Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery (NCT01134614)

🧪 Interventions in This Study

• Ipilimumab (BIOLOGICAL)
• Sargramostim (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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)
2. 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 setting
3. Histologic diagnosis of metastatic melanoma; for unknown primary disease, diagnosis of metastatic disease by cytology fine needle aspiration (FNA) is not acceptable
4. 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
5. White blood cells (WBC) \>= 2000/uL (obtained =\< 4 weeks prior to randomization)
6. Absolute neutrophil count (ANC) \>= 1500/mcL (obtained =\< 4 weeks prior to randomization)
7. Platelets \>= 100,000/mcL (obtained =\< 4 weeks prior to randomization)
8. Hemoglobin \>= 8 g/dL (obtained =\< 4 weeks prior to randomization)
9. Creatinine =\< 3.0 x upper limit of normal (ULN) (obtained =\< 4 weeks prior to randomization)
10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN (obtained =\< 4 weeks prior to randomization)
11. 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)
12. 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (257 Sites)

Showing the first 25 of 257 sites.

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
• Stanford Cancer Institute Palo Alto — Palo Alto, California
• VA Palo Alto Health Care System — Palo Alto, California
• Eisenhower Medical Center — Rancho Mirage, California
• The Medical Center of Aurora — Aurora, Colorado
• Boulder Community Foothills Hospital — Boulder, Colorado
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado
• AdventHealth Porter — Denver, Colorado
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado
• Saint Joseph Hospital - Cancer Centers of Colorado — Denver, Colorado
• Rose Medical Center — Denver, Colorado
• Western States Cancer Research NCORP — Denver, Colorado
• Swedish Medical Center — Englewood, Colorado
• Poudre Valley Hospital — Fort Collins, Colorado
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado
• Banner North Colorado Medical Center — Greeley, Colorado
• CommonSpirit Saint Anthony Hospital Cancer Center — Lakewood, Colorado
• Sky Ridge Medical Center — Lone Tree, Colorado
• Longmont United Hospital — Longmont, Colorado
• Banner North Colorado Medical Center - Loveland Campus — Loveland, Colorado
• Saint Mary Corwin Medical Center — Pueblo, Colorado
• North Suburban Medical Center — Thornton, Colorado
• Intermountain Health Lutheran Hospital — Wheat Ridge, Colorado
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut
• Manchester Memorial Hospital — Manchester, Connecticut

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Advanced Melanoma

• Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors — St Louis, Missouri
• FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma — Charlottesville, Virginia
• Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) — Phoenix, Arizona
• Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial — Fairhope, Alabama
• Naltrexone and Propranolol Combined With Immunotherapy — New Brunswick, New Jersey

Explore by condition: All Advanced Melanoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.