Combining durvalumab and tremelimumab for advanced rare solid tumors

A Phase II Study of Durvalumab (MEDI4736) (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Rare Solid Tumors

This study is testing a combination of two medications, durvalumab and tremelimumab, to see if they can help people with advanced rare solid tumors who haven't had success with other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Prisma Health-Upstate (Academic / other)
• Drugs / interventions: durvalumab, tremelimumab, chemotherapy, prednisone, immunotherapy
• Locations: 1 site (Greenville, South Carolina)
• Trial ID: NCT02938793 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with rare advanced solid malignancies who have not responded to or are ineligible for standard treatments.

Not a fit: Patients with specific rare malignancies currently being investigated in other studies, such as thymic carcinoma and certain sarcomas, will not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced rare solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar immunotherapy combinations, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Greenville, South Carolina

• 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

Conditions Cancer; Rare Disease; cancer, malignancy