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Checkpoint Inhibitor
Stereotactic Body Radiation Therapy + Durvalumab ± Tremelimumab for Oropharyngeal Squamous Cell Cancer
Phase 1 & 2
Waitlist Available
Led By Robert Chin
Research Sponsored by Jonsson Comprehensive Cancer Center
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 from time of enrollment to the first occurrence of disease progression as determined by response evaluation criteria in solid tumors (recist) v 1.1 or death from any cause, assessed up to 2 years
Awards & highlights
Study Summary
This trial is testing a combination of two cancer treatments - radiation therapy and immunotherapy - to see if they're effective in treating HPV-positive oropharyngeal squamous cell cancer.
Eligible Conditions
- Human Papillomavirus
- Squamous Cell Carcinoma
- Oropharyngeal Carcinoma
- Oropharyngeal Cancer
- Neoplastic Cells Present
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of enrollment to the first occurrence of disease progression as determined by response evaluation criteria in solid tumors (recist) v 1.1 or death from any cause, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of enrollment to the first occurrence of disease progression as determined by response evaluation criteria in solid tumors (recist) v 1.1 or death from any cause, assessed up to 2 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 adverse events (Phase I safety lead-in) assessed Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 criteria
Incidence of grade >= adverse events (Phase II)
Progression-free survival (PFS) (Phase II)
Secondary outcome measures
Distant recurrence rate
Incidence of adverse events assessed by CTCAE v4
Locoregional control rate
+7 moreSide effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Nausea
64%
Dyspnea
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%
Depression
14%
Hypotension
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
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%
Blurred vision
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
2Treatment groups
Experimental Treatment
Group I: Cohort II (SBRT, durvalumab,tremelimumab,TORS,neck dissection)Experimental Treatment7 Interventions
Beginning day 0 of course 1, participants undergo stereotactic body radiation therapy 5 days a week for 1 week and receive tremelimumab IV and durvalumab IV over 1 hour on days 0 and 27 in the absence of disease progression or unacceptable toxicity. Participants then undergo transoral robotic surgery and modified radical neck dissection between weeks 6-8. Beginning week 12, participants then receive durvalumab IV over 1 hour every 4 weeks. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Group II: Cohort I (SBRT, durvalumab, TORS, neck dissection)Experimental Treatment6 Interventions
Beginning day 0 of course 1, participants undergo stereotactic body radiation therapy 5 days a week for 1 week and receive durvalumab IV over 1 hour on days 0 and 27 in the absence of disease progression or unacceptable toxicity. Participants then undergo transoral robotic surgery and modified radical neck dissection between weeks 6-8. Beginning week 12, participants then receive durvalumab IV over 1 hour every 4 weeks. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Tremelimumab
2017
Completed Phase 2
~3380
Durvalumab
2017
Completed Phase 2
~3870
Transoral Robotic Surgery
2012
N/A
~110
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
363 Previous Clinical Trials
27,774 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,289 Previous Clinical Trials
288,620,179 Total Patients Enrolled
Robert ChinPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an organ transplant from someone else (not your own body).You have a current illness that is not being properly managed.You have had head and neck cancer that has come back.You have been diagnosed with a type of throat cancer called squamous cell carcinoma that is caused by the human papillomavirus (HPV). This will be confirmed by a test called immunohistochemistry that looks for a protein called p16.You have cancer that can be surgically removed and the doctor thinks you are a good candidate for the specific type of surgery called TORS.You are able to perform daily activities with minor assistance.Your hemoglobin level is at least 9.0 grams per deciliter.You can participate in the study if you have smoked for less than 20 years.You have had another type of cancer before, except for certain cases.You have cancer in both sides of your body at the same time.You cannot have received a live vaccine within 30 days before starting the study or within 30 days after receiving durvalumab or tremelimumab.The cancer is only in a few lymph nodes in the neck and they are located next to each other.You weigh at least 50 kilograms.You are able to have surgery after receiving neoadjuvant therapy and you are willing to have the surgery.You need to have had specific imaging tests done recently to participate in this study.You or your legal representative have given written permission before any testing or procedures related to the study can be done.You are currently receiving treatment for cancer.You have a current or past history of autoimmune or inflammatory disorders.It is okay to participate if you have smoked for less than 20 years.You have a medical condition that could make it difficult to evaluate the study treatment or understand the study's results.You have seizures that are not under control.You cannot participate if you are already part of another clinical trial.If you are a woman who is pregnant or breastfeeding, or if you have the ability to become pregnant and do not plan to use two highly effective forms of birth control, you cannot participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort II (SBRT, durvalumab,tremelimumab,TORS,neck dissection)
- Group 2: Cohort I (SBRT, durvalumab, TORS, neck dissection)
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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