Combining durvalumab and tremelimumab for advanced rare solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness, safety, and tolerability of durvalumab combined with tremelimumab in patients with advanced rare solid tumors. It is an open-label, single-institution study that has completed its dose-exploration phase and is currently in the dose-expansion phase, focusing on specific tumor types such as soft tissue sarcomas and neuroendocrine tumors. Participants must have previously failed or been ineligible for standard treatments and must be able to provide tumor biopsy samples. The treatment regimen includes intravenous administration of durvalumab and a single dose of tremelimumab.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of a rare advanced solid malignancy meeting EORTC criteria.
* Subjects must have failed or been ineligible to receive standard treatment options if available.
* Subjects must be amenable to biopsy of a tumor site or have recent (\< 2 years) archival material available.
* ECOG performance status of 0 to 2.
* Life expectancy \> 3 months.
* Adequate normal organ and marrow function including: hemoglobin \> 9.0 g/dl; ANC \> 1500 per mm3; platelet count \> 100,000 per mm3; bilirubin \< 1.5 x ULN; ALT/AST \< 2.5 x ULN unless liver metastases present in which case must be \< 5 x ULN; creatinine clearance \> 40 ml/min by Cockcroft-Gault or 24 hour urine collection

Exclusion Criteria:

* Previous treatment with durvalumab or tremelimumab.
* Prior treatment with any checkpoint inhibitor (including anti-CTLA-4, anti-PD-1 and anti-PD-L1).
* Rare malignancies under investigation in other studies including thymic carcinoma, certain sarcomas, and neuroendocrine tumors.
* Untreated central nervous system metastatic disease.
* Active or documented autoimmune disease within previous 2 years.
* Uncontrolled psoriasis.
* Prior chemotherapy within 28 days of the first dose of durvalumab or tremelimumab.
* Steroid exposure within 28 days of the first dose of durvalumab or tremelimumab with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid

Where it's running

• Greenville Health System Cancer Institute
  Greenville, South Carolina, United States Recruiting

Study contacts

• Principal investigator: William J Edenfield, MD — Prisma Health-Upstate
• Study coordinator: Julie C Martin, DNP
• Email: julie.martin@prismahealth.org
• Phone: 864-455-3600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.