Clinical trial · Interventional
Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
Phase II Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Dacarbazine (DTIC) Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sorafenib (Nexavar, BAY43-9006) + Dacarbazine
- description
- Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
- Drug: Dacarbazine
- type
- ACTIVE_COMPARATOR
- label
- Placebo + Dacarbazine
- description
- Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have a life expectancy of at least 12 weeks * Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma * Patients who have an ECOG PS of 0, or 1 * Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria Exclusion Criteria: * Primary ocular or mucosal melanoma * Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\] \& T1 \[Tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 3 years prior to study entry * History of cardiac disease * Known history of human immunodeficiency virus (HIV) infection
References
Publications (1)
- RESULTMcDermott DF, Sosman JA, Gonzalez R, Hodi FS, Linette GP, Richards J, Jakub JW, Beeram M, Tarantolo S, Agarwala S, Frenette G, Puzanov I, Cranmer L, Lewis K, Kirkwood J, White JM, Xia C, Patel K, Hersh E. Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group. J Clin Oncol. 2008 May 1;26(13):2178-85. doi: 10.1200/JCO.2007.14.8288. PMID 18445842