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Re: This is good new for immunotheprapy and Celgene (combine one of these drugs with Abraxane and could be a game changer for Abraxane) There are existing examples of clinical trials combining Celgene compounds (Abraxane, CC-486, Pomalidomide, Revlimid) with immunoncology (I/O) agents. Note beyond I/O combos, that the Abraxane-gemcitabine backbone is in pancreatic clinical trials with over 10 compounds, some of which promise to also expand duration of therapy and number of settings in pancreatic cancer. At ASH2014, Celgene's Analyst Event included an informative presentation by Rob Herschberg, SVP Immuno-Oncology, who heads the recently-created Seattle-based Celgene Immuno-Oncology Center of Excellence and also serves as CEO of VentiRx, a clinical stage I/O company partnered with Celgene with an option to acquire. I/O will be a growing topic going forward (see selected ASH2014 slides at the bottom). Abraxane I/O Combo Trials Safety Study of Nivolumab With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast CancerThis study is currently recruiting participants. (see Contacts and Locations) Verified April 2015 by Celgene Corporation Sponsor: Celgene Corporation Information provided by (Responsible Party): Celgene Corporation ClinicalTrials.gov Identifier: NCT02309177 First received: December 3, 2014 Last updated: April 3, 2015 Last verified: April 2015 Purpose The purpose of this study is to assess safety of nab-paclitaxel based chemotherapy regimens administered prior to and/or in combination with nivolumab in Pancreatic Cancer, Non Small Cell Lung Cancer (NSCLC) and Metastatic Breast Cancer (mBC).
Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic MelanomaThis study is currently recruiting participants. (see Contacts and Locations) Verified December 2014 by M.D. Anderson Cancer Center Sponsor: M.D. Anderson Cancer Center Collaborator: Celgene Corporation Information provided by (Responsible Party): M.D. Anderson Cancer Center ClinicalTrials.gov Identifier: NCT01827111 First received: April 4, 2013 Last updated: December 18, 2014 Last verified: December 2014 Purpose The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied. Ipilimumab is designed to increase the immune system's ability to fight cancer. ABI-007 is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
This study is currently recruiting participants. (see Contacts and Locations) Verified April 2015 by Academic and Community Cancer Research United Sponsor: Academic and Community Cancer Research United Collaborator: Information provided by (Responsible Party): Academic and Community Cancer Research United ClinicalTrials.gov Identifier: NCT02158520 First received: June 5, 2014 Last updated: April 14, 2015 Last verified: April 2015 CC-486 I/O Clinical TrialsPhase II Anti-PD1 Epigenetic Priming Study in NSCLC. (NA_00084192) This study is currently recruiting participants. (see Contacts and Locations) Verified March 2015 by Sidney Kimmel Comprehensive Cancer Center Sponsor: Sidney Kimmel Comprehensive Cancer Center Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center ClinicalTrials.gov Identifier: NCT01928576 First received: August 21, 2013 Last updated: March 17, 2015 Last verified: March 2015 Purpose Response Rate
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This randomized phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab or ipilimumab works as first-line therapy in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab is more effective than ipilimumab in treating melanoma.
Condition | Intervention | Phase |
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Stage IIIA Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma | Drug: paclitaxel albumin-stabilized nanoparticle formulation Biological: bevacizumab Biological: ipilimumab Other: laboratory biomarker analysis Other: pharmacological study | Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Randomized Phase II Study of AB (Nab-paclitaxel [Abraxane™], Bevacizumab) Versus Ipilimumab for 1st Line Therapy of Unresectable Stage IV Metastatic Malignant Melanoma (BRAF V600E Negative) |
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