NCT04803877

SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma

SARC038: A Phase 2 Study of Regorafenib in Combination With Nivolumab in Patients With Refractory or Recurrent Osteosarcoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Sarcoma Alliance for Research through Collaboration · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

A phase 2 study of regorafenib in combination with nivolumab in patients with refractory or recurrent osteosarcoma.

Detailed description

This is a single arm, Simon two-stage historically controlled study to compare the 4 month progression-free survival rate of patients with relapsed/refractory osteosarcoma treated with regorafenib in combination with nivolumab to those who received regorafenib alone (historical control).

Conditions

• Osteosarcoma
• Osteosarcoma in Children
• Osteosarcoma Recurrent
• Osteosarcoma Metastatic

Interventions

Type	Name	Description
DRUG	Regorafenib 40 MG	For subjects age 18 and older, Regorafenib will be administered as 80mg oral once daily on Cycle 1, Days 1-7 and then escalated to 120 mg once daily for Cycle 1, Days 8-21 if no Grade 2 or above regorafenib adverse events occur. For subsequent cycles, the highest tolerated dose will be taken once daily on days 1-21 of each 28-day cycle.
DRUG	Regorafenib 20MG	For subjects younger than 18 years, Regorafenib will be administered as 60mg/m2/dose (rounded to the nearest 20mg, maximum dose of 80mg) once daily for Cycle 1, Days 8-21 if no Grade 2 or above regorafenib-related adverse events occur. For subsequent cycles, the highest tolerated dose will be taken once daily on days 1-21 of each 28-day cycle.
DRUG	Nivolumab	For subjects age 18 and older, Nivolumab will be administered at 480mg IV over 30 min every 28 days. For subjects younger than 18 years, Nivolumab 3mg/kg (maximum dose 240mg) will be administered IV over 30 minutes on day 1 and 15 of each 28-day cycle.

Timeline

• Start date: 2021-06-04
• Primary completion: 2025-11-01
• Completion: 2026-06-01
• First posted: 2021-03-18
• Last updated: 2025-10-31

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study