Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors (NCT04007744) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors
United States36 participantsStarted 2020-02-13
Plain-language summary
This phase I trial studies the best dose of sonidegib when given together with pembrolizumab and to see how well they work in treating patients with solid tumor that has spread to other places in the body (advanced). Sonidegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sonidegib and pembrolizumab may work better than standard treatment in treating patients with advanced 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:
* Age \>= 18 years
* Measurable disease by RECIST criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to registration).
* Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 28 days prior to registration).
* Platelet count \>= 100,000/mm\^3 (obtained =\< 28 days prior to registration).
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) OR direct bilirubin =\< ULN (obtained =\< 28 days prior to registration).
* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 2.5 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 28 days prior to registration).
* Creatinine phosphokinase (CK) =\< 2.5 x ULN (obtained =\< 28 days prior to registration).
* Serum creatinine =\< 1.5 x ULN or calculated creatinine clearance \>= 50 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to registration).
* Negative serum pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only.
* Patients of childbearing potential agree to use two forms of medically approved contraception while taking the study drug and for 20 months following the last dose of study drug. Patients with partners of childbearing potential agree to use condoms, even after vasectomy, to avoid potential drug exposure to partner during study drug and for 8 months following the last dose of study drug.
* Willing to return to en…
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
Maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab (Part A)
Timeframe: Up to 21 days
2
Response rate of sonidegib in combination with pembrolizumab (Part B)