Adults 12 to 70, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median Overall Survival Response to Abraxane Plus Ipilimumab TherapyPrimary· From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1) was used. Complete Response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, no new lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
ABI-007 + Ipilimumab
24.9
0 – 49
Median Progression Free SurvivalPrimary· From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months
Progression-free survival (PFS) is the time from random assignment in a clinical trial to disease progression or death from any cause.
Group
Value
95% CI
ABI-007 + Ipilimumab
10
0.0 – 27.2
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 50 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied.
Ipilimumab is designed to increase the immune system's ability to fight cancer.
Abraxane is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02103062 — Phase 2 Study With Abraxane (Nab®Paclitaxel) in Metastatic Colorectal Cancer
· Phase 2
· completed
NCT02021500 — A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.
· completed
NCT01478685 — A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or
· Phase 1
· completed
NCT00864253 — A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
· Phase 3
· completed
NCT00456846 — First Line Therapy for Patients With Metastatic Breast Cancer
· Phase 2
· terminated
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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 M.D. Anderson Cancer Center
Last refreshed: 8 February 2022
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/NCT01827111.