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Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 243 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 261 sites
  2. Study sites: 260 to 261
  3. Site details revised at 3 of 260 sites
  4. Re-verified, no change to tracked fields
  5. Trial sites expanded: 257 → 260 locations
Show 3 earlier versionsHide 3 earlier versions
  1. Site contacts updated at 1 of 257 sitesv238
  2. Site details revised at 4 of 257 sitesv237
  3. Site details revised at 12 of 257 sitesv236
  1. Primary and study completion moved earlier from Jun 30, 2035 to Apr 18, 2032 Site details revised at 9 of 257 sitesv235 Show 1 more changeShow less
    • Site details revised at 9 of 257 sites
  2. Primary and study completion dates: Jun 30, 2035 to Apr 18, 2032v234
  3. Site details revised at 1 of 257 sitesv233
  4. Site details revised at 1 of 257 sitesv232
  5. Site details revised at 1 of 257 sitesv231
  6. Site details revised at 1 of 257 sitesv230
  7. Site details revised at 1 of 257 sitesv229
  8. Study sites revised (257)v228 See this version in full on ClinicalTrials.gov ↗
  9. Site details revised at 1 of 257 sitesv227
  10. Site details revised at 1 of 257 sitesv226
  11. Study sites: 256 to 257v225
  12. Site contacts updated at 1 of 256 sitesv224
  13. Site details revised at 1 of 256 sitesv223
  14. Site contacts updated at 1 of 256 sitesv222
  15. Site details revised at 1 of 256 sitesv221
  16. Site details revised at 10 of 256 sitesv220
  17. Site contacts updated at 1 of 256 sitesv219
  18. Site details revised at 13 of 256 sitesv218
  19. Study sites revised (256)v217 See this version in full on ClinicalTrials.gov ↗
  20. Site contacts updated at 10 of 256 sitesv216
  21. Study sites: 255 to 256v215
  22. Study sites: 254 to 255v214
  23. Study sites: 253 to 254v213
  24. Study sites: 252 to 253v212
  25. Study sites: 251 to 252v211
  26. Study sites: 250 to 251v210
  27. Primary and study completion pushed from Jun 30, 2026 to Jun 30, 2035v209
  28. Re-verified, no change to tracked fieldsv208
  29. Study sites: 249 to 250v207
  30. Study sites: 248 to 249v206
  31. Study sites revised (248)v205 See this version in full on ClinicalTrials.gov ↗
  32. Site contacts updated at 1 of 248 sitesv204
  33. Site details revised at 2 of 248 sitesv203
  34. Site details revised at 1 of 248 sitesv202
  35. Re-verified, no change to tracked fieldsv201
  36. Study sites: 247 to 248v200
  37. 6 versions Re-verified since Mar 21, 2026, no change to tracked fieldsv194-v199
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable DDLPS, UPS or a related poorly differentiated sarcoma live longer without having disease progression.
Trial Details
NCT Number NCT06422806
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
Enrollment 365 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov