Phase 1
N=19
A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01308762 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Dec 2012
Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 6; 7; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 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 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Immodulon Therapeutics Ltd
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
6; 7; 6 | — |
| SECONDARY Administration Site Reactions |
1; 3; 5 | — |
Summary
To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in melanoma cancer patients.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01308762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.