Trial · NCT06422806
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
NCT06422806, Phase 3, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas. Trials, record NCT06422806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06422806
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
- NCT number
- NCT06422806
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 365 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Unresectable Dedifferentiated Liposarcoma, Unresectable Undifferentiated Pleomorphic Sarcoma
- Interventions
- Biospecimen Collection, Diagnostic Imaging Testing, Doxorubicin, Echocardiography Test, Multigated Acquisition Scan, Pembrolizumab
- First posted
- 2024-05-21
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival (PFS) | From randomization to documented progression (per Response Evaluation Criteria in Solid Tumors version 1.1) or death from any cause without prior progression, up to 5 years | Will be compared between the treatment arms (doxorubicin + pembrolizumab versus \[vs\] doxorubicin alone). The comparison of PFS between treatment arms will be done using a stratified (on Eastern Cooperative Oncology group performance status \[0 vs 1\]) log-rank test with a 2.5% type I error (1-sided). Will be analyzed separately for the undifferentiated pleomorphic sarcoma and related malignancies and for the dedifferentiated liposarcoma. |
| Secondary | Overall survival | From randomization to death, up to 5 years | Will be compared between doxorubicin + pembrolizumab vs doxorubicin alone to test the strategy of upfront pembrolizumab vs second line pembrolizumab. |
| Other | Progression status | From randomization to documented progression (per RECIST version 1.1) or death from any cause without prior progression, up to 5 years | Evaluated using Cohen's kappa coefficient. |
| Other | Progression time | From randomization to documented progression (per RECIST version 1.1) or death from any cause without prior progression, up to 5 years |
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT06422806
GET https://conductscience.org/api/trials/v1/NCT06422806/registered