Trial Outcomes & Findings for A Long Term Follow up Study for Patients Who Previously Took Part in the Phase I Study IMM-101-001 (NCT NCT01559818)
NCT ID: NCT01559818
Last Updated: 2023-06-22
Results Overview
Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities. Treatment related Adverse Events were defined as being definitely, probably or possibly related to IMM-101 or with an unknown relationship.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
IMM-101
IMM-101 1.0 mg administered intradermally
IMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
IMM-101
IMM-101 1.0 mg administered intradermally
IMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Study terminated by Sponsor
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Long Term Follow up Study for Patients Who Previously Took Part in the Phase I Study IMM-101-001
Baseline characteristics by cohort
| Measure |
IMM-101
n=10 Participants
IMM-101 1.0 mg I.D.
IMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).Population: Safety population = all enrolled patients
Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities. Treatment related Adverse Events were defined as being definitely, probably or possibly related to IMM-101 or with an unknown relationship.
Outcome measures
| Measure |
IMM-101
n=10 Participants
IMM-101 1.0 mg I.D.
IMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
|
|---|---|
|
Adverse Events With a Causal Relationship to IMM-101
|
27 Events
|
PRIMARY outcome
Timeframe: From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).Population: Safety population = all enrolled patients
Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities
Outcome measures
| Measure |
IMM-101
n=10 Participants
IMM-101 1.0 mg I.D.
IMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
|
|---|---|
|
Treatment Emergent Adverse Events of NCI CTCAE ≥Grade 3
|
16 Events
|
PRIMARY outcome
Timeframe: From the time of signing informed consent until 30 days after the end of study or withdrawal, a median of 4.4 years (range 1.2 to 6.7).Population: Safety population = all enrolled patients
Adverse events measured throughout the study and assessed for severity using NCI CTCAE and causality to measure the profile and number of local and systemic toxicities. There were no IMM-101 related serious adverse events reported during the study.
Outcome measures
| Measure |
IMM-101
n=10 Participants
IMM-101 1.0 mg I.D.
IMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
|
|---|---|
|
Treatment Emergent Serious Adverse Events
|
3 Events
|
SECONDARY outcome
Timeframe: Overall survival was defined as the time from enrolment until date of death for up to 81 months. Patients still alive after 81 months were censored at withdrawal from the study or at last known date alive if later.Population: There was only one analysis population in the study. Safety, tolerability and efficacy endpoints were summarised using the safety population, defined as all patients who received at least one dose of the study treatment
Overall survival
Outcome measures
| Measure |
IMM-101
n=10 Participants
IMM-101 1.0 mg I.D.
IMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
|
|---|---|
|
Survival
Died
|
3 Participants
|
|
Survival
Censored
|
1 Participants
|
|
Survival
Alive
|
6 Participants
|
SECONDARY outcome
Timeframe: From Informed Consent to death or withdrawal (median 4.4 years, range 1.2 - 6.7)Population: All enrolled patients
The protocol required any change in metastatic disease to be documented where possible. However, given this was a real-life long-term follow-up study, CT or MRI scans were not mandated as part of the protocol and were only performed as clinically indicated. Very few scans were performed during the course of the study (0 to nine events per patient). Given the fact patients could receive anti-cancer therapy on study, disease status fluctuated throughout the study (better, worse, no change). This coupled with the sparsity of CT or MRI scan data collected on a per patient basis resulted in only Best Overall Response being described.
Outcome measures
| Measure |
IMM-101
n=10 Participants
IMM-101 1.0 mg I.D.
IMM-101: IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
|
|---|---|
|
Incidence of Change in Metastatic Disease
Best Overall Response = Not known
|
1 participants
|
|
Incidence of Change in Metastatic Disease
Best overall response = Improved
|
4 participants
|
|
Incidence of Change in Metastatic Disease
Best Overall Response = No Change / Stable Disease
|
4 participants
|
|
Incidence of Change in Metastatic Disease
Best Overall Response = Disease worsening
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to death or withdrawalPopulation: Extensive translational research on serum samples from other studies with IMM-101 failed to identify any clinically significant impact on relevant immunological markers or mediators. Therefore no analysis was perform on the samples from this study.
Blood samples were collected and sera prepared for analysis of immunological markers and mediators. Exploratory endpoints may include a change in one or more markers of immune status based on cellular involvement, function or cytokine/immune mediator production such as, for example, cytokines and antibodies, or any other clinically or immunologically relevant assays.
Outcome measures
Outcome data not reported
Adverse Events
IMM-101
Serious events: 2 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
IMM-101
n=10 participants at risk
IMM-101 1.0 mg I.D.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
Other adverse events
| Measure |
IMM-101
n=10 participants at risk
IMM-101 1.0 mg I.D.
|
|---|---|
|
General disorders
Injection site reaction
|
60.0%
6/10 • Number of events 12 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
General disorders
Injection site pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
General disorders
Influenza like illness
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
General disorders
Injection site ulcer
|
10.0%
1/10 • Number of events 3 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
General disorders
Injection site erythema
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
General disorders
Injection site infection
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
General disorders
Injection site necrosis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
General disorders
Injection site swelling
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
General disorders
Peripheral swelling
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
Nervous system disorders
Night sweats
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the time of informed consent until study completion (median 4.4 years, range 1.2 - 6.7)
Adverse events (including those reported spontaneously by the patient, observed by the Investigator or elicited using non-leading questions) were collected from the time of signing informed consent until 30 days after the end of study or withdrawal. Adverse event information could be obtained during study visits or by telephone contact with the patient between visits.
|
Additional Information
Chief Medical Officer
Immodulon Therapeutics Ltd
Phone: +44 (0)20 3137 6346
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place