Nivolumab and Ipilimumab With or Without Sargramostim in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery



Status:Suspended
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/16/2017
Start Date:September 10, 2015

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Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients With Unresectable Stage III or Stage IV Melanoma

This randomized phase II/III trial studies the side effects and best dose of nivolumab and
ipilimumab when given together with or without sargramostim and to see how well they work in
treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal
antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to
the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific
tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as
sargramostim, may increase the production of white blood cells. It is not yet known whether
nivolumab and ipilimumab are more effective with or without sargramostim in treating patients
with melanoma.

PRIMARY OBJECTIVES:

I. To compare the overall survival (OS) of nivolumab/ipilimumab/sargramostim (GM-CSF) versus
nivolumab/ipilimumab.

SECONDARY OBJECTIVES:

I. To evaluate progression free survival (PFS) of patients treated with
nivolumab/ipilimumab/GM-CSF versus nivolumab/ipilimumab.

II. To assess for differences in tolerability, specifically the rate of grade III or higher
adverse events, between nivolumab/ipilimumab/GM-CSF versus nivolumab/ipilimumab.

III. To evaluate immune-related response rate (based on immune-related response criteria and
response rate (based on Response Evaluation Criteria in Solid Tumors [RECIST] criteria) and
to compare them.

TERTIARY OBJECTIVES:

I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other
forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported
cancer-treatment toxicity (adverse events [both clinical and hematologic] and dose
modifications).

II. To determine the effects of tobacco on patient-reported physical symptoms and
psychological symptoms.

III. To examine quitting behaviors and behavioral counseling/support and cessation medication
utilization.

IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose
intensity, and therapeutic benefit.

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

ARM I: INDUCTION THERAPY: Patients receive nivolumab intravenously (IV) over 60 minutes on
day 1, ipilimumab IV over 90 minutes on day 1, and sargramostim subcutaneously (SC) on days
1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive nivolumab and sargramostim as in Induction therapy.
Patients with partial response (PR), stable disease (SD), or complete response (CR) at 24
weeks may continue maintenance therapy for up to 2 years in the absence of disease
progression or unacceptable toxicity.

ARM II: INDUCTION THERAPY: Patients receive nivolumab and ipilimumab as in Arm I. Treatment
repeats every 21 days for 4 courses in the absence of disease progression or unacceptable
toxicity.

MAINTENANCE THERAPY: Patients receive nivolumab as in Induction therapy. Patients with PR,
SD, or CR at 24 weeks may continue maintenance therapy for up to 2 years in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1

- Patients must have known v-raf murine sarcoma viral oncogene homolog B1 (BRAF)
mutational status of tumor; wild-type (WT) or mutated, prior to randomization

- Women must not be pregnant or breast-feeding; all females of childbearing potential
must have a blood test or urine study within 2 weeks prior to randomization to rule
out pregnancy; a female of childbearing potential is any woman, regardless of sexual
orientation or whether they have undergone tubal ligation, who meets the following
criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not
been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses
at any time in the preceding 24 consecutive months)

- Women of childbearing potential and sexually active males must be strongly advised to
use an accepted and effective method of contraception or to abstain from sexual
intercourse for at least one week prior to the start of the research study, and
continuing for 5 months for women of childbearing potential and 7 months for sexually
active males after the last dose of the study drugs

- Patients must have unresectable stage III or stage IV melanoma; patients must have
histological or cytological confirmation of melanoma that is metastatic or
unresectable and clearly progressive

- Patients must have measurable disease per RECIST 1.1 criteria; all sites of disease
must be evaluated within 4 weeks prior to randomization

- Patients may have had prior systemic therapy in the adjuvant setting (e.g. interferon,
BRAF, or mitogen-activated protein kinase [MEK] agents); patients may have had prior
anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) in the adjuvant setting, if at least
one year from last dose of treatment has passed prior to beginning treatment; patients
may not have had any prior programmed cell death (PD)-1/PD-ligand (PD-L)1 agent in the
adjuvant setting

- Patients may not have had any prior ipilimumab and/or anti-PD-1/PD-L1 agent in the
metastatic setting

- Patients must have discontinued chemotherapy, immunotherapy or other investigational
agents used in the adjuvant setting >= 4 weeks prior to randomization and recovered
from adverse events due to those agents; mitomycin and nitrosoureas must have been
discontinued at least 6 weeks prior to entering the study; patients must have
discontinued radiation therapy >= 2 weeks prior to entering the study and recovered
from any adverse events associated with treatment; prior surgery must be >= 4 weeks
from randomization and patients must be fully recovered from post-surgical
complications

- Patients must not receive any other investigational agents while on study or within
four weeks prior to randomization

- Patients are excluded for receiving any non-oncology vaccine therapy used for
prevention of infectious diseases for up to four weeks (28 days) prior to or after any
dose of ipilimumab; NOTE: Patients are permitted to receive the seasonal influenza
vaccine; if seasonal influenza vaccine is considered, killed vaccines should be
recommended

- Patients are ineligible if they have any currently active central nervous system (CNS)
metastases; patients who have treated brain metastases (with either surgical resection
or stereotactic radiosurgery) that have been stable on head magnetic resonance imaging
(MRI) or contrast computed tomography (CT) scan for at least 4 weeks following
treatment and within 4 weeks prior to randomization are eligible; patients must not
have taken any steroids =< 14 days prior to randomization for the purpose of managing
their brain metastases; patients with only whole brain irradiation for treatment of
CNS metastases will be ineligible

- Patients must not have other current malignancies, other than basal cell skin cancer,
squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in
situ of the breast; patients with other malignancies are eligible if they have been
continuously disease-free for > 3 years prior to the time of randomization

- White blood count >= 3,000/uL

- Absolute neutrophil count (ANC) >= 1,500/uL

- Platelet count >= 100,000/uL

- Hemoglobin >= 9 g/dL

- Serum creatinine =< 1.5 x upper limit of normal (ULN) or serum creatinine clearance
(CrCl) >= 40 ml/min

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x
ULN for patients with documented liver metastases)

- Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement
and =< 7 x ULN for patients with known bone involvement)

- Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those
with known Gilbert's syndrome

- Serum lactate dehydrogenase (LDH) =< 10 X ULN

- Patients must not have any serious or unstable pre-existing medical conditions (aside
from malignancy exceptions specified above), including but not limited to, ongoing or
active infection requiring parenteral antibiotics on day 1, history of bleeding
diathesis or need for concurrent anticoagulation (international normalized ratio [INR]
=< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric
illness/social situations that would limit compliance with study requirements,
interfere with subject's safety, or obtaining informed consent

- Patients with human immunodeficiency virus (HIV) infection are ineligible

- Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV)
infection are not eligible; patients with cleared HBV and HCV (0 viral load) infection
will be allowed

- Patients must not have autoimmune disorders or conditions of immunosuppression that
require current ongoing treatment with systemic corticosteroids (or other systemic
immunosuppressants), including oral steroids (e.g., prednisone, dexamethasone) or
continuous use of topical steroid creams or ointments or ophthalmologic steroids; a
history of occasional (but not continuous) use of steroid inhalers is allowed;
replacement doses of steroids for patients with adrenal insufficiency are allowed;
patients who discontinue use of these classes of medication for at least 2 weeks prior
to randomization are eligible if, in the judgment of the treating physician
investigator, the patient is not likely to require resumption of treatment with these
classes of drugs during the study

- Exclusion from this study also includes patients with a history of symptomatic
autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis
[scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis
[e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin
(e.g., Guillain-Barre syndrome and myasthenia gravis); other CNS autoimmune disease
(e.g., multiple sclerosis)

- Patients with autoimmune hypothyroid disease or type I diabetes on replacement
treatment are eligible

- Patients must not have a history of inflammatory bowel disease or diverticulitis
(history of diverticulosis is allowed)

- Patients must not have other significant medical, surgical, or psychiatric conditions
or require any medication or treatment that in the opinion of the investigator may
interfere with compliance, make the administration of the study drugs hazardous or
obscure the interpretation of adverse events (AEs), such as a condition associated
with frequent diarrhea; patients must not have an active infection requiring current
treatment with parenteral antibiotics
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1600 South Canton Center Road
Canton, Michigan 48188
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-4673
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Canton, MI
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: James L. Wade
Phone: 217-876-4740
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: 217-876-4740
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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401 North Hooper Street
Caro, Michigan 48723
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-4673
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Caro, MI
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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: 217-876-4740
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Centralia, IL
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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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775 South Main Street
Chelsea, Michigan 48118
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-4673
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Chelsea, MI
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14650 East Old US Highway 12
Chelsea, Michigan 48118
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-4673
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Chelsea, MI
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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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12961 27th Ave
Chippewa Falls, Wisconsin 54729
715-738-3700
Principal Investigator: Seth O. Fagbemi
Phone: 715-389-4457
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 45202
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45211
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45230
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45236
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45242
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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5680 Bow Pointe Drive
Clarkston, Michigan 48346
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-4673
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Clarkston, MI
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31500 Telegraph Road
Clarkston, Michigan 48346
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-4673
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Clarkston, MI
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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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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Henry B. Koon
Phone: 800-641-2422
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Cleveland, OH
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Clinton, North Carolina 28328
Principal Investigator: James N. Atkins
Phone: 919-580-0000
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Clinton, NC
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
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Coeur d'Alene, ID
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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Colorado Springs, CO
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810 Jasonway Avenue
Columbus, Ohio 43214
614/442-3130
Principal Investigator: Timothy D. Moore
Phone: 614-488-2745
Columbus Oncology and Hematology Associates Inc Columbus Oncology and Hematology Associates is a group of...
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Columbus, OH
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Principal Investigator: Timothy D. Moore
Phone: 614-488-2745
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Columbus, OH
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Principal Investigator: David M. King
Phone: 952-993-1517
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Coon Rapids, MN
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Cooperstown, New York 13326
Principal Investigator: Eric Bravin
Phone: 607-547-3073
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Cooperstown, NY
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