Who is sponsoring NCT01308762?

NCT01308762 is sponsored by Immodulon Therapeutics Ltd.

What drugs are being tested in NCT01308762?

Interventions in NCT01308762: Heat killed whole cell M. obuense (IMM-101) 0.1 mg, Heat-killed whole cell M.obuense (IMM-101) 0.5 mg, Heat killed whole cell M.obuense (IMM-101) 1.0 mg.

Is NCT01308762 still recruiting?

NCT01308762 is currently completed. Last updated 8 November 2012.

Are results published for NCT01308762?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2012-11-08 · How we verify

NCT01308762

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 8 November 2012

What this trial tests

Phase 1 trial testing Heat killed whole cell M. obuense (IMM-101) 0.1 mg in Melanoma in 19 participants. Completed in 1 September 2010.

Timeline

1 March 2010

Primary endpoint
1 September 2010

1 September 2010

Quick facts

Lead sponsor	Immodulon Therapeutics Ltd
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	single
Enrollment	19
Start date	1 March 2010
Primary completion	1 September 2010
Estimated completion	1 September 2010
Sites	1 location across United Kingdom

Drugs / interventions tested

Heat killed whole cell M. obuense (IMM-101) 0.1 mg — full drug profile →
Heat-killed whole cell M.obuense (IMM-101) 0.5 mg — full drug profile →
Heat killed whole cell M.obuense (IMM-101) 1.0 mg — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →

Sponsor

Immodulon Therapeutics Ltd — full company profile →

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 56 days
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.

Sponsor's own description

To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in melanoma cancer patients.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Trial Watch: Experimental Toll-like receptor agonists for cancer therapy.
Galluzzi L, Vacchelli E, Eggermont A, Fridman WH, et al · · 2012 · cited 162× · PMID 22934262 · DOI 10.4161/onci.20696
Long-term survival and outcome of patients originally given Mycobacterium vaccae for metastatic malignant melanoma.
Cananzi FC, Mudan S, Dunne M, Belonwu N, et al · · 2013 · cited 12× · PMID 23863507 · DOI 10.4161/hv.25618
Mycobacteria-Based Vaccines as Immunotherapy for Non-urological Cancers.
Noguera-Ortega E, Guallar-Garrido S, Julián E. · · 2020 · cited 11× · PMID 32635668 · DOI 10.3390/cancers12071802
Advances in Bacterial Lysate Immunotherapy for Infectious Diseases and Cancer.
Rahman MM, Grice ID, Ulett GC, Wei MQ. · · 2024 · cited 10× · PMID 38962577 · DOI 10.1155/2024/4312908

Verify or expand the search:

Other recruiting trials for Melanoma

Currently open trials in the same condition.

NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07225036 — Promoting Immunotherapy Efficacy With Low-Dose Liver RT · NA · recruiting
NCT07379138 — Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improve · NA · recruiting

Other Immodulon Therapeutics Ltd trials

Trials by the same sponsor.

NCT03711188 — A Study of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Advanced Melanoma · Phase 2 · completed
NCT03009058 — Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer · Phase 1, PHASE2 · terminated
NCT01539824 — A Study of IMM-101 in Combination With Radiation Induced Tumour Necrosis in Colorectal Cancer · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01308762 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Immodulon Therapeutics Ltd
Last refreshed: 8 November 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01308762.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing