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

Not Recruiting

Trial ID: NCT01134614


This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.

Official Title

A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients With Advanced Melanoma

Stanford Investigator(s)

Susan M. Swetter, MD
Susan M. Swetter, MD

Professor of Dermatology

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery


Inclusion Criteria:

   - All sites of disease must be evaluated within 4 weeks prior to randomization; patients
   must have measurable disease as defined by Response Evaluation Criteria in Solid
   Tumors (RECIST)

   - No more than one prior systemic therapeutic regimen for unresectable stage III or
   stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or
   investigational treatment; this does not include any therapies given in the adjuvant

   - Histologic diagnosis of metastatic melanoma; for unknown primary disease, diagnosis of
   metastatic disease by cytology fine needle aspiration (FNA) is not acceptable

   - Women must not be pregnant or breast-feeding due to unknown effects of ipilimumab and
   GM-CSF on the unborn fetus; all women of childbearing potential must have a blood test
   within 72 hours prior to randomization to rule out pregnancy; women of childbearing
   potential and sexually active males must be strongly advised to use an accepted and
   effective method of contraception; women of childbearing potential (WOCBP) must be
   using an adequate method of contraception to avoid pregnancy throughout the study and
   for up to 12 weeks after the last dose of investigational product, in such a manner
   that the risk of pregnancy is minimized; sexually mature females who have not
   undergone a hysterectomy or who have not been postmenopausal naturally for at least 24
   consecutive months (i.e., who have had menses at some time in the preceding 24
   consecutive months) are considered to be of childbearing potential; women who are
   using oral contraceptives, other hormonal contraceptives (vaginal products, skin
   patches, or implanted or injectable products), or mechanical products such as an
   intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent
   pregnancy, or are practicing abstinence or where their partner is sterile (e.g.,
   vasectomy) should be considered to be of childbearing potential

   - White blood cells (WBC) >= 2000/uL (obtained =< 4 weeks prior to randomization)

   - Absolute neutrophil count (ANC) >= 1500/mcL (obtained =< 4 weeks prior to

   - Platelets >= 100,000/mcL (obtained =< 4 weeks prior to randomization)

   - Hemoglobin >= 8 g/dL (obtained =< 4 weeks prior to randomization)

   - Creatinine =< 3.0 x upper limit of normal (ULN) (obtained =< 4 weeks prior to

   - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
   (obtained =< 4 weeks prior to randomization)

   - Bilirubin =< 3.0 x ULN, (except patients with Gilbert's syndrome, who must have a
   total bilirubin less than 3.0 mg/dL) (obtained =< 4 weeks prior to randomization)

   - No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or
   other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive
   agents; other investigation therapies; or chronic use of systemic corticosteroids;
   must have been discontinued >= 4 weeks

   - No infection with human immunodeficiency virus (HIV); due to the mechanism of action
   of ipilimumab and GM-CSF, activity and side effects in an immune compromised patient
   are unknown

   - No active infection with hepatitis B

   - No active or chronic infection with hepatitis C

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

Exclusion Criteria:

   - Patients with any history of central nervous system (CNS) metastases are excluded

   - Patients are excluded if they have a history of any other malignancy from which the
   patient has been disease-free for less than 2 years, with the exception of adequately
   treated and cured basal or squamous cell skin cancer, superficial bladder cancer or
   carcinoma in situ of the cervix

   - Patients are excluded if they have a history of any autoimmune disease; patients with
   a history of autoimmune thyroiditis are eligible if their current thyroid disorder is
   treated and stable with replacement or other medical therapy

   - Patients are excluded for any underlying medical or psychiatric condition, which in
   the opinion of the investigator, will make the administration of study drug hazardous
   or obscure the interpretation of adverse events, such as a condition associated with
   frequent diarrhea

   - 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

   - Patients are excluded if they have a history of prior treatment with ipilimumab or
   prior cluster of differentiation (CD)137 agonist or cytotoxic T-lymphocyte antigen 4
   (CTLA-4) inhibitor or agonist

   - Any concurrent medical condition requiring the use of systemic steroids is not
   permitted (the use of inhaled or topical steroids is permitted)


biological: ipilimumab

biological: sargramostim

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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