Clinical trial · Interventional
A Long Term Follow up Study for Patients Who Previously Took Part in the Phase I Study IMM-101-001
An Open Label Long Term Follow up Study for Patients With Melanoma Who Were Previously Enrolled in the Phase I Study IMM-101-001
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor considered no further meaningful data was being collected, nor were likely to be collected in the future.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMM-101 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMM-101
- description
- IMM-101 1.0 mg administered intradermally
- interventionNames
- Biological: IMM-101
Primary outcomes (3)
- measure
- Adverse Events With a Causal Relationship to IMM-101
- 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).
- description
- 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.
- measure
- Treatment Emergent Adverse Events of NCI CTCAE ≥Grade 3
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available