Trial Outcomes & Findings for Durvalumab, Tremelimumab and Hypofractionated Radiation Therapy in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (NCT NCT03522584)
NCT ID: NCT03522584
Last Updated: 2023-06-12
Results Overview
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
From the start of study treatment up to 3 months after last study treatment, up to 38 months
Results posted on
2023-06-12
Participant Flow
Participant milestones
| Measure |
Treatment (Tremelimumab, Durvalumab, HIGRT, SBRT)
Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1, week 1. Treatment repeats every 4 weeks for up to 4 cycles or every 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes on day 1, week 16. Treatment repeats every 4 weeks for up to 9 cycles or every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo hypofractionated radiation therapy using either HIGRT or SBRT over 3 fractions QOD during week 3.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
Hypofractionated Image-Guided Radiation Therapy: Undergo HIGRT
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Durvalumab, Tremelimumab and Hypofractionated Radiation Therapy in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Treatment (Tremelimumab, Durvalumab, HIGRT, SBRT)
n=6 Participants
Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1, week 1. Treatment repeats every 4 weeks for up to 4 cycles or every 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes on day 1, week 16. Treatment repeats every 4 weeks for up to 9 cycles or every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo hypofractionated radiation therapy using either HIGRT or SBRT over 3 fractions QOD during week 3.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
Hypofractionated Image-Guided Radiation Therapy: Undergo HIGRT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of study treatment up to 3 months after last study treatment, up to 38 monthsToxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Treatment (Tremelimumab, Durvalumab, HIGRT, SBRT)
n=6 Participants
Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1, week 1. Treatment repeats every 4 weeks for up to 4 cycles or every 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes on day 1, week 16. Treatment repeats every 4 weeks for up to 9 cycles or every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo hypofractionated radiation therapy using either HIGRT or SBRT over 3 fractions QOD during week 3.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
Hypofractionated Image-Guided Radiation Therapy: Undergo HIGRT
|
|---|---|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Anorexia
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Concentration Impairment
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Cough
|
2 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Depression
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Diarrhea
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Dizziness
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Dry Mouth
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Fatigue
|
4 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Fever
|
2 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Headache
|
2 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Hypercalcemia
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Hyperalbuminemia
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Increased Dyspnea
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Non-Cardiac Chest Pain
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Infusion Related Reaction
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Mucositis
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Nausea
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Neck Pain
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Night Sweats
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Otitis Externa
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Pruritus
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Right Shoulder Pain
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Maculopapular Rash
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Rhinorrhea
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Shingles
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Sore Throat
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Weight Loss
|
3 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Wheezing
|
1 Participants
|
|
Number of Patients With Adverse Effects Graded According to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
Oral Thrush
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Tremelimumab, Durvalumab, HIGRT, SBRT)
n=5 Participants
Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1, week 1. Treatment repeats every 4 weeks for up to 4 cycles or every 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes on day 1, week 16. Treatment repeats every 4 weeks for up to 9 cycles or every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo hypofractionated radiation therapy using either HIGRT or SBRT over 3 fractions QOD during week 3.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
Hypofractionated Image-Guided Radiation Therapy: Undergo HIGRT
|
|---|---|
|
Response Rate
Stable Disease
|
3 Participants
|
|
Response Rate
Progressive Disease
|
1 Participants
|
|
Response Rate
Complete Response
|
1 Participants
|
SECONDARY outcome
Timeframe: From the date of study enrollment for up to 2 yearsSurvival estimates will be calculated using the Kaplan-Meier method. Progression free survival is measured in months. PFS is defined as the amount of time between treatment initiation and when the disease progresses per RECIST 1.1 criteria
Outcome measures
| Measure |
Treatment (Tremelimumab, Durvalumab, HIGRT, SBRT)
n=6 Participants
Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1, week 1. Treatment repeats every 4 weeks for up to 4 cycles or every 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes on day 1, week 16. Treatment repeats every 4 weeks for up to 9 cycles or every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo hypofractionated radiation therapy using either HIGRT or SBRT over 3 fractions QOD during week 3.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
Hypofractionated Image-Guided Radiation Therapy: Undergo HIGRT
|
|---|---|
|
Progression-free Survival
|
7 months
Standard Deviation 2
|
SECONDARY outcome
Timeframe: From the date of study enrollment for up to 2 yearsSurvival estimates will be calculated using the Kaplan-Meier method. Overall survival is measured in months. OS is defined as the amount of time between treatment initiation and when the patient is deceased.
Outcome measures
| Measure |
Treatment (Tremelimumab, Durvalumab, HIGRT, SBRT)
n=6 Participants
Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1, week 1. Treatment repeats every 4 weeks for up to 4 cycles or every 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes on day 1, week 16. Treatment repeats every 4 weeks for up to 9 cycles or every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo hypofractionated radiation therapy using either HIGRT or SBRT over 3 fractions QOD during week 3.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
Hypofractionated Image-Guided Radiation Therapy: Undergo HIGRT
|
|---|---|
|
Overall Survival
|
8 months
Interval 4.0 to 14.0
|
Adverse Events
Treatment (Tremelimumab, Durvalumab, HIGRT, SBRT)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Tremelimumab, Durvalumab, HIGRT, SBRT)
n=6 participants at risk
Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1, week 1. Treatment repeats every 4 weeks for up to 4 cycles or every 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes on day 1, week 16. Treatment repeats every 4 weeks for up to 9 cycles or every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo hypofractionated radiation therapy using either HIGRT or SBRT over 3 fractions QOD during week 3.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Stereotactic Body Radiation Therapy: Undergo SBRT
Tremelimumab: Given IV
Hypofractionated Image-Guided Radiation Therapy: Undergo HIGRT
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Nervous system disorders
Concentration Impairment
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 3 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Nervous system disorders
Depression
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 2 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Metabolism and nutrition disorders
Dry Mouth
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Infections and infestations
Fever
|
33.3%
2/6 • Number of events 2 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
General disorders
Headache
|
33.3%
2/6 • Number of events 2 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Endocrine disorders
Hypercalcemia
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Endocrine disorders
Hyperalbuminemia
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Respiratory, thoracic and mediastinal disorders
Increased Dyspnea
|
16.7%
1/6 • Number of events 2 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Musculoskeletal and connective tissue disorders
Non-Cardiac Chest Pain
|
16.7%
1/6 • Number of events 2 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Gastrointestinal disorders
Mucositis
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Musculoskeletal and connective tissue disorders
Otitis Externa
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 2 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Musculoskeletal and connective tissue disorders
Right Shoulder Pain
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Infections and infestations
Shingles
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Metabolism and nutrition disorders
Weight Loss
|
50.0%
3/6 • Number of events 3 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
Infections and infestations
Oral Thrush
|
16.7%
1/6 • Number of events 1 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 4 • 3 years, 2 months
Adverse events and serious adverse events will be recorded from time of administration of the first dose of investigational drug, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + tremelimumab).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place