Clinical Trials

6 studies in Melanoma

1. Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma Rochester, MN View Summary
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   Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: - To collect clinical history, family history, and blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, pancreatic cancer, or melanoma. - To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers. OUTLINE: Study participants undergo collection of blood and/or tissue samples as well as survey data for inclusion in a familial data and tissue registry. Participants complete two baseline surveys regarding their personal, family, health, and environmental exposure histories and regarding their opinions on cancer and cancer screening. Patients also complete a follow-up survey at 1 year and undergo review of their medical records.

   NCT ID:

   NCT00835133

   IRB Number:

   355-06

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   
   

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2. Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III or Stage IV Melanoma That Has Been Removed by Surgery Jacksonville, FL View Summary
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   Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III or Stage IV Melanoma That Has Been Removed by Surgery

   Location:

   Jacksonville, FL

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (high dose ipilimumab; HIP) or 3 mg/kg (low dose ipilimumab: LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). II. To evaluate overall survival (OS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (HIP) or 3 mg/kg (LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). SECONDARY OBJECTIVES: I. To evaluate safety and tolerability of post-operative adjuvant ipilimumab therapy given at either 10 mg/kg (HIP) or 3 mg/kg (LIP). II. Among patients enrolled by CCOPs, to compare the global QOL between the ipilimumab arms versus HDI using FACT-G form and to evaluate the effect of treatment-related side effects that may have an impact on the health-related domains of QOL using FACIT-D and FACT-BRM. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive induction ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive induction high-dose recombinant interferon alfa-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alfa-2b subcutaneously on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 15 years.

   NCT ID:

   NCT01274338

   IRB Number:

   11-005866

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   Who can I contact for additional information about this study?

   
   
   Jacksonville: Richard W. Joseph 507-538-7623
                       
   

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3. A Phase 3 Study Comparing GDC-0973, a MEK Inhibitor, in Combination With Vemurafenib vs Vemurafenib Alone in Patients With Metastatic Melanoma Rochester, MN View Summary
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   A Phase 3 Study Comparing GDC-0973, a MEK Inhibitor, in Combination With Vemurafenib vs Vemurafenib Alone in Patients With Metastatic Melanoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This multicenter, randomized, double-blind, placebo-controlled phase 3 study will evaluate the safety and efficacy of vemurafenib alone and vemurafenib in combination with GDC-0973, a MEK inhibitor, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma. Patients will be randomized to one of two treatment arms, Arm A: vemurafenib 960 mg twice a day (days 1-28 of each cycle) and placebo (days 1-21 of each cycle); Arm B: vemurafenib 960 mg twice a day (days 1-28 of each cycle) and GDC-0973 60 mg once daily (days 1-21 of each cycle). Patients will receive treatment until disease progression, unacceptable toxicity or withdrawal of consent.

   NCT ID:

   NCT01689519

   IRB Number:

   12-009030

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4. Study of MK-3475 Versus Chemotherapy in Participants With Advanced Melanoma (P08719/MK-3475-002) Rochester, MN View Summary
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   Study of MK-3475 Versus Chemotherapy in Participants With Advanced Melanoma (P08719/MK-3475-002)

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This study is being done to compare survival using MK-3475 or standard chemotherapy for participants with advanced melanoma (MEL) who have progressed after prior therapy. Participants will be randomized to receive either low dose MK-3475, higher dose MK-3475, or Investigator-choice chemotherapy. The MK-3475 dose will be blinded to Investigators and participants. The randomization to either MK-3475 or Investigator choice chemotherapy will be conducted in open-label fashion. The five standard chemotherapy choices are carboplatin + paclitaxel, carboplatin alone, paclitaxel alone, dacarbazine, or temozolomide.

   NCT ID:

   NCT01704287

   IRB Number:

   12-007337

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5. Ipilimumab With or Without Talimogene Laherparepvec in Unresectable Melanoma Rochester, MN View Summary
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   Ipilimumab With or Without Talimogene Laherparepvec in Unresectable Melanoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone. Talimogene laherparepvec will be administered by intratumor injection, and ipilimumab will be administered by intravenous infusion for a total of 4 infusions. Subjects will be treated with talimogene laherparepvec until complete response, all injectable tumors have disappeared, disease progression per a modified Immune-Related Response Criteria (irRC), or intolerance of study treatment.

   NCT ID:

   NCT01740297

   IRB Number:

   12-007178

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6. Granulocyte Macrophage-Colony Stimulating Factor and Ipilimumab as Therapy in Melanoma Rochester, MN View Summary
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   Granulocyte Macrophage-Colony Stimulating Factor and Ipilimumab as Therapy in Melanoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The study is an open-label, single arm single Center Phase II study to evaluate the safety and efficacy of the combination of Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF, Leukine) and Ipilimumab (Yervoy) as therapy for patients with unresectable metastatic malignant melanoma. The patient sample will be approximately 43 evaluable individuals, males and females 18 years of age or older with measurable metastatic melanoma. Immunologic testing will be done to evaluate correlation with clinical outcome. Patients will be treated with 4 courses of GM-CSF and ipilimumab administered every 3 weeks. GM-CSF will be administered subcutaneously daily for 14 days in a dose of 125 µg/m2 beginning on D1 of each 21-day cycle. Ipilimumab intravenously in a dose of 10 mg/kg, with appropriate stopping/de-escalation rules. After the initial 3 months (4 cycles) of treatment, GM-CSF administration will continue for 4 additional cycles on the same schedule and dose without ipilimumab for 14 days every 21 days until month 6. Maintenance therapy will begin at month 6 and will consist of ipilimumab in the same dose administered at the end of cycle 4 combined with 14 days of GM-CSF. Administration of this combination will be repeated every 3 months for up to 2 years or until disease progression, whichever occurs first. During the maintenance phase, GM-CSF will only be administered for 14 days in conjunction with ipilimumab and will not be administered in the intervening time period.

   NCT ID:

   NCT01363206

   IRB Number:

   12-003707

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   Who can I contact for additional information about this study?

   Rochester: Svetomir Markovic, MD, PhD 507-538-7623
                       Lisa Kottschade, RN, MSN, CNP 507-538-7888
   
   
   

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