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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
Phase 1 trial testing CC-5013 in Malignant Melanoma in 28 participants. Completed in 1 June 2007.
1 June 2007
Quick facts
| Lead sponsor | Celgene |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 1 September 2005 |
| Primary completion | 1 June 2007 |
| Estimated completion | 1 June 2007 |
| Sites | 1 location across United States |
Drugs / interventions tested
- CC-5013 — full drug profile →
Conditions studied
- Malignant Melanoma — all drugs for Malignant Melanoma →
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):
-
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:
- PubMed search for NCT00179608
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CC-5013
Trials testing the same drug.
- NCT00065351 — Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma · Phase 2 · completed
- NCT00622336 — A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma · Phase 3 · completed
- NCT00056160 — CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Phase 3 · completed
- NCT00057616 — Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma. · Phase 3 · completed
- NCT00044382 — Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome · Phase 2 · completed
Other recruiting trials for Malignant Melanoma
Currently open trials in the same condition.
- NCT07371663 — An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06961006 — A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-0 · Phase 2 · recruiting
- NCT06974734 — A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies · Phase 1 · active not recruiting
- NCT06980740 — Video-Tumorboard PLUS · recruiting
- NCT06560905 — Preoperative Planning With PSMA-PET in Melanoma Surgery Trial · Phase 2 · recruiting
Other Celgene trials
Trials by the same sponsor.
- NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
- NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide · Phase 1, PHASE2 · recruiting
- NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
- NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
- NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00179608 (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 Celgene
- Last refreshed: 8 November 2019
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