Phase I study of axitinib and everolimus in metastatic solid tumours and extension to metastatic renal cell carcinoma: Results of EVAX study

2017 ◽  
Vol 85 ◽  
pp. 39-48 ◽  
Author(s):  
Alain Ravaud ◽  
Carlos Gomez-Roca ◽  
Marie-Quitterie Picat ◽  
Laurence Digue ◽  
Christine Chevreau ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study ◽  
Solid Tumours

scholarly journals A Phase I Study of High-Dose Interleukin-2 With Sorafenib in Patients With Metastatic Renal Cell Carcinoma and Melanoma

2014 ◽  
Vol 37 (3) ◽  
pp. 180-186 ◽  
Author(s):  
Paul Monk ◽  
Elaine Lam ◽  
Amir Mortazavi ◽  
Kari Kendra ◽  
Gregory B. Lesinski ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study ◽  
Interleukin 2 ◽  
High Dose

scholarly journals Phase I Study of Nivolumab in Combination with Ipilimumab in Metastatic Renal Cell Carcinoma (Mrcc)

2014 ◽  
Vol 25 ◽  
pp. iv361 ◽  
Author(s):  
H. Hammers ◽  
E.R. Plimack ◽  
J.R. Infante ◽  
M. Ernstoff ◽  
B.I. Rini ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study

scholarly journals A Phase I Study of Alpha‐1,3‐Galactosyltransferase‐Expressing Allogeneic Renal Cell Carcinoma Immunotherapy in Patients with Refractory Metastatic Renal Cell Carcinoma

2019 ◽  
Vol 25 (2) ◽  
pp. 121 ◽  
Author(s):  
Andrew W. Hahn ◽  
Charles Drake ◽  
Samuel R. Denmeade ◽  
Yousef Zakharia ◽  
Benjamin L. Maughan ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study

A phase I study of BMS-936558 plus sunitinib or pazopanib in patients with metastatic renal cell carcinoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS2614-TPS2614
Author(s):  
Hans J. Hammers ◽  
Brian I. Rini ◽  
Gary R. Hudes ◽  
Marc S. Ernstoff ◽  
Christian K. Kollmannsberger ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Disease Progression ◽  
Metastatic Renal Cell Carcinoma ◽  
Dose Escalation ◽  
Renal Cell ◽  
Phase I Study ◽  
Predictive Biomarkers ◽  
Treatment Naïve

TPS2614 Background: Standard treatments for metastatic renal cell carcinoma (mRCC) block the vascular endothelial growth factor pathway (eg, sunitinib, pazopanib) or mammalian target of rapamycin pathway (e.g., temsirolimus, everolimus). However, most patients (pts) develop resistance and complete responses are rare. Upregulation of programmed death-1 (PD-1) in tumor infiltrating lymphoctyes, and its ligand PD-L1 in tumors, is associated with more aggressive disease and poor prognosis. Blocking the PD-1/PD-L1 interaction is a novel immunotherapeutic approach for mRCC. In preliminary results of a phase I trial, the anti-PD-1 monoclonal antibody BMS-936558 had antitumor activity in pts with advanced tumors, including objective responses (ORs) in 6 of 18 pts with mRCC. Here we describe a phase I study planned to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of BMS-936558, when combined with sunitinib or pazopanib in pts with mRCC. Methods: This open-label study will have two parallel treatment arms (BMS-936558 plus sunitinib and BMS-936558 plus pazopanib) conducted in two parts (dose escalation and dose expansion). Pts must have received ≥1 prior systemic therapy to be eligible for dose escalation. Only treatment-naïve pts will be eligible for dose expansion. Up to 36 pts (18 per arm) will be treated in the dose-escalation phase. After determining the MTD of BMS-936558, treatment-naïve pts will be enrolled to expansion cohorts allowing 24 pts to be treated at the MTD of each arm. Each treatment cycle will be 6 weeks, with BMS-936558 dosed on Days 1 and 22 and sunitinib or pazopanib given according to product label. Adverse events will be graded according to NCI CTCAE v4.0. Disease will be assessed every 6 weeks for the first four assessments and then every 12 weeks until disease progression. Pts will be treated until unacceptable toxicity, disease progression, or withdrawal of consent. The safety profile in pts treated at the MTD will be used to determine the recommended phase II study dose of BMS-936558 in each combination arm. Secondary objectives will include OR rate and duration of response based on RECIST 1.1. Exploratory analyses will investigate predictive biomarkers of BMS-936558.

Phase I study of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma (mRCC).

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 4504-4504 ◽  
Author(s):  
Hans J. Hammers ◽  
Elizabeth R. Plimack ◽  
Jeffrey R. Infante ◽  
Marc S. Ernstoff ◽  
Brian I. Rini ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study

Phase I study of dalteparin in combination with sunitinib as first-line treatment in patients with metastatic renal cell carcinoma.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. e15607-e15607
Author(s):  
Roberto Pili ◽  
Sumanta Kumar Pal ◽  
Saby George ◽  
Jens Voortman ◽  
Pongwut Danchaivijitr ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Expanded cohort results from CheckMate 016: A phase I study of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma (mRCC).

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 4516-4516 ◽  
Author(s):  
Hans J. Hammers ◽  
Elizabeth R. Plimack ◽  
Jeffrey R. Infante ◽  
Brian I. Rini ◽  
David F. McDermott ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study
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