Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors

Part of paid clinical trials in Palo Alto, California.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT03583086
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vorolanib — DRUG
    Given by mouth
  • Nivolumab — BIOLOGICAL
    Given by IV

Study Details

This is a two-agent, open-label, non-randomized, Phase 1/2 dose escalation and dose expansion study of combinatorial oral vorolanib plus infusional nivolumab in patients with Non-Small Cell Lung Cancer naïve to checkpoint inhibitor therapy, Non-Small Cell Lung Cancer who have progressed on checkpoint inhibitor therapy, Small Cell Lung Cancer ( who have progressed on platinum-based chemotherapy, and thymic carcinoma.

Key Dates

Start date
Jul 10, 2018
Status verified
Sep 2024
Primary completion
Feb 21, 2024
Completion
Apr 27, 2024

Study Design

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

Arms

  • Experimental: Escalation
    Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
  • Experimental: Dose Expansion - Non Small-Cell-Lung Cancer Acquired Resistance
    Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
  • Experimental: Dose Expansion - Non Small-Cell-Lung Cancer Naive
    Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
  • Experimental: Dose Expansion - Non Small-Cell-Lung Cancer Primary Refractory
    Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
  • Experimental: Dose Expansion - Small Cell Lung Cancer - Progressed on Platinum-based Chemotherapy
    Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.
  • Experimental: Dose Expansion - Thymic Carcinoma
    Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.

Primary Outcome Measure

Recommended Phase II Combination Dose in Phase I (Per Common Terminology Criteria for Adverse Events (CTCAE) Criteria Version 5) [ Time Frame: At 28 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstitutePalo AltoCalifornia94304-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
University of Chicago Medical CenterChicagoIllinois60637-
Providence Cancer Institute Franz ClinicPortlandOregon97213-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Baptist Clinical Research InstituteMemphisTennessee38120-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Palo Alto, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Stanford Cancer Institute· Palo Alto, CAWinship Cancer Institute, Emory University· Atlanta, GAUniversity of Chicago Medical Center· Chicago, ILProvidence Cancer Institute Franz Clinic· Portland, ORFox Chase Cancer Center· Philadelphia, PABaptist Clinical Research Institute· Memphis, TN

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