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Checkpoint Inhibitor
Sonidegib + Pembrolizumab for Advanced Cancers
Phase 1
Recruiting
Led By Mojun Zhu, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed recurrent or metastatic HNSCC
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
Study Summary
This trial is testing the best dose of sonidegib in combination with pembrolizumab to treat patients with advanced solid tumors. Sonidegib may stop tumor growth by blocking enzymes needed for cell growth. Pembrolizumab may help the body's immune system attack the cancer and prevent tumor cells from growing and spreading. Giving sonidegib and pembrolizumab may work better than standard treatment.
Who is the study for?
Adults with advanced solid tumors, including various cancers like melanoma and lung cancer, who have tried other treatments without success. They must be in good physical condition (ECOG 0 or 1), have measurable disease, and agree to use two forms of contraception if of childbearing potential. Not eligible if pregnant, nursing, expected to live less than three months, or unable to take the study drug due to certain health conditions.Check my eligibility
What is being tested?
The trial is testing the combination of Sonidegib and Pembrolizumab for treating advanced solid tumors. It aims to find the best dose of Sonidegib that works well with Pembrolizumab—an antibody therapy—to potentially stop tumor growth by blocking enzymes needed for cell growth while helping the immune system attack cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation which may affect organs, fatigue, digestive issues and muscle-related problems such as inflammation or rhabdomyolysis—a serious syndrome resulting from direct or indirect muscle injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has returned or spread and is confirmed by tests.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can swallow pills and my stomach absorbs medications well.
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My cancer has worsened after treatment with platinum-based chemotherapy.
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I have EGFR, ALK, or BRAF mutations and my cancer progressed after FDA-approved treatments.
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My head/neck cancer returned or spread after treatment with platinum-based chemotherapy.
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My tumor is advanced or has spread and tests positive for PD-L1.
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My condition worsened after at least one treatment.
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My melanoma cannot be removed by surgery or has spread.
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My colorectal cancer has worsened despite treatment with standard therapies.
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I have squamous cell cancer in my head or neck.
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I am 18 years old or older.
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My condition worsened after two or more treatments.
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I am fully active or can carry out light work.
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My cancer is in the stomach or where the stomach meets the esophagus.
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My cancer cannot be surgically removed, has spread, and is either MSI-H or mismatch repair deficient.
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My cancer got worse within a year of platinum-based treatment.
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My cancer is identified as MSI-H.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My cancer is advanced or has spread and is in the urinary system.
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I have been newly diagnosed and cannot receive cisplatin.
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My lung cancer has spread and is confirmed by tests.
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I have EGFR, ALK, or BRAF mutations and my cancer progressed after FDA-approved treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab (Part A)
Response rate of sonidegib in combination with pembrolizumab (Part B)
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Incidence of adverse events
+3 moreOther outcome measures
Changes in immune cell markers, cytokines, and soluble PD-L1
Level of serum soluble PDL-1
Levels of Bcl-2 interacting mediator of cell death (BIM)
Side effects data
From 2021 Phase 2 trial • 28 Patients • NCT0208655293%
Fatigue
85%
Neutrophil count decreased
74%
Diarrhea
74%
Peripheral sensory neuropathy
70%
White blood cell decreased
70%
Myalgia
67%
Platelet count decreased
52%
Rash maculo-papular
44%
Dysgeusia
37%
Constipation
37%
Vomiting
19%
Lymphocyte count decreased
19%
Weight loss
19%
Alopecia
15%
Musculoskeletal and connective tissue disorder - Other, specify
11%
Anorexia
11%
Anemia
11%
Skin and subcutaneous tissue disorders - Other, specify
7%
Tinnitus
7%
Alkaline phosphatase increased
7%
Arthralgia
7%
Infections and infestations - Other, specify
7%
Hot flashes
7%
Thromboembolic event
4%
CPK increased
4%
Syncope
4%
Blurred vision
4%
Abdominal pain
4%
Gastritis
4%
Dehydration
4%
Febrile neutropenia
4%
Nausea
4%
Lung infection
4%
Acute kidney injury
4%
Hematuria
4%
Bladder infection
4%
Corneal infection
4%
Sinusitis
4%
Alanine aminotransferase increased
4%
Headache
4%
Cough
4%
Dry skin
4%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Sonidegib, Lenalidomide)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (sonidegib, pembrolizumab)Experimental Treatment2 Interventions
Patients receive sonidegib PO QD on days 1-8, and pembrolizumab IV over 30 minutes on day 8. Treatment repeats every 21 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sonidegib
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,766,928 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,088 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Mojun Zhu, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease needing regular immune system medications.I had a severe reaction to previous immunotherapy that needed steroids or stopped treatment.My cancer has returned or spread and is confirmed by tests.Women who can have children must have a negative pregnancy test within 7 days before joining the study.I am fully active or restricted in physically strenuous activity but can do light work.I can swallow pills and my stomach absorbs medications well.I have not had major surgery in the last 4 weeks.My cancer has worsened after treatment with platinum-based chemotherapy.The level of creatinine phosphokinase in your body should be no more than 2.5 times the upper limit of normal.I have EGFR, ALK, or BRAF mutations and my cancer progressed after FDA-approved treatments.My head/neck cancer returned or spread after treatment with platinum-based chemotherapy.I have brain metastases that are either untreated, causing symptoms, or need steroids.My tumor is advanced or has spread and tests positive for PD-L1.I have not received a live vaccine in the last 30 days.My condition worsened after at least one treatment.My melanoma cannot be removed by surgery or has spread.My colorectal cancer has worsened despite treatment with standard therapies.I have squamous cell cancer in my head or neck.My side effects from previous treatments are mild or gone.I am 18 years old or older.I haven't taken any experimental drugs or cancer treatments in the last 4 weeks.My condition worsened after two or more treatments.Your white blood cell count is at least 1000 cells per cubic millimeter.Your hemoglobin level is at least 9.0 grams per deciliter.I haven't taken high doses of steroids or immunosuppressants in the last 2 weeks.I have a neuromuscular disorder or a history of severe muscle breakdown.I am fully active or can carry out light work.You are expected to live less than 3 months.My cancer is in the stomach or where the stomach meets the esophagus.I am not taking medications known to cause severe muscle damage, like statins.Your disease can be measured using specific criteria.My cancer has returned or spread from its original site.I am not taking any strong drugs that affect liver enzymes or consuming grapefruit/starfruit products.My cancer cannot be surgically removed, has spread, and is either MSI-H or mismatch repair deficient.It has been over 8 weeks since I finished treatment for brain cancer spread.I have had previous treatments.Your liver enzyme levels need to be within a certain range, and this will be checked within a month before you join the study.My cancer got worse within a year of platinum-based treatment.My cancer is identified as MSI-H.I have non-small cell lung cancer.My NSCLC does not respond to current treatments.Your platelet count is at least 100,000 per cubic millimeter in a recent blood test.Your bilirubin levels must be within a certain range, which will be checked within 28 days before joining the study.My kidney function, measured by creatinine levels or clearance, is within the required range.I have been diagnosed with melanoma.My cancer is advanced or has spread and is in the urinary system.I have been newly diagnosed and cannot receive cisplatin.My lung cancer has spread and is confirmed by tests.I have EGFR, ALK, or BRAF mutations and my cancer progressed after FDA-approved treatments.You have a disease that can be measured using specific criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sonidegib, pembrolizumab)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can the potential risks of Sonidegib be managed?
"Given the Phase 1 status of Sonidegib, there is only minimal data to verify both its efficacy and safety; as such, our team at Power has assigned it a score of 1."
Answered by AI
What health conditions has Sonidegib been clinically tested to treat?
"Sonidegib is a common treatment for malignant neoplasms, and it has also been found to be efficacious in cases of advanced melanoma, microsatellite instability high, or chemotherapy-resistant disease progression."
Answered by AI
Are any new volunteers being taken into this investigation?
"Affirmative. Clinicaltrials.gov reveals that this experiment, initially posted on February 13th 2020, is actively seeking participants. A total of 45 people are needed to be enrolled from 3 distinct locations."
Answered by AI
What are the prime goals of this clinical experiment?
"The primary purpose of this trial, measured over a 30-day post-treatment span, is to assess the Maximum Tolerated Dose (MTD) when combining sonidegib with pembrolizumab (Part A). Secondary outcomes encompass Response Profile - calculated using RECIST 1.1 criteria and measuring Complete/Partial Responses as well as Stable or Progressive Disease - Progression Free Survival (PFS), determined by RECIST 1.1 metrics, estimated via Kaplan Meier Methodology; Duration of Response for those achieving Verified Objective Improvement but not yet experiencing Radiographic/ Clinical Progression that is evaluated"
Answered by AI
Are there any other investigations involving Sonidegib that have been conducted?
"Presently, 966 Sonidegib trials are ongoing. 122 of these studies have reached Phase 3 testing and the vast majority is taking place in Houston, Texas; though 35738 medical sites are running clinical research for this medication."
Answered by AI
What is the aggregate census of participants in this trial?
"Absolutely. Clinicaltrials.gov shows that this clinical trial has opened recruitment, with its initial post dating back to February 13th 2020 and the most recent update on September 8th 2022. To reach completion, 45 participants need to be enrolled from 3 different sites."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Arizona
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Mayo Clinic in Arizona: < 48 hours
Average response time
- < 2 Days
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