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COMPLETEDPHASE2

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)

NCT02187302•NewLink Genetics Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (43)

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

Key Dates

Start Date

July 1, 2014

Primary Completion Date

July 1, 2016

Completion Date

January 1, 2017

Last Updated

May 28, 2020

Enrollment

115

ACTUAL participants

Conditions

Metastatic Renal Cell Carcinoma

Interventions

CRLX101

DRUG

Bevacizumab

DRUG

Standard of Care (Investigator Choice)

DRUG

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RECRUITINGPHASE1/PHASE2

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)

PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk

Drug Screening Using Novel IMD in Renal Cell Carcinoma

CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer