Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas

Starting soon · Phase 2

Conditions studied: MPNST, NF1, Sarcoma

In brief

A multi-institutional open-label phase 1/2 trial of selumetinib in combination with ZEN-3694 and durvalumab in refractory/unresectable sarcomas including MPNST. The phase 1 portion will be separated in two parts and will be open to all patients with refractory/relapsed sarcomas. The phase 2 portion will be for patients with refractory/unresectable NF1-associated MPNST.

Key facts

Study ID

NCT05253131

Run by

University of Alabama at Birmingham

People needed

41

Starts

2026-11-15

Expected to finish

2032-11-15

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria AGE: ≥ 18 years of age Weight: >30 kg Life expectancy of at least 12 weeks
• Part A and B (Phase 1): Patients with histologically confirmed soft tissue or bone sarcoma of the following subtypes:
• MFH/ undifferentiated pleomorphic sarcoma
• Unclassified sarcoma
• Rhabdomyosarcoma
• Malignant peripheral nerve sheath tumor (MPNST)
• Osteosarcoma
• Ewing or Ewing-like sarcoma
• Synovial sarcoma
• Desmoplastic small round blue cell tumor (DSRCT)
• Patients must have progressed or demonstrated disease that is refractory to standard therapies.
• Patients for whom no standard of care treatments exist are eligible.
• Part C (Phase 2): Patients with progressive, relapsed, unresectable or metastatic NF associated MPNST.
• MEASURABLE DISEASE:
• Patients must have evaluable or measurable disease (Phase 1) and measurable disease by RECISTv1.1 (Phase 2).
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering on this study excluding chronic grade 1 toxicities and alopecia.
• No limitation on the number of prior chemotherapy regimens that the patient may have received prior to study entry.
• Myelosuppressive chemotherapy: The last dose of all myelosuppressive anticancer drugs must be at least 3 weeks (≥21 days) and 42 days if prior nitrosourea prior to study entry.
• Immunotherapy: The last dose of immunotherapy (monoclonal antibody or vaccine) must be at least 4 weeks prior to study entry.
• Biologic (anti-cancer agent): The last dose of all biologic agents for the treatment of the patient's cancer (such as retinoids or tyrosine kinase inhibitors) must be at least 7 days prior to study entry. Prior therapy with a MEK, Ras, or Raf inhibitor used for treatment of malignant sarcoma is not allowed. Prior therapy of MEK, Ras, or Raf inhibitor for other tumor such as plexiform neurofibroma or glioma is allowed.
• Radiation therapy: The last dose of radiation to more than 25% of marrow containing bones (pelvis, spine, skull) must be at least 4 weeks prior to study
• Radiation therapy: The last dose of radiation to more than 25% of marrow containing bones (pelvis, spine, skull) must be at least 4 weeks prior to study entry. The last dose of all other local palliative (limited port) radiation must be at least 2 weeks prior to study entry.
• Stem Cell Transplantation. At least 2 months post-autologous stem cell transplant.
• Growth Factors. The last dose of colony stimulating factors, such as filgrastim, sargramostim, and erythropoietin, must be at least 1 week prior to study entry, the last dose of long-acting colony stimulating factors, such as pegfilgrastim, must be at least 2 weeks prior to study entry.
• Karnofsky performance level ≥ 50% (See Appendix II).

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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