MELANOMA: METASTATIC: 2nd Line post PD-1; Immunotherapy: "SWOG S1616"

A Phase II Randomized Study of Nivolumab (NSC-732442) With Ipilimumab (NSC-748726) or Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD1 or Anti-PD-L1 Agent

Title
SWOG S1616- Melanoma
Study Title

A Phase II Randomized Study of Nivolumab (NSC-732442) With Ipilimumab (NSC-748726) or Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD1 or Anti-PD-L1 Agent

Site Link
Malignancy
Melanoma, Skin Cancer, Cutaneous Melanoma, Mucosal Melanoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd line or later
Investigational Agent
Nivolumab and Ipilimumab
Drug Class
PD-1 inhibitor and CTLA-4 inhibitor
PI
Ari VanderWalde, MD
Sponsor
SWOG
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Stage 4 or unresectable Stage III melanoma
  • Must have had prior treatment with PD-1 or PD-L1 antibody
    • Must have had best response of SD (no PR or CR) on PD-1 or PD-L1 antibody
    • Must have documented disease progression either while on PD-1 or PD-L1 agents or since stopping therapy with these agents with no intervening treatment
  • No prior therapy with ipilimumab or other anti-CTLA-4 agents
  • No systemic therapy between progression on the PD(L)-1 therapy and registration
  • ECOG PS 0-2
  • No active CNS disease
    • Patients with history of CNS disease must have been treated with XRT or surgery and have no evidence of CNS progression, and been off steroids for at least 14 days
  • No history of autoimmune pneumonitis or colitis that required interruption fo therapy or steroid treatment
  • No known HBV or HCV. HIV is allowed if CD4 count is normal.
  • No ocular melanoma

 

 

 

 

 

Objective

Primary- PFS; Secondary- CD8+ expression levels, Adverse Events, OS, ORR

Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Cutaneous or Mucosal Melanoma
Dosing Frequency
Control Agents
Ipilimumab 3mg/kg x4 doses
Study Protocol
Randomized
Yes
X