Hodgkin LymphomaPhase 1/2NCT02572167
A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
A Phase 1/2 study testing brentuximab vedotin and nivolumab in people with Hodgkin Lymphoma, run by Seagen Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to assess the safety profile and antitumor activity of brentuximab vedotin administered in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (HL) 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 and nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 13 sitesUnited States
- Study dates
- 31 Oct 2015to 21 Oct 2021
- Phase
- Phase 1/2
- 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 Hodgkin lymphoma following failure of standard frontline chemotherapy for the treatment of classical Hodgkin lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Previously treated with brentuximab vedotin, immune-oncology agents, or received an allogeneic or autologous stem cell transplant
- Documented history of a cerebral vascular event
- History of another invasive malignancy that has not been in remission for at least 3 years
- History of progressive multifocal leukoencephalopathy (PML)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
James Cancer Hospital / Ohio State University
Columbus, Ohio, 43210
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, 11725
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, 75246
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010-3000
Duke University Medical Center
Durham, North Carolina, 27710
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305
About this study
Official title: A Phase 1/2 Study Evaluating Brentuximab Vedotin in Combination With Nivolumab in Patients With Relapsed or Refractory Hodgkin Lymphoma After Failure of Frontline Therapy
The purpose of this study is to assess the safety profile and antitumor activity of brentuximab vedotin administered in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (HL)
Read the detailed description
This study will examine the safety profile and antitumor activity when brentuximab vedotin is combined with nivolumab. Patients will be treated for up to four 21-day cycles with brentuximab vedotin 1.8 mg/kg and nivolumab 3 mg/kg.
There will be 3 parts to this study. In Part 1, the safety of combination treatment will be evaluated by a Safety Monitoring Committee (SMC) prior to expansion of enrollment to evaluate treatment effect in Part 2. Part 2 of the study will further characterize the safety and antitumor activity of brentuximab vedotin combined with nivolumab by enrolling patients at the recommended dose schedule determined in Part 1. Part 3 of the study will evaluate the safety and antitumor activity of combination treatment administered at an alternate dosing schedule determined by cumulative safety and activity data from Parts 1 and 2.
- Conditions
- Hodgkin Lymphoma
- Being tested
- brentuximab vedotin, nivolumab
- Keywords
- Monomethyl auristatin E, Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Immunotherapy, Autologous stem cell transplant
- 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
Also called SGN-35, ADCETRIS
1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles
nivolumabDrug
Also called BMS-936558, OPDIVO
3 mg/kg by intravenous (IV) infusion for up to 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab Vedotin + Nivolumab | Experimental | Brentuximab vedotin plus nivolumab Receives: Drug: brentuximab vedotin; Drug: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 month safety reporting period and additional long-term follow up through 28.9 months.
Measured: Up to 28.9 months
Complete Remission Rate
Number of patients with complete metabolic response (CMR) at end of treatment
Measured: Up to 3.42 months
Secondary outcomes (4)
Objective Response Rate
Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)
Measured: Up to 3.42 months
Duration of Complete Response
The time from start of the first documentation of complete response (CR) to the first documentation of tumor progression (PD) including radiographic evidence of progression and clinical progression per investigator or to death due to any cause, whichever comes first.
Measured: Up to 69.3 months
Duration of Objective Response
The time from start of the first documentation of OR (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first.
Measured: Up to 69.3 months
Progression-free Survival Post-autologous Stem Cell Transplant
For participants who undergo ASCT, the time from ASCT to the first documentation of PD or to death due to any cause, whichever comes first.
Measured: Up to 67.3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start31 Oct 2015
- Primary completion1 Mar 2018
- Study completion21 Oct 2021
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Faith Galderisi, DO, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572167
- Sponsor's protocol ID
- SGN35-025
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2015
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Herrera AF, Moskowitz AJ, Bartlett NL, Vose JM, Ramchandren R, Feldman TA, LaCasce AS, Ansell SM, Moskowitz CH, Fenton K, Ogden CA, Taft D, Zhang Q, Kato K, Campbell M, Advani RH. Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2018 Mar 15;131(11):1183-1194. doi: 10.1182/blood-2017-10-811224. Epub 2017 Dec 11.
PubMed 29229594Advani RH, Moskowitz AJ, Bartlett NL, Vose JM, Ramchandren R, Feldman TA, LaCasce AS, Christian BA, Ansell SM, Moskowitz CH, Brown L, Zhang C, Taft D, Ansari S, Sacchi M, Ho L, Herrera AF. Brentuximab vedotin in combination with nivolumab in relapsed or refractory Hodgkin lymphoma: 3-year study results. Blood. 2021 Aug 12;138(6):427-438. doi: 10.1182/blood.2020009178.
PubMed 33827139
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study Evaluating Brentuximab Vedotin in Combination With Nivolumab in Patients With Relapsed or Refractory Hodgkin Lymphoma After Failure of Frontline Therapy
- ClinicalTrials.gov ID
- NCT02572167
- Acronym / sponsor ID
- SGN35-025
- Conditions
- Hodgkin Lymphoma
- Keywords
- Monomethyl auristatin E, Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Immunotherapy, Autologous stem cell transplant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 31 Oct 2015 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Posted 7 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety profile and antitumor activity of brentuximab vedotin administered in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (HL)
Detailed description
This study will examine the safety profile and antitumor activity when brentuximab vedotin is combined with nivolumab. Patients will be treated for up to four 21-day cycles with brentuximab vedotin 1.8 mg/kg and nivolumab 3 mg/kg.
There will be 3 parts to this study. In Part 1, the safety of combination treatment will be evaluated by a Safety Monitoring Committee (SMC) prior to expansion of enrollment to evaluate treatment effect in Part 2. Part 2 of the study will further characterize the safety and antitumor activity of brentuximab vedotin combined with nivolumab by enrolling patients at the recommended dose schedule determined in Part 1. Part 3 of the study will evaluate the safety and antitumor activity of combination treatment administered at an alternate dosing schedule determined by cumulative safety and activity data from Parts 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brentuximab Vedotin + Nivolumab | Experimental | Drug: brentuximab vedotin, Drug: nivolumabBrentuximab vedotin plus nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Relapsed or refractory Hodgkin lymphoma following failure of standard frontline chemotherapy for the treatment of classical Hodgkin lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (4 listed)
- Previously treated with brentuximab vedotin, immune-oncology agents, or received an allogeneic or autologous stem cell transplant
- Documented history of a cerebral vascular event
- History of another invasive malignancy that has not been in remission for at least 3 years
- History of progressive multifocal leukoencephalopathy (PML)
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: SGN-35, ADCETRIS1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles | Drug | Brentuximab Vedotin + Nivolumab |
| nivolumabAlso: BMS-936558, OPDIVO3 mg/kg by intravenous (IV) infusion for up to 4 cycles | Drug | Brentuximab Vedotin + Nivolumab |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to 28.9 months
Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 month safety reporting period and additional long-term follow up through 28.9 months.
Complete Remission Rate
Time frame: Up to 3.42 months
Number of patients with complete metabolic response (CMR) at end of treatment
4 secondary outcomes
Objective Response Rate
Time frame: Up to 3.42 months
Duration of Complete Response
Time frame: Up to 69.3 months
Duration of Objective Response
Time frame: Up to 69.3 months
Progression-free Survival Post-autologous Stem Cell Transplant
Time frame: Up to 67.3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29229594Herrera AF, Moskowitz AJ, Bartlett NL, Vose JM, Ramchandren R, Feldman TA, LaCasce AS, Ansell SM, Moskowitz CH, Fenton K, Ogden CA, Taft D, Zhang Q, Kato K, Campbell M, Advani RH. Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2018 Mar 15;131(11):1183-1194. doi: 10.1182/blood-2017-10-811224. Epub 2017 Dec 11.
- Derived from this study: PubMed 33827139Advani RH, Moskowitz AJ, Bartlett NL, Vose JM, Ramchandren R, Feldman TA, LaCasce AS, Christian BA, Ansell SM, Moskowitz CH, Brown L, Zhang C, Taft D, Ansari S, Sacchi M, Ho L, Herrera AF. Brentuximab vedotin in combination with nivolumab in relapsed or refractory Hodgkin lymphoma: 3-year study results. Blood. 2021 Aug 12;138(6):427-438. doi: 10.1182/blood.2020009178.
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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.
Faith Galderisi, DO study director
Seagen Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing brentuximab vedotin and nivolumab in people with Hodgkin Lymphoma, run by Seagen Inc. at 13 sites 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 7 Mar 2019). 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?
Number of Participants With Adverse Events (AEs) (time frame: Up to 28.9 months). The study lists 2 primary outcomes in all. 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 NCT02572167, which also lists 2 linked publications.
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 8 Nov 2022.