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

Metastatic Renal Cell Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187302
• Other study ID #: CRLX101-208
• Status: Completed
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: January 2017

Study information

• Verified date: May 2020
• Source: Lumos Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: January 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• CRLX101

• Bevacizumab

• Standard of Care (Investigator Choice)

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severence Hospital	Seoul
United States	New York Oncology Hematology	Albany	New York
United States	Texas Oncology, Amarillo	Amarillo	Texas
United States	Ann Arbor Hematoloty-Oncology	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Texas Oncology P.A.	Austin	Texas
United States	University of Maryland, Greenebaum Cancer Center	Baltimore	Maryland
United States	Our Lady of the Lake Physician Group	Baton Rouge	Louisiana
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	CAMC Health Education and Research Institute	Charleston	West Virginia
United States	Texas Oncology, Dallas	Dallas	Texas
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Texas Oncology, El Paso	El Paso	Texas
United States	The University of Kansas Cancer Center	Fairway	Kansas
United States	Texas Oncology, Flower Mound	Flower Mound	Texas
United States	Texas Oncology, Fort Worth	Fort Worth	Texas
United States	St. Vincent Regional Cancer Center CCOP	Green Bay	Wisconsin
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Kaiser Permanente	Honolulu	Hawaii
United States	Texas Oncology, P.A.	Houston	Texas
United States	Franciscan St. Francis Health	Indianapolis	Indiana
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of California San Diego	La Jolla	California
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	David Geffen School of Medicine UCLA	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center Cancer Institute	Pittsburgh	Pennsylvania
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Cancer Center Network of South Texas	San Antonio	Texas
United States	June E. Nylen Cancer Center	Sioux City	Iowa
United States	SUNY Upstate Medical University	Syracuse	New York
United States	North Mississippi Hematology and Oncology Associates	Tupelo	Mississippi
United States	MD Anderson Cooper Cancer Institute	Voorhees	New Jersey
United States	Cancer Center of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
NewLink Genetics Corporation

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	at least 30 days post last dose of study drug
Secondary	Overall survival	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
Secondary	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	at least 6 months
Secondary	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	at least 6 months
Secondary	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	at least 6 months
Secondary	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	at least 6 months