Clinical trial · Interventional
A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients
An Intra-patient Placebo-controlled, Phase I Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 (Heat-killed Mycobacterium Obuense) in Adult Melanoma Cancer Patients
NCT01308762CI-TRIAL-00008615completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in melanoma cancer patients.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Heat killed whole cell M. obuense (IMM-101) 0.1 mg | Biological | — | UNRESOLVED |
| Heat-killed whole cell M.obuense (IMM-101) 0.5 mg | Biological | — | UNRESOLVED |
| Heat killed whole cell M.obuense (IMM-101) 1.0 mg | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMM-101
- description
- Patients received an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28. Doses used were: 'Heat killed whole cell M. obuense (IMM-101) 0.1 mg', 'Heat killed whole cell M. obuense (IMM-101) 0.5 mg', or 'Heat killed whole cell M. obuense (IMM-101) 1.0 mg'
- interventionNames
- Biological: Heat killed whole cell M. obuense (IMM-101) 0.1 mg
- Biological: Heat-killed whole cell M.obuense (IMM-101) 0.5 mg
- Biological: Heat killed whole cell M.obuense (IMM-101) 1.0 mg
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 56 days
- description
- Safety and tolerability were measured with respect to: 1. Safety measurements 2. Local tolerability at the site of intradermal injection 3. Incidence of adverse events.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * confirmed diagnosis of disease free stage III or stage IV melanoma (with or without metastases) or stable disease (if with metastases) and receiving no other treatment * willing to use effective contraception for the duration of the study * able to comply with the requirement to complete a diary card Exclusion Criteria: * Pregnant or lactating females * Major surgery within the 14 days preceding the screening visit * Suspicion of a previous infection with mycobacteria including previous tuberculosis (TB) prophylaxis * Treatment with another investigational medicinal product within the last 30 days prior to the screening visit * Previous treatment with M. vaccae * Exposure to Bacille Calmette Guérin vaccine (BCG) within the last 12 months * Concurrent uses of drugs likely to reduce inflammation at the local injection site or dampen/modulate the immune system * Depot injection of corticosteroids within 6 weeks of the screening visit or chronic systemic corticosteroids in the 2 weeks prior to the screening visit * Ongoing treatment with radiotherapy, cytotoxic chemotherapy or chemotherapy in the last 30 days prior to the screening visit
References
Publications (1)
- DERIVEDStebbing J, Dalgleish A, Gifford-Moore A, Martin A, Gleeson C, Wilson G, Brunet LR, Grange J, Mudan S. An intra-patient placebo-controlled phase I trial to evaluate the safety and tolerability of intradermal IMM-101 in melanoma. Ann Oncol. 2012 May;23(5):1314-1319. doi: 10.1093/annonc/mdr363. Epub 2011 Sep 19. PMID 21930686