Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas (NCT05253131) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas
United States41 participantsStarted 2026-05-15
Plain-language summary
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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: Safety and Tolerability Selumetinib with ZEN-3694
Timeframe: From first dose through the end of the first treatment cycle for each participant at each dose level (up to 28 days).
2
Part B: Safety and Tolerability of Durvalumab with Combination of Selumetinib and ZEN-3694
Timeframe: From first dose through the end of the first treatment cycle for each participant at each dose level (up to 28 days).
3
Part C: Determine the Clinical Benefit of Selumetinib, ZEN-3694 and Durvalumab
Timeframe: From first dose through completion of 4 treatment cycles for each participant (up to 112 days).