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NCT number NCT03396211
Study type Interventional
Source LSK BioPartners Inc.
Contact Scott Houston
Phone 8013037440
Status Recruiting
Phase Phase 1
Start date December 22, 2017
Completion date December 22, 2019

Clinical Trial Summary

This is an open-labeled, single-center, Phase I study to evaluate the safety, tolerability, and efficacy of adding apatinib to ongoing nivolumab treatment in patients with unresectable or metastatic cancer. Approximately 9-18 subjects in Phase I dose escalation phase and up to 12 additional subjects in Part II expansion phase. Total study duration will be approximately 12 months: 6 months of recruitment plus 6 months of treatment.

Clinical Trial Description

Primary objectives:

- To evaluate the safety and tolerability of apatinib with nivolumab in patients 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 RECIST v1.1 and iRECIST

- To assess disease control rate (DCR), and duration of disease control (DDC) by RECIST v1.1, and iRECIST

Secondary objectives:

• To evaluate the efficacy of apatinib with nivolumab in patients with unresectable or metastatic cancer as measured by:

- Overall survival (OS)

- Progression-free survival (PFS)

- Event-free survival (EFS)

Exploratory objectives:

- Tumor mutational burden and mutations at baseline and at the time of progression

- Changes in serum cytokines pursuant to treatment response

- Changes in PBMC subsets and MDSC populations as determined by flow cytometry

Study Design

Related Conditions & MeSH terms

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