Durvalumab in Combination With Tremelimumab in Subjects With Advanced Rare Solid Tumors (NCT02938793) | Clinical Trial Compass
TerminatedPhase 2
Durvalumab in Combination With Tremelimumab in Subjects With Advanced Rare Solid Tumors
Stopped: poor enrollment likely due to expanded availability of immunotherapy for patients
United States92 participantsStarted 2016-12-01
Plain-language summary
This is an investigator initiated single institution, open-label study to evaluate the antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab in subjects with select advanced rare solid tumors.
Who can participate
Age range
18 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:
* 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 co…
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
Antitumor Activity
Timeframe: 24 months
2
Incidence of Treatment-Emergent and Non Treatment-Emergent Adverse Events [Safety and Tolerability]