A Phase 2 interventional study of CRLX101 and Bevacizumab in Metastatic Renal Cell Carcinoma, sponsored by NewLink Genetics Corporation. Completed at 43 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-28.
Sponsored by NewLink Genetics Corporation · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 115 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →NewLink Genetics Corporation is the lead sponsor of 34 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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: CRLX101 · Drug: Bevacizumab
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)
Also known as: NLG207
Also known as: Avastin
Also known as: sorafenib (Nexavar), sunitinib (Sutent), axitinib (Inlyta), pazopanib (Votrient), bevacizumab (Avastin),, everolimus (Afinitor), Other
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
Time frame: at least 6 months
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.
Time frame: at least 30 days post last dose of study drug
Overall survival
To compare time to death between treatment groups of CRLX101 in combination with bevacizumab compared to SOC.
Time frame: on average 12 months after discontinuation of study treatment
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
Time frame: at least 6 months
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
Time frame: at least 6 months
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
Time frame: at least 6 months
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
Time frame: at least 6 months
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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NewLink Genetics Corporation