SWOG clinical trial number

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 -

Abbreviated Title
MK-3475, Interferon, Resected High-Risk Melanoma
Status Notes
Step 2 (randomization) of the above-referenced study will be permanently closed to accrual effective November 2, 2017 at 11:59 p.m. Pacific Time.

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).

Research committees

Symptom Control and Quality of Life


Interferon alpha 2a Ipilimumab MK-3475

Other Study Materials

Eligibility Criteria Expand/Collapse

STEP 1 REGISTRATION: Pts must have completely resected melanoma of cutaneous origin or of unknown primary and must be classified as Stage IIIA (N2a), IIIB, IIIC, or Stage IV melanoma. Pts w/melanoma of mucosal or other non-cutaneous origin are eligible. Pts must not have melanoma of ocular origin or a history of brain metastases; Pts at eligible at initial presentation of melanoma or at the time of first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site. Nodal, satellite/in-transit metastasis, distant metastases or disease in prior complete lymphadenectomy basin must have been confirmed histologically by H&E stained slides; Pts w/multiple regional nodal basin involvement are eligible. Gross or microscopic extracapsular nodal extension is permitted; Pts at initial presentation of melanoma must undergo an adequate wide excision of primary lesion, if present. Pts w/previously diagnosed melanoma must have had all current disease resected with pathologically negative margins and have no evidence of disease at primary site, or must undergo re-resection of the primary site. Full lymphadenectomy is required for all node-positive pts including those with positive sentinel nodes. All pts must have all disease resected with negative pathological margins and no clinical, radiologic, or pathological evidence of any incompletely resected melanoma. PTS MUST BE REGISTERED W/IN 98 DAUS OF THE LAST SURGERY PERFORMED TO RENDER PT FREE OF DISEASE; Must be able/willing to submit min of 5 unstained slides to determine PDL1 expression; must be offered the opportunity to participate in specimen banking.; must be willing to have blood draws for PK/ADA analysis; prior radiation therapy is allowed; must not have had prior neoadjuvant trt for melanoma and must not have had prior immunotherapy and must not be planning to receive any prohibited therapies listed in Section 7.2 during screening or treatment; must not be planning to receive concomitant or other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, surgery, or other therapy after Step 2 registration; must be 18 years of age or older; must have disease-free status documented by complete physical and imaging studies w/in 42 days prior to reg. Imaging studies must include total body PET-CT (of diagnostic quality) or CT of chest, abdomen, and pelvis; Pts w/melanoma arising from head and neck must have dedicated neck imaging; if pt has had unknown primary with disease in axilla, neck imagining is req�d. All pts must have CT or MRI of brain within 90 days prior to reg. Must have the following lab values within 42 days prior to reg: ANC >/= 1,500 mcL, platelets >/= 100,000mcl, hemoglobin >/= 10 g/dL, total bilirubin </= 1.5 x IULN, SGOT (AST) and SGPT (ALT) and alkaline phosphatase </= 2 x IULN, serum creatinine </= IULN OR measured or calculated creatinine clearance >/= 60 mL/min, and LDH must be performed; Zubrod PS </= 1; ECG w/in 42 days prior to reg that is considered normal or not clinical significant by site investigator; no evidence of active, non-infectious pneumonitis; no active infection requiring systemic therapy; no active autoimmune disease that has required systemic treatment in the past 2 years; must not have received live vaccines w/in 42 days prior to reg; if HIV positive, must have stable and adequate CD4 counts (>/= 350 mm3) and serum HIV viral load of < 25,000 UI/ml w/in 30 days prior to reg; no known active HBV or HCV infection prior to reg; no history or current evidence of any condition, therapy, or lab abnormality that might confound trial results, interfere in pts participation in full duration of trial, or indication that participation is not in the patient�s best interests, in the opinion of treating investigator; no prior malignancy except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma of the breast in situ, atypical melanocytic hyperplasia or melanoma in situ, adequately treated Stage I or II cancer from which the patient is current in complete remission or any other cancer from which the pt has been disease free for three years; serum pregnancy test for women of childbearing potential w/in 28 days prior to reg; pts that can respond to questionnaires in English must participate in QOL assessments.

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


Association between Postoperative Circulating Tumor DNA (ctDNA) and Recurrence-Free Survival (RFS) in Patients with Resected Stage III Melanoma - an Exploratory Analysis of SWOG S1404

M LaPelusa;D Marcano;M Othus;A Grossmann;V Aushev;B Sridhar;D Renner;H Sethi;M Liu;A Tarhini;J Kirkwood;K Grossmann;J Moon;H Li;S Mashrun;N Khushalani;E Sharon;L Korde;A Ribas;S Patel ASCO Annual Meeting (May 31 - June 4, 2024, Chicago, IL ), poster; J Clin Oncol 42, 2024 (suppl 16; abstr 9564)


Effectiveness of adjuvant pembrolizumab improves quality-of-life outcomes compared to high dose interferon or ipilimumab in patients with resected melanoma; SWOG S1404, A Randomized Clinical Trial

J Unger;A Darke;M Othus;A Tarhini;J Kirkwood;E Sharon;V Sondak;S Guild;T Truong;Z Eroglu;K Kendra;K Lewis;B Faller;P Funchain;E Buchbinder;K Grossmann;A Ribas;S Patel JAMA Oncology Feb 1;9(2):251-260

PMid: PMID36416836 | PMC number: PMC9685550

Granulomatous and Sarcoid-like Immune Related Adverse Events Following CTLA4 and PD1 Blockade Adjuvant Therapy of Melanoma: A Combined Analysis of ECOG-ACRIN E1609 and SWOG S1404 Phase III Trials and A Literature Review

I Eljilany;A Noor;M Paravathaneni;I Yassine;S Lee;M Othus;J Moon;J Kirkwood;V Sondak;A Ribas;K Grossmann;A Tarhini Cancers (Basel) Apr 29;15(9):2561

PMid: PMID37174027 | PMC number: PMC10177189


Role of Adjuvant Regional Nodal Irradiation in Locoregionally Advanced Melanoma: A Secondary Analysis of SWOG 1404

M Bhandari;M Othus;J Kirkwood;V Sondak;A Tarhini;E Sharon;K Grossmann;A Ribas;S Patel;E Wuthrick ASTRO Annual Meeting (October 23 - 26, 2022, San Antonio, TX), oral


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

K Grossmann;M Othus;S Patel;A Tarhini;V Sondak;T Petrella;T-G Truong;N Khushalani;JV Cohen;E Buchbinder;K Kendra;P Funchain;K Lewis;B Chmielowski;H Li;J Moon;K Gunturu;Z Eroglu;JM Kirkwood;A Ribas J Clin Oncol 39, 2021 (suppl 15; abstr 9501) (American Society of Clinical Oncology Annual Meeting 2021, oral)

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

A Noor;I Yassine;S Lee;M Othus;J Moon;J Kirkwood;V Sondak;A Ribas;K Grossmann;A Tarhini Annals of Oncology 32 (suppl_5): S867-S905. 10.1016/annonc/annonc706ESMO Annual Meeting (September 16-21, 2021), accepted, E-poster presentation abst #1069P

Quality of life (QOL) endpoints of the Phase III Intergroup S1404 adjuvant melanoma trial

SP Patel;M Othus;A Darke;K Stevinson;E Sharon;V Sondak;A Ribas;K Grossmann Annals of Oncology (2021) 32 (suppl_5): S867-S905 (ESMO Annual Meeting (September 16-21, 2021), accepted, E-poster, abst# 1073P)

Adjuvant pembrolizumab versus interferon alfa-2b or ipilimumab in resected high-risk melanoma

K Grossmann;M Othus;S Patel;A Tarhini;V Sondak;M Knopp;T Petrella;T-G Truong;N Khushalani;J Cohen;E Buchbinder;K Kendra;P Funchain;K Lewis;R Conry;B Chmielowski;R Kudchadkar;D Johnson;H Li;J Moon;J Eroglu;B Gastman;M Kovacsovics;K Gunturu;S Ebbinghaus;S Ahsan;N Ibrahim;E Sharon;L Korde;J Kirkwood;A Ribas Cancer Discovery Mar 1;12(3):644-653

PMid: PMID34764195 PMC8904282 | PMC number: PMC8904282


A Programmatic Approach to the Increased Data Monitoring in the Cooperative Group System Required for FDA Registration Trials

H Li;J Moon;M Othus Society for Clinical Trials (May 19-22, 2019, New Orleans, LA), poster


SWOG S1404: A phase III randomized trial comparing high dose interferon to pembrolizumab in patients with high risk resected melanoma

K Grossman;M Othus;A Tarhini;SP Patel;J Moon;V Sondak;JM Kirkwood;A Ribas Journal of Clinical Oncology 34, 2016 (suppl; abstr e21032); American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), publication only

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

K Grossmann;V Sondak;M Othus;A Tarhini;S Patel;J Kirkwood;A Ribas;J Moon American Association for Cancer Research Annual Meeting (2016, April 16-20, New Orleans, LA), poster session, abst #CT125

Integrating traditional Electronic Data Capture (EDC) with new systems

C Cook;T Phillips;M Leblanc Society for Clinical Trials (May 15-18, 2016, Montreal,Quebec, Canada), poster


SWOG S1404: A phase III randomized trial comparing high dose interferon to MK-3475 (pembrolizumab) in patients with high risk resected melanoma

K Grossmann;M Othus;A Tarhini;S Patel;J Moon;V Sondak;J Kirkwood;A Ribas Journal of Clinical Oncology 33:5s (suppl; abstr TPS9085); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), poster session;

Long-term survival as a treatment benchmark in melanoma: latest results and clinical implications

KF Grossmann;K Margolin Therapeutic Advances in Medical Oncology May;7(3):181-191

PMid: PMID26673806 | PMC number: PMC4406913


Future perspectives in melanoma research: meeting report from the "Melanoma Bridge", Napoli, December 5th-8th 2013

PA Ascierto;AM Grimaldi;A Carrizosa Anderson;C Bifulco;A Cochran;C Garbe;AM Eggermont;M Faries;S Ferrone;J Gershenwald;TF Gajewski;R Halaban;FS Hodi;R Kefford;JM Kirkwood;J Larkin;S Leachman;M Maio;R Marais;G Masucci;I Melero;G Palmieri;A Puzanov;A Ribas;Y Saenger;B Schilling;B Seliger;D Stroncek;R Sullivan;A Testori;E Wang;G Ciliberto;N Mozzillo;FM Marincola;M Thurin Journal of Translational Medicine Oct 28;12(1):277

PMid: PMID25348889 | PMC number: PMC4232645

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Research Committee(s)
Symptom Control and Quality of Life