A Long Term Follow up Study for Patients Who Previously Took Part in the Phase I Study IMM-101-001

NCT01559818 | Terminated Phase 1 Results

• 1 other identifier: IMM-101-008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who were previously enrolled in Study IMM-101-001 and who provided informed consent were eligible to participate in this study. Once eligibility was confirmed, a full medical history covering the period from completion of Study IMM-101-001 to date was taken. The treatment regimen with IMM-101 was one dose given every 4 weeks or as close to this interval as permitted due to practical or logistic considerations. The dose interval could be modified at the discretion of the Investigator provided the minimum period between doses was no less than 14 days. The overall objective was to determine the long term safety profile of IMM-101 administered intradermally for extended use.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (3)

• Adverse Events With a Causal Relationship to IMM-101

  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.

  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).

• Treatment Emergent Adverse Events of NCI CTCAE ≥Grade 3

  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

  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).

• Treatment Emergent Serious Adverse Events

  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.

  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).

Secondary Outcomes (2)

• Survival

  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.

• Incidence of Change in Metastatic Disease

  From Informed Consent to death or withdrawal (median 4.4 years, range 1.2 - 6.7)

Other Outcomes (1)

• Translational Research

  From baseline to death or withdrawal

Study Arms (1)

IMM-101

EXPERIMENTAL

IMM-101 1.0 mg administered intradermally

Biological: IMM-101

Interventions

IMM-101 BIOLOGICAL

IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.

Also known as: Heat-killed whole cell M. obuense

IMM-101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient was previously enrolled in Study IMM-101-001
• Patient gave consent to make their disease and treatment history for the intervening period between their completion of Study IMM-101-001 and enrollment in this study available to the Sponsor
• Patient gave signed informed consent for participation in the study

You may not qualify if:

• Female patient of child-bearing potential who was not, in the opinion of the Investigator, using an approved method of birth control (e.g., physical barrier \[patient and partner\], contraceptive pill or patch, spermicide and barrier, or intrauterine device \[IUD\]).
• Those patients that utilised hormonal contraceptives must have used the same method for at least three months before additional barrier contraception (as described above) was discontinued from being used concomitantly with the hormonal contraception.
• Patient of non-child-bearing potential were defined as having 12 month amenorrhoea or were surgically sterile.
• Female patient who was pregnant, breast feeding or planning a pregnancy during the course of the study. A pre-treatment urine pregnancy test measuring human chorionic gonadotrophin (hCG) must be negative.
• Patient was unable or unwilling to comply with the protocol.

Sponsors & Collaborators

• Immodulon Therapeutics Ltd: lead

Study Sites (1)

St Georges University of London

London, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Interventions

IMM-101

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The median survival time was not calculable as less than 50% patients died. No inferences can be made from the rate of survival due to the small sample size. 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.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Immodulon Therapeutics Ltd

info@immodulon.com

+44 (0)20 3137 6346

Study Officials

• Alberto Fusi, Dr

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 21, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 22, 2023
• Results First Posted: May 24, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)