Trial Outcomes & Findings for Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC (NCT NCT03646461)
NCT ID: NCT03646461
Last Updated: 2026-05-22
Results Overview
The primary endpoint is the clinical efficacy of each combinatorial treatment regimen as defined by the best overall response rate (proportion of patients with a partial or complete response in tumor burden) using RECIST v1.1. 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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 22 months
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
Arm A: Ibrutinib + Cetuximab
Ibrutinib 560mg PO daily (Imbruvica) PLUS Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Cetuximab: Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
|
Arm B: Ibrutinib + Nivolumab
Ibrutinib 560mg PO daily (Imbruvica) PLUS Nivolumab 3mg/kg biweekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Nivolumab: Nivolumab 3mg/kg biweekly 28 day cycle
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC
Baseline characteristics by cohort
| Measure |
Arm A: Ibrutinib + Cetuximab
n=3 Participants
Ibrutinib 560mg PO daily (Imbruvica) PLUS Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Cetuximab: Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
|
Arm B: Ibrutinib + Nivolumab
n=2 Participants
Ibrutinib 560mg PO daily (Imbruvica) PLUS Nivolumab 3mg/kg biweekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Nivolumab: Nivolumab 3mg/kg biweekly 28 day cycle
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 Years
n=2 Participants
|
58 Years
n=4 Participants
|
63 Years
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Human Papillomavirus (HPV) Status
Negative
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
|
Human Papillomavirus (HPV) Status
Positive
|
2 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 22 monthsThe primary endpoint is the clinical efficacy of each combinatorial treatment regimen as defined by the best overall response rate (proportion of patients with a partial or complete response in tumor burden) using RECIST v1.1. 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 |
Arm A: Ibrutinib + Cetuximab
n=3 Participants
Ibrutinib 560mg PO daily (Imbruvica) PLUS Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Cetuximab: Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
|
Arm B: Ibrutinib + Nivolumab
n=2 Participants
Ibrutinib 560mg PO daily (Imbruvica) PLUS Nivolumab 3mg/kg biweekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Nivolumab: Nivolumab 3mg/kg biweekly 28 day cycle
|
|---|---|---|
|
Clinical Efficacy of Combined Therapies Using RECIST v1.1
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsProgression-free survival (PFS), defined as the interval from the date of first dose of ibrutinib to disease progression or death from any cause
Outcome measures
| Measure |
Arm A: Ibrutinib + Cetuximab
n=3 Participants
Ibrutinib 560mg PO daily (Imbruvica) PLUS Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Cetuximab: Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
|
Arm B: Ibrutinib + Nivolumab
n=2 Participants
Ibrutinib 560mg PO daily (Imbruvica) PLUS Nivolumab 3mg/kg biweekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Nivolumab: Nivolumab 3mg/kg biweekly 28 day cycle
|
|---|---|---|
|
Progression Free Survival
|
17.03 weeks
Standard Deviation 8.58
|
6.65 weeks
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: Up to 30 monthsOverall survival (OS), defined as the date of first dose of ibrutinib to the date of death from any cause.
Outcome measures
| Measure |
Arm A: Ibrutinib + Cetuximab
n=3 Participants
Ibrutinib 560mg PO daily (Imbruvica) PLUS Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Cetuximab: Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
|
Arm B: Ibrutinib + Nivolumab
n=2 Participants
Ibrutinib 560mg PO daily (Imbruvica) PLUS Nivolumab 3mg/kg biweekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Nivolumab: Nivolumab 3mg/kg biweekly 28 day cycle
|
|---|---|---|
|
Overall Survival
|
51.07 weeks
Standard Deviation 7.53
|
30.7 weeks
Standard Deviation 16.3
|
Adverse Events
Arm B: Ibrutinib + Nivolumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Arm A: Ibrutinib + Cetuximab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm B: Ibrutinib + Nivolumab
n=2 participants at risk
Ibrutinib 560mg PO daily (Imbruvica) PLUS Nivolumab 3mg/kg biweekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Nivolumab: Nivolumab 3mg/kg biweekly 28 day cycle
|
Arm A: Ibrutinib + Cetuximab
n=3 participants at risk
Ibrutinib 560mg PO daily (Imbruvica) PLUS Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
Ibrutinib 560mg PO daily (Imbruvica): BTK inhibitor combined with PD-1 inhibitor
Cetuximab: Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypothyroidism
|
50.0%
1/2 • Up to 30 months
|
33.3%
1/3 • Up to 30 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Up to 30 months
|
66.7%
2/3 • Up to 30 months
|
|
Gastrointestinal disorders
Oral mucositis
|
50.0%
1/2 • Up to 30 months
|
66.7%
2/3 • Up to 30 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Up to 30 months
|
33.3%
1/3 • Up to 30 months
|
|
General disorders
Fatigue
|
0.00%
0/2 • Up to 30 months
|
100.0%
3/3 • Up to 30 months
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Up to 30 months
|
33.3%
1/3 • Up to 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/2 • Up to 30 months
|
66.7%
2/3 • Up to 30 months
|
|
Skin and subcutaneous tissue disorders
Acneiform Rash
|
0.00%
0/2 • Up to 30 months
|
100.0%
3/3 • Up to 30 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place