Trial Outcomes & Findings for A Study of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Advanced Melanoma (NCT NCT03711188)

NCT ID: NCT03711188

Last Updated: 2024-04-29

Results Overview

Incidence, frequency and severity of treatment emergent adverse events (TEAEs) throughout the study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

From the point of Informed Consent until end of the study assessment (up to 84 weeks) or until withdrawal from the study.

Results posted on

2024-04-29

Participant Flow

Twenty-two patients at 2 centres were consented and screened. Six patients failed to meet one or more of the specific inclusion criteria or met one or more exclusion criteria and were deemed screen failures.

Participant milestones

Participant milestones
Measure	IMM-101 (and Nivolumab or Ipilimumab) Patients in cohort A were given IMM-101 in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab. Nivolumab: Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information. Ipilimumab: Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information. IMM-101: A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Overall Study STARTED	16
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	IMM-101 (and Nivolumab or Ipilimumab) Patients in cohort A were given IMM-101 in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab. Nivolumab: Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information. Ipilimumab: Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information. IMM-101: A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Overall Study Disease progression	11
Overall Study Adverse Event	1

Baseline Characteristics

PDL-1 status was only determined in Cohort A patients (n=11) thus the Row population differs from the Overall population (n=16).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMM-101 (and Nivolumab or Ipilimumab) n=16 Participants Patients in cohort A were given IMM-101 in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab. Nivolumab: Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information. Ipilimumab: Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information. IMM-101: A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
Age, Categorical <=18 years	0 Participants n=16 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=16 Participants
Age, Categorical >=65 years	10 Participants n=16 Participants
Age, Continuous	68.5 years n=16 Participants
Sex: Female, Male Female	5 Participants n=16 Participants
Sex: Female, Male Male	11 Participants n=16 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=16 Participants
Race (NIH/OMB) Asian	0 Participants n=16 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants
Race (NIH/OMB) Black or African American	0 Participants n=16 Participants
Race (NIH/OMB) White	15 Participants n=16 Participants
Race (NIH/OMB) More than one race	0 Participants n=16 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=16 Participants
Region of Enrollment United Kingdom	16 participants n=16 Participants
PD-L1 status in Cohort A patients only PD-L1 Positive	6 participants n=11 Participants • PDL-1 status was only determined in Cohort A patients (n=11) thus the Row population differs from the Overall population (n=16).
PD-L1 status in Cohort A patients only PD-L1 Negative or Indeterminate	4 participants n=11 Participants • PDL-1 status was only determined in Cohort A patients (n=11) thus the Row population differs from the Overall population (n=16).
PD-L1 status in Cohort A patients only PD_L1 status Not Assessed or Unknown	1 participants n=11 Participants • PDL-1 status was only determined in Cohort A patients (n=11) thus the Row population differs from the Overall population (n=16).

PRIMARY outcome

Timeframe: From the point of Informed Consent until end of the study assessment (up to 84 weeks) or until withdrawal from the study.

Population: The Safety Analysis Set (SAF) included all patients who received at least one dose of IMM-101, irrespective of compliance with eligibility and other protocol criteria.

Incidence, frequency and severity of treatment emergent adverse events (TEAEs) throughout the study.

Outcome measures

Outcome measures
Measure	IMM-101 (and Nivolumab or Ipilimumab) n=16 Participants Patients in cohort A were given IMM-101 in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab. Nivolumab: Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information. Ipilimumab: Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information. IMM-101: A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.	Cohort B Patients in cohort B were either currently on (or had previously received) treatment with an anti-PD-1 therapy (monotherapy or in combination) for advanced melanoma and had progressive disease by RECIST 1.1 after at least 3 doses of anti-PD-1 given as monotherapy or at least 2 doses of anti-PD-1 given in combination regimes and had not received any therapy since for advanced melanoma.
Safety and Tolerability of the Combination of IMM-101 + Nivolumab Treatment emergent adverse events (TEAEs)	16 Participants	—
Safety and Tolerability of the Combination of IMM-101 + Nivolumab Treatment-related TEAEs	14 Participants	—
Safety and Tolerability of the Combination of IMM-101 + Nivolumab Serious TEAEs	6 Participants	—
Safety and Tolerability of the Combination of IMM-101 + Nivolumab Immune relared TEAEs	14 Participants	—
Safety and Tolerability of the Combination of IMM-101 + Nivolumab TEAEs leading to discontinuation of IMM-101	3 Participants	—
Safety and Tolerability of the Combination of IMM-101 + Nivolumab TEAEs leading to withdrawal	1 Participants	—
Safety and Tolerability of the Combination of IMM-101 + Nivolumab TEAEs leading to death	0 Participants	—

PRIMARY outcome

Timeframe: From enrollment to end of study (18 months) or withdrawal, whichever was soonest

Population: Intent-to-treat

The primary endpoint of Overall Response Rate (ORR) is defined as the number of subjects with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of subjects in the Intent-to-treat analysis set in each cohort of the study. The BOR will be determined once all the data up to and including the 12-month assessments for Cohort A or the 6-month assessment for Cohort B are available. It is defined as the best response designation based on confirmed responses determined by the investigator according to RECIST 1.1, recorded between the date of first postscreening scan and the date of last scan at/prior to the assessment at the 12-month assessment (Cohort A) and 6-month assessment/last assessment prior to change of treatment to IMM-101 + ipilimumab whichever is sooner (Cohort B).

Outcome measures

Outcome measures
Measure	IMM-101 (and Nivolumab or Ipilimumab) n=11 Participants Patients in cohort A were given IMM-101 in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab. Nivolumab: Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information. Ipilimumab: Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information. IMM-101: A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.	Cohort B n=5 Participants Patients in cohort B were either currently on (or had previously received) treatment with an anti-PD-1 therapy (monotherapy or in combination) for advanced melanoma and had progressive disease by RECIST 1.1 after at least 3 doses of anti-PD-1 given as monotherapy or at least 2 doses of anti-PD-1 given in combination regimes and had not received any therapy since for advanced melanoma.
Overall Response Rate	8 Participants	0 Participants

SECONDARY outcome

Timeframe: 18 months

Population: Intent to treat population - all patients who received at least one dose of IMM-101

Best Overall Response (BOR) is defined as the best response (complete or partial response, stable disease or progressive disease) designation based on confirmed responses determined by the investigator according to RECIST 1.1, recorded between the date of first postscreening scan and the date of last scan at/prior to the assessment at the 12-month assessment (Cohort A) and 6-month assessment/last assessment prior to change of treatment to IMM-101 + ipilimumab whichever is sooner (Cohort B).) Patients in cohort B who changed therapy without documented progression were censored at their last scan assessment prior to the change of therapy.

Outcome measures

Outcome measures
Measure	IMM-101 (and Nivolumab or Ipilimumab) n=11 Participants Patients in cohort A were given IMM-101 in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab. Nivolumab: Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information. Ipilimumab: Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information. IMM-101: A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.	Cohort B n=5 Participants Patients in cohort B were either currently on (or had previously received) treatment with an anti-PD-1 therapy (monotherapy or in combination) for advanced melanoma and had progressive disease by RECIST 1.1 after at least 3 doses of anti-PD-1 given as monotherapy or at least 2 doses of anti-PD-1 given in combination regimes and had not received any therapy since for advanced melanoma.
Best Overall Response (BOR) Using RECIST 1.1 Complete Response (CR)	2 Participants	0 Participants
Best Overall Response (BOR) Using RECIST 1.1 Partial Response (PR)	6 Participants	0 Participants
Best Overall Response (BOR) Using RECIST 1.1 Stable Disease	1 Participants	0 Participants
Best Overall Response (BOR) Using RECIST 1.1 Disease Progression	2 Participants	5 Participants

SECONDARY outcome

Timeframe: From Visit 1 (week 0) and the first confirmation of progression using RECIST 1.1 (confirmed or unconfirmed), or death from any cause (whichever occurred first).

Population: Intent-to-treat

Progression-free survival was defined as the time from Visit 1 (week 0) to the first confirmation of progression using RECIST 1.1 (confirmed or unconfirmed), or death from any cause (whichever occurred first). Progression was determined by the investigator using the CT or MRI scan or death due to any cause. Patients who died without reporting progression were considered to have progressed on the date of their death. Progression is defined by RECIST 1.1 guidelines as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	IMM-101 (and Nivolumab or Ipilimumab) n=11 Participants Patients in cohort A were given IMM-101 in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab. Nivolumab: Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information. Ipilimumab: Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information. IMM-101: A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.	Cohort B n=5 Participants Patients in cohort B were either currently on (or had previously received) treatment with an anti-PD-1 therapy (monotherapy or in combination) for advanced melanoma and had progressive disease by RECIST 1.1 after at least 3 doses of anti-PD-1 given as monotherapy or at least 2 doses of anti-PD-1 given in combination regimes and had not received any therapy since for advanced melanoma.
Progression Free Survival (PFS) Less than or equal to 3 months	2 Participants	4 Participants
Progression Free Survival (PFS) >3 months but < or = to 6 months	1 Participants	1 Participants
Progression Free Survival (PFS) >6 months but < or = to 9 months	3 Participants	0 Participants
Progression Free Survival (PFS) >9 months but < or = to 12 months	1 Participants	0 Participants
Progression Free Survival (PFS) >12 months but < or = to 18 months	0 Participants	0 Participants
Progression Free Survival (PFS) .18 months	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Overall survival was defined as the time from Visit 1 (week 0) until the end of the study (80 weeks) or until the date of death from any cause.

Population: Intent-to-treat

Overall survival was defined as the time from Visit 1 (week 0) until date of death from any cause. OS was calculated for the entire study duration, where patients without a death date were right censored at the date the patient was last known to be alive. Post-study survival information was collected until database lock, for subjects completing or withdrawing from the study and included in the analysis.

Outcome measures

Outcome measures
Measure	IMM-101 (and Nivolumab or Ipilimumab) n=11 Participants Patients in cohort A were given IMM-101 in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab. Nivolumab: Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information. Ipilimumab: Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information. IMM-101: A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.	Cohort B n=5 Participants Patients in cohort B were either currently on (or had previously received) treatment with an anti-PD-1 therapy (monotherapy or in combination) for advanced melanoma and had progressive disease by RECIST 1.1 after at least 3 doses of anti-PD-1 given as monotherapy or at least 2 doses of anti-PD-1 given in combination regimes and had not received any therapy since for advanced melanoma.
Overall Survival (OS) < or = to 3 months	1 Participants	0 Participants
Overall Survival (OS) >3 months but < or = to 6 months	0 Participants	0 Participants
Overall Survival (OS) >6 months but < or = to 9 months	1 Participants	2 Participants
Overall Survival (OS) >9 months but < or = to 12 months	0 Participants	2 Participants
Overall Survival (OS) >12 months but < or = to 18 months	0 Participants	1 Participants
Overall Survival (OS) >18 months	9 Participants	0 Participants

SECONDARY outcome

Timeframe: OS at 1 year was calculated after all patients had had the opportunity of 12 months treatment of study

Population: Intent-to-treat

Number of patients surviving at leat 12 months

Outcome measures

Outcome measures
Measure	IMM-101 (and Nivolumab or Ipilimumab) n=11 Participants Patients in cohort A were given IMM-101 in combination with nivolumab. Patients in cohort B who fail to respond to treatment with IMM-101 and nivolumab, and who meet certain criteria, have the option to change treatment on study to IMM-101 and ipilimumab. Nivolumab: Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information. Ipilimumab: Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information. IMM-101: A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.	Cohort B n=5 Participants Patients in cohort B were either currently on (or had previously received) treatment with an anti-PD-1 therapy (monotherapy or in combination) for advanced melanoma and had progressive disease by RECIST 1.1 after at least 3 doses of anti-PD-1 given as monotherapy or at least 2 doses of anti-PD-1 given in combination regimes and had not received any therapy since for advanced melanoma.
Overall Survival (OS) at One Year	9 Participants	1 Participants

Adverse Events

IMM-101 and Nivolumab

Serious events: 12 serious events

Other events: 16 other events

Deaths: 8 deaths

IMM-101 and Ipilimumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	IMM-101 and Nivolumab n=16 participants at risk * Patients in Cohort A were initially treated with IMM-101 and nivolumab. * Patients in Cohort B were initially treated with IMM-101 + nivolumab and when they failed to respond to nivolumab they had the option to switch treatment. Nivolumab was administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information.	IMM-101 and Ipilimumab n=1 participants at risk • Patients from Cohort B who failed to respond to nivolumab and met certain criteria had the option to switch to ipilimumab. Ipilimumab, when used as subsequent treatment for patients in Cohort B, was administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information.
Cardiac disorders Atrioventricular block	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
Respiratory, thoracic and mediastinal disorders Pneumonia	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
Blood and lymphatic system disorders Epistaxis	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
General disorders Pyrexia	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
General disorders Chills	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
General disorders Fatigue	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
General disorders Lethargy	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
General disorders Pain	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
Gastrointestinal disorders Dysphagia	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	100.0% 1/1 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
Musculoskeletal and connective tissue disorders Wrist fracture	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
Musculoskeletal and connective tissue disorders Spinal cord compression	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).
Endocrine disorders Cortisol deficiency	6.2% 1/16 • Number of events 1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).	0.00% 0/1 • All adverse events (AEs) were recorded on the patient's electronic case report form (eCRF) from the time of informed consent until the end of study (18 months later) . All AEs were followed until resolution, death, or 30 days after the last administration of study treatment (whichever came first). Incidence, frequency and severity of treatment-emergent adverse events (TEAEs; all TEAEs, serious adverse events (SAEs), treatment-related TEAEs, immune-related AEs, and TEAEs leading to IMM-101 discontinuation or study withdrawal).

Other adverse events

Additional Information

Clinical Trial Information Desk,

Immodulon Therapeutics Ltd

Phone: 0044 0203137 6346

Email: [email protected]

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Principal investigator is a sponsor employee
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