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

NCT ID: NCT02187302

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-01-31

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.

Conditions

Metastatic Renal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRLX101 + 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.

Group Type: EXPERIMENTAL

CRLX101

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Standard of Care

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

Group Type: ACTIVE_COMPARATOR

Standard of Care (Investigator Choice)

Intervention Type: DRUG

Interventions

CRLX101

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Standard of Care (Investigator Choice)

Intervention Type: DRUG

Other Intervention Names

NLG207; Avastin; sorafenib (Nexavar), sunitinib (Sutent), axitinib (Inlyta), pazopanib (Votrient), bevacizumab (Avastin),; everolimus (Afinitor), Other

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NewLink Genetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

NewLink Genetics

Role: STUDY_CHAIR

NewLink Genetics Inc

Locations

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

University of Pittsburgh Medical Center Cancer Institute

Pittsburgh, Pennsylvania, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Texas Oncology, Amarillo

Amarillo, Texas, United States

Texas Oncology P.A.

Austin, Texas, United States

Texas Oncology, Dallas

Dallas, Texas, United States

Texas Oncology, El Paso

El Paso, Texas, United States

Texas Oncology, Flower Mound

Flower Mound, Texas, United States

Texas Oncology, Fort Worth

Fort Worth, Texas, United States

Texas Oncology, P.A.

Houston, Texas, United States

Cancer Center Network of South Texas

San Antonio, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

CAMC Health Education and Research Institute

Charleston, West Virginia, United States

St. Vincent Regional Cancer Center CCOP

Green Bay, Wisconsin, United States

National Cancer Center

Goyang-si Gyeonggi-do, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severence Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Countries

United States; South Korea

References

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.

Reference Type: DERIVED

PMID: 28950297 (View on PubMed)

Other Identifiers

CRLX101-208

Identifier Type: -

Identifier Source: org_study_id