A Study to Evaluate Apatinib (Also Known as Rivoceranib) Plus Nivolumab in Participants With Unresectable or Metastatic Cancer

Part of paid clinical trials in Santa Monica, California.

Sponsor
Elevar Therapeutics
Study ID
NCT03396211
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    Apatinib tablets
  • Nivolumab — DRUG
    Fixed dose of nivolumab given intravenously every 2 weeks

Study Details

This is an open-labeled, single-center, Phase I study to evaluate the safety, tolerability, and efficacy of apatinib with nivolumab treatment in participants with unresectable or metastatic cancer. Total study duration will be approximately 50 months: 12 months of recruitment plus 6 months of treatment and subsequent survival follow up.

Key Dates

Start date
Dec 22, 2017
Status verified
Apr 2023
Primary completion
Oct 28, 2020
Completion
Mar 16, 2022

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib with Nivolumab
    Participants will receive an oral dose of apatinib once per day with a fixed dose of nivolumab given intravenously every 2 weeks.

Primary Outcome Measure

Number of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sarcoma Oncology Research CenterSanta MonicaCalifornia90403-

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By research site
Sarcoma Oncology Research Center· Santa Monica, CA

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