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

May 26, 2020 updated by: NewLink Genetics Corporation

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Goyang-si Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severence Hospital
  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90024
        • David Geffen School of Medicine UCLA
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
      • Indianapolis, Indiana, United States, 46237
        • Franciscan St. Francis Health
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • June E. Nylen Cancer Center
    • Kansas
      • Fairway, Kansas, United States, 66205
        • The University of Kansas Cancer Center
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Physician Group
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaum Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Ann Arbor Hematoloty-Oncology
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Hematology and Oncology Associates
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • MD Anderson Cooper Cancer Institute
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Chapel Hill
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center Cancer Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology, Amarillo
      • Austin, Texas, United States, 78745
        • Texas Oncology P.A.
      • Dallas, Texas, United States, 75246
        • Texas Oncology, Dallas
      • El Paso, Texas, United States, 79902
        • Texas Oncology, El Paso
      • Flower Mound, Texas, United States, 75028
        • Texas Oncology, Flower Mound
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, Fort Worth
      • Houston, Texas, United States, 77024
        • Texas Oncology, P.A.
      • San Antonio, Texas, United States, 78217
        • Cancer Center Network of South Texas
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Health Education and Research Institute
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • St. Vincent Regional Cancer Center CCOP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Bevacizumab
Other Names:
  • Avastin
Drug: CRLX101
Other Names:
  • NLG207
Active Comparator: 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
Drug: Standard of Care (Investigator Choice)
Other Names:
  • sorafenib (Nexavar), sunitinib (Sutent), axitinib (Inlyta), pazopanib (Votrient), bevacizumab (Avastin),
  • everolimus (Afinitor), Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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
at least 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Safety and tolerability (AEs, SAEs, Clinical Laboratory Parameters, Vital Signs, Concomitant Medications)
Time Frame: 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.
at least 30 days post last dose of study drug
Overall survival
Time Frame: 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.
on average 12 months after discontinuation of study treatment
Objective response rate
Time Frame: 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
at least 6 months
Duration of Response
Time Frame: 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
at least 6 months
PFS
Time Frame: at least 6 months
To assess PFS in patients with clear cell metastatic RCC treated with CRLX101+bevacizumab vs. SOC per investigator's choice, as assessed at the site level by the Investigator according to RECIST version 1.1
at least 6 months
PFS
Time Frame: 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
at least 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NewLink Genetics Corporation

Investigators

  • Study Chair: NewLink Genetics, NewLink Genetics Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRLX101-208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Renal Cell Carcinoma

Clinical Trials on Bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe