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

Completed · Phase 2

Conditions studied: Metastatic Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT02187302

Run by

NewLink Genetics Corporation

People needed

115

Starts

2014-07-01

Expected to finish

2017-01-01

Last updated by the study team

2020-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have histologically confirmed renal cell carcinoma of any pathologic subtype.
• Must have unresectable metastatic disease, and have tumor(s) present that is (are) evaluable by the RECIST, v1.1; may have spinal-associated metastases but must have concluded dexamethasone therapy and be evaluated by the Investigator to have stable CNS disease.
• Must have received 2 or 3 prior lines of conventional molecularly targeted therapy
• Must have full recovery from any toxicities from prior therapy CTCAE Grade 1 or less with the exception of Grade 2 alopecia) prior to randomization.
• ECOG performance status 0 or 1.
• Age 18 years and older.
• Life expectancy of at least 3 months.
• Must have normal organ and marrow function reported within 14 days prior to randomization
• Ability to understand and willingness to sign a written informed consent document.
• Able to comply with study visit schedule and assessments.

You may not qualify if…

• Any conventional molecularly targeted therapy within 2 weeks or, chemotherapy or radiotherapy within 2 weeks (local) or 4 weeks (systemic) prior to entering the study.
• Failure to recover to grade 1 or less all prior adverse events.
• Any major surgery within 4 weeks of study randomization.
• Any prior treatment with topoisomerase I therapy.
• Prior treatment with any drugs or therapies that will be administered during the course of this trial including CRLX101, any topoisomerase 1 inhibitor, bevacizumab or the conventional molecularly targeted agent intended for use as standard of care treatment.
• Patients receiving any other current investigational therapeutic agent.
• Other active malignancies
• Patients with brain metastasis treated or untreated, or other CNS disease
• Any clinically significant cardiac disease defined as NYHA class III or IV.
• Uncontrolled hypertension
• Uncontrolled concurrent illness
• History of non-healing wounds or ulcers.
• Pregnancy, or inadequate contraception for men or women of childbearing age, or lactating / breast-feeding
• Patients with known HIV or with solid organ transplant

Where it is running

• University of California San Diego — La Jolla, California, United States
• David Geffen School of Medicine UCLA — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• Kaiser Permanente — Honolulu, Hawaii, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Franciscan St. Francis Health — Indianapolis, Indiana, United States
• June E. Nylen Cancer Center — Sioux City, Iowa, United States
• The University of Kansas Cancer Center — Fairway, Kansas, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Our Lady of the Lake Physician Group — Baton Rouge, Louisiana, United States
• University of Maryland, Greenebaum Cancer Center — Baltimore, Maryland, United States
• Ann Arbor Hematoloty-Oncology — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• North Mississippi Hematology and Oncology Associates — Tupelo, Mississippi, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• MD Anderson Cooper Cancer Institute — Voorhees Township, New Jersey, United States
• New York Oncology Hematology — Albany, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• UNC Chapel Hill — Chapel Hill, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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