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Checkpoint Inhibitor
Stereotactic Body Radiation Therapy for Major Salivary Gland Cancer
Phase 1 & 2
Waitlist Available
Led By Cristina Rodriguez
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing the side effects and efficacy of nivolumab and ipilimumab given with stereotactic body radiation therapy for patients with salivary gland cancers.
Eligible Conditions
- Stage IV Major Salivary Gland Cancer
- Bone Metastasis
- Major Salivary Gland Cancer
- Salivary Gland Cancer
- Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Secondary outcome measures
Objective Response Rate (ORR)
Overall Survival (OS)
Progression-free Survival (PFS)
Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Back pain
29%
Anemia
29%
Vomiting
21%
Anorexia
21%
Lymphocyte count decreased
21%
Chest pain
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Blurred vision
7%
Creatinine increased
7%
Alopecia
7%
Confusion
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Dementia
7%
Productive cough
7%
Dysuria
7%
Throat pain
7%
Hearing impaired
7%
Rash
7%
Bone marrow biopsy
7%
Hypernatremia
7%
Eye pain
7%
Tachycardia
7%
Lung infection
7%
Amnesia
7%
Neuropathy
7%
Dehydration
7%
Pneumonitis
7%
Pleuritic pain
7%
Otitis externa
7%
White blood cell count decreased
7%
Neutropenia
7%
Hypertension
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, ipilimumab, SBRT)Experimental Treatment3 Interventions
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2610
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,749 Previous Clinical Trials
1,838,624 Total Patients Enrolled
Cristina RodriguezPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer that has spread to your brain or spinal cord, unless it has been stable and you have not taken steroids for at least 14 days before the study treatment.You have an autoimmune disease that requires treatment or has been severe within the past 2 years.You have a mental health or substance abuse issue that may make it difficult for you to follow the study requirements.You have been treated with a specific type of medication called monoclonal antibodies within the last 4 weeks, or you still have side effects from medications taken more than 4 weeks ago.You have cancer in your salivary gland that has spread to your head, neck, lungs, or bones and you are not eligible for curative treatment.Your condition has continued to worsen despite treatment with the most recent medication, or if you have not received any prior medication, your condition has worsened within the last 3 months according to your doctor.You are physically able to lie flat and stay still during the required SBRT treatments, according to your doctor's assessment.You need to provide a sample of your tumor tissue, either from a previous biopsy or a new one. If getting a tissue sample is not recommended or not possible, the study doctor may approve a waiver of this requirement.You are in good physical condition and have a score of 0 or 1 on the ECOG performance scale.You have had an organ transplant before or have a weakened immune system from birth.You have an ongoing illness that is not under control.You cannot have taken part in another clinical trial using a new drug or device within the past four weeks.The target lesion/s for this treatment require specific size or location.You have cancer that started in the salivary gland and has spread to other parts of the head and neck, lungs, or bones. The cancer cannot be cured with current treatments.You have already received treatment for your condition in the past.You must be willing to sign a form saying you agree to participate in the study and commit to attending all scheduled visits.You have a detectable medical condition that can be measured using a specific scale called RECIST 1.1, besides the one being treated with stereotactic radiation therapy.Your hemoglobin level, which measures the amount of oxygen in your blood, is at least 9.0 grams per deciliter.You have up to three tumors in the head and neck region or cancer that has spread to the lung or bone, which will be treated with a type of radiation called SBRT. You also have other measurable tumors that will be monitored according to standard guidelines. If the area being treated with SBRT was previously treated with high doses of radiation, there should be at least a six month gap before starting SBRT.You have received any type of treatment using medications for your condition before.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, ipilimumab, SBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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