Trial Outcomes & Findings for Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer (NCT NCT03009058)

Last Updated: 2024-11-25

Results Overview

Safety and tolerability will be measured by incidence and severity of adverse events (AEs), Laboratory abnormalities and local injection site reactions.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months.

Results posted on

2024-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	IMM-101 in Combination With Anti PDL1 in Melanoma Patients diagnosed with metastatic melanoma who were receiving an anti-programmed death (PD)-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	IMM-101 in Combination With Anti PDL1 in Melanoma Patients diagnosed with metastatic melanoma who were receiving an anti-programmed death (PD)-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.
Overall Study Study terminated soon after initiation for commercial reasons	2

Baseline Characteristics

Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMM-101 in Combination With Anti PDL1 in Melanoma n=2 Participants Patients diagnosed with metastatic melanoma who were receiving an anti-programmed death-1 (PD-1) agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 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	2 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	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months.

Population: Both patients were assessed

Safety and tolerability will be measured by incidence and severity of adverse events (AEs), Laboratory abnormalities and local injection site reactions.

Outcome measures

Outcome measures
Measure	IMM-101 in Combination With Anti PDL1 in Melanoma n=2 Participants Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	1 Participants

SECONDARY outcome

Timeframe: Week 28 through study completion (maximum 4.5 years)

Population: Study was terminated before the Week 28 timepoint was reached.

Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From screening until study termination an average of 3 months.

Population: Both patients enrolled

Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions to evaluate whether there is any exacerbation of toxicity normally observed with these agents

Outcome measures

Outcome measures
Measure	IMM-101 in Combination With Anti PDL1 in Melanoma n=2 Participants Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.
Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor	1 Participants

SECONDARY outcome

Timeframe: Per protocol the initial assessment was at Week 28 then through study completion (maximum 4.5 years). Due to early termination of the study, response to treatment was measured at Week 11 for both patients

Response to treatment, (defined as immune related Stable Disease (irSD), immune related Partial Response (irPR) and immune related Complete Response (irCR) as assessed by the Investigator: * Immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions * Immune-related Partial Response (irPR) is a ≥50% drop in tumour burden from baseline as defined by the irRC * Immune-related Progressive Disease (irPD) is ≥25% increase in tumour burden from the lowest level recorded. * Everything else is considered immune-related Stable Disease (irSD).

Outcome measures

Outcome measures
Measure	IMM-101 in Combination With Anti PDL1 in Melanoma n=2 Participants Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.
Response to Treatment immune related Stable Disease [irSD]	1 Participants
Response to Treatment immune related Partial Response [irPR]	1 Participants
Response to Treatment immune related Complete Response [irCR]	0 Participants

SECONDARY outcome

Timeframe: From date of randomization until date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Population: Assessment of overall survival (defined as the time from enrolment to death due to any cause). However, whilst 2 participants were monitored and analyzed, neither patient died before the study was terminated.

Assessment of overall survival (defined as the time from enrolment to death due to any cause).

Outcome measures

Outcome measures
Measure	IMM-101 in Combination With Anti PDL1 in Melanoma n=2 Participants Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.
Overall Survival (OS)	0 Participants

Adverse Events

IMM-101 in Combination With Anti PDL1 in Melanoma

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IMM-101 in Combination With Anti PDL1 in Melanoma n=2 participants at risk Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study.
Injury, poisoning and procedural complications Procedural pain	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time of consent until 28(±7 days) received at week 10 date which is around 3 months after the last dose of IMM-101. Serious Adverse Events were followed to resolution irrespective of the date of the last dose Adverse events (including those reported spontaneously by the patient or observed by the Investigator) were recorded from the time of informed consent. All adverse events were followed until resolution, death or 30 days after the End of Study/Withdrawal visit (whichever came first). Study treatment related serious adverse events (SAEs) were recorded regardless of time from last dose.
Endocrine disorders Hyperthyroidism	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time of consent until 28(±7 days) received at week 10 date which is around 3 months after the last dose of IMM-101. Serious Adverse Events were followed to resolution irrespective of the date of the last dose Adverse events (including those reported spontaneously by the patient or observed by the Investigator) were recorded from the time of informed consent. All adverse events were followed until resolution, death or 30 days after the End of Study/Withdrawal visit (whichever came first). Study treatment related serious adverse events (SAEs) were recorded regardless of time from last dose.
Musculoskeletal and connective tissue disorders Myalgia	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time of consent until 28(±7 days) received at week 10 date which is around 3 months after the last dose of IMM-101. Serious Adverse Events were followed to resolution irrespective of the date of the last dose Adverse events (including those reported spontaneously by the patient or observed by the Investigator) were recorded from the time of informed consent. All adverse events were followed until resolution, death or 30 days after the End of Study/Withdrawal visit (whichever came first). Study treatment related serious adverse events (SAEs) were recorded regardless of time from last dose.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time of consent until 28(±7 days) received at week 10 date which is around 3 months after the last dose of IMM-101. Serious Adverse Events were followed to resolution irrespective of the date of the last dose Adverse events (including those reported spontaneously by the patient or observed by the Investigator) were recorded from the time of informed consent. All adverse events were followed until resolution, death or 30 days after the End of Study/Withdrawal visit (whichever came first). Study treatment related serious adverse events (SAEs) were recorded regardless of time from last dose.

Additional Information

Chief Medical Odfficer

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