title: A phase 2 randomised study of ramucirumab (IMC-1121B) with or without dacarbazine in patients with metastatic melanoma.
abstract: BACKGROUND
  To evaluate the efficacy and safety of ramucirumab (IMC-1121B; LY3009806), a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-2, alone and in combination with dacarbazine in chemotherapy-naïve patients with metastatic melanoma (MM).
  
  
  METHODS
  Eligible patients received ramucirumab (10mg/kg) + dacarbazine (1000 mg/m(2)) (Arm A) or ramucirumab only (10mg/kg) (Arm B) every 3 weeks. The primary end-point was progression-free survival (PFS); secondary end-points included overall survival (OS), overall response and safety.
  
  
  RESULTS
  Of 106 randomised patients, 102 received study treatment (Arm A, N=52; Arm B, N=50). Baseline characteristics were similar in both arms. Median PFS was 2.6 months (Arm A) and 1.7 months (Arm B); median 6-month PFS rates were 30.7% and 17.9% and 12-month PFS rates were 23.7% and 15.6%, respectively. In Arm A, 9 (17.3%) patients had partial response (PR) and 19 (36.5%), stable disease (SD); PR and SD in Arm B were 2 (4.0%) and 21 (42.0%), respectively. Median OS was 8.7 months in Arm A and 11.1 months in Arm B. Patients in both arms tolerated the treatment with limited Grade 3/4 toxicities.
  
  
  CONCLUSIONS
  Ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with MM. Although the study was not powered for comparison between treatment arms, PFS appeared greater with combination therapy. Sustained disease control was observed on both study arm.
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York, NY, USA. Electronic address: carvajar@mskcc.org.
authors.forename: Richard D
authors.initials: RD
authors.lastname: Carvajal
authors.affiliation: USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
authors.forename: Michael K
authors.initials: MK
authors.lastname: Wong
authors.affiliation: Seattle Cancer Care Alliance, Seattle, WA, USA.
authors.forename: John A
authors.initials: JA
authors.lastname: Thompson
authors.affiliation: Pinnacle Oncology Hematology, Scottsdale, AZ, USA.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Gordon
authors.affiliation: University of Colorado Denver, Aurora, CO, USA.
authors.forename: Karl D
authors.initials: KD
authors.lastname: Lewis
authors.affiliation: New York University, New York, NY, USA.
authors.forename: Anna C
authors.initials: AC
authors.lastname: Pavlick
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: Jedd D
authors.initials: JD
authors.lastname: Wolchok
authors.affiliation: ImClone Systems LLC, a wholly-owned subsidiary of Eli Lilly and Company, Bridgewater, NJ, USA.
authors.forename: Patrick B
authors.initials: PB
authors.lastname: Rojas
authors.affiliation: ImClone Systems LLC, a wholly-owned subsidiary of Eli Lilly and Company, Bridgewater, NJ, USA.
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Schwartz
authors.affiliation: MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Agop Y
authors.initials: AY
authors.lastname: Bedikian
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D003606:Dacarbazine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000556:secondary; D016019:Survival Analysis; D055815:Young Adult; D000096662:Ramucirumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D003606:Dacarbazine; D000096662:Ramucirumab
keywords: Metastatic melanoma; Phase II; Ramucirumab