Trial · NCT04803877
SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma
NCT04803877, Phase 2, Active not recruiting, Sarcoma Alliance for Research through Collaboration
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma. Trials, record NCT04803877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04803877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma
- NCT number
- NCT04803877
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 48 participants, estimated
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Conditions
- Osteosarcoma, Osteosarcoma in Children, Osteosarcoma Recurrent, Osteosarcoma Metastatic
- Interventions
- Regorafenib 40 MG, Regorafenib 20MG, Nivolumab
- First posted
- 2021-03-18
- Last updated
- 2025-10-31
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compare the 4-month progression-free survival rate to historical controls | 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. |
| Secondary | Objective Response Rate | 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. |
| Secondary | Progression-Free Survival | 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. |
| Secondary | Progression-Free Survival and Objective Response Rate | 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. |
| Secondary | Describe adverse events | 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. |
| Secondary | Estimate 1-year and 2-year Overall Survival | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04803877
GET https://conductscience.org/api/trials/v1/NCT04803877/registered