Trial · NCT03277924
Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas
NCT03277924, Phase 1, Phase 2, Completed, Grupo Espanol de Investigacion en Sarcomas
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas. Trials, record NCT03277924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03277924
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas
- NCT number
- NCT03277924
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 197 participants, actual
- Lead sponsor
- Grupo Espanol de Investigacion en Sarcomas
- Conditions
- Soft Tissue Sarcoma, Bone Sarcoma
- Interventions
- Sunitinib 37.5 MG, Sunitinib 25 MG [Sutent], Nivolumab 100 MG/10 ML [Opdivo], Epirubicin, Ifosfamide, Doxorubicin, Dacarbazine, Cisplatin, Methotrexate
- First posted
- 2017-09-11
- Last updated
- 2024-08-13
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage 1 - PHASE 1 | 6 months | The recommended dose of the sunitinib and nivolumab combination for phase II part will be determined by assessing adverse events according to CTCAE 4.0 and they will be used as a rule for escalating or diminishing dose levels according to the dose-limiting toxicities detailed in the protocol |
| Primary | Stage 1 - PHASE 2 | 6 months | Progression-free survival rate (PFSR): Efficacy measured by the PFSR at 6 months according to RECIST 1.1. PFSR at 6 months is defined as the percentage of patients who did not experience progression or death due to any cause since enrollment until month 6 after enrollment. |
| Primary | Stage 2 - Cohort 1-6: Progression-free survival rate (PFSR) | 6 months for CS/DDCS, EMC, VS, SFT, and CCS and 12 months for ASPS | CS/DDCS, EMC, VS, SFT, and CCS cohorts: 6-month progression-free survival rate (PFSR): Efficacy measured by the PFSR at 6 months according to RECIST 1.1. PFSR at 6 months is defined as the percentage of patients who did not experience progression or death due to any cause since enrollmentuntil month 6 after enrollment. ASPS cohort: 12-month progression-free survival rate (PFSR): Efficacy measured by the PFSR at 12 months according to RECIST 1.1. PFSR at 12 months is defined as the percentage of patients who did not experience progression or death due to any cause since the date of enrollment until month 12 after enrollment. |
| Primary | Stage 2 - Cohort 7: Maximum tolerated dose (MTD) | 1 year | The maximum tolerated dose (MTD) of the epirubicin + ifosfamide + nivolumab combination will be determined by assessing adverse events according to CTCAE 5.0 and they will be used for adjusting dose levels according to the dose-limiting toxicities detailed in the protocol. |
| Primary | Stage 2 - Cohort 8: Maximum tolerated dose (MTD) | 1 year | The maximum tolerated dose (MTD) of the MAP + nivolumab combination will be determined by assessing adverse events according to CTCAE 5.0 and they will be used for adjusting dose levels according to the dose-limiting toxicities detailed in the protocol. |
| Secondary | Stage 1 and Stage 2 - Overall survival (OS) | 2 years | OS is defined as the time between the date of enrollment and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive. |
| Secondary | Stage 1 and Stage 2 - Objective response rate (ORR) | 2 months | ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of response evaluable subjects (according to RECIST 1.1 criteria). |
| Secondary | Stage 2 - Cohort 1-6 Correlation between efficacy and potential predictive biomarkers | 2 years | Assessed by finding relationships between clinical efficacy results and translational data. |
| Secondary | Stage 1 and Stage 2 - Safety profile: Adverse events | 3 years | Safety profile of the experimental treatment, through assessment of adverse event type, incidence, severity, time of appearance, related causes, as well as physical explorations and laboratory tests. Toxicity will be graded and tabulated by using CTCAE 5.0. |
| Secondary | Stage 1 (PHASE 2) and Stage 2 - Cohort 1-6 Clinical outcome | At 36 months | Clinical outcomes of post protocol treatments assessed by observation of such treatments in follow-up stage. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
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.
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT03277924
GET https://conductscience.org/api/trials/v1/NCT03277924/registered