Trial Outcomes & Findings for Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies (NCT NCT02369458)
NCT ID: NCT02369458
Last Updated: 2025-11-18
Results Overview
* TRR will be evaluated separately in p16- (HPV-unrelated) HNSCC patients and in p16+ (HPV positive) OPSCC patients using two optimal two-stage Simon designs. In both cases, the expected TRR is 10%. A TRR of 30% is considered a clinically significant increase. * RECIST 1.1 will be used for this outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Approximately 6 months (median 5.6 months with full range of 0.1-33.7 months)
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
Cohort A: p16+ OPSCC
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
Cohort B: p16- HNSCC
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
13
|
|
Overall Study
COMPLETED
|
34
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: p16+ OPSCC
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
Cohort B: p16- HNSCC
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
|---|---|---|
|
Overall Study
Determined to be not eligible
|
1
|
0
|
Baseline Characteristics
Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies
Baseline characteristics by cohort
| Measure |
Cohort A: p16+ OPSCC
n=35 Participants
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
Cohort B: p16- HNSCC
n=13 Participants
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=202 Participants
|
61 years
n=283 Participants
|
61 years
n=120 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
6 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=202 Participants
|
8 Participants
n=283 Participants
|
42 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=202 Participants
|
13 Participants
n=283 Participants
|
48 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
5 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=202 Participants
|
8 Participants
n=283 Participants
|
43 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=202 Participants
|
13 participants
n=283 Participants
|
48 participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 months (median 5.6 months with full range of 0.1-33.7 months)Population: One participant in each arm were not evaluable for tumor response rate.
* TRR will be evaluated separately in p16- (HPV-unrelated) HNSCC patients and in p16+ (HPV positive) OPSCC patients using two optimal two-stage Simon designs. In both cases, the expected TRR is 10%. A TRR of 30% is considered a clinically significant increase. * RECIST 1.1 will be used for this outcome.
Outcome measures
| Measure |
Cohort A: p16+ OPSCC
n=33 Participants
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
Cohort B: p16- HNSCC
n=12 Participants
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
|---|---|---|
|
Tumor Response Rate (TRR)
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 months (median 4.0 months with full range of 0.5-12.0 months)Population: Only participants enrolled post October 2020 are evaluable for this outcome measure.
* TRR will be evaluated in p16+ (HPV positive) OPSCC HNSCC patients * RECIST 1.1 will be used for this outcome.
Outcome measures
| Measure |
Cohort A: p16+ OPSCC
n=11 Participants
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
Cohort B: p16- HNSCC
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
|---|---|---|
|
Tumor Response Rate (TRR) for Participants Enrolled Post October 2020
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 months (median 5.6 months with full range of 0.1-33.7 months)Population: One participant in each arm were not evaluable for this outcome measure.
* PFS is defined as the duration of time from start of treatment to time of first radiologic confirmation of progression or death, whichever occurs first. * Progressive disease per RECIST 1.1 * Target lesions - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. * Non-target lesions - Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Cohort A: p16+ OPSCC
n=33 Participants
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
Cohort B: p16- HNSCC
n=12 Participants
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
|---|---|---|
|
Progression-free Survival (PFS)
|
2.2 months
Interval 1.6 to 3.4
|
2.1 months
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 28 days after completion of treatment (median length of follow-up was 96 days, full range of 3-463 days)-Using CTCAE Version 3.0
Outcome measures
| Measure |
Cohort A: p16+ OPSCC
n=47 Participants
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
Cohort B: p16- HNSCC
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
|---|---|---|
|
Number of Participants With Grade 3/4/5 Adverse Events
|
26 Participants
|
—
|
SECONDARY outcome
Timeframe: Through completion of follow-up (median length of follow-up Cohort A= 6.6 months IQR 2.7-12.0 months, median length of follow-up Cohort B=3.2 months IQR 1.5-9.4 months)-Defined as the date of first treatment to the date of death, last date alive, or date of patient withdrawal.
Outcome measures
| Measure |
Cohort A: p16+ OPSCC
n=34 Participants
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
Cohort B: p16- HNSCC
n=13 Participants
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
|---|---|---|
|
Overall Survival (OS)
|
6.6 months
Interval 3.5 to 9.9
|
3.2 months
Interval 1.5 to 9.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, every 5 weeks, and end of treatment (estimated at 6 months)-EORTC QLQ-C30: this has a total score, one general QOL, and one "within the last week" subscale, as well as a general health item and a single overall QOL item. This study does not use current empirical guidelines for the EORTC-QLQ-30 global score with the understanding that both the magnitude and variance of scores vary considerably from patient to patient, from one time point to another and by such factors as disease condition, age, and comorbidity. The participants can choose from 1-4 with 1 being Not At All and 4 being Very Much.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, every 5 weeks, and end of treatment (estimated at 6 months)-Cognitive Failures Questions (CFQ) - has 3 subscales describing perception, memory, and motor function. A change in 1 standard deviation will be considered a perceptible difference. The participants can choose a scale from 0-4 with 0 being Never and 4 being Very Often.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC
Serious events: 21 serious events
Other events: 47 other events
Deaths: 47 deaths
Serious adverse events
| Measure |
Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC
n=47 participants at risk
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
|---|---|
|
Cardiac disorders
Injury to carotid artery
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Cardiac disorders
Pericardial effusion
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Cardiac disorders
Sinus tachycardia
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Eye disorders
Double vision
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
General disorders
Death NOS
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
General disorders
Fever
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
General disorders
Pain
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
General disorders
Tumor fevers
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Infections and infestations
Device related infection
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Infections and infestations
Infection with normal ANC - catheter related
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Infections and infestations
Lung infection
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Infections and infestations
Sepsis
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Nervous system disorders
Headache
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Nervous system disorders
Midline shift
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.5%
4/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
Other adverse events
| Measure |
Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC
n=47 participants at risk
* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
* Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
95.7%
45/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Cardiac disorders
Sinus tachycardia
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Ear and labyrinth disorders
Ear popping
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Ear and labyrinth disorders
Hearing loss (no program)
|
6.4%
3/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.4%
3/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Endocrine disorders
Diabetes
|
6.4%
3/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Endocrine disorders
Hypothyroidism
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Eye disorders
Glaucoma
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
3/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Constipation
|
17.0%
8/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Diarrhea
|
14.9%
7/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Dysphagia
|
34.0%
16/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Nausea
|
23.4%
11/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Salivary gland changes
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Stomatitis
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Gastrointestinal disorders
Xerostomia
|
19.1%
9/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
General disorders
Chills
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
General disorders
Edema: limb
|
12.8%
6/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
General disorders
Edema: head and neck
|
6.4%
3/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
General disorders
Fatigue
|
61.7%
29/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
General disorders
Fever
|
12.8%
6/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Hepatobiliary disorders
Hepatitis (drug induced suspected pembrolizumab)
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Immune system disorders
Allergic reaction to CT dye
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Immune system disorders
Allergic reaction to cetuximab
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Immune system disorders
Allergic rhinitis
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Infections and infestations
Infection with grade 3/4 neutrophils: upper airway
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Infections and infestations
Infection with normal ANC: catheter
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Infections and infestations
Infection with normal ANC: skin
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Infections and infestations
Infection with normal ANC: tooth
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Infections and infestations
Infection with normal ANC: upper airway NOS
|
12.8%
6/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Infections and infestations
Infection with normal ANC: chronic urinary tract infections
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
Alanine aminotransferase increased
|
14.9%
7/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
Alkaline phosphatase increased
|
36.2%
17/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
Aspartate aminotransferase increased
|
25.5%
12/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
Blood bilirubin increased
|
14.9%
7/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
Creatinine increased
|
17.0%
8/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
INR increased
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
Lymphocyte count decreased
|
89.4%
42/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
Neutrophil count decreased
|
6.4%
3/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
PTT increased
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
Platelet count decreased
|
40.4%
19/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
Weight loss
|
14.9%
7/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Investigations
White blood cell count decreased
|
14.9%
7/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.5%
12/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
High cholesterol
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.9%
7/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.6%
5/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.5%
4/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
57.4%
27/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
27.7%
13/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.0%
8/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
44.7%
21/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.5%
4/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.8%
6/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Fracture - rib
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Joint function
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.4%
3/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.4%
3/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Reflex sympathetic dystrophy
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemorrhage, tumor
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
27.7%
13/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Nervous system disorders
Accessory nerve disorder
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Nervous system disorders
Confusion
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Nervous system disorders
Dizziness
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Nervous system disorders
Dysarthria
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Nervous system disorders
Headache
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Nervous system disorders
Memory impairment
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Nervous system disorders
Sensory neuropathy
|
17.0%
8/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Psychiatric disorders
Anxiety
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Psychiatric disorders
Depression
|
10.6%
5/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Psychiatric disorders
Insomnia
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Renal and urinary disorders
Benign prostatic hypertrophy
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Renal and urinary disorders
Hematuria
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Renal and urinary disorders
Hemoglobinuria
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Renal and urinary disorders
Proteinuria
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Renal and urinary disorders
Renal stones
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Renal and urinary disorders
Urinary retention
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.1%
9/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
34.0%
16/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/hoarseness
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
10.6%
5/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.5%
4/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Skin and subcutaneous tissue disorders
Fingertip cracking
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Skin and subcutaneous tissue disorders
Itching
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Skin and subcutaneous tissue disorders
Keratosis
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Vascular disorders
Hypertension
|
19.1%
9/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Vascular disorders
Hypotension
|
2.1%
1/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
|
Vascular disorders
Thromboembolic event
|
4.3%
2/47 • -Adverse events were collected from start of treatment through 28 days following day of last treatment (median length of follow-up was 96 days, full range of 3-463 days). -Adverse events and all cause mortality were not collected separately by cohort.
|
Additional Information
Peter Oppelt, M.D.
Washington University School of Medicine
Phone: 636-916-9922
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place