CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)
A Randomized, Phase 2 Study to Assess the Safety and Efficacy of CRLX101 in Combination With Bevacizumab in Patients With Metastatic Renal Cell Carcinoma (RCC) Versus Standard of Care (SOC) (Investigator's Choice)
1 other identifier
interventional
115
2 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2014
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMay 28, 2020
May 1, 2020
2 years
June 30, 2014
May 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
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
at least 6 months
Secondary Outcomes (6)
Overall Safety and tolerability (AEs, SAEs, Clinical Laboratory Parameters, Vital Signs, Concomitant Medications)
at least 30 days post last dose of study drug
Overall survival
on average 12 months after discontinuation of study treatment
Objective response rate
at least 6 months
Duration of Response
at least 6 months
PFS
at least 6 months
- +1 more secondary outcomes
Study Arms (2)
CRLX101 + bevacizumab
EXPERIMENTALCRLX101 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
ACTIVE COMPARATORStandard 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
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
University of California San Diego
La Jolla, California, 92093, United States
David Geffen School of Medicine UCLA
Los Angeles, California, 90024, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Emory University
Atlanta, Georgia, 30322, United States
Kaiser Permanente
Honolulu, Hawaii, 96819, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Franciscan St. Francis Health
Indianapolis, Indiana, 46237, United States
June E. Nylen Cancer Center
Sioux City, Iowa, 51101, United States
The University of Kansas Cancer Center
Fairway, Kansas, 66205, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Ann Arbor Hematoloty-Oncology
Ann Arbor, Michigan, 48106, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, 38801, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
MD Anderson Cooper Cancer Institute
Voorhees Township, New Jersey, 08043, United States
New York Oncology Hematology
Albany, New York, 12208, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615, United States
Texas Oncology, Amarillo
Amarillo, Texas, 79106, United States
Texas Oncology P.A.
Austin, Texas, 78745, United States
Texas Oncology, Dallas
Dallas, Texas, 75246, United States
Texas Oncology, El Paso
El Paso, Texas, 79902, United States
Texas Oncology, Flower Mound
Flower Mound, Texas, 75028, United States
Texas Oncology, Fort Worth
Fort Worth, Texas, 76104, United States
Texas Oncology, P.A.
Houston, Texas, 77024, United States
Cancer Center Network of South Texas
San Antonio, Texas, 78217, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
CAMC Health Education and Research Institute
Charleston, West Virginia, 25304, United States
St. Vincent Regional Cancer Center CCOP
Green Bay, Wisconsin, 54301, United States
National Cancer Center
Goyang-si Gyeonggi-do, 410-769, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severence Hospital
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Related Publications (1)
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.
PMID: 28950297DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
NewLink Genetics
NewLink Genetics Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2014
First Posted
July 11, 2014
Study Start
July 1, 2014
Primary Completion
July 1, 2016
Study Completion
January 1, 2017
Last Updated
May 28, 2020
Record last verified: 2020-05