Trial Outcomes & Findings for Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma (NCT NCT03304639)
NCT ID: NCT03304639
Last Updated: 2025-11-12
Results Overview
Will compare PFS in non-radiated lesion(s) of patients receiving either (a) stereotactic body radiation therapy (SBRT) + pembrolizumab compared to (b) pembrolizumab alone in patients with advanced Merkel cell carcinoma. Kaplan- Meier curves will be constructed and median PFS times will be calculated for each arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
From randomization to either disease progression or death (without progression), assessed up to 3 years
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
Group I (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\>
\> Pembrolizumab: Given IV
|
Group II (Pembrolizumab, SBRT)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.\> \> Pembrolizumab: Given IV\>
\> Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Group I (Pembrolizumab)
n=4 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\>
\> Pembrolizumab: Given IV
|
Group II (Pembrolizumab, SBRT)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.\> \> Pembrolizumab: Given IV\>
\> Stereotactic Body Radiation Therapy: Undergo SBRT
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.0 years
STANDARD_DEVIATION 9.7 • n=10 Participants
|
69.0 years
STANDARD_DEVIATION 9.2 • n=10 Participants
|
72.1 years
STANDARD_DEVIATION 9.5 • n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: From randomization to either disease progression or death (without progression), assessed up to 3 yearsWill compare PFS in non-radiated lesion(s) of patients receiving either (a) stereotactic body radiation therapy (SBRT) + pembrolizumab compared to (b) pembrolizumab alone in patients with advanced Merkel cell carcinoma. Kaplan- Meier curves will be constructed and median PFS times will be calculated for each arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Group I (Pembrolizumab)
n=4 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Pembrolizumab: Given IV
|
Group II (Pembrolizumab, SBRT)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.
\>
\> Pembrolizumab: Given IV
\>
\> Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|
|
Progression-free Survival (PFS)
|
7.5 months
Interval 1.6 to
Insufficient number of participants with events
|
5.5 months
Interval 3.7 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization to either evidence of disease progression or death (without evidence of progression), assessed up to 3 yearsSame as the primary endpoint, but includes both irradiated and non-radiated lesions. It is a time to event endpoint and will be evaluated using the Kaplan- Meier method. Median PFS times will be calculated for each arm and a cox proportional hazards model will be constructed to determine if there is a PFS benefit for patients receiving SBRT + pembrolizumab compared to pembrolizumab alone.
Outcome measures
| Measure |
Group I (Pembrolizumab)
n=4 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Pembrolizumab: Given IV
|
Group II (Pembrolizumab, SBRT)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.
\>
\> Pembrolizumab: Given IV
\>
\> Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|
|
PFS Among All Response Evaluation Criteria in Solid Tumors Lesions
|
7.5 months
Interval 1.6 to
Insufficient number of participants with events
|
NA months
Interval 5.5 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 3 yearsDefined as partial response (PR) on 2 consecutive evaluations. Response rates will be calculated and compared across treatment arms utilizing a chi-square test.
Outcome measures
| Measure |
Group I (Pembrolizumab)
n=4 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Pembrolizumab: Given IV
|
Group II (Pembrolizumab, SBRT)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.
\>
\> Pembrolizumab: Given IV
\>
\> Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|
|
Overall Response Rate
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 6 monthsThe rates of success will be calculated and compared across treatment arms utilizing a chi-square test.
Outcome measures
| Measure |
Group I (Pembrolizumab)
n=4 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Pembrolizumab: Given IV
|
Group II (Pembrolizumab, SBRT)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.
\>
\> Pembrolizumab: Given IV
\>
\> Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|
|
Progression-free Survival
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsGraded according to National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0. Maximum grade adverse events will be summarized by treatment arm in a tabular setting.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Group I did not receive radiation per protocol.
The protocol irradiated tumors are considered to be controlled if they have no evidence of progression. No evidence of progression is defined as complete response, PR, or stable disease. Local control of the protocol-irradiated tumor will be described using the Kaplan-Meier technique.
Outcome measures
| Measure |
Group I (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Pembrolizumab: Given IV
|
Group II (Pembrolizumab, SBRT)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.
\>
\> Pembrolizumab: Given IV
\>
\> Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|
|
PFS for Lesions Chosen for Radiation Prior to Randomization
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Group I did not receive radiation per protocol.
Radiation doses will be summarized descriptively and compared to the planned dose.
Outcome measures
| Measure |
Group I (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
\>
\> Pembrolizumab: Given IV
|
Group II (Pembrolizumab, SBRT)
n=5 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.
\>
\> Pembrolizumab: Given IV
\>
\> Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|
|
Delivered Radiation Dose Using Cone-beam Computed Tomography (CT) Images
Planned Dose Cycle 1
|
—
|
24 cGY
Interval 8.0 to 24.0
|
|
Delivered Radiation Dose Using Cone-beam Computed Tomography (CT) Images
Actual Dose Cycle 1
|
—
|
24 cGY
Interval 8.0 to 24.0
|
|
Delivered Radiation Dose Using Cone-beam Computed Tomography (CT) Images
Planned Dose Cycle 2
|
—
|
16 cGY
Interval 8.0 to 24.0
|
|
Delivered Radiation Dose Using Cone-beam Computed Tomography (CT) Images
Actual Dose Cycle 2
|
—
|
16 cGY
Interval 8.0 to 24.0
|
Adverse Events
Group I (Pembrolizumab)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group II (Pembrolizumab, SBRT)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group I (Pembrolizumab)
n=4 participants at risk
Pembrolizumab: Given IV
|
Group II (Pembrolizumab, SBRT)
n=5 participants at risk
Stereotactic Body Radiation Therapy: Undergo SBRT
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 28 • Up to 5 years
|
20.0%
1/5 • Number of events 33 • Up to 5 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 4 • Up to 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • Number of events 22 • Up to 5 years
|
20.0%
1/5 • Number of events 8 • Up to 5 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 4 • Up to 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 4 • Up to 5 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 8 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
80.0%
4/5 • Number of events 27 • Up to 5 years
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
40.0%
2/5 • Number of events 23 • Up to 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 7 • Up to 5 years
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
40.0%
2/5 • Number of events 28 • Up to 5 years
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
40.0%
2/5 • Number of events 59 • Up to 5 years
|
|
General disorders
Fever
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 35 • Up to 5 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 14 • Up to 5 years
|
|
General disorders
Generalized edema
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
General disorders
Pain
|
0.00%
0/4 • Up to 5 years
|
60.0%
3/5 • Number of events 5 • Up to 5 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 4 • Up to 5 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 9 • Up to 5 years
|
40.0%
2/5 • Number of events 2 • Up to 5 years
|
|
Investigations
Creatinine increased
|
50.0%
2/4 • Number of events 2 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 3 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Investigations
Weight loss
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
2/4 • Number of events 2 • Up to 5 years
|
40.0%
2/5 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 21 • Up to 5 years
|
20.0%
1/5 • Number of events 4 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 5 • Up to 5 years
|
40.0%
2/5 • Number of events 3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 6 • Up to 5 years
|
20.0%
1/5 • Number of events 4 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 35 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 35 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/4 • Up to 5 years
|
40.0%
2/5 • Number of events 11 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 19 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 5 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
2/4 • Number of events 3 • Up to 5 years
|
40.0%
2/5 • Number of events 37 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • Number of events 2 • Up to 5 years
|
20.0%
1/5 • Number of events 14 • Up to 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 12 • Up to 5 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 12 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 14 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 3 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 2 • Up to 5 years
|
0.00%
0/5 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Up to 5 years
|
60.0%
3/5 • Number of events 22 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Up to 5 years
|
40.0%
2/5 • Number of events 5 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 3 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • Up to 5 years
|
20.0%
1/5 • Number of events 30 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/4 • Up to 5 years
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60