A Phase III Randomized Trial of Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High-Risk Resected Melanoma -
Closure to Step 1 (prestudy screening) was effective August 15th.
NOTE: This is a potential FDA registration study. There will be additional centralized and on-site monitoring conducted in addition to routine audits. Sites must also maintain a study specific Trial Master File for this study (https://swog.org/Visitors/QA/Index.asp).
Other Study Materials
Eligibility Criteria Expand/Collapse
STEP 2 REGISTRATION: Pts must not be registered until receiving confirmation the tissue is adequate for PD-L1 testing; must verify there is no known change in Step 1 eligibility since initial registration; women of childbearing potential must have pregnancy test within 72hrs prior to receiving first dose of study medication. No tests/exams must be repeated for Step 2 reg, but pts known to have change in eligibility status after Step 1 reg are not eligible for Step 2 reg.
Publication Information Expand/Collapse
Role of Adjuvant Regional Nodal Irradiation in Locoregionally Advanced Melanoma: A Secondary Analysis of SWOG 1404
Final Analysis of Overall Survival (OS) and Relapse-Free-Survival (RFS) in the Intergroup S1404 Phase III Randomized Trial Comparing Either High Dose Interferon (HDI) or Ipilimumab to Pembrolizumab in Patients with High Risk Resected Melanoma
Granulomatous and sarcoid-like immune related adverse events (irAEs) following CTLA4 and PD1 blockade adjuvant therapy of high-risk melanoma: A combined analysis of ECOG-ACRIN E1609 and SWOG S1404 Phase III Trials
Adjuvant pembrolizumab versus interferon alfa-2b or ipilimumab in resected high-risk melanoma
PMid: PMID34764195 PMC8904282 | PMC number: PMC8904282
SWOG S1404: A phase III randomized trial comparing high dose interferon to pembrolizumab in patients with high risk resected melanoma
A phase III randomized trial comparing FDA approved standard of care adjuvant therapy to one year of pembrolizumab in patients with high risk resected melanoma SWOG 1404
Integrating traditional Electronic Data Capture (EDC) with new systems
SWOG S1404: A phase III randomized trial comparing high dose interferon to MK-3475 (pembrolizumab) in patients with high risk resected melanoma
Long-term survival as a treatment benchmark in melanoma: latest results and clinical implications
PMid: PMID26673806 | PMC number: PMC4406913
Future perspectives in melanoma research: meeting report from the "Melanoma Bridge", Napoli, December 5th-8th 2013
PMid: PMID25348889 | PMC number: PMC4232645