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M7824 in Subjects With HPV Associated Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03427411
Recruitment Status : Active, not recruiting
First Posted : February 9, 2018
Results First Posted : February 28, 2022
Last Update Posted : March 22, 2022
Sponsor:
Information provided by (Responsible Party):
Julius Strauss, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Human Papilloma Virus
Cervical Cancer
Oropharyngeal Cancer
Anal Cancer
Vaginal or Penile Cancer
Intervention Drug: M7824
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal. Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Period Title: Overall Study
Started 30 27
Completed 30 26
Not Completed 0 1
Reason Not Completed
Screen failure - platelets too low             0             1
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Total
Hide Arm/Group Description Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal. Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal. Total of all reporting groups
Overall Number of Baseline Participants 30 27 57
Hide Baseline Analysis Population Description
One participant enrolled in the refractory group was a screen failure and was not treated. However, collected baseline data is shown here.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  83.3%
18
  66.7%
43
  75.4%
>=65 years
5
  16.7%
9
  33.3%
14
  24.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 27 participants 57 participants
53.48  (13.49) 58.73  (11.94) 55.96  (12.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
Female
25
  83.3%
11
  40.7%
36
  63.2%
Male
5
  16.7%
16
  59.3%
21
  36.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
Hispanic or Latino
2
   6.7%
2
   7.4%
4
   7.0%
Not Hispanic or Latino
28
  93.3%
25
  92.6%
53
  93.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   6.7%
0
   0.0%
2
   3.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  10.0%
1
   3.7%
4
   7.0%
White
23
  76.7%
26
  96.3%
49
  86.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   6.7%
0
   0.0%
2
   3.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 27 participants 57 participants
30 27 57
Site of Primary Tumor  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 30 participants 27 participants 57 participants
Anus
4
  13.3%
6
  22.2%
10
  17.5%
Cervix
15
  50.0%
6
  22.2%
21
  36.8%
Head-face or neck - Not Otherwise Specified
1
   3.3%
1
   3.7%
2
   3.5%
Head/Neck
1
   3.3%
2
   7.4%
3
   5.3%
Hypopharynx
0
   0.0%
1
   3.7%
1
   1.8%
Oropharynx
0
   0.0%
1
   3.7%
1
   1.8%
Rectum
3
  10.0%
1
   3.7%
4
   7.0%
Tongue
0
   0.0%
1
   3.7%
1
   1.8%
Tongue, Base of Tongue
1
   3.3%
3
  11.1%
4
   7.0%
Tonsil
1
   3.3%
5
  18.5%
6
  10.5%
Vagina
1
   3.3%
0
   0.0%
1
   1.8%
Vulva
2
   6.7%
0
   0.0%
2
   3.5%
Penile
1
   3.3%
0
   0.0%
1
   1.8%
1.Primary Outcome
Title Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response
Hide Description The percentage of participants that achieved an objective confirmed complete or partial overall tumor response was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame Every six weeks for up to one year
Hide Outcome Measure Data
Hide Analysis Population Description
1/30 participants was not evaluable in the naïve group because the participant was determined to be HPV negative. 1/27 was not evaluable in the refractory group because one participant was a screen failure and was not treated.
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description:
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Overall Number of Participants Analyzed 29 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31
(15.3 to 50.8)
7.7
(0.9 to 25.1)
2.Secondary Outcome
Title Progression-free Survival Time (PFS)
Hide Description PFS is defined as the time from the date of first treatment to the date of disease progression or death. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions.
Time Frame Time from the date of first treatment to the date of disease progression or death, up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
1/30 participants was not evaluable in the naïve group because they were found to be HPV negative and 1/27 was not evaluable in the refractory group because one participant was a screen failure.
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description:
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Overall Number of Participants Analyzed 29 26
Median (95% Confidence Interval)
Unit of Measure: Months
3.5
(1.5 to 7.4)
1.4
(0.0 to 9.2)
3.Secondary Outcome
Title Percentage of Participants With Disease Control Who Achieved a Complete Response, Partial Response and Stable Disease Defined by the Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1 Lasting at Least 6 Months
Hide Description The percentage of participants with disease control who achieved a complete response, partial response and stable disease lasting at least 6 months was measured by the response evaluation criteria in solid tumors (RECIST)version 1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) (at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
1/30 participants was not evaluable in the naïve group because they were determined to be HPV negative, and 1/27 was not evaluable in the refractory group because one participant was a screen failure.
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description:
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Overall Number of Participants Analyzed 29 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62.1
(42.3 to 79.3)
19.2
(6.6 to 39.4)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from the date of first treatment to the date of death and was measured by Kaplan-Meier analysis.
Time Frame Time from the date of first treatment to the date of death, up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
1/30 participants was not evaluable in the naïve group because the patient was determined to be HPV negative, and 1/27 was not evaluable in the refractory group because one participant was a screen failure and was not treated.
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description:
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Overall Number of Participants Analyzed 29 26
Median (95% Confidence Interval)
Unit of Measure: Months
19.2 [1] 
(9.7 to NA)
4.4
(2.7 to 13.2)
[1]
The upper limit of the confidence interval cannot be estimated because several participants are still alive.
5.Secondary Outcome
Title Number of Participants With Serious Grade ≥3 Adverse Events Considered Related to Study Treatment of M7824
Hide Description Adverse events were assessed by the Common Terminology Criteria for Adverse Events version 5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
Time Frame 28 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
One participant enrolled in the refractory group was a screen failure and was not treated.
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description:
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Overall Number of Participants Analyzed 30 26
Measure Type: Count of Participants
Unit of Measure: Participants
6
  20.0%
4
  15.4%
6.Secondary Outcome
Title Number of Checkpoint Inhibitor Naive Participants With Response Based on Adequate Similarity (Defined as P-value > 0.2 With Fisher's Exact Test) of Results in Cohorts 1 and 2
Hide Description Response based on adequate similarity defined as P-value > 0.2 with Fisher's exact test of results in cohorts 1 and 2 was compared with a two-sided Fishers exact test, and response was measured by the response evaluation criteria in solid tumors (RECIST)version 1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Time Frame median of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only cohorts 1 and 2 was evaluable for this outcome measure.
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description:
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
2
   6.9%
Partial Response
7
  24.1%
Progressive Disease
10
  34.5%
Stable Disease
9
  31.0%
Not Evaluable
1
   3.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was defined as response rates which were sufficiently similar (p>0.20 by Fisher's exact test).
Statistical Test of Hypothesis P-Value 0.6143
Comments The p value was calculated and was 0.6143 which is > 0.2 (pre-defined threshold).
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants That Were Hospitalized Because of Adverse Events Attributed to Disease Progression
Hide Description Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Disease progression is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time Frame Up to 30 days from last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
One participant enrolled in the refractory group was a screen failure and was not treated.
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description:
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Overall Number of Participants Analyzed 30 26
Measure Type: Number
Unit of Measure: percentage of participants
37.9 69.2
8.Secondary Outcome
Title Duration of Response (Complete Response or Partial Response)
Hide Description Duration of response is defined as the time from complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions.
Time Frame Time from complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented, up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description:
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Overall Number of Participants Analyzed 9 2
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(8.3 to NA)
4.0 [2] 
(2.8 to NA)
[1]
Median and upper end of the confidence interval cannot be estimated because duration of response was censored at the time of data cut off in 6/9 responders since these 6 participants have not had disease recurrence and therefore did not have a duration of response. The other 20 participants on this cohort were not assessed for duration of response as they did not have a response to begin with. Therefore median duration of response and upper end of the confidence interval cannot be calculated.
[2]
The upper end of the confidence interval cannot be estimated because of the low number of responding participants (n=2) assessed for duration of response in this cohort. In addition, the other 24 participants on this cohort were not assessed for duration of response as they did not have a response to begin with. Therefore the upper end of the confidence interval cannot be calculated.
9.Other Pre-specified Outcome
Title Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Hide Description Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 42 months and 28 days for the naïve group, and 40 months and 16 days for the refractory group.
Hide Outcome Measure Data
Hide Analysis Population Description
One enrolled participant was a screen failure and was not treated.
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description:
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Overall Number of Participants Analyzed 30 26
Measure Type: Count of Participants
Unit of Measure: Participants
30
 100.0%
26
 100.0%
Time Frame Date treatment consent signed to date off study, approximately 42 months and 28 days for the naïve group, and 40 months and 16 days for the refractory group.
Adverse Event Reporting Description One participant enrolled in the refractory group was a screen failure and was not treated.
 
Arm/Group Title Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Hide Arm/Group Description Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal. Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
All-Cause Mortality
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   18/30 (60.00%)      22/26 (84.62%)    
Hide Serious Adverse Events
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/30 (63.33%)      21/26 (80.77%)    
Blood and lymphatic system disorders     
Anemia † 1  3/30 (10.00%)  6 6/26 (23.08%)  12
Cardiac disorders     
Atrial fibrillation † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Atrial flutter † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Myocarditis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Sinus tachycardia † 1  0/30 (0.00%)  0 2/26 (7.69%)  2
Gastrointestinal disorders     
Abdominal distension † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Abdominal pain † 1  3/30 (10.00%)  4 3/26 (11.54%)  5
Ascites † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Diarrhea † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Esophagitis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Gastric hemorrhage † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Ileus † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Lower gastrointestinal hemorrhage † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Nausea † 1  3/30 (10.00%)  3 1/26 (3.85%)  2
Small intestinal obstruction † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Upper gastrointestinal hemorrhage † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Vomiting † 1  3/30 (10.00%)  3 1/26 (3.85%)  1
General disorders     
Death Not Otherwise Specified (NOS) † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Disease progression † 1  0/30 (0.00%)  0 5/26 (19.23%)  5
Fatigue † 1  0/30 (0.00%)  0 3/26 (11.54%)  4
Fever † 1  1/30 (3.33%)  1 2/26 (7.69%)  3
Pain † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Hepatobiliary disorders     
Bile duct stenosis † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Cholecystitis † 1  2/30 (6.67%)  2 0/26 (0.00%)  0
Hepatobiliary disorders - Other, Hepatic duct stenosis † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Hepatobiliary disorders - Other, Nodular Regenerative Hyperplasia † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Hepatobiliary disorders - Other, left hepatic lobe abscesses † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Portal vein thrombosis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Infections and infestations     
Bronchial infection † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Fungemia † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Sepsis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Urinary tract infection † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Injury, poisoning and procedural complications     
Fall † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Fracture † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Tracheal obstruction † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Investigations     
Alanine aminotransferase increased † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Alkaline phosphatase increased † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Aspartate aminotransferase increased † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Blood bilirubin increased † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Metabolism and nutrition disorders     
Dehydration † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Hypercalcemia † 1  2/30 (6.67%)  2 1/26 (3.85%)  1
Hyperglycemia † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Hyperkalemia † 1  0/30 (0.00%)  0 1/26 (3.85%)  2
Hypokalemia † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Hyponatremia † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Musculoskeletal and connective tissue disorders     
Flank pain † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Muscle weakness lower limb † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Myositis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Pain in extremity † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [1]  1/30 (3.33%)  1 0/26 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Disease progression † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [2]  1/30 (3.33%)  1 2/26 (7.69%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, brain metastasis † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [3]  1/30 (3.33%)  1 0/26 (0.00%)  0
Tumor hemorrhage † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Tumor pain † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders     
Depressed level of consciousness † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Dizziness † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Ischemia cerebrovascular † 1  1/30 (3.33%)  2 0/26 (0.00%)  0
Nervous system disorders - Other, Vocal fold paralysis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Nervous system disorders - Other, balance difficulties † 1  0/30 (0.00%)  0 2/26 (7.69%)  2
Paresthesia † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Presyncope † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Spinal cord compression † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Psychiatric disorders     
Confusion † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Renal and urinary disorders     
Acute kidney injury † 1  0/30 (0.00%)  0 1/26 (3.85%)  2
Hematuria † 1  0/30 (0.00%)  0 3/26 (11.54%)  3
Renal and urinary disorders - Other, Specify † 1 [4]  0/30 (0.00%)  0 1/26 (3.85%)  1
Urinary tract obstruction † 1  1/30 (3.33%)  1 2/26 (7.69%)  2
Urinary tract pain † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Reproductive system and breast disorders     
Vaginal hemorrhage † 1  0/30 (0.00%)  0 1/26 (3.85%)  2
Respiratory, thoracic and mediastinal disorders     
Cough † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Dyspnea † 1  2/30 (6.67%)  3 2/26 (7.69%)  3
Pneumothorax † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Voice alteration † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Surgical and medical procedures     
Surgical and medical procedures - Other, Left Psoas Mass Resection † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Surgical and medical procedures - Other, Nephrostomy tube exchange trauma † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Surgical and medical procedures - Other, Resection abdominal (abd) wall mets † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Surgical and medical procedures - Other, Resection abd wall mets w/abd wall reconstruction † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Surgical and medical procedures - Other, TAVR aortic valve replacement † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Surgical and medical procedures - Other, craniotomy for resection of cerebellar tumors † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Surgical and medical procedures - Other, specify † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Surgical and medical procedures - Other, radiation therapy for cerebellar tumor † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Surgical and medical procedures - Other, surgery to stabilize leg bone metastasis † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Vascular disorders     
Hypotension † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Thromboembolic event † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
1
Term from vocabulary, CTCAE (5.0)
†
Indicates events were collected by systematic assessment
[1]
Death due to disease progression reported to principal investigator on 8/16/18
[2]
Neoplasm, Malignant, Metastatic Rectal Cancer
[3]
disease progression head and neck squamous cell carcinoma (HNSCC)
[4]
Hydronephrosis secondary to UT obstruction-stent replacement indicated
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/30 (100.00%)      26/26 (100.00%)    
Blood and lymphatic system disorders     
Anemia † 1  19/30 (63.33%)  44 19/26 (73.08%)  53
Cardiac disorders     
Atrial fibrillation † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Atrial flutter † 1  0/30 (0.00%)  0 1/26 (3.85%)  2
Myocarditis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Palpitations † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Pericardial effusion † 1  0/30 (0.00%)  0 2/26 (7.69%)  2
Sinus tachycardia † 1  3/30 (10.00%)  3 7/26 (26.92%)  7
Supraventricular tachycardia † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Ear and labyrinth disorders     
Ear and labyrinth disorders - Other, Continuous drainage L ear; hospitalized † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Ear and labyrinth disorders - Other, Intermittent bloody discharge L ear † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Ear and labyrinth disorders - Other, Specify † 1 [1]  0/30 (0.00%)  0 1/26 (3.85%)  1
Ear and labyrinth disorders - Other, Left ear fullness/congestion-ENT consult ordered † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Ear and labyrinth disorders - Other, fullness/congestion left ear † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Ear pain † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Hearing impaired † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Tinnitus † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Endocrine disorders     
Adrenal insufficiency † 1  2/30 (6.67%)  2 0/26 (0.00%)  0
Hyperthyroidism † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Hypothyroidism † 1  7/30 (23.33%)  8 0/26 (0.00%)  0
Eye disorders     
Blurred vision † 1  2/30 (6.67%)  2 0/26 (0.00%)  0
Dry eye † 1  1/30 (3.33%)  4 0/26 (0.00%)  0
Eye disorders - Other, peripheral visual fields altered left eye, r/t brain lesion † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Flashing lights † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Retinopathy † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Vision decreased † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain † 1  8/30 (26.67%)  11 7/26 (26.92%)  10
Anal hemorrhage † 1  2/30 (6.67%)  3 0/26 (0.00%)  0
Ascites † 1  3/30 (10.00%)  5 2/26 (7.69%)  2
Bloating † 1  3/30 (10.00%)  3 1/26 (3.85%)  1
Colitis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Colonic obstruction † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Constipation † 1  10/30 (33.33%)  11 6/26 (23.08%)  7
Diarrhea † 1  9/30 (30.00%)  16 4/26 (15.38%)  5
Dry mouth † 1  2/30 (6.67%)  3 2/26 (7.69%)  2
Duodenal obstruction † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Dyspepsia † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Dysphagia † 1  3/30 (10.00%)  3 3/26 (11.54%)  5
Esophagitis † 1  0/30 (0.00%)  0 1/26 (3.85%)  2
Fecal incontinence † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Flatulence † 1  1/30 (3.33%)  1 2/26 (7.69%)  2
Gastric ulcer † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Gastritis † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Gastroesophageal reflux disease † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Gastrointestinal disorders - Other, Diverticulosis † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Gastrointestinal disorders - Other, Esophageal erosions † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Gastrointestinal disorders - Other, Hyperpigmentation of tongue † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Gingival pain † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Hemorrhoidal hemorrhage † 1  2/30 (6.67%)  2 2/26 (7.69%)  2
Mucositis oral † 1  4/30 (13.33%)  6 1/26 (3.85%)  1
Nausea † 1  11/30 (36.67%)  18 8/26 (30.77%)  10
Oral hemorrhage † 1  9/30 (30.00%)  10 6/26 (23.08%)  9
Oral pain † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Rectal hemorrhage † 1  6/30 (20.00%)  11 3/26 (11.54%)  3
Rectal pain † 1  2/30 (6.67%)  2 0/26 (0.00%)  0
Small intestinal obstruction † 1  1/30 (3.33%)  2 0/26 (0.00%)  0
Upper gastrointestinal hemorrhage † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Vomiting † 1  8/30 (26.67%)  12 8/26 (30.77%)  11
General disorders     
Chills † 1  2/30 (6.67%)  3 1/26 (3.85%)  1
Death NOS † 1  3/30 (10.00%)  3 0/26 (0.00%)  0
Edema face † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Edema limbs † 1  8/30 (26.67%)  9 3/26 (11.54%)  4
Fatigue † 1  18/30 (60.00%)  32 11/26 (42.31%)  14
Fever † 1  7/30 (23.33%)  11 1/26 (3.85%)  1
Flu like symptoms † 1  6/30 (20.00%)  7 3/26 (11.54%)  3
Gait disturbance † 1  2/30 (6.67%)  2 1/26 (3.85%)  1
Pain † 1  6/30 (20.00%)  9 3/26 (11.54%)  3
Pain in extremity † 1  3/30 (10.00%)  7 6/26 (23.08%)  7
Hepatobiliary disorders     
Portal vein thrombosis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Immune system disorders     
Allergic reaction † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Infections and infestations     
Bacteremia † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Bronchial infection † 1  2/30 (6.67%)  2 1/26 (3.85%)  3
Herpes simplex reactivation † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Infections and infestations - Other, Specify † 1 [2]  1/30 (3.33%)  1 0/26 (0.00%)  0
Lung infection † 1  1/30 (3.33%)  1 1/26 (3.85%)  2
Mucosal infection † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Nail infection † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Skin infection † 1  3/30 (10.00%)  3 1/26 (3.85%)  1
Upper respiratory infection † 1  2/30 (6.67%)  3 1/26 (3.85%)  1
Urinary tract infection † 1  3/30 (10.00%)  3 2/26 (7.69%)  2
Injury, poisoning and procedural complications     
Dermatitis radiation † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Fall † 1  3/30 (10.00%)  5 3/26 (11.54%)  4
Fracture † 1  2/30 (6.67%)  4 0/26 (0.00%)  0
Infusion related reaction † 1  2/30 (6.67%)  2 1/26 (3.85%)  1
Intestinal stoma site bleeding † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Wound dehiscence † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Investigations     
Alanine aminotransferase increased † 1  4/30 (13.33%)  5 4/26 (15.38%)  4
Alkaline phosphatase increased † 1  1/30 (3.33%)  1 4/26 (15.38%)  4
Aspartate aminotransferase increased † 1  4/30 (13.33%)  8 4/26 (15.38%)  6
Blood bilirubin increased † 1  1/30 (3.33%)  3 1/26 (3.85%)  1
CPK increased † 1  1/30 (3.33%)  3 0/26 (0.00%)  0
Cardiac troponin I increased † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Creatinine increased † 1  3/30 (10.00%)  3 2/26 (7.69%)  2
Electrocardiogram QT corrected interval prolonged † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
INR increased † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Lipase increased † 1  1/30 (3.33%)  3 1/26 (3.85%)  2
Lymphocyte count decreased † 1  11/30 (36.67%)  22 12/26 (46.15%)  27
Neutrophil count decreased † 1  3/30 (10.00%)  16 0/26 (0.00%)  0
Platelet count decreased † 1  0/30 (0.00%)  0 2/26 (7.69%)  8
Serum amylase increased † 1  1/30 (3.33%)  2 1/26 (3.85%)  1
Weight gain † 1  2/30 (6.67%)  7 1/26 (3.85%)  1
Weight loss † 1  6/30 (20.00%)  14 7/26 (26.92%)  10
White blood cell decreased † 1  3/30 (10.00%)  4 1/26 (3.85%)  1
Metabolism and nutrition disorders     
Anorexia † 1  10/30 (33.33%)  10 12/26 (46.15%)  16
Dehydration † 1  3/30 (10.00%)  4 7/26 (26.92%)  8
Hypercalcemia † 1  0/30 (0.00%)  0 2/26 (7.69%)  4
Hyperglycemia † 1  2/30 (6.67%)  2 0/26 (0.00%)  0
Hyperkalemia † 1  1/30 (3.33%)  1 3/26 (11.54%)  3
Hyperphosphatemia † 1  0/30 (0.00%)  0 2/26 (7.69%)  2
Hyperuricemia † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Hypoalbuminemia † 1  7/30 (23.33%)  9 8/26 (30.77%)  8
Hypocalcemia † 1  4/30 (13.33%)  5 0/26 (0.00%)  0
Hypokalemia † 1  7/30 (23.33%)  14 3/26 (11.54%)  5
Hypomagnesemia † 1  3/30 (10.00%)  4 3/26 (11.54%)  5
Hyponatremia † 1  3/30 (10.00%)  4 6/26 (23.08%)  12
Hypophosphatemia † 1  2/30 (6.67%)  3 6/26 (23.08%)  11
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/30 (3.33%)  3 2/26 (7.69%)  2
Back pain † 1  6/30 (20.00%)  10 4/26 (15.38%)  4
Bone pain † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Chest wall pain † 1  0/30 (0.00%)  0 1/26 (3.85%)  2
Flank pain † 1  0/30 (0.00%)  0 2/26 (7.69%)  2
Generalized muscle weakness † 1  2/30 (6.67%)  3 2/26 (7.69%)  2
Joint effusion † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Muscle cramp † 1  2/30 (6.67%)  2 2/26 (7.69%)  2
Muscle weakness lower limb † 1  2/30 (6.67%)  2 2/26 (7.69%)  2
Muscle weakness upper limb † 1  2/30 (6.67%)  2 0/26 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, TMJ symptoms, Left jaw † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, partial tendon rupture † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Myalgia † 1  4/30 (13.33%)  6 0/26 (0.00%)  0
Myositis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Neck pain † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Non-cardiac chest pain † 1  2/30 (6.67%)  2 4/26 (15.38%)  4
Rhabdomyolysis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [3]  1/30 (3.33%)  1 0/26 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Brain lesion † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [4]  0/30 (0.00%)  0 1/26 (3.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [5]  0/30 (0.00%)  0 1/26 (3.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [6]  0/30 (0.00%)  0 1/26 (3.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [7]  1/30 (3.33%)  1 0/26 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [8]  1/30 (3.33%)  1 0/26 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [9]  1/30 (3.33%)  1 0/26 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Keratoacanthomas † 1  1/30 (3.33%)  1 1/26 (3.85%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [10]  0/30 (0.00%)  0 1/26 (3.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [11]  1/30 (3.33%)  1 0/26 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [12]  1/30 (3.33%)  1 0/26 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify † 1 [13]  0/30 (0.00%)  0 1/26 (3.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Keratoacanthoma † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Tumor pain † 1  1/30 (3.33%)  1 4/26 (15.38%)  4
Nervous system disorders     
Anosmia † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Concentration impairment † 1  2/30 (6.67%)  2 0/26 (0.00%)  0
Dizziness † 1  4/30 (13.33%)  4 5/26 (19.23%)  6
Dysgeusia † 1  1/30 (3.33%)  1 2/26 (7.69%)  3
Extrapyramidal disorder † 1  2/30 (6.67%)  2 0/26 (0.00%)  0
Facial muscle weakness † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Facial nerve disorder † 1  1/30 (3.33%)  2 0/26 (0.00%)  0
Headache † 1  9/30 (30.00%)  10 4/26 (15.38%)  4
Lethargy † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Memory impairment † 1  2/30 (6.67%)  2 0/26 (0.00%)  0
Movements involuntary † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders - Other, Specify † 1 [14]  1/30 (3.33%)  1 0/26 (0.00%)  0
Nervous system disorders - Other, balance difficulties † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Paresthesia † 1  1/30 (3.33%)  1 2/26 (7.69%)  3
Peripheral motor neuropathy † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Presyncope † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Somnolence † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Psychiatric disorders     
Agitation † 1  0/30 (0.00%)  0 2/26 (7.69%)  2
Anxiety † 1  0/30 (0.00%)  0 3/26 (11.54%)  3
Confusion † 1  0/30 (0.00%)  0 4/26 (15.38%)  6
Delirium † 1  0/30 (0.00%)  0 2/26 (7.69%)  2
Depression † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Hallucinations † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Insomnia † 1  2/30 (6.67%)  2 4/26 (15.38%)  5
Libido decreased † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Psychosis † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Restlessness † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Renal and urinary disorders     
Bladder spasm † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Cystitis noninfective † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Hematuria † 1  5/30 (16.67%)  8 3/26 (11.54%)  3
Renal and urinary disorders - Other, Specify † 1 [15]  1/30 (3.33%)  1 0/26 (0.00%)  0
Renal and urinary disorders - Other, Hydronephrosis-moderate, L-sided † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Renal and urinary disorders - Other, Urinary hesitancy and sensation of incomplete voiding † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Renal and urinary disorders - Other, Urinary frequency † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Urinary frequency † 1  2/30 (6.67%)  2 0/26 (0.00%)  0
Urinary retention † 1  1/30 (3.33%)  1 2/26 (7.69%)  2
Urinary tract obstruction † 1  2/30 (6.67%)  2 1/26 (3.85%)  1
Urinary urgency † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Reproductive system and breast disorders     
Pelvic pain † 1  2/30 (6.67%)  5 0/26 (0.00%)  0
Perineal pain † 1  1/30 (3.33%)  2 0/26 (0.00%)  0
Uterine hemorrhage † 1  1/30 (3.33%)  2 0/26 (0.00%)  0
Vaginal hemorrhage † 1  3/30 (10.00%)  5 2/26 (7.69%)  2
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Bronchial obstruction † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Bronchopulmonary hemorrhage † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Cough † 1  9/30 (30.00%)  12 5/26 (19.23%)  8
Dyspnea † 1  11/30 (36.67%)  14 11/26 (42.31%)  14
Epistaxis † 1  8/30 (26.67%)  10 4/26 (15.38%)  4
Hoarseness † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Hypoxia † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Nasal congestion † 1  0/30 (0.00%)  0 2/26 (7.69%)  2
Pleural effusion † 1  1/30 (3.33%)  1 4/26 (15.38%)  5
Pneumonitis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Postnasal drip † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders - Other, Specify † 1 [16]  0/30 (0.00%)  0 1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders - Other, Specify † 1 [17]  1/30 (3.33%)  1 0/26 (0.00%)  0
Rhinorrhea † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Sore throat † 1  2/30 (6.67%)  3 0/26 (0.00%)  0
Stridor † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Wheezing † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Bullous dermatitis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Dry skin † 1  1/30 (3.33%)  2 1/26 (3.85%)  1
Erythroderma † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Hyperhidrosis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Papulopustular rash † 1  1/30 (3.33%)  1 1/26 (3.85%)  1
Pruritus † 1  8/30 (26.67%)  14 8/26 (30.77%)  16
Rash acneiform † 1  10/30 (33.33%)  17 6/26 (23.08%)  10
Rash maculo-papular † 1  9/30 (30.00%)  16 1/26 (3.85%)  1
Rash pustular † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Skin and subcutaneous tissue disorders - Other, seborrheic dermatitis † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Skin papilloma † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Skin ulceration † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Urticaria † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Surgical and medical procedures     
Surgical and medical procedures - Other, inguinal hernia † 1  0/30 (0.00%)  0 1/26 (3.85%)  1
Surgical and medical procedures - Other, surgical de-bulking condyloma † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Vascular disorders     
Flushing † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Hot flashes † 1  5/30 (16.67%)  6 1/26 (3.85%)  1
Hypertension † 1  0/30 (0.00%)  0 2/26 (7.69%)  4
Hypotension † 1  0/30 (0.00%)  0 4/26 (15.38%)  4
Lymphedema † 1  1/30 (3.33%)  1 0/26 (0.00%)  0
Thromboembolic event † 1  4/30 (13.33%)  5 6/26 (23.08%)  6
1
Term from vocabulary, CTCAE (5.0)
†
Indicates events were collected by systematic assessment
[1]
Intermittent serous and sanguineous discharge L ear s/p Myringotomy; Ofloxacin indicated
[2]
Diagnosed with Influenza A associated with malaise, nausea and interim fever; Tamiflu indicated
[3]
Benign Keratoacanthomas back of neck and R clavicle-dermatology (DERM) consult and monitoring
[4]
Dermal carcinoma with lymphovascular invasion (LVI) on forehead, mid-back, and abdomen (R lateral and superior chest)
[5]
KERATOACANTHOMA, right forearm
[6]
Keratoacanthoma lesions as per Dermatology bx results; steroid cream and prednisone indicated
[7]
Keratoacanthoma on face & neck
[8]
Keratoacanthoma on face/neck-cryotherapy indicated on 11/6/18
[9]
Keratoacanthoma, site left upper eyelid
[10]
Keratoacanthomas (left shoulder)
[11]
Keratoacanthomas, bilateral arms, chest, back, neck per Derm dx; study drug held beg 10/23/18
[12]
Keratoacanthomas; liquid nitrogen to lesions on nose, R knee; neck +R chest lesions resolved
[13]
Per DERM, described as clinically a Keratoacanthoma
[14]
Withdrawal sys: tremulousness, fever, chills since stoppage of MS Contin
[15]
Bacteriuria as per urine culture collected per Urology Consult; negative for infection
[16]
Intermittent hemoptysis; Lovenox dose adjustment indicated-Low-molecular-weight heparin (LMWH) dose initiated
[17]
Intermittent sneezing and rhinorrhea which resolve with Tylenol
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Julius Strauss
Organization: National Cancer Institute
Phone: 240-858-3999
EMail: julius.strauss@nih.gov
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Julius Strauss, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03427411    
Other Study ID Numbers: 180056
18-C-0056
First Submitted: February 8, 2018
First Posted: February 9, 2018
Results First Submitted: December 27, 2021
Results First Posted: February 28, 2022
Last Update Posted: March 22, 2022