CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)

Summary

This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101 in combination with bevacizumab compared to treatment with a standard of care therapy. The study will compare which treatment resulted in longer time before progression of the RCC. Patients will be treated and followed for progression of their disease on average for up to 6 months.

Timeline

Start

2014-07

Primary completion

2016-07

Completion

2017-01

Outcome

Missed primary endpoint

paper and 3.9 months (95% confidence interval 2.2-5.4), respectively (stratified log-rank P = 0.831). PMID 28950297 ↗

paper this randomized trial did not demonstrate improvement in PFS for the CRLX101 + bevacizumab combination PMID 28950297 ↗

Publications

• Voss MH, Hussain A, Vogelzang N, Lee JL, Keam B, Rha SY, Vaishampayan U, Harris WB, Richey S, Randall JM, Shaffer D, Cohn A, Crowell T, Li J, Senderowicz A, Stone E, Figlin R, Motzer RJ, Haas NB, Hutson T. A randomized phase II trial of CRLX101 in combination with bevacizumab versus standard of care in patients with advanced renal cell carcinoma. Ann Oncol. 2017 Nov 1;28(11):2754-2760. doi: 10.1093/annonc/mdx493.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Axitinib	Small molecule	—	—
Subject	Bevacizumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	DAVAMOTECAN PEGADEXAMER	Other / unclassified	15 mg/m2	Intravenous
Comparator	Everolimus	Small molecule	—	—
Comparator	Pazopanib	Small molecule	—	—
Comparator	Sorafenib	Small molecule	—	—
Comparator	Sunitinib	Small molecule	—	—
Comparator	Temsirolimus	Small molecule	—	—

Indications