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

Part of paid clinical trials in La Jolla, California.

Sponsor
NewLink Genetics Corporation
Study ID
NCT02187302
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CRLX101 — DRUG
  • Bevacizumab — DRUG
  • Standard of Care (Investigator Choice) — DRUG

Study Details

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.

Key Dates

First listed
Jul 11, 2014
Start date
Jul 31, 2014
Status verified
May 2020
Primary completion
Jul 31, 2016
Completion
Jan 31, 2017

Study Design

Enrollment
115 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: at least 6 months ]

Locations (38)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
David Geffen School of Medicine UCLALos AngelesCalifornia90024-
Rocky Mountain Cancer CentersDenverColorado80218-
Emory UniversityAtlantaGeorgia30322-
Kaiser PermanenteHonoluluHawaii96819-
Decatur Memorial HospitalDecaturIllinois62526-
Franciscan St. Francis HealthIndianapolisIndiana46237-
Indiana University School of MedicineIndianapolisIndiana46202-
June E. Nylen Cancer CenterSioux CityIowa51101-
The University of Kansas Cancer CenterFairwayKansas66205-
Cancer Center of KansasWichitaKansas67214-
Our Lady of the Lake Physician GroupBaton RougeLouisiana70808-
University of Maryland, Greenebaum Cancer CenterBaltimoreMaryland21201-
Ann Arbor Hematoloty-OncologyAnn ArborMichigan48106-
Karmanos Cancer InstituteDetroitMichigan48201-
North Mississippi Hematology and Oncology AssociatesTupeloMississippi38801-
University of Nebraska Medical CenterOmahaNebraska68130-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
MD Anderson Cooper Cancer InstituteVoorhees TownshipNew Jersey08043-
New York Oncology HematologyAlbanyNew York12208-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
SUNY Upstate Medical UniversitySyracuseNew York13210-
UNC Chapel HillChapel HillNorth Carolina27599-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center Cancer InstitutePittsburghPennsylvania15232-
Cancer Centers of the CarolinasGreenvilleSouth Carolina29615-
Texas Oncology, AmarilloAmarilloTexas79106-
Texas Oncology P.A.AustinTexas78745-
Texas Oncology, DallasDallasTexas75246-
Texas Oncology, El PasoEl PasoTexas79902-
Texas Oncology, Flower MoundFlower MoundTexas75028-
Texas Oncology, Fort WorthFort WorthTexas76104-
Texas Oncology, P.A.HoustonTexas77024-
Cancer Center Network of South TexasSan AntonioTexas78217-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
CAMC Health Education and Research InstituteCharlestonWest Virginia25304-
St. Vincent Regional Cancer Center CCOPGreen BayWisconsin54301-

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