Receive monthly emails about the latest oncology research and technology, new patient services, resources and more!

Please select an option below to help us tailor your newsletter to best suit your content interests!

No thanks
MELANOMA: Adjuvant: Stage III-IV(resected): Immunotherapy: "SWOG S1404"

A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients With High Risk Resected Melanoma

Title
SWOG S1404
Study Title

A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients With High Risk Resected Melanoma

Site Link
Malignancy
Skin Cancer, Melanoma, Cutaneous Melanoma, Mucosal Melanoma
Stage
Disease Setting
Adjuvant/Curative
Line Of Therapy
Adjuvant
Investigational Agent
Pembrolizumab
Drug Class
PD-1 inhibitor
PI
Ari VanderWalde, MD
Sponsor
SWOG
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Completely resected cutaneous or mucosal melanoma (or unknown primary)

  • Stage IIIB, IIIC, or IV (M1a, M1b, or M1c allowed). IIIA allowed only if N2a

  • May be eligible either at initial presentation or following resection of recurrence

  • Must have undergone wide excision of primary lesion (if present)

  • Full lymphadenectomy required for all patients with positive sentinel nodes

  • Must be registered within 98 days of final surgery for melanoma

  • Must have 5 unstained slides available from original or current tumor

  • Must be disease free on scans within 42 days of therapy

  • ECOG PS 0-1

  • No prior systemic therapy for melanoma

  • Prior radiation is allowed

  • No brain mets (or history of brain mets)

  • No autoimmune disease

  • No HBV or HCV

  • HIV allowed if CD4 counts >350, viral load <25,000

Objective

Primary- OS, DFS: Secondary- QOLD, efficacy by BRAF and PD-L1 status, post-relapse threapy, long term survival

Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Cutaneous or mucosal melanoma
Dosing Frequency

Pembrolizumab 200mg IV q3 weeks x 1 year; Ipilimumab 10mg/kg IV q3 weeks x4 doses then q12 weeks x3 years; Interferon per prescribing information

Control Agents
Ipilimumab 10mg/kg or Interferon (Investigator's choice)
Study Protocol
Randomized
Yes
X