Clinical trial NCT02187302: CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Renal Cell Carcinoma
Keywords: nanopharmaceutical,
Lead sponsor: Lumos Pharma
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: at least 6 months
Secondary outcomes:
measure: Overall Safety and tolerability (AEs, SAEs, Clinical Laboratory Parameters, Vital Signs, Concomitant Medications)
timeFrame: at least 30 days post last dose of study drug
measure: Overall survival
timeFrame: on average 12 months after discontinuation of study treatment
measure: Objective response rate
timeFrame: at least 6 months
measure: Duration of Response
timeFrame: at least 6 months
measure: PFS
timeFrame: at least 6 months
measure: PFS
timeFrame: at least 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine UCLA
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente
state: Hawaii
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Sioux City
country: United States
facility: June E. Nylen Cancer Center
state: Iowa
city: Fairway
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Physician Group
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Cancer Center
state: Maryland
city: Ann Arbor
country: United States
facility: Ann Arbor Hematoloty-Oncology
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Hematology and Oncology Associates
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Voorhees
country: United States
facility: MD Anderson Cooper Cancer Institute
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Cancer Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Amarillo
country: United States
facility: Texas Oncology, Amarillo
state: Texas
city: Austin
country: United States
facility: Texas Oncology P.A.
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, Dallas
state: Texas
city: El Paso
country: United States
facility: Texas Oncology, El Paso
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology, Flower Mound
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, Fort Worth
state: Texas
city: Houston
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: San Antonio
country: United States
facility: Cancer Center Network of South Texas
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Charleston
country: United States
facility: CAMC Health Education and Research Institute
state: West Virginia
city: Green Bay
country: United States
facility: St. Vincent Regional Cancer Center CCOP
state: Wisconsin
city: Goyang-si Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severence Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: NewLink Genetics Inc
name: NewLink Genetics
role: STUDY_CHAIR
References:
citation: 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.