Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03511222
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Vorolanib — DRUG
    Patients should take vorolanib at approximately the same time every day with food.
  • Nivolumab — DRUG
    Standard of care
  • Pembrolizumab — DRUG
    Standard of care

Study Details

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.

Key Dates

Start date
Sep 11, 2018
Status verified
Jul 2020
Primary completion
Aug 15, 2019
Completion
May 28, 2020

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: Vorolanib + Nivolumab
    * Vorolanib is an oral drug which will be administered daily on an outpatient basis at the assigned dose level. * Patients receiving nivolumab will get it on an outpatient basis as a 30-minute intravenous infusion at a dose of 480 mg on Day 1 of each 28-day cycle * In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST
  • Experimental: Dose Escalation: Vorolanib + Pembrolizumab
    * Vorolanib is an oral drug which will be administered daily on an outpatient basis at the assigned dose level * Patients receiving pembrolizumab will get it on an outpatient basis as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 200 mg on Day 1 of each 21-day cycle * In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST
  • Experimental: Vorolanib + Nivolumab (Small Cell Lung Cancer)
    * Vorolanib is an oral drug which will be administered daily on an outpatient basis at 300 mg daily * Patients receiving nivolumab will get it on an outpatient basis as a 30-minute intravenous infusion at a dose of 480 mg on Day 1 of each 28-day cycle * In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST

Primary Outcome Measure

Recommended phase II dose (RP2D) of vorolanib plus pembrolizumab [ Time Frame: Completion of enrollment to Dose Escalation cohorts (estimated to be 13 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Gastric cancerLiver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Washington University School of Medicine· St Louis, MO

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