Trial Outcomes & Findings for Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer (NCT NCT03829722)
NCT ID: NCT03829722
Last Updated: 2026-01-22
Results Overview
Estimated using the Kaplan-Meier method. Evaluated using imaging and clinical exams
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Up to 2 years after completion of study treatment
Results posted on
2026-01-22
Participant Flow
2 subjects screen failed before enrollment
Participant milestones
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Physician Decision
|
5
|
Baseline Characteristics
Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
n=26 Participants
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=270 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=270 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=270 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=270 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=270 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=270 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=270 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=270 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years after completion of study treatmentEstimated using the Kaplan-Meier method. Evaluated using imaging and clinical exams
Outcome measures
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
n=26 Participants
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Progression-free Survival (PFS)
|
65 percentage of patients
Interval 46.0 to 79.0
|
SECONDARY outcome
Timeframe: Up to 2 years after completion of study treatmentTo characterize patterns of failure, investigators will summarize the proportion of patients who progressed in any location and whether the first progression was local, regional, distant or in multiple locations.
Outcome measures
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
n=26 Participants
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Proportion of Patients Who Progressed in Any Location
|
15 percentage of patients
Interval 7.0 to 33.0
|
SECONDARY outcome
Timeframe: 2 years after completion of study treatmentEstimated using the Kaplan-Meier method
Outcome measures
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
n=26 Participants
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Overall Survival (OS)
|
26 Participants
|
SECONDARY outcome
Timeframe: at 1 month post chemoradiationToxicity evaluation per CTCAE v 5.0
Outcome measures
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
n=26 Participants
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Incidence of Acute Toxicity
Xerostomia- Grade 2
|
9 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Xerostomia- Grade 3
|
0 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Pain- Grade 1
|
39 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Pain- Grade 2
|
40 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Pain- Grade 3
|
1 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Dysphagia- Grade 1
|
26 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Dysphagia- Grade 2
|
29 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Dysphagia- Grade 3
|
11 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Oral Mucositis- Grade 1
|
21 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Oral Mucositis- Grade 2
|
50 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Oral Mucositis- Grade 3
|
6 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Dermatitis- Grade 1
|
33 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Dermatitis- Grade 2
|
31 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Dermatitis- Grade 3
|
9 Number of Incidents Occurred
|
|
Incidence of Acute Toxicity
Xerostomia- Grade 1
|
65 Number of Incidents Occurred
|
SECONDARY outcome
Timeframe: 12 months post chemoradiationToxicity evaluation per CTCAE v 5.0
Outcome measures
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
n=26 Participants
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Incidence of Late Toxicity
Pain- Grade 1
|
15 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Pain- Grade 2
|
0 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Pain- Grade 3
|
0 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Dysphagia- Grade 1
|
22 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Dysphagia- Grade 2
|
4 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Dysphagia- Grade 3
|
1 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Oral Mucositis- Grade 1
|
0 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Oral Mucositis- Grade 2
|
0 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Oral Mucositis- Grade 3
|
0 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Dermatitis- Grade 1
|
0 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Dermatitis- Grade 2
|
0 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Dermatitis- Grade 3
|
0 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Xerostomia- Grade 1
|
60 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Xerostomia- Grade 2
|
1 Number of Incidents Occurred
|
|
Incidence of Late Toxicity
Xerostomia- Grade 3
|
0 Number of Incidents Occurred
|
SECONDARY outcome
Timeframe: 12 weeks after completion of study treatmentCorrelation of metabolic image uptake data on mid-treatment FDG-PET scans performed between fractions 8-12 with standard 12 week post-treatment PET-CT. The number of patients with midtreatment ≥50% decrease of MTV2.5 from baseline.
Outcome measures
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
n=26 Participants
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Correlation of Mid-treatment FDG-PET Scans With Post-treatment PET-CT.
|
13 Participants
|
Adverse Events
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
Serious events: 9 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
n=26 participants at risk
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Immune system disorders
Allergic reaction
|
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Cardiac disorders
Atrial flutter
|
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Infections and infestations
Encephalitis infection
|
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Mucositis oral
|
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Infections and infestations
Sepsis
|
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Infections and infestations
Skin infection
|
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Investigations
Weight loss
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
Other adverse events
| Measure |
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
n=26 participants at risk
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab: Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Carboplatin: Given IV once per week during radiation therapy (AUC=1).
Paclitaxel: Given IV once per week during radiation therapy (30mg/m\^2)
Radiation Therapy: Given 5 days/week for a total of 35 doses (70 gray total).
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
2/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Psychiatric disorders
Anxiety
|
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Constipation
|
65.4%
17/26 • Number of events 18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Metabolism and nutrition disorders
Dehydration
|
53.8%
14/26 • Number of events 15 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
88.5%
23/26 • Number of events 35 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Nervous system disorders
Dizziness
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Dry mouth
|
92.3%
24/26 • Number of events 30 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Nervous system disorders
Dysgeusia
|
96.2%
25/26 • Number of events 36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Dysphagia
|
34.6%
9/26 • Number of events 13 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Ear and labyrinth disorders
Ear pain
|
7.7%
2/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Esophageal pain
|
34.6%
9/26 • Number of events 15 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Esophagitis
|
11.5%
3/26 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
General disorders
Fatigue
|
69.2%
18/26 • Number of events 22 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
15.4%
4/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Nervous system disorders
Headache
|
15.4%
4/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.5%
3/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Vascular disorders
Hypotension
|
15.4%
4/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Endocrine disorders
Hypothyroidism
|
15.4%
4/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Vascular disorders
Lymphedema
|
15.4%
4/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Investigations
Lymphocyte count decreased
|
23.1%
6/26 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Mucositis oral
|
96.2%
25/26 • Number of events 48 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Nausea
|
80.8%
21/26 • Number of events 28 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Oral pain
|
34.6%
9/26 • Number of events 16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
General disorders
Pain
|
19.2%
5/26 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.4%
4/26 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Infections and infestations
Shingles
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Infections and infestations
Sinusitis
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Infections and infestations
Thrush
|
34.6%
9/26 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
2/26 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
19.2%
5/26 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
6/26 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Investigations
Weight loss
|
76.9%
20/26 • Number of events 26 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place