NCT03396211

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

An Open-Labeled, Phase I Study to Evaluate the Safety and Tolerability of Apatinib With Nivolumab in Patients With Unresectable or Metastatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Elevar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary objectives: * To evaluate the safety and tolerability of apatinib with nivolumab in participants with unresectable or metastatic cancer. * To assess efficacy by objective response rate (ORR), best overall response (BOR), time to response (TTR), and duration of response (DoR) per response evaluation criteria for solid tumors (RECIST) v1.1 and/or response evaluation criteria for solid tumors for immune-based therapeutics (iRECIST). * To assess disease control rate (DCR), and duration of disease control (DDC) by RECIST v1.1, and/or iRECIST. Secondary objectives: * To evaluate the efficacy of apatinib with nivolumab in participants with unresectable or metastatic cancer as measured by: * Overall survival (OS) * Progression-free survival (PFS) * Event-free survival (EFS)

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib tablets
DRUG	Nivolumab	Fixed dose of nivolumab given intravenously every 2 weeks

Timeline

• Start date: 2017-12-22
• Primary completion: 2020-10-28
• Completion: 2022-03-16
• First posted: 2018-01-10
• Last updated: 2023-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study