Phase 3
Completed N=502
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
Source: ClinicalTrials.gov NCT00324155 ↗Enrolled (actual)
502
Serious AEs
58.4%
Results posted
Mar 2014
Primary outcomePrimary: Overall Survival (OS) — 11.17; 9.07 Months — p=0.0009
Summary
The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
11.17; 9.07 | 0.0009 sig |
| SECONDARY Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years |
47.3; 36.3; 35.6; 26.1; 28.5; 17.9 | — |
| SECONDARY Disease Control Rate (DCR) |
33.2; 30.2 | 0.4067 |
| SECONDARY Median Number of Months of Progression-free Survival (PFS) |
2.76; 2.60; 2.73; 2.63 | — |
| SECONDARY Progression-free Survival (PFS) Rate Truncated at Week 12 |
55.4; 50.7; 58.5; 54.0 | — |
| SECONDARY Best Overall Response Rate (BORR) |
15.2; 10.3; 16.8; 11.1 | — |
| SECONDARY Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR) |
19.3; 8.1; 21.1; 10.2 | — |
| SECONDARY Time to Response: All Randomized Participants With Response to Treatment |
2.6; 2.7 | — |
| SECONDARY Duration of Stable Disease (SD): Randomized Participants With Stable Disease |
4.7; 4.6; 4.8; 3.4 | — |
| SECONDARY Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff |
93.6; 90.9 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Hypersensitivity, Immune-related AEs/SAEs, and Inflammatory AEs/SAEs |
244; 236; 221; 192; 114; 46 | — |
| SECONDARY Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved |
36; 7; 13; 0; 81; 4 | — |
| SECONDARY Time to Resolution of Grade 2-3, Grade 3-4 Immune-related Adverse Events (irAEs) |
2.00; 0.14; 2.14; NA; 3.43; NA | — |
Eligibility Criteria
Inclusion Criteria
- Informed Consent
- Measurable Disease
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Lab / imaging requirements
- Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C
- Men and Women > 18 years (16 were allowable)
- Prior therapy restriction (adjuvant only)
Exclusion:
- Pregnant / nursing
- Inadequate contraception
- Brain metastasis
- Primary ocular or mucosal melanoma
Data sourced from ClinicalTrials.gov (NCT00324155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.