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NCT04803877 · ClinicalTrials.gov registry record · Phase 2
SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma
A Phase 2 study of Osteosarcoma and Osteosarcoma Recurrent, sponsored by Sarcoma Alliance for Research through Collaboration.
- Active
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 8
- Study locations
NCT04803877: Active Phase 2 study of Osteosarcoma and Osteosarcoma Recurrent, sponsored by Sarcoma Alliance for Research through Collaboration.
NCT04803877 is a Phase 2 study of Osteosarcoma and Osteosarcoma Recurrent that is active but no longer recruiting, run by Sarcoma Alliance for Research through Collaboration. The registered enrollment target is 48 participants, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (84% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04803877, a Phase 2 study of Osteosarcoma and Osteosarcoma Recurrent, is active but no longer recruiting, sponsored by Sarcoma Alliance for Research through Collaboration.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 8
- Study locations
Study Summary
A phase 2 study of regorafenib in combination with nivolumab in patients with refractory or recurrent osteosarcoma.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Regorafenib 40 MG
- DRUG Regorafenib 20MG
Study Locations (8)
California
- Children's Hospital of Los Angeles - Los Angeles
Florida
- University of Miami - Miami
Maryland
- Johns Hopkins - Baltimore
Michigan
- University of Michigan - Ann Arbor
Minnesota
- University of Minnesota - Minneapolis
Ohio
- Cincinnati Children's - Cincinnati
Oregon
- Oregon Health and Sciences University - Portland
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-06-04 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What the registry record for NCT04803877 still lists
NCT04803877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (84% lower).
The record links to 4 conditions, with Osteosarcoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT04803877 lists 8 locations in 8 states (California, Florida, Maryland).
Frequently Asked Questions
What is clinical trial NCT04803877 about?
NCT04803877 is a clinical study titled "SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma". A phase 2 study of regorafenib in combination with nivolumab in patients with refractory or recurrent osteosarcoma.
What is the current status of trial NCT04803877?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2021-06-04. Estimated completion is 2026-06.
What conditions does trial NCT04803877 study?
This clinical trial studies the following conditions: Osteosarcoma, Osteosarcoma Recurrent, Osteosarcoma in Children, Osteosarcoma Metastatic.
What interventions are being tested in trial NCT04803877?
The interventions under investigation include: Nivolumab (DRUG), Regorafenib 40 MG (DRUG), Regorafenib 20MG (DRUG).
Who is sponsoring clinical trial NCT04803877?
This trial is sponsored by Sarcoma Alliance for Research through Collaboration, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04803877 being conducted?
This trial has 8 study locations across California, Florida, Maryland, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04803877's enrollment target sits among peer trials
48 20th of 46 higher than 26 of 46 other Osteosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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