SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma
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|ClinicalTrials.gov Identifier: NCT04803877|
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : November 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma Osteosarcoma in Children Osteosarcoma Recurrent Osteosarcoma Metastatic||Drug: Regorafenib 40 MG Drug: Regorafenib 20MG Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SARC038: A Phase 2 Study of Regorafenib in Combination With Nivolumab in Patients With Refractory or Recurrent Osteosarcoma|
|Actual Study Start Date :||June 4, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2026|
|Experimental: Regorafenib and Nivolumab||
Drug: Regorafenib 40 MG
For subjects age 18 and older, Regorafenib will be administered as 120mg oral 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 72mg/m2/dose (rounded to the nearest 20mg, maximum dose of 120mg) oral once daily on days 1-21 of each 28-day cycle.
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.
- Compare the 4-month progression-free survival rate to historical controls [ Time Frame: Approximately 4 months ]To compare the 4-month progression-free survival (PFS) rate in patients with relapsed or refractory osteosarcoma administered regorafenib in combination with nivolumab to historical controls who received regorafenib alone, as per iRECIST. PFS will be determined as the time from the start of study treatment (Cycle 1, Day 1) to time of disease relapse, disease progression, or death from any cause, using iRECIST. The proportion of patients who do not experience one of these events at 4 months will be determined.
- Objective Response Rate [ Time Frame: Approximately 5 years ]To estimate the objective response rate (ORR) in patients with relapsed or refractory osteosarcoma administered regorafenib in combination with nivolumab, according to iRECIST. Objective tumor response, defined as achievement of nadir response of complete response (CR) or partial response (PR) by iRECIST without prior progression any time during protocol therapy.
- Progression-Free Survival [ Time Frame: Approximately 5 years ]To estimate the PFS, including median PFS, in this population. Progression-free survival (PFS) defined as the time from study entry to disease relapse, disease progression, or death from any cause, using iRECIST. Patients without an event will be censored at the time of last disease follow-up.
- Progression-Free Survival and Objective Response Rate [ Time Frame: Approximately 5 years ]To compare the 4-month PFS rate and ORR to historical controls in this population, according to RECIST 1.1. Duration of response is defined as the time from a nadir tumor response of CR/PR to disease progression.
- Describe adverse events [ Time Frame: Approximately 5 years ]To describe the toxicities of regorafenib in combination with nivolumab in patients with relapsed or refractory osteosarcoma. Adverse events will be graded as defined in CTCAE v. 5.0 during each therapy course.
- Estimate 1-year and 2-year Overall Survival [ Time Frame: Approximately 5 years ]To estimate 1-year and 2-year overall survival (OS) in patients with relapsed or refractory osteosarcoma treated with regorafenib in combination with nivolumab. Overall survival, defined as the time from study entry to death from any cause. Patients who are alive at the time of analysis will be censored at the date of last follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803877
|Contact: SARC Operations Officefirstname.lastname@example.org|
|United States, California|
|Children's Hospital of Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Principal Investigator: Fariba Navid, MD|
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator: Scott Schuetze, MD, PhD|
|United States, Oregon|
|Oregon Health and Sciences University||Recruiting|
|Portland, Oregon, United States, 97239|
|Principal Investigator: Lara Davis, MD|