Trial Outcomes & Findings for CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma (NCT NCT04695977)

NCT ID: NCT04695977

Last Updated: 2025-09-05

Results Overview

ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST vl.l) as assessed by Blinded Independent Central Review (BICR)

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to approximately 39 months
• Results posted on: 2025-09-05

Participant Flow

Participant milestones

Measure	Nivolumab Monotherapy All participants received nivolumab monotherapy intravenously (IV) according to the treatment schedule.	CMP-001 and Nivolumab All participants received CMP-001 IT and nivolumab intravenously (IV) according to the treatment schedule.
Overall Study STARTED	11	9
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	11	9

Reasons for withdrawal

Measure	Nivolumab Monotherapy All participants received nivolumab monotherapy intravenously (IV) according to the treatment schedule.	CMP-001 and Nivolumab All participants received CMP-001 IT and nivolumab intravenously (IV) according to the treatment schedule.
Overall Study Sponsor Decision	9	4
Overall Study Death	2	5

Baseline Characteristics

CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma

Baseline characteristics by cohort

Measure	Nivolumab Monotherapy n=11 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=9 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.	Total n=20 Participants Total of all reporting groups
Age, Continuous	71.3 years STANDARD_DEVIATION 10.22 • n=5 Participants	66.8 years STANDARD_DEVIATION 7.14 • n=7 Participants	69.3 years STANDARD_DEVIATION 9.04 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 39 months

Population: ITT Analysis Set (includes all participants who were randomized)

ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST vl.l) as assessed by Blinded Independent Central Review (BICR)

Outcome measures

Measure	Nivolumab Monotherapy n=11 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=9 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR)	73 Percentage of participants Interval 39.03 to 93.98	44 Percentage of participants Interval 13.7 to 78.8

SECONDARY outcome

Timeframe: Up to approximately 28 months (122 weeks)

Population: Safety Analysis Set (all participants who received at least 1 dose of study treatment)

Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.

Outcome measures

Measure	Nivolumab Monotherapy n=11 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=9 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death Any TEAE	11 Participants	9 Participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death Any Serious TEAE	5 Participants	2 Participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death Any TEAE leading to death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 28 months (122 weeks)

Population: Safety Analysis Set (all participants who received at least 1 dose of study treatment)

Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living; Grade 4 Life-threatening consequences: urgent intervention indicated; Grade 5 Death related to adverse event.

Outcome measures

Measure	Nivolumab Monotherapy n=11 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=9 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 1 Mild	2 Participants	0 Participants
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 Moderate	1 Participants	6 Participants
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 Severe	8 Participants	3 Participants
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 4 Life-threatening	0 Participants	0 Participants
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 5 Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 39 months

Population: Number of participants analyzed for TTR included only participants in the ITT Analysis Set who had a confirmed best overall response (BOR) of CR or PR by BICR.

TTR, defined as the time from the date of randomization to the first time when criteria are first met for complete response (CR) or partial response (PR), whichever occurred first, per RECIST vl.1 by BICR.

Outcome measures

Measure	Nivolumab Monotherapy n=8 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=4 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Time to Response (TTR) by BICR	2.14 Months Interval 1.81 to 25.03	2.27 Months Interval 2.07 to 4.7

SECONDARY outcome

Timeframe: Up to approximately 39 months

Population: Number of participants analyzed for TTR included only participants in the ITT Analysis Set who had a confirmed BOR of CR or PR by Investigator.

TTR, defined as the time from the date of randomization to the first time when criteria are first met for CR or PR, whichever occurred first, per RECIST vl.1 by Investigator.

Outcome measures

Measure	Nivolumab Monotherapy n=9 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=5 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Time to Response (TTR) by Investigator	2.14 Months Interval 1.81 to 3.48	3.45 Months Interval 2.17 to 3.58

SECONDARY outcome

Timeframe: Up to approximately 39 months

Population: Number of participants analyzed for DOR included only participants in the ITT Analysis Set who had a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) by BICR.

DOR, defined as time from the date of first documented response (CR or PR) to the date of documented progressive disease (PD), based on RECIST vl.1 by BICR or death, whichever occurred first.

Outcome measures

Measure	Nivolumab Monotherapy n=8 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=4 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Duration of Response (DOR) by BICR	NA Months Median duration of DOR not reached; Insufficient number of participants with events for estimated lower and upper confidence interval	NA Months Interval 10.185 to Median duration of DOR not reached; Insufficient number of participants with events for estimated upper confidence interval

SECONDARY outcome

Timeframe: Up to approximately 39 months

Population: Number of participants analyzed for DOR included only participants in the ITT Analysis Set who had a confirmed BOR of CR or PR by Investigator.

DOR, defined as time from the date of first documented response (CR or PR) to the date of documented progressive disease (PD), based on RECIST vl.1 by Investigator or death, whichever occurred first.

Outcome measures

Measure	Nivolumab Monotherapy n=9 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=5 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Duration of Response (DOR) by Investigator	NA Months Interval 4.172 to Median duration of DOR not reached; Insufficient number of participants with events for estimated upper confidence interval	NA Months Interval 6.702 to Median duration of DOR not reached; Insufficient number of participants with events for estimated upper confidence interval

SECONDARY outcome

Timeframe: Up to approximately 39 months

Population: Number of participants analyzed included only participants in the ITT Analysis Set who had at least one non-injected target lesion, as assessed by Investigator, in the CMP-001 and Nivolumab reporting group, as prespecified by the protocol.

Confirmed ORR, defined as the percentage of participants in the analysis set who had confirmed BOR of CR or PR based on RECIST vl.1 as assessed by Investigator.

Outcome measures

Measure	Nivolumab Monotherapy n=9 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Confirmed ORR in Non-injected Target Lesions by Investigator	56 Percentage of participants Interval 21.2 to 86.3	—

SECONDARY outcome

Timeframe: Up to approximately 39 months

Population: ITT Analysis Set (includes all participants who were randomized)

PFS, defined as the time from the date of randomization to date of documented PD based on RECIST vl.1 by BICR or death, whichever occurred first.

Outcome measures

Measure	Nivolumab Monotherapy n=11 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=9 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Progression-free Survival (PFS) by BICR	NA Months Interval 2.07 to Median duration of PFS not reached; Insufficient number of participants with events for estimated upper confidence interval	14.85 Months Interval 1.971 to Insufficient number of participants with events for estimated upper confidence interval

SECONDARY outcome

Timeframe: Up to approximately 39 months

Population: ITT Analysis Set (includes all participants who were randomized)

PFS, defined as the time from the date of randomization to date of documented PD based on RECIST vl.1 by Investigator or death, whichever occurred first.

Outcome measures

Measure	Nivolumab Monotherapy n=11 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=9 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Progression-free Survival (PFS) by Investigator	NA Months Interval 2.103 to Median duration of PFS not reached; Insufficient number of participants with events for estimated upper confidence interval	10.25 Months Interval 1.971 to Insufficient number of participants with events for estimated upper confidence interval

SECONDARY outcome

Timeframe: Up to approximately 40 months (174 weeks)

Population: ITT Analysis Set (includes all participants who were randomized)

OS, defined as the time from the date of randomization to the date of death from any cause.

Outcome measures

Measure	Nivolumab Monotherapy n=11 Participants All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=9 Participants All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Overall Survival (OS) by Investigator	NA Months Interval 3.52 to 37.26 Median duration of OS not reached	20.04 Months Interval 13.8 to 39.89

Adverse Events

Nivolumab Monotherapy

Serious events: 5 serious events

Other events: 11 other events

Deaths: 2 deaths

CMP-001 and Nivolumab

Serious events: 2 serious events

Other events: 9 other events

Deaths: 5 deaths

Serious adverse events

Measure	Nivolumab Monotherapy n=11 participants at risk All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=9 participants at risk All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Endocrine disorders Hypophysitis	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Endocrine disorders Hypothyroidism	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations Pseudomonal skin infection	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations Sepsis	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Cardiac disorders Atrial fibrillation	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Lactic acidosis	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Respiratory, thoracic and mediastinal disorders Haemoptysis	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).

Other adverse events

Measure	Nivolumab Monotherapy n=11 participants at risk All participants received nivolumab monotherapy IV according to the treatment schedule.	CMP-001 and Nivolumab n=9 participants at risk All participants received CMP-001 IT and nivolumab IV according to the treatment schedule.
Gastrointestinal disorders Nausea	18.2% 2/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	55.6% 5/9 • Number of events 13 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Gastrointestinal disorders Vomiting	18.2% 2/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	33.3% 3/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Gastrointestinal disorders Constipation	18.2% 2/11 • Number of events 5 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Gastrointestinal disorders Diarrhoea	27.3% 3/11 • Number of events 8 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Gastrointestinal disorders Dry mouth	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Gastrointestinal disorders Gastrooesophageal reflux disease	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Gastrointestinal disorders Pancreatitis	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Gastrointestinal disorders Stomatitis	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Chills	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	66.7% 6/9 • Number of events 47 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Fatigue	45.5% 5/11 • Number of events 8 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	44.4% 4/9 • Number of events 9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Pyrexia	18.2% 2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	33.3% 3/9 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Face oedema	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Injection site erythema	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Injection site oedema	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Injection site vesicles	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Localised oedema	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Oedema peripheral	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Influenza like illness	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
General disorders Non-cardiac chest pain	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Decreased appetite	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	66.7% 6/9 • Number of events 7 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Hyponatraemia	18.2% 2/11 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	33.3% 3/9 • Number of events 5 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Hypomagnesaemia	27.3% 3/11 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 5 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Hypophosphataemia	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Polydipsia	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Hypoglycaemia	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Hypokalaemia	36.4% 4/11 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Lactic acidosis	9.1% 1/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Metabolism and nutrition disorders Obesity	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Pruritus	18.2% 2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	44.4% 4/9 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Rash maculo-papular	27.3% 3/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	44.4% 4/9 • Number of events 7 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Achromotrichia acquired	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Rash	27.3% 3/11 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Skin and subcutaneous tissue disorders Vitiligo	9.1% 1/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Blood creatinine increased	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	33.3% 3/9 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Lipase increased	18.2% 2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	33.3% 3/9 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Weight decreased	18.2% 2/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Activated partial thromboplastin time prolonged	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Activated partial thromboplastin time shortened	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Amylase increased	18.2% 2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Aspartate aminotransferase increased	9.1% 1/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Blood lactate dehydrogenase increased	18.2% 2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Blood prolactin abnormal	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Blood thyroid stimulating hormone decreased	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Blood thyroid stimulating hormone increased	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations International normalised ratio increased	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Platelet count decreased	9.1% 1/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations White blood cell count increased	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Blood alkaline phosphatase increased	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Blood pressure increased	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations Lymphocyte count decreased	27.3% 3/11 • Number of events 11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Investigations White blood cell count decreased	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Musculoskeletal and connective tissue disorders Groin pain	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Musculoskeletal and connective tissue disorders Muscular weakness	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Vascular disorders Hypertension	18.2% 2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	33.3% 3/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Vascular disorders Embolism	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Vascular disorders Lymphoedema	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Vascular disorders Hot flush	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Vascular disorders Hypotension	27.3% 3/11 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations Enterococcal infection	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations Fungal infection	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations Pneumonia	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations Skin infection	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations Upper respiratory tract infection	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations COVID-19	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations COVID-19 pneumonia	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations Cellulitis	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations Enterocolitis infectious	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Infections and infestations Urinary tract infection	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Nervous system disorders Headache	18.2% 2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Nervous system disorders Dysgeusia	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Nervous system disorders Paraesthesia	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Nervous system disorders Restless legs syndrome	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Nervous system disorders Tremor	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Nervous system disorders Aphasia	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Nervous system disorders Dizziness	18.2% 2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Nervous system disorders Lethargy	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Injury, poisoning and procedural complications Fall	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Injury, poisoning and procedural complications Procedural pain	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Renal and urinary disorders Chronic kidney disease	9.1% 1/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Renal and urinary disorders Glycosuria	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Renal and urinary disorders Haematuria	18.2% 2/11 • Number of events 6 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Renal and urinary disorders Pollakiuria	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Renal and urinary disorders Proteinuria	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Renal and urinary disorders Urinary tract obstruction	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Blood and lymphatic system disorders Anaemia	27.3% 3/11 • Number of events 5 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.2% 2/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	22.2% 2/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Respiratory, thoracic and mediastinal disorders Cough	27.3% 3/11 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Respiratory, thoracic and mediastinal disorders Hypoxia	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Cardiac disorders Sinus bradycardia	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Cardiac disorders Bradycardia	9.1% 1/11 • Number of events 2 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Cardiac disorders Palpitations	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Cardiac disorders Sinus tachycardia	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Cardiac disorders Tachycardia	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Ear and labyrinth disorders Vertigo	0.00% 0/11 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Ear and labyrinth disorders Deafness	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Ear and labyrinth disorders Tinnitus	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Psychiatric disorders Anxiety	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	11.1% 1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Endocrine disorders Adrenal insufficiency	27.3% 3/11 • Number of events 4 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Endocrine disorders Hyperthyroidism	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Endocrine disorders Hypothyroidism	18.2% 2/11 • Number of events 5 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).
Reproductive system and breast disorders Genital rash	9.1% 1/11 • Number of events 1 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).	0.00% 0/9 • From signing of informed consent through end of study up to approximately 40 months (174 weeks).

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: clinicaltrials@regeneron.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER