Trial Outcomes & Findings for Ibrutinib and Nivolumab in Treating Patients With Previously-Treated Metastatic Kidney Cancer (NCT NCT02899078)
NCT ID: NCT02899078
Last Updated: 2025-05-18
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
From baseline to death or progression, assessed for up to 6 months
Results posted on
2025-05-18
Participant Flow
Participant milestones
| Measure |
Treatment (Ibrutinib, Nivolumab)
Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO Nivolumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibrutinib and Nivolumab in Treating Patients With Previously-Treated Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Ibrutinib, Nivolumab)
n=31 Participants
Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO Nivolumab: Given IV
|
|---|---|
|
Age, Continuous
|
60 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From baseline to death or progression, assessed for up to 6 monthsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Treatment (Ibrutinib, Nivolumab)
n=28 Participants
Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO Nivolumab: Given IV
|
|---|---|
|
Progression-free Survival (PFS)
|
2.5 months
Interval 1.9 to 4.8
|
SECONDARY outcome
Timeframe: Up to 30 daysNumber of participants with adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Outcome measures
| Measure |
Treatment (Ibrutinib, Nivolumab)
n=31 Participants
Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO Nivolumab: Given IV
|
|---|---|
|
National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03
|
31 participants
|
SECONDARY outcome
Timeframe: Up to 32 months.Overall survival, calculated using the Kaplan-Meier method as the duration from start of treatment to death by any cause.
Outcome measures
| Measure |
Treatment (Ibrutinib, Nivolumab)
n=28 Participants
Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO Nivolumab: Given IV
|
|---|---|
|
Overall Survival
|
9.1 months
Interval 6.6 to 19.0
|
SECONDARY outcome
Timeframe: Up to 6 monthsResponse Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Treatment (Ibrutinib, Nivolumab)
n=28 Participants
Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO Nivolumab: Given IV
|
|---|---|
|
Response
|
10.7 percentage of evaluable participants
Interval 3.7 to 27.2
|
Adverse Events
Treatment (Ibrutinib, Nivolumab)
Serious events: 17 serious events
Other events: 31 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Treatment (Ibrutinib, Nivolumab)
n=31 participants at risk
Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO Nivolumab: Given IV
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Cardiac disorders
Pericardial effusion
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Gastrointestinal disorders
Ascites
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Gastrointestinal disorders
Esophagitis
|
100.0%
1/1 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
100.0%
1/1 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
100.0%
1/1 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Infections and infestations
Lung infection
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Renal and urinary disorders
Acute kidney injury
|
6.5%
2/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Renal and urinary disorders
Hematuria
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Renal and urinary disorders
Urinary retention
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Vascular disorders
Hematoma
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.2%
1/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
Other adverse events
| Measure |
Treatment (Ibrutinib, Nivolumab)
n=31 participants at risk
Patients receive ibrutinib PO QD on days 1-28 and nivolumab intravenously IV over 60 minutes on days 1 and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO Nivolumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
35.5%
11/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
Investigations
Lymphocyte count reduction
|
38.7%
12/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
|
General disorders
Fatigue
|
58.1%
18/31 • Adverse events were assessed from enrollment until 30 days after last dose of study drug. All-Cause Mortality was from first dose until death, assessed up to about 28 months.
Incidence of adverse events according to CTCAE v4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place