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NCT00179608

Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy

Completed Phase 1 Last updated 8 November 2019
What this trial tests

Phase 1 trial testing CC-5013 in Malignant Melanoma in 28 participants. Completed in 1 June 2007.

Timeline
1 September 2005
Primary endpoint
1 June 2007
1 June 2007

Quick facts

Lead sponsorCelgene
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment28
Start date1 September 2005
Primary completion1 June 2007
Estimated completion1 June 2007
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Celgene — full company profile →

Who can join

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

Sponsor's own description

This study will determine the MDT of intravenous DTIC when administered in combination with a fixed dose of oral lenalidomide in subjects with metastatic malignant melanoma previously untreated with systemic chemotherapy. This study will evaluate the safety and preliminary efficacy of the combination of lenalidomide and DTIC. Subjects will be receive lenalidomide for 14 consecutive days and DTIC on day one of each 21 day cycle.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mechanisms and Therapeutic Strategies to Overcome Immune Checkpoint Inhibitor Resistance in Melanoma, Head and Neck, and Triple-Negative Breast Cancers.
    Voloshyna I, Tyagi A, Idga S, Wang N, et al · · 2025 · cited 1× · PMID 41799379 · DOI 10.33696/immunology.7.235

Verify or expand the search:

Other trials of CC-5013

Trials testing the same drug.

Other recruiting trials for Malignant Melanoma

Currently open trials in the same condition.

Other Celgene trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT00179608.

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