Hodgkin LymphomaPhase 2NCT05922904
PET Adapted Brentuximab Vedotin and Pembrolizumab in Combination With Doxorubicin and Dacarbazine in Classic Hodgkin Lymphoma
A Phase 2 study testing Brentuximab vedotin, Doxorubicin Hydrochloride and Pembrolizumab in people with Hodgkin Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn about the effects of brentuximab vedotin and pembrolizumab in combination with doxorubicin and dacarbazine when given to patients who have Stage II cHL with bulky mediastinal disease or advanced cHL (Stage III or IV) and who have not received treatment for the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Brentuximab vedotin, Doxorubicin Hydrochloride and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2023to 30 Oct 2027
- 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
- Treatment-naïve, HL subjects with Ann Arbor stage III, IV, or stage II with bulky disease (>10 cm).
- Histologically confirmed cHL according to the current World Health Organization Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted, classical HL, or not otherwise specified). a. Subjects enrolling must submit a tumor block for analysis. Availability of tissue must be confirmed prior to enrollment.
- Bidimensional measurable disease as documented by PET/CT or CT imaging. Must have at least one lesion >15 mm (1.5 cm) in the longest diameter on cross-sectional imaging, measurable in 2 perpendicular dimensions on CT (or MRI), and FDG avid by PET.
- Age 18 years or older.
- An Eastern Cooperative Oncology Group (ECOG) performance status zero, or one.
- Subjects of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of brentuximab vedotin. Subjects with false positive results and documented verification that the subject is not pregnant are eligible for participation. Subjects of non-childbearing potential are those who are postmenopausal >1 year or who have had a bilateral oophorectomy or hysterectomy.
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- If sexually active in a way that could result in pregnancy, subjects of childbearing potential must agree to use 2 effective contraception methods during the study and for 7 months following the last dose of study drug. Subjects who can father children and have partners of childbearing potential must agree to use 2 effective contraception methods during the study and for 7 months following the last dose of study drug. Subjects who can father children must also be willing to refrain from sperm donation during this time.
- The subject or the subject's legally acceptable representative must provide written informed consent. Cognitive ability will be assessed according to policy CLN0547.
- The following baseline laboratory data:
- absolute neutrophil count ≥1500/μL unless there is known HL marrow involvement
- platelet count ≥75,000/μL
- serum bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for subjects with Gilbert's disease
- estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) study equation as applicable
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN or ≤5 x ULN if there is documented hepatic involvement of HL
- hemoglobin ≥8 g/dL
Who cannot join
- Nodular lymphocyte predominant HL.
- History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. Subjects with nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 4 weeks of first study drug dose, unless underlying disease has progressed on treatment.
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Active cerebral/meningeal disease related to the underlying malignancy, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or history of PML. Subjects with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been treated.
- Any active Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.03) viral, bacterial, or fungal infection within 1 week prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted.
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- Current therapy with other systemic anti-neoplastic or investigational agents.
- Planned consolidative radiotherapy.
- Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- Grade 3 or higher pulmonary disease unrelated to underlying malignancy.
- Idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide (adjusted for hemoglobin) <50% predicted.
- Documented 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 their first dose of brentuximab vedotin. See Appendix E
- Subjects with Child-Pugh class B or C hepatic impairment.
- Other serious underlying medical condition that, in the opinion of the investigator, would impair the subject's ability to receive or tolerate the planned treatment and follow-up.
- Symptomatic neurologic disease compromising normal activities of daily living or requiring medications. See Appendix G
- Grade 2 or higher peripheral sensory or motor neuropathy at baseline.
- Left ventricular ejection fraction <45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or previous treatment with complete cumulative doses of doxorubicin or other anthracyclines.
- Subjects with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD.
- Previous treatment with brentuximab vedotin.
- Known history of hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Known to be positive for human immunodeficiency virus (HIV).
- Subjects who are pregnant or breastfeeding.
- Known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin, any component of AD, pembrolizumab, doxorubicin, dacarbazine, filgrastim, or pegfilgrastim.
- Treatment with botanical preparations (e.g., herbal supplements, traditional Chinese medicines) intended to treat the disease under study within 2 weeks prior to treatment.
- Subjects who have received a live or attenuated vaccine within 30 days prior to treatment.
- Subjects with an active autoimmune disease or any other condition requiring systemic treatment with either corticosteroids within 7 days (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 30 days of starting treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. a. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects who received organ transplant or allogeneic stem cell transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
To learn about the effects of brentuximab vedotin and pembrolizumab in combination with doxorubicin and dacarbazine when given to patients who have Stage II cHL with bulky mediastinal disease or advanced cHL (Stage III or IV) and who have not received treatment for the disease.
Read the detailed description
Primary Objectives:
● To assess the complete response (CR) rate at the end of therapy (EOT) with Brentuximab vedotin and pembrolizumab, doxorubicin and dacarbazine in subject with previously untreated stage II bulky mediastinal disease or advanced stage cHL.
Secondary Objectives:
- To assess the safety of BvP+AD
- To assess the complete remission rate at interim PET (CR iPET)
- To assess the overall response rate (ORR)
- To assess the duration of response (DOR)
- To assess the duration of complete response (DOCR)
- To assess event-free survival (EFS)
- To assess progression free survival (PFS)
- To assess overall survival (OS)
- Conditions
- Hodgkin Lymphoma
- Being tested
- Brentuximab vedotin, Doxorubicin Hydrochloride, Pembrolizumab, Dacarbazine
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab vedotinDrug
Given by IV (vein)
Also called Adriamycin PFS®, Adriamycin RDF™, Adriamycin®, Rubex®
Given by IV (vein)
PembrolizumabDrug
Also called SGN-35, Adcetris
Given by IV (vein)
DacarbazineDrug
Also called DTIC-Dome®
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Pembrolizumab and Brentuximab +AD | Experimental | Not described Receives: Drug: Brentuximab vedotin; Drug: Doxorubicin Hydrochloride; Drug: Pembrolizumab; Drug: Dacarbazine |
| Part B: De-Escalation | Experimental | Not described Receives: Drug: Brentuximab vedotin; Drug: Doxorubicin Hydrochloride; Drug: Pembrolizumab; Drug: Dacarbazine |
| Part C: Standard Risk Arm | Experimental | Not described Receives: Drug: Brentuximab vedotin; Drug: Doxorubicin Hydrochloride; Drug: Pembrolizumab; Drug: Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start14 Dec 2023
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Hun Lee, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922904
- Sponsor's protocol ID
- 2022-0492
- Other IDs
- NCI-2023-05028
- Status last verified
- Oct 2026
- First submitted
- 20 Jun 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
PubMed 40135712
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Adapted Brentuximab Vedotin and Pembrolizumab in Combination With Doxorubicin and Dacarbazine in Classic Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05922904
- Acronym / sponsor ID
- 2022-0492
- Conditions
- Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Seagen Inc.
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 28 Jun 2023 (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.
To learn about the effects of brentuximab vedotin and pembrolizumab in combination with doxorubicin and dacarbazine when given to patients who have Stage II cHL with bulky mediastinal disease or advanced cHL (Stage III or IV) and who have not received treatment for the disease.
Detailed description
Primary Objectives:
● To assess the complete response (CR) rate at the end of therapy (EOT) with Brentuximab vedotin and pembrolizumab, doxorubicin and dacarbazine in subject with previously untreated stage II bulky mediastinal disease or advanced stage cHL.
Secondary Objectives:
- To assess the safety of BvP+AD
- To assess the complete remission rate at interim PET (CR iPET)
- To assess the overall response rate (ORR)
- To assess the duration of response (DOR)
- To assess the duration of complete response (DOCR)
- To assess event-free survival (EFS)
- To assess progression free survival (PFS)
- To assess overall survival (OS)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Pembrolizumab and Brentuximab +AD | Experimental | Drug: Brentuximab vedotin, Drug: Doxorubicin Hydrochloride, Drug: Pembrolizumab, Drug: Dacarbazine |
| Part B: De-Escalation | Experimental | Drug: Brentuximab vedotin, Drug: Doxorubicin Hydrochloride, Drug: Pembrolizumab, Drug: Dacarbazine |
| Part C: Standard Risk Arm | Experimental | Drug: Brentuximab vedotin, Drug: Doxorubicin Hydrochloride, Drug: Pembrolizumab, Drug: Dacarbazine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Treatment-naïve, HL subjects with Ann Arbor stage III, IV, or stage II with bulky disease (>10 cm).
- Histologically confirmed cHL according to the current World Health Organization Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted, classical HL, or not otherwise specified). a. Subjects enrolling must submit a tumor block for analysis. Availability of tissue must be confirmed prior to enrollment.
- Bidimensional measurable disease as documented by PET/CT or CT imaging. Must have at least one lesion >15 mm (1.5 cm) in the longest diameter on cross-sectional imaging, measurable in 2 perpendicular dimensions on CT (or MRI), and FDG avid by PET.
- Age 18 years or older.
- An Eastern Cooperative Oncology Group (ECOG) performance status zero, or one.
Key exclusion criteria (27 listed)
- Nodular lymphocyte predominant HL.
- History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. Subjects with nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 4 weeks of first study drug dose, unless underlying disease has progressed on treatment.
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Active cerebral/meningeal disease related to the underlying malignancy, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or history of PML. Subjects with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been treated.
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 |
|---|---|---|
| Brentuximab vedotinGiven by IV (vein) | Drug | Part A: Pembrolizumab and Brentuximab +AD, Part B: De-Escalation, Part C: Standard Risk Arm |
| Doxorubicin HydrochlorideAlso: Adriamycin PFS®, Adriamycin RDF™, Adriamycin®, Rubex®Given by IV (vein) | Drug | Part A: Pembrolizumab and Brentuximab +AD, Part B: De-Escalation, Part C: Standard Risk Arm |
| PembrolizumabAlso: SGN-35, AdcetrisGiven by IV (vein) | Drug | Part A: Pembrolizumab and Brentuximab +AD, Part B: De-Escalation, Part C: Standard Risk Arm |
| DacarbazineAlso: DTIC-Dome®Given by IV (vein) | Drug | Part A: Pembrolizumab and Brentuximab +AD, Part B: De-Escalation, Part C: Standard Risk Arm |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year.
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 6 Oct 2026.
- Derived from this study: PubMed 40135712Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Hun Lee, MD principal investigator
M.D. Anderson Cancer 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 Brentuximab vedotin, Doxorubicin Hydrochloride and Pembrolizumab in people with Hodgkin Lymphoma, run by M.D. Anderson Cancer 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 15 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922904, which also lists 1 linked publication.
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 6 Oct 2026.