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TerminatedNCT02442466Updated May 20, 2015

Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma

An Early Phase 1 interventional study of Endothelin Receptor B inhibitor BQ788 and PBS in Melanoma, sponsored by MelCure SA. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-20.

Sponsored by MelCure SA · Early Phase 1 and Interventional

Why this study was terminated
Difficulties to recruit on time the required patient population.
Phase
Early Phase 1
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and relevance of results observed in pre-clinical studies to the human disease.

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Conditions studied

  • Melanoma

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In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 5 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.

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Lead sponsor

This is the only study on the registry with MelCure SA as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written Informed consent
  • Histologically confirmed melanoma
  • Disease stage III or IV
  • At least 2 injectable and surgically removable cutaneous metastasis
  • Age > 18 years
  • Clinically stable medical condition

Exclusion criteria

Exclusion Criteria:

  • Primary ocular melanoma
  • Symptomatic intracranial melanoma
  • History of severe neurological, cardiovascular, renal, hepatic, endocrinological, respiratory, bone marrow, autoimmune or infectious (HIV) disease
  • Pregnancy or lactation
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Study design

Phase
Early Phase 1
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Endothelin receptor B inhibitor BQ-788

    Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788)

    Drug: Endothelin Receptor B inhibitor BQ788

  • Experimental
    PBS

    Intra-lesion administration of vehicle

    Drug: PBS

Interventions

  • DrugEndothelin Receptor B inhibitor BQ788
  • DrugPBS
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What researchers measure

Primary outcomes

  1. Tumour response by size measurement and histological examination

    Time frame: 3 to14 days

Secondary outcomes

  1. Measuring changes in tumor cell proliferation by histological analyses using Ab staining

    Time frame: 3 to 14 days

  2. Evaluation of changes in mRNA as well as protein expression levels of Endothelin Receptor B by PCR and Ab staining

    Time frame: 3 to 14 days

  3. Evaluation of changes in blood vessels formation by histological examination using Ab staining

    Time frame: 3 to 14 days

  4. Evaluation of changes in immune cell infiltration by histological examination using Ab staining

    Time frame: 3 to 14 days

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Lahav R, Ziller C, Dupin E, Le Douarin NM. Endothelin 3 promotes neural crest cell proliferation and mediates a vast increase in melanocyte number in culture. Proc Natl Acad Sci U S A. 1996 Apr 30;93(9):3892-7. doi: 10.1073/pnas.93.9.3892. PubMed 8632985 ↗
  • Lahav R, Dupin E, Lecoin L, Glavieux C, Champeval D, Ziller C, Le Douarin NM. Endothelin 3 selectively promotes survival and proliferation of neural crest-derived glial and melanocytic precursors in vitro. Proc Natl Acad Sci U S A. 1998 Nov 24;95(24):14214-9. doi: 10.1073/pnas.95.24.14214. PubMed 9826680 ↗
  • Lahav R, Heffner G, Patterson PH. An endothelin receptor B antagonist inhibits growth and induces cell death in human melanoma cells in vitro and in vivo. Proc Natl Acad Sci U S A. 1999 Sep 28;96(20):11496-500. doi: 10.1073/pnas.96.20.11496. PubMed 10500205 ↗
  • Lahav R, Suva ML, Rimoldi D, Patterson PH, Stamenkovic I. Endothelin receptor B inhibition triggers apoptosis and enhances angiogenesis in melanomas. Cancer Res. 2004 Dec 15;64(24):8945-53. doi: 10.1158/0008-5472.CAN-04-1510. PubMed 15604257 ↗
  • Lahav R. Endothelin receptor B is required for the expansion of melanocyte precursors and malignant melanoma. Int J Dev Biol. 2005;49(2-3):173-80. doi: 10.1387/ijdb.041951rl. PubMed 15906230 ↗
  • Wouters J, Hunger RE, Garrod T, Dubuis B, Hunziker T, van den Oord JJ, Lahav-le Coutre R. First-in-Human Proof-of-Concept Study: Intralesional Administration of BQ788, an Endothelin Receptor B Antagonist, to Melanoma Skin Metastases. Oncologist. 2015 Oct;20(10):1121-2. doi: 10.1634/theoncologist.2015-0139. Epub 2015 Sep 1. PubMed 26330458 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02442466
Lead sponsor
MelCure SA
Collaborators
California Institute of Technology, University of Bern, Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
May 13, 2015
Start date
May 2011
Primary completion
May 2012
Last update
May 20, 2015
View the source record on ClinicalTrials.gov ↗

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