Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Non-Small Cell Lung Cancer (NSCLC)
A Phase II Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Advanced Non-Small Cell Lung Cancer
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
The goal of this clinical research study is to learn if Imbruvica (ibrutinib) alone and then in combination with Opdivo (nivolumab) can control NSCLC in patients who have received previous chemotherapy treatment.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedFebruary 13, 2017
February 1, 2017
3 years
October 27, 2016
February 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate in Participants with Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) Treated with Ibrutinib Followed by a Combination of Ibrutinib and Nivolumab
Response rate defined as the sum of complete plus partial responses (CR+PR). Response assessed by RECIST 1.1 criteria.
8 weeks from start of combination therapy
Secondary Outcomes (1)
Disease Control Rate
30 days after the last dose of study medication
Study Arms (1)
Ibrutinib + Nivolumab
EXPERIMENTALIbrutinib administered by mouth daily in 28 day cycles. Nivolumab administered by vein beginning with cycle 2, and given on Days 1 and 15 of every 28 day cycle.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed stage IV non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy.
- Patients must have measurable disease by RECIST 1.1 criteria
- Patients must have experienced progressive disease following at least one platinum-based chemotherapy regimen in the setting of advanced disease or have progressed within 6 months of receiving chemotherapy as part of loco-regional therapy.
- Patients must have biopsy accessible disease and must be willing and able to undergo a biopsy
- Age \>/= 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status \</= 2
- Ability to take pills by mouth
- Patients must have adequate organ and marrow function as defined below: leukocytes \>/= 3,000/mcL absolute neutrophil count \>/= 1,000/mcL independent of growth factor support platelet count \>/= 100,000/mm3 independent of transfusion support OR \>/= 50,000/mm3 independent of transfusion support if bone marrow involvement total bilirubin \</= 1.5 x institutional upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome AST(SGOT)/ALT(SGPT) \</= 3 Ă— ULN creatinine clearance \>/= 25 mL/min
- Patients with asymptomatic brain metastases are allowed, as long as they are treated, stable, and do not require treatment with anticonvulsants or escalating doses of steroids. Maximum daily dose of steroids should be prednisone 10 mg or equivalent. Radiation therapy for brain metastases must be completed at least 14 days prior to treatment on protocol. Patients with untreated brain metastases who are stable, asymptomatic and not requiring treatment with anticonvulsants or escalating doses of steroids are eligible.
- Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 3 months after the last dose of ibrutinib and 6 month after the last dose of nivolumab. For males, these restrictions apply for 3 month after the last dose of study drugs.
- Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b-hCG)) or urine pregnancy test within 7 days prior to treatment initiation and when clinically indicated every 4 weeks +/- 7 days while receiving study drugs, as shown in study calendar. Women who are pregnant or breastfeeding are ineligible for this study.
- Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
You may not qualify if:
- Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Prior treatment with ibrutinib, a PD-1 inhibitor, a PD-L1 inhibitor, or a CTLA-4 inhibitor
- Known hypersensitivity to ibrutinib or nivolumab
- Major surgery or a wound that has not fully healed within 4 weeks of treatment.
- Known central nervous system lymphoma
- History of stroke or intracranial hemorrhage within 6 months prior to treatment.
- Treatment with warfarin or other vitamin K antagonists. Patients who are on active treatment with warfarin or other vitamin K antagonists for conditions requiring anticoagulation will be switched, when not contraindicated, to a different form of anticoagulation, including low molecular weight heparin (LMWHs) (ex: enoxaparin, dalteparin) or oral anti-Xa drugs (ex: rivaroxaban or apixaban) Patients who switch to these alternative forms of anticoagulation will be eligible.
- Current or prior use of immunosuppressive medication within 14 days of treatment on protocol, with the exception of intranasal and inhaled corticosteroids or oral corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
- Active or prior documented autoimmune disease within the past 2 years. Patients with a history of vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Active or prior documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
- Known history or previous clinical diagnosis of tuberculosis
- History of primary immunodeficiency
- History of organ transplant requiring therapeutic immunosuppression
- Patients requiring chronic treatment with strong CYP3A inhibitors
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Janssen Scientific Affairs, LLCcollaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Heymach, MD, PHD
M.D. Anderson Cancer Center
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
October 27, 2016
First Posted
October 31, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2019
Last Updated
February 13, 2017
Record last verified: 2017-02