Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors (NCT03511222) | Clinical Trial Compass
TerminatedPhase 1
Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors
Stopped: Low accrual
United States16 participantsStarted 2018-09-11
Plain-language summary
The investigators hypothesize that vorolanib in combination with checkpoint inhibitors (pembrolizumab for gastric/gastroesophageal (GE) junction cancers and nivolumab for hepatocellular carcinoma (HCC)) may improve immunotherapy efficacy by overcoming treatment resistance of checkpoint inhibitors in gastrointestinal (GI) cancers.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Dose escalation cohort: histologically or cytologically confirmed diagnosis of a solid tumor that can be treated with either pembrolizumab or nivolumab as part of standard of care or whom no standard of therapy exists except pembrolizumab or nivolumab
* SCLC cohort: histologically or cytologically confirmed diagnosis of small cell lung cancer whose disease progressed on platinum-based chemotherapy or refused chemotherapy
* Evidence of measurable disease per RECIST 1.1. Measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan.
* At least 18 years of age.
* ECOG performance status ≤ 1
* Normal bone marrow and organ function as defined below:
* Leukocytes ≥ 2,000/mcL
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Hemoglobin ≥ 9.0 g/dL
* Total bilirubin ≤ 1.5 x IULN
* AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (≤ 5 x IULN for patients with liver metastases or hepatocellular carcinoma (HCC))
* Creatinine ≤ 1.5 x IULN OR measured or calculated creatinine clearance ≥ 50 mL/min for patients with creatinine levels \> 1.5 x IULN
* Urine protein ≤1+ or urine protein to creatinine ratio ≤ 1; if UPC ratio is \>1 on urinalysis, then 24-hour urine collection from protein must be obtained and level must be \<1,000 mg for patient enrollment.
* aPTT and either INR or PT ≤ 1.5 x ILUN unless participant is receiving anticoagulant therapy as long…
What they're measuring
1
Recommended phase II dose (RP2D) of vorolanib plus pembrolizumab
Timeframe: Completion of enrollment to Dose Escalation cohorts (estimated to be 13 months)
2
Recommended phase II dose (RP2D) of vorolanib plus nivolumab
Timeframe: Completion of enrollment to Dose Escalation cohorts (estimated to be 13 months)