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.


Background: IMM-101 is a heat-killed innate and adaptive immune-activating mycobacterial product; a phase I study aimed to determine its safety and tolerability in individuals with melanoma.

Patients and methods: An intra-patient placebo-controlled study evaluated the safety and tolerability of three doses, namely, 0.1 (1 mg/ml), 0.5 (5 mg/ml) and 1.0 mg (10 mg/ml) of IMM-101 in stage III or IV melanoma. Each dose was administered in ascending order to one of the three cohorts.

Results: Based on observations from patients administered the 0.1-mg dose, it was considered appropriate to proceed with dosing the patients in the 0.5-mg dose cohort and then the 1.0-mg cohort (n = 6 per cohort). Treatment-emergent adverse events that would be considered typical of a post-vaccination state (including joint pains/aches, headaches and influenza-like symptoms) occurred at all dose levels, along with injection site reactions. These were mainly mild in intensity, resolved in a matter of days and responded well to supportive care. During post-study follow-up, two clinical responses (15%) were observed in patients with stage IV disease.

Conclusion: IMM-101 is safe and well tolerated and there is a rationale for studying IMM-101 at a nominal 1.0-mg dose to complement conventional cytotoxic therapy for patients with advanced cancer.

Trial registration: NCT01308762.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects*
  • Bacterial Vaccines / administration & dosage
  • Bacterial Vaccines / adverse effects
  • Cancer Vaccines / administration & dosage*
  • Cancer Vaccines / adverse effects*
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Humans
  • Immunotherapy / adverse effects
  • Injections, Intradermal
  • Male
  • Melanoma / immunology
  • Melanoma / therapy*
  • Middle Aged
  • Models, Biological
  • Mycobacterium / immunology
  • Placebos
  • Skin Neoplasms / immunology
  • Skin Neoplasms / therapy*


  • Antineoplastic Agents
  • Bacterial Vaccines
  • Cancer Vaccines
  • Placebos
  • IMM-101

Associated data