Durvalumab in Combination With Tremelimumab in Subjects With Advanced Rare Solid Tumors

Launched by PRISMA HEALTH-UPSTATE · Oct 17, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, durvalumab and tremelimumab, to see how effective they are in treating certain advanced rare solid tumors in cancer patients. The goal is to find out if this treatment can help shrink tumors and how safe it is for patients to use. The trial is currently recruiting participants who have a specific type of rare cancer that has not responded to standard treatments or for whom standard treatments are not available.

To be eligible for this trial, participants must be between the ages of 65 and 74 and have a confirmed diagnosis of a rare solid cancer. They should be in good enough health to undergo a biopsy, which is a procedure to take a small sample of tissue from the tumor. Participants should also have a life expectancy of more than three months and meet certain health criteria related to their blood and organ function. Throughout the trial, participants will receive the new treatment and will be monitored for any side effects or changes in their condition. It’s important to note that individuals who have previously received these specific medications or have certain other health issues may not be eligible to join the study.

Gender

ALL

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