Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

NCT02940301 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-16077NCI-2016-01473
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies how well ibrutinib and nivolumab work in treating patients with classical Hodgkin lymphoma that has come back or has not responded to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells. Giving ibrutinib and nivolumab may work better in treating patients with classical Hodgkin lymphoma.

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Proportion of patients in CR

  Simon's two-stage design will be used to test the null hypothesis that the true CR rate is =\< 20% versus the alternative hypothesis that the true CR rate is \>= 50%.

  Up to course 7 (147 days)

Secondary Outcomes (4)

• Duration of response

  From the first documentation of response (CR, partial response) to the first documentation of definitive disease progression or death from any cause, whichever occurs first, assessed up to 3 years

• Incidence of adverse events measured by Common Terminology Criteria for Adverse Events version 4.03

  Up to 3 years

• ORR

  Up to 3 years

• PFS

  From the date of enrollment until the first documentation of objective disease progression or death from any cause, whichever occurs first, assessed up to 3 years

Study Arms (1)

Treatment (ibrutinib, nivolumab)

EXPERIMENTAL

Patients receive ibrutinib PO QD on days 1-21 and nivolumab IV continuously over 60 minutes on day 1. Treatment with nivolumab repeats every 21 days for up to 16 courses and treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity.

Drug: Ibrutinib; Other: Laboratory Biomarker Analysis; Biological: Nivolumab

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (ibrutinib, nivolumab)

Nivolumab BIOLOGICAL

Given IV

Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo

Treatment (ibrutinib, nivolumab)

Ibrutinib DRUG

Given PO

Also known as: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765

Treatment (ibrutinib, nivolumab)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed classical HL that is relapsed or refractory after at least one prior therapy are eligible
• Patients with lymphocyte predominant Hodgkin's are eligible
• Prior treatments: patients must have had at least one prior therapy
• Patients with previous autologous transplant are permitted
• Patients who are eligible and willing to undergo autologous transplant should not be enrolled on this trial
• Prior allogeneic transplant is NOT permitted
• Prior treatment with Bruton's tyrosine kinase (BTK) inhibitors is NOT permitted
• Prior treatment with nivolumab is permitted
• Presence of radiographically measurable disease (defined as the presence of a \>= 1.0 cm lesion, as measured in the longest dimension by computed tomography \[CT\] scan or positron emission tomography \[PET\]/CT scan or magnetic resonance imaging \[MRI\] scan)
• Absolute neutrophil count (ANC) \> 1000/uL
• Platelets \> 75,000/uL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2 x upper limit of normal (ULN)
• Total bilirubin =\< 1.5 x ULN
• Creatinine =\< 2.0 mg/dl
• Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2

You may not qualify if:

• Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for \>= 2 years or which will not limit survival to \< 2 years
• A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib, or put the study outcomes at undue risk
• Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
• Central nervous system (CNS) involvement by lymphoma
• Has a diagnosis of immunosuppression or is receiving ongoing immunosuppressive therapy, including systemic or enteric corticosteroids for treatment of lymphoid cancer or other conditions
• Note: subjects may use topical or inhaled corticosteroids or low-dose steroids (=\< 20 mg of prednisone or equivalent per day) as therapy for comorbid conditions; during study participation, subjects may also receive systemic or enteric corticosteroids as needed for treatment-related toxicities
• Has an active autoimmune disease or history of autoimmune disease such as hepatitis, hypophysitis, nephritis, hyperthyroidism or hypothyroidism, interstitial lung disease, colitis
• Requires or is currently receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 28 days of first dose of study drug
• Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
• Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
• Major surgery within 4 weeks before first dose of study drug
• History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (2)

Winship Cancer Center of Emory University

Atlanta, Georgia, 30322, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Interventions

ibrutinib; Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lapo Alinari, MD, PhD

  Ohio State University Comprehensive Cancer Center

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 20, 2016
• Study Start: December 20, 2016
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)