NCT03057795

Brief Summary

This phase II trial studies how well nivolumab and brentuximab vedotin work after stem cell transplant in treating patients with high-risk classical Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab and brentuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
10mo left

Started Apr 2017

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Apr 2017Feb 2027

First Submitted

Initial submission to the registry

February 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 23, 2023

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2027

Expected
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

February 14, 2017

Results QC Date

February 23, 2023

Last Update Submit

April 17, 2026

Conditions

Classic Hodgkin LymphomaRecurrent Hodgkin LymphomaRefractory Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival at 18 Months

    Progression-free survival will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. When there is no censoring in progression-free survival prior to 18 months after the first dose of study treatment, the observed 18-month progression-free survival will be compared to the baseline of 65% by one-sided exact test of binomial proportion. In case of censoring in progression-free survival prior to 18 months after the first dose of study treatment, the Kaplan-Meier estimate for 18-month progression-free survival along with the Greenwood standard error estimator will be used for the testing of null hypothesis at 65%. Hodgkin Lymphoma(HL) response/progression was evaluated using 2014 Lugano Classification \[Cheson, Journal of Clinical Oncology 2014 Sep 20;32(27):3059-68\].

    From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 18 months.

Secondary Outcomes (1)

  • Overall Survival at 18 Months

    From the first dose of study treatment to death from any cause, assessed up to 18 months

Study Arms (1)

Treatment (brentuximab vedotin, nivolumab)

EXPERIMENTAL

Beginning 30-60 days post-ASCT, patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Drug: Brentuximab VedotinOther: Laboratory Biomarker AnalysisBiological: Nivolumab

Interventions

Brentuximab VedotinDRUG

Given IV

Also known as: ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35, Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35, cAC10-vcMMAE, SGN-35
Treatment (brentuximab vedotin, nivolumab)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (brentuximab vedotin, nivolumab)
NivolumabBIOLOGICAL

Given IV

Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo
Treatment (brentuximab vedotin, nivolumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented informed consent
  • Agreement to allow the use of archival tissue from pre-ASCT tumor biopsies
  • If unavailable, exceptions may be granted with study principal investigator (PI) approval
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  • Histologically confirmed 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
  • Have high-risk relapsed or refractory Hodgkin lymphoma (HL), defined as at least one of the following:
  • Primary refractory disease to front-line therapy
  • Relapse within 1 year of completing front-line therapy
  • Extranodal involvement at the time of pre-ASCT relapse
  • B symptoms at pre-ASCT relapse
  • More than one type of pre-ASCT salvage therapy required
  • Planning to receive or have received autologous stem cell transplantation (ACST) per institutional standards as part of standard of care

You may not qualify if:

  • All participants must initiate day 1 of protocol therapy within 30-60 days post stem cell reinfusion; study PI can grant exception for a patient to start as late as 75 days post stem cell reinfusion with a reasonable justification for a delay (e.g. recovery from post -ASCT toxicity) and this will not be a protocol deviation, nor require an exception to be filled
  • Recovery from ASCT toxicity as defined as outpatient status, able to drink, eat normally, and do not need intravenous hydration prior to day 1 of therapy
  • Achieved at least stable disease to salvage treatment determined by positron emission tomography (PET)/computed tomography (CT) using 2014 Lugano Classification prior to ASCT
  • Brentuximab vedotin naive OR had at least stable disease by Lugano Classification to prior brentuximab vedotin treatment
  • Absolute neutrophil count (ANC) \>= 1000/mm\^3
  • Platelets \>= 50,000/mm\^3
  • Hemoglobin \>= 8 g/dL
  • Total bilirubin =\< 1.5 x upper limit of normal (ULN) or 3 x ULN for Gilbert's disease
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
  • Creatinine clearance \>= 40 mL/min per 24 hour urine collection or the Cockcroft-Gault formula
  • Calculated per institutional standard
  • Forced expiratory volume in one second (FEV1) and carbon monoxide diffusion capacity (DLCO) (adjusted for hemoglobin \[Hb\]) \>= 50% adjusted
  • Women of childbearing potential (WOCBP) only: Negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\])
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Woman of childbearing potential (WOCBP): use two effective methods of contraception (hormonal or barrier method) or be surgically sterile, or abstain from heterosexual activity for the course of the study through 7 months post last dose of nivolumab
  • +37 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Herrera AF, Chen L, Nieto Y, Holmberg L, Johnston P, Mei M, Popplewell L, Armenian S, Cao T, Farol L, Sahebi F, Spielberger R, Chen R, Nademanee A, Puverel S, Nwangwu M, Lee P, Song J, Skarbnik A, Kennedy N, Peters L, Rosen ST, Kwak LW, Forman SJ, Feldman T. Brentuximab vedotin plus nivolumab after autologous haematopoietic stem-cell transplantation for adult patients with high-risk classic Hodgkin lymphoma: a multicentre, phase 2 trial. Lancet Haematol. 2023 Jan;10(1):e14-e23. doi: 10.1016/S2352-3026(22)00318-0. Epub 2022 Nov 17.

    PMID: 36403579DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab VedotinNivolumab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Dr. Alex Herrera
Organization
City of Hope Medical Center
aherrera@coh.org
626-359-8111

Study Officials

  • Alex Herrera

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

February 14, 2017

First Posted

February 20, 2017

Study Start

April 3, 2017

Primary Completion

January 30, 2021

Study Completion (Estimated)

February 25, 2027

Last Updated

May 1, 2026

Results First Posted

March 23, 2023

Record last verified: 2026-04

Locations

US(6)