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Metastatic Renal Cell CarcinomaPhase 2NCT02187302

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

A Phase 2 study testing CRLX101 and Bevacizumab in people with Metastatic Renal Cell Carcinoma, run by NewLink Genetics Corporation at 43 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Renal Cell Carcinoma
What is being tested?
CRLX101 and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
43 sitesin 2 countries
Study dates
Jul 2014to Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

United States38 sites

  • New York Oncology Hematology

    Albany, New York, 12208

  • Texas Oncology, Amarillo

    Amarillo, Texas, 79106

  • Ann Arbor Hematoloty-Oncology

    Ann Arbor, Michigan, 48106

  • Emory University

    Atlanta, Georgia, 30322

  • Texas Oncology P.A.

    Austin, Texas, 78745

  • University of Maryland, Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599

  • CAMC Health Education and Research Institute

    Charleston, West Virginia, 25304

  • Texas Oncology, Dallas

    Dallas, Texas, 75246

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Texas Oncology, El Paso

    El Paso, Texas, 79902

  • The University of Kansas Cancer Center

    Fairway, Kansas, 66205

  • Texas Oncology, Flower Mound

    Flower Mound, Texas, 75028

  • Texas Oncology, Fort Worth

    Fort Worth, Texas, 76104

  • St. Vincent Regional Cancer Center CCOP

    Green Bay, Wisconsin, 54301

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29615

  • Kaiser Permanente

    Honolulu, Hawaii, 96819

  • Texas Oncology, P.A.

    Houston, Texas, 77024

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • University of California San Diego

    La Jolla, California, 92093

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • David Geffen School of Medicine UCLA

    Los Angeles, California, 90024

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68130

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Cancer Center Network of South Texas

    San Antonio, Texas, 78217

  • June E. Nylen Cancer Center

    Sioux City, Iowa, 51101

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • North Mississippi Hematology and Oncology Associates

    Tupelo, Mississippi, 38801

  • MD Anderson Cooper Cancer Institute

    Voorhees Township, New Jersey, 08043

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

South Korea5 sites

  • National Cancer Center

    Goyang-si Gyeonggi-do, 410-769

  • Seoul National University Hospital

    Seoul, 110-744

  • Severence Hospital

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: 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.

Being tested
CRLX101, Bevacizumab, Standard of Care (Investigator Choice)
Keywords
nanopharmaceutical,
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRLX101Drug

    Also called NLG207

  • BevacizumabDrug

    Also called Avastin

  • Standard of Care (Investigator Choice)Drug

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

Study groups in NCT02187302
Study groupRoleWhat they receive
CRLX101 + bevacizumabExperimentalCRLX101 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.
Receives: Drug: CRLX101; Drug: Bevacizumab
Standard of CareActive 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
Receives: Drug: Standard of Care (Investigator Choice)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at least 6 months

Secondary outcomes (6)

  1. Overall Safety and tolerability (AEs, SAEs, Clinical Laboratory Parameters, Vital Signs, Concomitant Medications)

    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.

    Measured: at least 30 days post last dose of study drug

  2. Overall survival

    To compare time to death between treatment groups of CRLX101 in combination with bevacizumab compared to SOC.

    Measured: on average 12 months after discontinuation of study treatment

  3. Objective response rate

    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

    Measured: at least 6 months

  4. Duration of Response

    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

    Measured: at least 6 months

  5. PFS

    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

    Measured: at least 6 months

  6. PFS

    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

    Measured: at least 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02187302
Sponsor's protocol ID
CRLX101-208
Status last verified
May 2020
First submitted
30 Jun 2014
Last updated
28 May 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28950297

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CRLX101 and Bevacizumab in people with Metastatic Renal Cell Carcinoma, run by NewLink Genetics Corporation at 43 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: at least 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02187302, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.

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