Recurrent Hodgkin LymphomaPhase 2NCT01703949
Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma
A Phase 2 study testing Brentuximab Vedotin, Laboratory Biomarker Analysis and Nivolumab in people with Recurrent Hodgkin Lymphoma and Recurrent Non-Hodgkin Lymphoma, run by University of Washington at 1 site in United States.
Trial summary
This phase II pilot trial studies how well brentuximab vedotin with or without nivolumab works in treating patients with CD30+ lymphoma that has come back after a period of improvement or does not respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Refractory Hodgkin Lymphoma
- What is being tested?
- Brentuximab Vedotin, Laboratory Biomarker Analysis and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2013to 3 Jun 2030
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Relapsed or refractory CD30+ lymphoma that has either achieved < PR to brentuximab vedotin (minimum of 2 cycles), progressed while receiving brentuximab vedotin, or progressed within 6 months of the last dose of brentuximab vedotin
- Documented expression of CD30 on tumor cells
- Absolute neutrophil count (ANC) > 1,000/uL
- Platelets > 50,000/uL
- Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min
- Bilirubin < 1.5 x upper limit of normal (ULN)
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- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
- Measurable disease by computed tomography (CT) or similar (e.g. magnetic resonance imaging [MRI]) criteria (> 1.5 cm). (Patients with cutaneous lymphoma only require measurable disease by Olsen Criteria)
- Age >= 18 yrs at the time of the first dose of study drug
- Resolution of all non-hematologic brentuximab vedotin-related and nivolumab-related adverse events (AEs) to < Grade 2
- All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
- Patients must be anticipated to complete at least 2 cycles of chemotherapy on study
- Expected survival if untreated of > 90 days
Who cannot join
- Prior transplant within 100 days
- Radioimmunotherapy within 12 weeks
- Known human immunodeficiency virus (HIV) or hepatitis B positivity or prior progressive multifocal leukoencephalopathy (PML)
- Active infection or other medical condition which would preclude treatment in the opinion of the principal investigator; this would include a corrected diffusing capacity of the lungs for carbon monoxide (DLCO) of < 60% predicted or symptomatic interstitial lung disease
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
- Known active central nervous system (CNS) involvement
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- Peripheral neuropathy > grade 1 if due to brentuximab vedotin or any peripheral neuropathy > grade 2
- Intolerance to brentuximab vedotin
- Concurrent use of other anti-cancer agents or experimental treatments
- No current or prior autoimmune disease with the exception of vitiligo and autoimmune alopecia (Arm B only)
- Pregnancy or breastfeeding; (females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin [beta-hCG] pregnancy test result within 7 days prior to the first dose of brentuximab vedotin; females with false positive results and documented verification that the patient is not pregnant are eligible for participation; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraceptive methods during the study and for 6 months following the last dose of brentuximab vedotin or 6 months following the last dose of nivolumab, whichever is later)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Pilot Study of Weekly Brentuximab Vedotin or Brentuximab Vedotin Plus Nivolumab Every 3 Weeks in Patients With CD30+ Malignancies Refractory to Every ≥ 3 Week Brentuximab Vedotin
This phase II pilot trial studies how well brentuximab vedotin with or without nivolumab works in treating patients with CD30+ lymphoma that has come back after a period of improvement or does not respond to treatment. Biological therapies, such as brentuximab vedotin, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as nivolumab may interfere with the ability of tumor cells to grow and spread. Giving brentuximab vedotin with or without nivolumab may work better in treating patients with CD30+ lymphoma.
Read the detailed description
OUTLINE:
ARM A (CLOSED TO ACCRUAL): Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-5 weeks, every 3 months for 1 year, and then every 6 months for 4 years.
- Conditions
- Recurrent Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
- Being tested
- Brentuximab Vedotin, Laboratory Biomarker Analysis, Nivolumab
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Also called ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
NivolumabBiological
Also called BMS-936558, MDX-1106, NIVO, ONO-4538
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A (brentuximab vedotin) | Experimental | Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Brentuximab Vedotin; Other: Laboratory Biomarker Analysis |
| Arm B (brentuximab vedotin, nivolumab) | Experimental | Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Brentuximab Vedotin; Other: Laboratory Biomarker Analysis; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate as Measured by the Cheson 2007 Criteria
No formal statistical measures will be pre-specified. This protocol will be deemed a "success" if the absolute response rate in this group of patients is ≥20% in Arm A or ≥40% in Arm B.
Measured: For Arm A: Up to 5 weeks after completion of study treatment (an average of 1 month). For Arm B: within 6 months following treatment (an average of 1 month).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study start20 Mar 2013
- Primary completion3 Jun 2025
- Study completion3 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajay Gopal, University of Washington
- Investigators
- Ajay K. Gopal, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703949
- Sponsor's protocol ID
- 7808
- Other IDs
- NCI-2012-01696, 7808, RG1713010
- Status last verified
- Mar 2026
- First submitted
- 8 Oct 2012
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Weekly Brentuximab Vedotin or Brentuximab Vedotin Plus Nivolumab Every 3 Weeks in Patients With CD30+ Malignancies Refractory to Every ≥ 3 Week Brentuximab Vedotin
- ClinicalTrials.gov ID
- NCT01703949
- Acronym / sponsor ID
- 7808
- Conditions
- Recurrent Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 20 Mar 2013 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2030 (estimated)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Posted 12 May 2026
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 pilot trial studies how well brentuximab vedotin with or without nivolumab works in treating patients with CD30+ lymphoma that has come back after a period of improvement or does not respond to treatment. Biological therapies, such as brentuximab vedotin, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as nivolumab may interfere with the ability of tumor cells to grow and spread. Giving brentuximab vedotin with or without nivolumab may work better in treating patients with CD30+ lymphoma.
Detailed description
OUTLINE:
ARM A (CLOSED TO ACCRUAL): Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-5 weeks, every 3 months for 1 year, and then every 6 months for 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (brentuximab vedotin) | Experimental | Drug: Brentuximab Vedotin, Other: Laboratory Biomarker AnalysisPatients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
| Arm B (brentuximab vedotin, nivolumab) | Experimental | Drug: Brentuximab Vedotin, Other: Laboratory Biomarker Analysis, Biological: NivolumabPatients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Relapsed or refractory CD30+ lymphoma that has either achieved < PR to brentuximab vedotin (minimum of 2 cycles), progressed while receiving brentuximab vedotin, or progressed within 6 months of the last dose of brentuximab vedotin
- Documented expression of CD30 on tumor cells
- Absolute neutrophil count (ANC) > 1,000/uL
- Platelets > 50,000/uL
- Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min
Key exclusion criteria (11 listed)
- Prior transplant within 100 days
- Radioimmunotherapy within 12 weeks
- Known human immunodeficiency virus (HIV) or hepatitis B positivity or prior progressive multifocal leukoencephalopathy (PML)
- Active infection or other medical condition which would preclude treatment in the opinion of the principal investigator; this would include a corrected diffusing capacity of the lungs for carbon monoxide (DLCO) of < 60% predicted or symptomatic interstitial lung disease
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
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 VedotinAlso: ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35Given IV | Drug | Arm A (brentuximab vedotin), Arm B (brentuximab vedotin, nivolumab) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (brentuximab vedotin), Arm B (brentuximab vedotin, nivolumab) |
| NivolumabAlso: BMS-936558, MDX-1106, NIVO, ONO-4538Given IV | Biological | Arm B (brentuximab vedotin, nivolumab) |
Primary outcome
Overall Response Rate as Measured by the Cheson 2007 Criteria
Time frame: For Arm A: Up to 5 weeks after completion of study treatment (an average of 1 month). For Arm B: within 6 months following treatment (an average of 1 month).
No formal statistical measures will be pre-specified. This protocol will be deemed a "success" if the absolute response rate in this group of patients is ≥20% in Arm A or ≥40% in Arm B.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ajay K. Gopal principal investigator
Fred Hutch/University of Washington Cancer Consortium
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, Laboratory Biomarker Analysis and Nivolumab in people with Recurrent Hodgkin Lymphoma and Recurrent Non-Hodgkin Lymphoma, run by University of Washington 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 13 inclusion and 11 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 12 May 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?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate as Measured by the Cheson 2007 Criteria (time frame: For Arm A: Up to 5 weeks after completion of study treatment (an average of 1 month). For Arm B: within 6 months following treatment (an average of 1 month).). 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 12 May 2026.