence of adverse events (for patients who receive salvage therapy)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Mei principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Brentuximab Vedotin and Computed Tomography in people with Classic Hodgkin Lymphoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 48 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete metabolic response (CMR) to pembrolizumab and gemcitabine (P-G) (time frame: During/after cycles 1-8 of P-G (cycle length = 21 days), before initiation of salvage or maintenance therapy or non-protocol lymphoma therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.