CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)
- Conditions
- Metastatic Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT02187302
- Lead Sponsor
- NewLink Genetics Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRLX101 + bevacizumab CRLX101 CRLX101 in combination with bevacizumab: * CRLX101 15 mg/m\^2 IV on days 1 and 15 of a 28-day cycle; * bevacizumab 10 mg/kg IV on days 1 and 15 of a 28-day cycle. Standard of Care Standard of Care (Investigator Choice) Standard of care treatment include one of the following agents to which the patient can have no prior exposure: sorafenib; everolimus; pazopanib; axitinib; bevacizumab; sunitinib, or other approved drug considered by the Medical Monitor to represent an acceptable standard of care therapy CRLX101 + bevacizumab Bevacizumab CRLX101 in combination with bevacizumab: * CRLX101 15 mg/m\^2 IV on days 1 and 15 of a 28-day cycle; * bevacizumab 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) at least 6 months To assess progression free survival (PFS) in patients with clear cell metastatic renal cell carcinoma (RCC) treated with CRLX101 in combination with bevacizumab (CRLX101+bevacizumab) vs. standard of care (SOC) per investigator's choice, as assessed by blinded independent radiological review (IRR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Secondary Outcome Measures
Name Time Method Overall survival on average 12 months after discontinuation of study treatment To compare time to death between treatment groups of CRLX101 in combination with bevacizumab compared to SOC.
Overall Safety and tolerability (AEs, SAEs, Clinical Laboratory Parameters, Vital Signs, Concomitant Medications) at least 30 days post last dose of study drug AEs will be coded using MedDRA and graded according to CTCAE (v 4.03). The number and percentage of patients with any treatment-emergent AE (TEAE) will be summarized for each treatment group. The number of patients with TEAEs assessed by the Investigator as at least possibly related to treatment will be tabulated. The number of patients with any CTCAE grade ≥ 3 treatment-emergent AE will be tabulated. Serious AEs (SAEs) will also be tabulated.
For Clinical Laboratory Parameters - Shift tables that present changes from baseline to worst on-study values relative to CTCAE grading will be produced.
For Vital Signs - By-patient data listings of vital sign measurements will be presented.
For Concomitant Medications - The use of concomitant medications will be included in by-patient data listings. A summary table of concomitant medications by WHO drug class will also be provided.Duration of Response at least 6 months Evaluate time to response comparing the investigational treatment of CRLX101 in combination with bevacizumab compared to SOC as assessed by blinded IRR as well as by the Investigator
Objective response rate at least 6 months Evaluate response rates comparing the investigational treatment of CRLX101 in combination with bevacizumab compared to SOC as assessed by blinded IRR as well as by the Investigator
PFS at least 6 months To assess PFS (as assessed at the site level by the Investigator and separately by blinded IRR) in clear cell RCC patients treated with CRLX101+bevacizumab compared to bevacizumab treatment alone
Trial Locations
- Locations (43)
University of California San Diego
🇺🇸La Jolla, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Texas Oncology, Dallas
🇺🇸Dallas, Texas, United States
CAMC Health Education and Research Institute
🇺🇸Charleston, West Virginia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
MD Anderson Cooper Cancer Institute
🇺🇸Voorhees, New Jersey, United States
University of Pittsburgh Medical Center Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Oncology P.A.
🇺🇸Austin, Texas, United States
New York Oncology Hematology
🇺🇸Albany, New York, United States
Texas Oncology, Fort Worth
🇺🇸Fort Worth, Texas, United States
Our Lady of the Lake Physician Group
🇺🇸Baton Rouge, Louisiana, United States
North Mississippi Hematology and Oncology Associates
🇺🇸Tupelo, Mississippi, United States
Texas Oncology, Amarillo
🇺🇸Amarillo, Texas, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severence Hospital
🇰🇷Seoul, Korea, Republic of
David Geffen School of Medicine UCLA
🇺🇸Los Angeles, California, United States
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Ann Arbor Hematoloty-Oncology
🇺🇸Ann Arbor, Michigan, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Texas Oncology, El Paso
🇺🇸El Paso, Texas, United States
St. Vincent Regional Cancer Center CCOP
🇺🇸Green Bay, Wisconsin, United States
UNC Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
June E. Nylen Cancer Center
🇺🇸Sioux City, Iowa, United States
University of Maryland, Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Franciscan St. Francis Health
🇺🇸Indianapolis, Indiana, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Cancer Center Network of South Texas
🇺🇸San Antonio, Texas, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Texas Oncology, P.A.
🇺🇸Houston, Texas, United States
The University of Kansas Cancer Center
🇺🇸Fairway, Kansas, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Kaiser Permanente
🇺🇸Honolulu, Hawaii, United States
Texas Oncology, Flower Mound
🇺🇸Flower Mound, Texas, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si Gyeonggi-do, Korea, Republic of
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States