A Phase I/II Open-Label Study of Ipilimumab & GM-CSF Administered to

Clinical Trial Summary

The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which cannot be removed by surgery.

See also
Status	Clinical Trial	Phase
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Active, not recruiting	`NCT05470283` - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma	Phase 1
Recruiting	`NCT05388877` - E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma	Phase 1
Active, not recruiting	`NCT05103891` - Relative Bioavailability of Binimetinib 3 x 15 mg and 45 mg Formulations	Phase 1
Completed	`NCT00414765` - Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma	Phase 4
Completed	`NCT02857270` - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer	Phase 1
Completed	`NCT01621490` - PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma	Phase 1
Recruiting	`NCT05779423` - Cryoablation+Ipilimumab+Nivolumab in Melanoma	Phase 2
Active, not recruiting	`NCT04940299` - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma	Phase 2
Active, not recruiting	`NCT02278887` - Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma	Phase 3
Active, not recruiting	`NCT02360579` - Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma	Phase 2
Terminated	`NCT02521870` - A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma	Phase 1/Phase 2
Completed	`NCT02177110` - A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
Withdrawn	`NCT01340729` - Open-Label Study of TPI 287 for Patients With Metastatic Melanoma	Phase 1/Phase 2
Withdrawn	`NCT01416844` - Study of Immune Responses in Patients With Metastatic Melanoma	Phase 2
Terminated	`NCT01468818` - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma	Phase 2
Completed	`NCT00984464` - Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma	Phase 2
Completed	`NCT00631618` - Clinical Trial of Sutent to Treat Metastatic Melanoma	Phase 2
Terminated	`NCT00571116` - Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy	Phase 1
Recruiting	`NCT00226473` - Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma	Phase 4

NCT number	NCT02009397
Study type	Interventional
Source	University of Louisville
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	February 2012
Completion date	November 2016

A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms