Clinical trial · Interventional
Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)
- 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 study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dacarbazine plus Genasense | Drug | — | UNRESOLVED |
| dacarbazine plus placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Dacarbazine with Genasense
- interventionNames
- Drug: dacarbazine plus Genasense
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Dacarbazine with placebo
- interventionNames
- Drug: dacarbazine plus placebo
Primary outcomes (1)
- measure
- Progression-free survival and overall survival
- timeFrame
- Every 42 days from date of randomization during protocol therapy
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of melanoma * Progressive disease that is not surgically resectable, or metastatic Stage IV * Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal * No prior chemotherapy * Measurable disease * ECOG performance status ≤ 1 * At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy * Prior immunotherapy allowed * Adequate organ function Exclusion Criteria: * Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment * Primary ocular or mucosal melanoma * Bone-only metastatic disease * History or presence of brain metastasis or leptomeningeal disease * Significant medical disease other than cancer * Organ allograft
References
Publications (2)
- BACKGROUNDBedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 [Abstract T-26].
- BACKGROUNDBedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG; Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006 Oct 10;24(29):4738-45. doi: 10.1200/JCO.2006.06.0483. Epub 2006 Sep 11. PMID 16966688