Pembrolizumab Followed by Chemotherapy for the Treatment of Patients With Classical Hodgkin Lymphoma

NCT06164275 | Active Not Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: NU 23H06NCI-2023-08756STU00219738P30CA060553
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

This phase II trial tests how well giving pembrolizumab followed by chemotherapy with doxorubicin, vinblastine and dacarbazine works to treat patients with classical Hodgkin lymphoma. Pembrolizumab is a type of drug called a "monoclonal antibody (mAb)" that uses the body's immune system to help fight and kill cancer cells. Chemotherapy drugs, such as doxorubicin, vinblastine and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Giving pembrolizumab followed by chemotherapy may work to treat patients with classical Hodgkin lymphoma.

Conditions

Classic Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Rate of complete response (CR)

  Assessed by position emission tomography (PET)-computed tomography (CT). CR defined as 1-3 on the five-point scale per Lugano (Lugano 2014 Response Criteria). Patients with 1-3 per Deauville criteria will be considered a complete response. Response will be determined, using a proportion and an exact binomial 95% confidence interval.

  Up to 5 years

Secondary Outcomes (5)

• Efficacy of reduced cycles of treatment with doxorubicin (adriamycin) vinblastine, doxorubicin (AVD) for patients with CR

  Up to 5 years

• Incidence of adverse events

  Up to 5 years

• Overall survival (OS)

  From start of treatment administration per protocol until death, up to 5 years

• Progression free survival (PFS)

  From the start of treatment administration per protocol until the first occurrence of disease relapse, progression, re-initiation of cytotoxic chemotherapy, or death due to disease, up to 5 years

• Assess the CR rate at the end of PEM induction by PET-CT i

  Up to 5 years

Study Arms (1)

Treatment (Pembrolizumab and AVD)

EXPERIMENTAL

INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo disease assessment. Patients with a response complete 3 additional cycles of pembrolizumab, undergo disease assessment and proceed to consolidation. Patients without response or with progressive disease proceed to consolidation. CONSOLIDATION: Patients receive doxorubicin IV, vinblastine IV and dacarbazine IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for 2 to 6 cycles dependent upon response and disease type. Patients undergo echocardiography/MUGA scan, CT scan, PET scan and blood sample collection throughout the study and may undergo tumor biopsy during screening.

Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Dacarbazine; Drug: Doxorubicin; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Biological: Pembrolizumab; Procedure: Positron Emission Tomography; Drug: Vinblastine

Interventions

Biopsy PROCEDURE

Undergo tumor biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (Pembrolizumab and AVD)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (Pembrolizumab and AVD)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Treatment (Pembrolizumab and AVD)

Dacarbazine DRUG

Given IV

Also known as: 4-(Dimethyltriazeno)imidazole-5-carboxamide, 5-(Dimethyltriazeno)imidazole-4-carboxamide, Asercit, Biocarbazine, Dacarbazina, Dacarbazina Almirall, Dacarbazine - DTIC, Dacatic, Dakarbazin, Deticene, Detimedac, DIC, Dimethyl (triazeno) imidazolecarboxamide, Dimethyl Triazeno Imidazol Carboxamide, Dimethyl Triazeno Imidazole Carboxamide, dimethyl-triazeno-imidazole carboxamide, Dimethyl-triazeno-imidazole-carboximide, DTIC, DTIC-Dome, Fauldetic, Imidazole Carboxamide, Imidazole Carboxamide Dimethyltriazeno, WR-139007

Treatment (Pembrolizumab and AVD)

Doxorubicin DRUG

Given IV

Also known as: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

Treatment (Pembrolizumab and AVD)

Echocardiography PROCEDURE

Undergo echocardiography

Also known as: EC

Treatment (Pembrolizumab and AVD)

Multigated Acquisition Scan PROCEDURE

Undergo MUGA scan

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, MUGA, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

Treatment (Pembrolizumab and AVD)

Pembrolizumab BIOLOGICAL

Given IV

Also known as: BCD-201, Keytruda, Lambrolizumab, MK-3475, Pembrolizumab Biosimilar BCD-201, SCH 900475

Treatment (Pembrolizumab and AVD)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (Pembrolizumab and AVD)

Vinblastine DRUG

Given IV

Also known as: Vincaleucoblastine, VLB

Treatment (Pembrolizumab and AVD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologically confirmed diagnosis of Ann Arbor Stage III or IV classic Hodgkin lymphoma (cHL) or Ann Arbor Stage I and Stage II classic Hodgkin lymphoma with at least one unfavorable risk factor by National Comprehensive Cancer Network (NCCN) criteria.
• NCCN Unfavorable Factors include bulky disease defined as:
• A mass \>10 cm disease in any dimension or
• Mediastinal mass ratio greater than one third defined as maximum width of mediastinal ass/intrathoracic diameter at T5-6
• B symptoms
• Erythrocyte sedimentation rate (ESR) ≥ 50
• And \>3 sites of disease
• Patients must have measurable fludeoxyglucose (FDG)-avid disease by Lugano 2014 response criteria
• Patients must have previously untreated disease
• Patients must be age ≥ 18 years
• Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 per evaluation performed within 7 days prior to the date of the first dose of study intervention
• Leukocytes (WBC) ≥ 3,000/mcL unless attributed to neoplastic involvement of the bone marrow
• Platelet transfusions are acceptable prior to treatment to achieve the above numbers, however growth factors are not allowed within 14 days of registration
• No lower limit if cytopenia is related to bone marrow involvement.
• Absolute neutrophil count (ANC) ≥ 500/mcL unless attributed to neoplastic involvement of the bone marrow

You may not qualify if:

• Diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma
• Patients who have had prior systemic chemotherapy, radiation therapy, immunotherapy, or other systemic therapy (including investigational agents) for the treatment of cHL.
• NOTE: If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. No radiation therapy for Hodgkin lymphoma (cHL) will be allowed prior to and while participation on this clinical trial, including for system control
• Patients who are actively participating in a clinical trial with an investigational agent or device or has participated in a clinical trial with an investigational agent or device within 30 days of the anticipated treatment start date.
• NOTE: Patients who have entered the follow-up phase of an investigational study will be eligible to participate as long as ≥ 30 days has elapsed since the administration of the last dose of an investigational treatment for a disease/condition other than cHL
• Patients who have known active central nervous system (CNS) metastases and/or lymphomatous meningitis are not eligible
• Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, and/or any of its excipients
• Patients who have any contraindication to the use of any of the chemotherapeutic agents used in this study
• Patients who have had an allogenic tissue or solid organ transplant
• Patients who are pregnant or nursing NOTE: Pregnant persons are excluded from this study because the chemotherapy regimen (AVD) includes adriamycin (also known as doxorubicin), which is an anthracycline; anthracyclines are known chemotherapy agents with the potential for teratogenic or abortifacient effects. In addition, the investigational agent, pembrolizumab, has the potential for embryo-fetal toxicity. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with adriamycin (doxorubicin) as part of the AVD chemotherapy regimen, and the investigational agent, pembrolizumab, breastfeeding should be discontinued if the mother is treated with AVD and/or pembrolizumab.
• Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to registration are not eligible. NOTE: Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
• Patients who have a known history of active TB (Bacillus Tuberculosis) are not eligible
• Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
• Symptomatic congestive heart failure (ejection fraction lower than institutional lower limit of normal \[LLN\]
• Unstable angina pectoris

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Stanford Cancer Center

Stanford, California, 94305-5824, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Northwestern Delnor IL258

Geneva, Illinois, 60134, United States

Location

Cadence Health - CDH

Warrenville, Illinois, 60555, United States

Location

MeSH Terms

Interventions

Biopsy; Specimen Handling; Dacarbazine; Doxorubicin; pembrolizumab; Magnetic Resonance Spectroscopy; Vinblastine

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Jane N Winter, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 11, 2023
• Study Start: February 6, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

US (4)