High-Dose Recombinant Interferon Alfa-2B, Ipilimumab, or Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/24/2017
Start Date:October 15, 2015
End Date:June 1, 2020

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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

This randomized phase III trial studies how well high-dose recombinant interferon alfa-2B or
ipilimumab works compared with pembrolizumab in treating patients with stage III-IV melanoma
that has been removed by surgery but is likely to come back or spread. High-dose recombinant
interferon alfa-2B may help shrink or slow the growth of melanoma. Monoclonal antibodies,
such as ipilimumab and pembrolizumab, may block tumor growth in different ways by targeting
certain cells. It is not yet known whether high-dose recombinant interferon alfa-2B or
ipilimumab is more effective than pembrolizumab in treating patients with melanoma.

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) of patients with resected stage III and IV melanoma
treated with physician/patient choice of either high dose interferon alfa-2b (recombinant
interferon alfa-2b) or ipilimumab versus MK-3475 (pembrolizumab).

II. Among patients who are PD-L1 positive, to compare OS of patients with resected stage III
and IV melanoma treated with physician/patient choice of either high dose interferon alfa-2b
or ipilimumab versus MK-3475 (pembrolizumab).

III. To compare relapse-free survival (RFS) of patients with resected stage III and IV
melanoma treated with physician/patient choice of either high dose interferon alfa-2b or
ipilimumab to MK-3475 (pembrolizumab).

IV. Among patients who are PD-L1 positive, to compare RFS of patients with resected stage III
and IV melanoma treated with physician/patient choice of either high dose interferon alfa-2b
or ipilimumab to MK-3475 (pembrolizumab).

SECONDARY OBJECTIVES:

I. To estimate OS and RFS for patients who are PD-L1 negative or PD-L1 indeterminate in this
population.

II. To compare OS and RFS of patients between the two arms within PD-L1 positive and negative
subgroups and to look at the interaction between PD-L1 (positive versus negative) and
treatment arm.

III. To assess the safety and tolerability of the regimens.

TERTIARY OBJECTIVES:

I. To bank tissue and whole blood in anticipation of future correlative studies in this
patient population.

II. To evaluate PD-L1 expression through immunohistochemistry assay. III. To evaluate the
effect of treatment-related side effects that may have an impact on the health-related
domains of quality of life (QOL) using the Functional Assessment of Cancer Therapy
(FACT)-Biological Response Modifiers (BRM), European Quality of Life Five Dimension Three
Level Scale (EQ-5D-3L), and Functional Assessment of Chronic Illness Therapy Diarrhea
(FACIT-D) between patients treated with physician/patient choice of either high-dose
interferon alfa-2b or ipilimumab and MK-3475 (pembrolizumab).

IV. Pharmacokinetic (PK) and anti-drug antibody (ADA) testing will be performed on all
patients receiving MK-3475 (pembrolizumab). These analyses will evaluate: exposure-response
analyses for activity and efficacy, potential pharmacodynamic biomarkers, and the safety of
MK-3475 (pembrolizumab).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I:

INDUCTION THERAPY: Patients receive high-dose recombinant interferon alfa-2B intravenously
(IV) over 20 minutes on days 1-5. Treatment repeats weekly for 4 weeks in the absence of
disease progression or unacceptable toxicity. Or patients receive ipilimumab IV over 90
minutes on day 1. Treatment repeats every 3 weeks for a total of 4 courses in the absence of
disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive high-dose recombinant interferon alfa-2B subcutaneously
(SC) on days 1, 3, and 5. Treatment repeats every 6 weeks for up to 48 weeks in the absence
of disease progression or unacceptable toxicity. Or patients receive ipilimumab IV over 90
minutes on day 1. Treatment repeats every 12 weeks for 3 years in the absence of disease
progression or unacceptable toxicity.

ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3
weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, 6 and 12 weeks,
every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.

Inclusion Criteria:

- STEP 1 REGISTRATION:

- Patients must have completely resected melanoma of cutaneous origin or of unknown
primary in order to be eligible for this study; patients must be classified as stage
IIIA (N2a), IIIB, IIIC, or stage IV melanoma; patients with non-ulcerated T1b N1a
disease are not eligible; patients with melanoma of mucosal or other non-cutaneous
origin are eligible; patients with melanoma of ocular origin are not eligible;
patients with a history of brain metastases are ineligible

- Patients are eligible for this trial either at initial presentation of their melanoma
or at the time of the 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 a prior complete
lymphadenectomy basin must have been confirmed histologically by hematoxylin and eosin
(H & E) stained slides

- Patients with multiple regional nodal basin involvement are eligible; gross or
microscopic extracapsular nodal extension is permitted

- Patients at initial presentation of melanoma must undergo an adequate wide excision of
the primary lesion, if present; patients with previously diagnosed melanoma must have
had all current disease resected with pathologically negative margins and must have no
evidence of disease at the primary site or must undergo re-resection of the primary
site; a full lymphadenectomy meeting the criteria outlined is required for all
node-positive patients including those with positive sentinel nodes; patients with
recurrent disease who have had a prior complete lymphadenectomy fulfill this
requirement as long as all recurrent disease has been resected; for all patients, all
disease must have been resected with negative pathological margins and no clinical,
radiologic, or pathological evidence of any incompletely resected melanoma; patients
must be registered within 98 days of the last surgery performed to render the patient
free of disease; patients must be registered within 98 days of the last surgery
performed to render the patient free of disease

- Patients must have available and be willing to submit a minimum of five unstained
slides from primary, lymph node, or metastatic site to determine PD-L1 expression; the
tumor tissue must be adequate for PD-L1 testing (defined as >= 100 tumor cells as
confirmed by the treating institution's local pathologist); this must be documented by
having a pathologist sign the S1404 Local Pathology Review form prior to step 1
registration; the specimens may come from an archived block but must be submitted
within 20 days from cutting the slides

- Patients must be offered the opportunity to participate in specimen banking as
outlined

- Patients must be willing to have blood draws for PK/ADA analysis as outlined, should
the patient be randomized to the MK-3475 arm

- Patients may have received prior radiation therapy, including after the surgical
resection; all adverse events associated with prior surgery and radiation therapy must
have resolved to =< grade 1 prior to registration

- Patients must not have received neoadjuvant treatment for their melanoma; patients
must not have had prior immunotherapy including, but not limited to ipilimumab,
interferon alfa-2b, high dose IL-2, pegylated (PEG)-IFN, anti-PD-1, anti-PD-L1
intra-tumoral, or vaccine therapies; patients must not be planning to receive any of
the prohibited therapies during the screening or treatment phases of the study

- Patients must not be planning to receive concomitant other biologic therapy, radiation
therapy, hormonal therapy, other chemotherapy, surgery or other therapy after step 2
registration

- All patients must have disease-free status documented by a complete physical
examination and imaging studies within 42 days prior to registration; imaging studies
must include a total body positron emission tomography (PET)-computed tomography (CT)
scan that is of diagnostic quality (with or without brain) or a CT of the chest,
abdomen and pelvis; for patients with melanoma arising from the head and neck,
dedicated neck imaging (CT with IV contrast or PET-CT through the region) is required;
if the patient has had unknown primary with disease in the axilla, neck imaging is
required to assure region is clear of cancer; CT imaging should be done with
intravenous contrast if there are no contraindications for it; any other
clinically-indicated imaging studies if performed (e.g. bone scan) must show no
evidence of disease

- All patients must have a CT or magnetic resonance imaging (MRI) of the brain within 90
days prior to registration; the brain CT or MRI should be performed with intravenous
contrast (unless contraindicated)

- Absolute neutrophil count (ANC) >= 1,500 microliter (mcL)

- Platelets >= 100,000 mcL

- Hemoglobin >= 10 g/dL

- Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's
syndrome, who must have a total bilirubin < 3.0 mg/dL)

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2 x
IULN

- Alkaline phosphatase =< 2 x IULN

- Serum creatinine =< IULN OR measured or calculated creatinine clearance >= 60 mL/min

- Patients must have lactate dehydrogenase (LDH) performed within 42 days prior to
registration

- Patients must have Zubrod performance status =< 1

- Patients must have a baseline electrocardiogram (ECG) performed within 42 days of
registration that is normal or considered not clinically significant by the site
investigator

- Patients must not have a history of (non-infectious) pneumonitis that required
steroids or current pneumonitis

- Patients must not have an active infection requiring systemic therapy

- Patients must not have active autoimmune disease that has required systemic treatment
in past 2 years (i.e., with use of disease modifying agents, corticosteroids or
immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency,
etc.) is not considered a form of systemic treatment

- Patients must not have received live vaccines within 42 days prior to registration;
examples of live vaccines include, but are not limited to, the following: measles,
mumps, rubella, chicken pox, shingles, yellow fever, rabies, bacillus Calmette-Guerin
(BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are
generally killed virus vaccines and are allowed; however, intranasal influenza
vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

- Patients known to be human immunodeficiency virus (HIV) positive are eligible if they
meet the following criteria within 30 days prior to registration: stable and adequate
cluster of differentiation 4 (CD4) counts (>= 350 mm^3), and serum HIV viral load of <
25,000 IU/ml; patients may be on or off anti-viral therapy so long as they meet the
CD4 count criteria

- Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV)
infection prior to registration

- Patients must not have a history or current evidence of any condition, therapy or
laboratory abnormality that might confound the trial results, interfere with the
patient's participation for the full duration of the trial, or indicate that
participation in the trial is not in the patient's best interests, in the opinion of
the treating investigator

- No other prior malignancy is allowed except for the following: 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 (including multiple primary melanomas) from which the
patient is currently in complete remission, or any other cancer from which the patient
has been disease free for three years

- Women of childbearing potential must have a negative urine or serum pregnancy test
within 28 days prior to registration; women/men of reproductive potential must have
agreed to use an effective contraceptive method for the course of the study through
120 days after the last dose of study medication; should a woman become pregnant or
suspect she is pregnant while she or her partner is participating in this study, she
should inform her treating physician immediately; a woman is considered to be of
"reproductive potential" if she has had menses at any time in the preceding 12
consecutive months; in addition to routine contraceptive methods, "effective
contraception" also includes heterosexual celibacy and surgery intended to prevent
pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
bilateral oophorectomy, or bilateral tubal ligation; however, if at any point a
previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures, he/she is responsible for beginning
contraceptive measures; patients must not be pregnant or nursing

- Patients who are able to complete questionnaires in English, Spanish or French must
participate in the quality of life assessments; (those patients who cannot complete
the quality of life questionnaires in English, Spanish or French can be registered to
S1404 without contributing to the quality of life studies)

- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent for this protocol in accordance with institutional
and federal guidelines

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system

- STEP 2 REGISTRATION (RANDOMIZATION CRITERIA):

- Patients must not be registered until receiving confirmation from the Southwest
Oncology Group (SWOG) Statistical Center that the patient's tissue specimen was
adequate for PD-L1 testing; patients must be registered within 7 working days of
receiving the e-mail notification

- Women of childbearing potential must plan to have a urine or serum pregnancy test
within 72 hours prior to receiving the first dose of study medication; if the urine
test is positive or cannot be confirmed as negative, a negative serum pregnancy test
will be required

- No tests or exams are required to be repeated for step 2 registration (randomization);
however, patients who are known to have a change in eligibility status after step 1
registration are not eligible for step 2 registration; for example, ANC is not
required to be repeated between step 1 and step 2 registration, but the most recent
ANC performed before step 2 registration is required to be >= 1,500 mcL
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: James L. Wade
Phone: 309-243-3605
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Bloomington, IL
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Boise, Idaho 83706
Principal Investigator: Christopher M. Reynolds
Phone: 208-367-7954
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Boise, ID
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, ID
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Bonne Terre, Missouri 63628
Principal Investigator: James L. Wade
Phone: 309-243-3605
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from
Bonne Terre, MO
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Boone, Iowa 50036
Principal Investigator: Joseph J. Merchant
Phone: 515-239-2621
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Boone, IA
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Elizabeth I. Buchbinder
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Elizabeth I. Buchbinder
Phone: 877-442-3324
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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from
Boston, MA
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Boston, Massachusetts 02118
Principal Investigator: Adam Lerner
Phone: 617-638-8265
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Boston, MA
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Bozeman, MT
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Brewer, Maine 04412
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
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Brewer, ME
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Bridgeport, West Virginia 26330
Principal Investigator: Inderjit Mehmi
Phone: 304-293-7374
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Bridgeport, WV
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Burlington, Massachusetts 01805
Principal Investigator: Krishna S. Gunturu
Phone: 781-744-8027
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Burlington, MA
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Burlington, Vermont 05405
Principal Investigator: Christopher J. Anker
Phone: 802-656-4101
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Burlington, VT
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Burlington, Wisconsin 53105
Principal Investigator: Manish K. Pant
Phone: 414-649-5717
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Burlington, WI
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Principal Investigator: David M. King
Phone: 952-993-1517
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Burnsville, MN
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400 South Clark Street
Butte, Montana 59701
406-723-2500
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
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Butte, MT
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
Principal Investigator: James L. Wade
Phone: 309-243-3605
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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Canton, IL
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: James L. Wade
Phone: 309-243-3605
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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Cape Girardeau, MO
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Principal Investigator: James L. Wade
Phone: 309-243-3605
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Cape Girardeau, MO
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1303 North Main Street
Cedar City, Utah 84721
(435) 868-5680
Principal Investigator: Tawnya L. Bowles
Phone: 801-507-3950
Sandra L. Maxwell Cancer Center The Huntsman-Intermountain Cancer Center at Valley View Medical Center in...
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Cedar City, UT
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Cedar Rapids, Iowa 52401
Principal Investigator: William P. Fusselman
Phone: 319-297-2900
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Cedar Rapids, IA
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Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Centerville, OH
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Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Centerville, OH
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Centralia, Illinois 62801
Principal Investigator: James L. Wade
Phone: 309-243-3605
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from
Centralia, IL
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Centralia, Washington 98531
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Centralia, WA
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Chanute, KS
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Charleston, South Carolina 29401
Principal Investigator: Steven A. Akman
Phone: 843-720-8386
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Charleston, SC
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Charleston, South Carolina 29403
Principal Investigator: Steven A. Akman
Phone: 843-720-8386
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Charleston, SC
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Charleston, South Carolina 29406
Principal Investigator: Steven A. Akman
Phone: 843-720-8386
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Charleston, SC
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Charleston, South Carolina 29414
Principal Investigator: Steven A. Akman
Phone: 843-720-8386
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Charleston, SC
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Charleston, South Carolina 29414
Principal Investigator: Steven A. Akman
Phone: 843-720-8386
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Charleston, SC
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Charleston, South Carolina 29414
Principal Investigator: Steven A. Akman
Phone: 843-720-8386
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Charleston, SC
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Charleston, West Virginia 25304
Principal Investigator: Steven J. Jubelirer
Phone: 304-388-9944
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Charleston, WV
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Jason J. Luke
Phone: 773-834-7424
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Chicago, IL
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Sunandana Chandra
Phone: 312-695-1301
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Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Timothy M. Kuzel
Phone: 312-942-5498
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Principal Investigator: Timothy D. Moore
Phone: 614-488-2745
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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Chillicothe, OH
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12961 27th Ave
Chippewa Falls, Wisconsin 54729
715-738-3700
Principal Investigator: Seth O. Fagbemi
Phone: 800-347-0673
Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
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Chippewa Falls, WI
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Cincinnati, Ohio 45219
Principal Investigator: John C. Morris
Phone: 513-558-4553
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Cincinnati, OH
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Bruce J. Averbook
Phone: 216-778-8526
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Aaron T. Gerds
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Principal Investigator: Aaron T. Gerds
Phone: 866-223-8100
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
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Cleveland, OH
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