Trial Outcomes & Findings for Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer (NCT NCT02827838)
NCT ID: NCT02827838
Last Updated: 2025-03-17
Results Overview
Concentration of certain immune effector will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Test
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
Treatment (Durvalumab, Surgery) HPV Negative
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV negative
|
Treatment (Durvalumab, Surgery) HPV Positive
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV positive
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
6
|
|
Overall Study
COMPLETED
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Durvalumab, Surgery) - HPV Negative
n=11 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV negative
|
Treatment (Durvalumab, Surgery) - HPV Positive
n=6 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV positive
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
58.0 years
STANDARD_DEVIATION 6.5 • n=107 Participants
|
58.3 years
STANDARD_DEVIATION 8.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
6 participants
n=107 Participants
|
17 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated and therefore is not available for analysis.
Concentration of certain immune effector will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Test
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At baseline and at one week post treatment startPercent change of levels of immune-regulatory miRs assessed in plasma assessed pre-treatment and one week post-treatment.
Outcome measures
| Measure |
Treatment (Durvalumab, Surgery)
n=11 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery
|
Treatment (Durvalumab, Surgery) - HPV Positive
n=6 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV positive
|
|---|---|---|
|
Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 223
|
13.7 percent change from baseline
Interval -61.3 to 51.0
|
1031.2 percent change from baseline
Interval 43.9 to 3034.1
|
|
Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 146
|
27.5 percent change from baseline
Interval -24.5 to 124.2
|
1251.6 percent change from baseline
Interval 116.6 to 6039.3
|
|
Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 155
|
19.7 percent change from baseline
Interval -24.2 to 364.3
|
814 percent change from baseline
Interval 100.7 to 2154.9
|
|
Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 181
|
25.7 percent change from baseline
Interval 1.7 to 189.8
|
893.2 percent change from baseline
Interval 107.8 to 3880.8
|
|
Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 20a
|
-15.6 percent change from baseline
Interval -55.2 to 6.4
|
520.6 percent change from baseline
Interval 43.4 to 1226.9
|
|
Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 335
|
12.5 percent change from baseline
Interval -44.9 to 142.8
|
1166.0 percent change from baseline
Interval 336.2 to 2070.6
|
|
Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 125
|
43.4 percent change from baseline
Interval -9.2 to 79.6
|
194.5 percent change from baseline
Interval 4.2 to 1789.6
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated and therefore is not available for analysis.
Lab results will be compared between patients who are HPV+ and HPV- using 2 sample t-tests. These measures will be compared in several ways. First, baseline, pre-treatment levels will be examined using descriptive statistics (n, mean, standard deviations, range). These measures will be examined overall and by HPV (+/-) groups. For each measure, and time point, 95% confidence intervals will be estimated. Next, two sample t-tests will be performed to compare levels of the measures at baseline. Next, measures taken post-treatment will be examined in a similar manner (descriptive statistics and 2-
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated and therefore is not available for analysis.
Concentration of certain regulatory cells will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Tes
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and one week post treatment startPercent change of levels of immune-regulatory miRs assessed in saliva assessed pre-treatment and one week post-treatment.
Outcome measures
| Measure |
Treatment (Durvalumab, Surgery)
n=11 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery
|
Treatment (Durvalumab, Surgery) - HPV Positive
n=6 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV positive
|
|---|---|---|
|
Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 125
|
351.6 percent change from baseline
Interval -34.9 to 471.6
|
64.9 percent change from baseline
Interval -10.8 to 457.9
|
|
Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 20a
|
163.9 percent change from baseline
Interval -63.1 to 1312.3
|
113.1 percent change from baseline
Interval 58.6 to 500.0
|
|
Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 223
|
66.4 percent change from baseline
Interval -47.0 to 502.1
|
199.2 percent change from baseline
Interval 0.0 to 465.7
|
|
Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 146
|
251.3 percent change from baseline
Interval -12.3 to 497.9
|
105.3 percent change from baseline
Interval -16.2 to 362.7
|
|
Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 155
|
141.2 percent change from baseline
Interval 4.6 to 970.3
|
255.0 percent change from baseline
Interval 0.0 to 367.5
|
|
Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 181
|
114.4 percent change from baseline
Interval -35.6 to 864.6
|
232.5 percent change from baseline
Interval 77.8 to 558.9
|
|
Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR)
miR 335
|
249.4 percent change from baseline
Interval 20.2 to 628.5
|
150.2 percent change from baseline
Interval 0.0 to 397.6
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated and therefore is not available for analysis.
Levels of immune-regulatory miRs assessed in blood, saliva and tumor tissue will be assessed pre- and post- treatments. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. In addition, correlations between the different methods will be examined (i.e., correlation between saliva and blood measures, saliva and tumor measures, and blood and tumor measures).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated and therefore is not available for analysis.
Lab results will be compared between patients who are HPV+ and HPV- using 2 sample t-tests. These measures will be compared in several ways. First, baseline, pre-treatment levels will be examined using descriptive statistics (n, mean, standard deviations, range). These measures will be examined overall and by HPV (+/-) groups. For each measure, and time point, 95% confidence intervals will be estimated. Next, two sample t-tests will be performed to compare levels of the measures at baseline. Next, measures taken post-treatment will be examined in a similar manner (descriptive statistics and 2-
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline (pre-treatment), during scheduled treatment and up to the 90-day follow up period after the last dose of study drug administered, with a median of 1 month and maximum of 13 monthsAEs will be coded using the Medical Dictionary for Regulatory Activities to their organ class by preferred term. Coded AEs will be displayed by frequency, severity, and relationship to treatment (durvalumab) in the safety population. In addition, summary tables will be generated for the following situations: 1) fatigue, diarrhea, nausea and skin rash; 2) Immune-mediated reactions of any grade; 3) other adverse events graded as 3 or more by CTCAE Version 4.03; 4) Durvalumab dose reductions; 5) discontinuations of treatment with durvalumab, with specification of reason for discontinuation; and 6) changes in the surgical treatment schedule. Toxicity grades Grade I (mild), Grade II (moderate), Grade III (severe), Grade IV (life threatening) and Grade V (fatal). Toxicities of greater than or equal to Grade III (except infusion reaction) are considered worse outcomes.
Outcome measures
| Measure |
Treatment (Durvalumab, Surgery)
n=11 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery
|
Treatment (Durvalumab, Surgery) - HPV Positive
n=6 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV positive
|
|---|---|---|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Alkaline phosphatase increased - Possible to Definitely related - Grade 2
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Neutrophil count decreased - Unrelated or Unlikely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Weight loss - Possible to Definitely relate - Grade 1
|
1 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Acute kidney injury - Unrelated or Unlikely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Alanine aminotransferase increased - Possible to Definitely related - Grade 2
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Alanine aminotransferase increased - Possible to Definitely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Alkaline phosphatase increased - Possible to Definitely related - Grade 1
|
2 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Anemia - Unrelated or Unlikely related - Grade 3
|
2 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Anorexia - Possible to Definitely relate - Grade 1
|
1 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Aspartate aminotransferase increased - Possible to Definitely related - Grade 1
|
2 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Aspartate aminotransferase increased - Possible to Definitely related - Grade 2
|
2 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Aspartate aminotransferase increased - Possible to Definitely related - Grade 4
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Blood bilirubin increased - Possible to Definitely related - Grade 1
|
2 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Blood bilirubin increased - Possible to Definitely relate - Grade 2
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Bullous dermatitis - Possible to Definitely relate - Grade 1
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Constipation - Possible to Definitely relate - Grade 1
|
1 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Constipation - Possible to Definitely relate - Grade 2
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Device related infection - Unrelated or Unlikely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Diarrhea - Possible to Definitely relate - Grade 1
|
3 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Diarrhea - Possible to Definitely relate - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Diarrhea - Unrelated or Unlikely related - Grade 1
|
4 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Fatigue - Possible to Definitely relate - Grade 1
|
6 events
|
3 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Fatigue - Possible to Definitely relate - Grade 2
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Fatigue - Unrelated or Unlikely related - Grade 1
|
1 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Fatigue - Unrelated or Unlikely related - Grade 2
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Head soft tissue necrosis - Unrelated or Unlikely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hyperglycemia - Unrelated or Unlikely related - Grade 3
|
0 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hyperglycemia - Unrelated or Unlikely related - Grade 4
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hypermagnesemia - Unrelated or Unlikely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hypertension - Unrelated or Unlikely related - Grade 3
|
0 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hypoalbuminemia - Unrelated or Unlikely related - Grade 3
|
2 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hypocalcemia - Unrelated or Unlikely related - Grade 3
|
4 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hypocalcemia - Unrelated or Unlikely related - Grade 4
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hypokalemia - Unrelated or Unlikely related - Grade 3
|
3 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hyponatremia - Unrelated or Unlikely related - Grade 3
|
4 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hypophosphatemia - Unrelated or Unlikely related - Grade 3
|
4 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hypotension - Unrelated or Unlikely related - Grade 3
|
2 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Hypothyroidism - Possible to Definitely relate - Grade 2
|
0 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Leukocytosis - Unrelated or Unlikely related - Grade 3
|
1 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Lipase increased - Possible to Definitely relate - Grade 3
|
0 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Malaise - Possible to Definitely relate - Grade 1
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Nausea - Possible to Definitely relate - Grade 1
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Nausea - Unrelated or Unlikely related - Grade 1
|
3 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Neck soft tissue necrosis - Unrelated or Unlikely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Pruritus - Possible to Definitely relate - Grade 1
|
0 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Rash maculo-papular - Possible to Definitely relate - Grade 1
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Rash pustular - Possible to Definitely relate - Grade 1
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Serum amylase increased - Possible to Definitely relate - Grade 1
|
0 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Skin ulceration - Unrelated or Unlikely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Skin ulceration - Unrelated or Unlikely related - Grade 4
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Taste alteration (dysgeusia) - Possible to Definitely relate - Grade 1
|
0 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Urine output decreased - Unrelated or Unlikely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Urticaria - Possible to Definitely relate - Grade 1
|
0 events
|
1 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Wound complication - Unrelated or Unlikely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Wound infection - Unrelated or Unlikely related - Grade 3
|
1 events
|
0 events
|
|
Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03
Discontinuation of Durvalumab due to immune-related hepatitis
|
1 events
|
0 events
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated for all patients.
Change in SUV activity as measured by PET scans from baseline to post-treatment not specific to HPV status.
Outcome measures
| Measure |
Treatment (Durvalumab, Surgery)
n=2 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery
|
Treatment (Durvalumab, Surgery) - HPV Positive
n=1 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV positive
|
|---|---|---|
|
Standardized Uptake Value (SUV) as Measured by PET Scans
|
-0.15 change in SUV
Standard Error 1.20
|
0 change in SUV
Standard Error 0
|
SECONDARY outcome
Timeframe: Up to 18 monthsChange in tumor diameters will be compared between groups (HPV +/-) pre- and post- treatment.
Outcome measures
| Measure |
Treatment (Durvalumab, Surgery)
n=11 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Therapeutic Conventional Surgery: Undergo surgery
|
Treatment (Durvalumab, Surgery) - HPV Positive
n=6 Participants
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV positive
|
|---|---|---|
|
Tumor Diameter Assessed Using RECIST Version 1.1 Criteria
|
1.0 mm
Interval 0.0 to 4.0
|
-2.0 mm
Interval -2.0 to 2.0
|
Adverse Events
Treatment (Durvalumab, Surgery) - HPV Negative
Serious events: 5 serious events
Other events: 11 other events
Deaths: 1 deaths
Treatment (Durvalumab, Surgery) - HPV Positive
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Durvalumab, Surgery) - HPV Negative
n=11 participants at risk
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV negative
|
Treatment (Durvalumab, Surgery) - HPV Positive
n=6 participants at risk
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV positive
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
Other adverse events
| Measure |
Treatment (Durvalumab, Surgery) - HPV Negative
n=11 participants at risk
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV negative
|
Treatment (Durvalumab, Surgery) - HPV Positive
n=6 participants at risk
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
Durvalumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
HPV positive
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
54.5%
6/11 • Number of events 8 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
83.3%
5/6 • Number of events 6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
33.3%
2/6 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Eye disorders
Corneal ulcer
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Eye disorders
Floaters
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Gastrointestinal disorders
Constipation
|
45.5%
5/11 • Number of events 5 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
33.3%
2/6 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Gastrointestinal disorders
Diarrhea
|
45.5%
5/11 • Number of events 7 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Gastrointestinal disorders
Dysphagia
|
18.2%
2/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Gastrointestinal disorders
Mucositis oral
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 4 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
General disorders
Chills
|
9.1%
1/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
General disorders
Edema face
|
18.2%
2/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
General disorders
Fatigue
|
63.6%
7/11 • Number of events 9 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
66.7%
4/6 • Number of events 4 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
General disorders
Fever
|
27.3%
3/11 • Number of events 3 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
General disorders
Gait disturbance
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
General disorders
Localized edema
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
General disorders
Malaise
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
General disorders
Neck edema
|
18.2%
2/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
General disorders
Non-cardiac chest pain
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
General disorders
Pain
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Infections and infestations
Device related infection
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Infections and infestations
Pharyngitis
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Infections and infestations
Rash pustular
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Infections and infestations
Wound infection
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Infections and infestations
Infections and infestations - Other: tumor infection per treating physician
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Injury, poisoning and procedural complications
Fracture
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Injury, poisoning and procedural complications
Venous injury
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Alkaline phosphatase increased
|
27.3%
3/11 • Number of events 5 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Aspartate aminotransferase increased
|
18.2%
2/11 • Number of events 6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Blood bilirubin increased
|
18.2%
2/11 • Number of events 3 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Lipase increased
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Neutrophil count decreased
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Platelet count decreased
|
27.3%
3/11 • Number of events 5 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
33.3%
2/6 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Serum amylase increased
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Urine output decreased
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Weight gain
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
Weight loss
|
18.2%
2/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.4%
4/11 • Number of events 4 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
83.3%
5/6 • Number of events 12 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
18.2%
2/11 • Number of events 4 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
27.3%
3/11 • Number of events 4 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
63.6%
7/11 • Number of events 18 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
33.3%
2/6 • Number of events 3 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
54.5%
6/11 • Number of events 20 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
50.0%
3/6 • Number of events 4 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
18.2%
2/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
36.4%
4/11 • Number of events 15 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
72.7%
8/11 • Number of events 19 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
63.6%
7/11 • Number of events 18 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
27.3%
3/11 • Number of events 10 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.1%
1/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Musculoskeletal and connective tissue disorders
Head soft tissue necrosis
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
2/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Nervous system disorders
Dizziness
|
36.4%
4/11 • Number of events 5 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.1%
1/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Psychiatric disorders
Agitation
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Psychiatric disorders
Anxiety
|
18.2%
2/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Renal and urinary disorders
Acute kidney injury
|
18.2%
2/11 • Number of events 3 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
36.4%
4/11 • Number of events 4 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other: skin irritation at G-tube site
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other: dental extraction site inflammation (dry sockets)
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Vascular disorders
Hematoma
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Vascular disorders
Hot flashes
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
33.3%
2/6 • Number of events 2 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Vascular disorders
Hypotension
|
27.3%
3/11 • Number of events 4 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
0.00%
0/6 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Vascular disorders
Lymphedema
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/11 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
16.7%
1/6 • Number of events 1 • Adverse events and serious adverse events was recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab), with a median of 1 month and maximum of 13 months
|
Additional Information
Mercedes Porosnicu
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-8664
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place