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Monoclonal Antibodies
Anti-OX40 Antibody for Head and Neck Cancer
Phase 1
Waitlist Available
Led By Richard B. Bell, MD
Research Sponsored by Providence Health & Services
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 5 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it is safe for patients with head and neck squamous cell carcinoma.
Who is the study for?
This trial is for adults with advanced head and neck squamous cell carcinoma who are candidates for surgery. They should have no history of autoimmune diseases, active infections, or prior treatment with mouse monoclonal antibodies. Participants must be able to understand the study and follow its procedures, have a life expectancy over 12 weeks, and an ECOG performance status of 0-2.Check my eligibility
What is being tested?
The trial is testing the safety of MEDI6469 (an anti-OX40 antibody) given before surgery in patients with certain types of head and neck cancer. The goal is to see how well patients tolerate this drug when it's administered before they undergo surgical tumor removal.See study design
What are the potential side effects?
Potential side effects from the anti-OX40 antibody may include immune-related reactions since it targets the immune system. These can range from mild skin reactions to more serious conditions affecting various organs like the liver or lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and feasibility of definitive surgical resection for locoregionally advanced OHNSCC following MEDI6469 administration
Secondary outcome measures
T-Lymphocyte Subsets
Other outcome measures
Clinical Outcome of Imaging
Side effects data
From 2021 Phase 2 trial • 22 Patients • NCT03019640100%
Lymphocyte count decreased
100%
White blood cell decreased
100%
Nausea
100%
Fever
100%
Platelet count decreased
100%
Anemia
100%
Neutrophil count decreased
95%
Diarrhea
82%
Hyperglycemia
77%
Mucositis oral
77%
Fatigue
64%
Sinus tachycardia
59%
Hypotension
59%
Anorexia
55%
Hypophosphatemia
55%
Constipation
55%
Edema limbs
55%
Rash maculo-papular
50%
Headache
45%
Hypoalbuminemia
45%
Hypocalcemia
45%
Alanine aminotransferase increased
41%
Hypokalemia
41%
Dizziness
36%
Hyponatremia
36%
Anxiety
32%
Investigations
32%
Insomnia
32%
Vomiting
32%
Chills
32%
Cough
32%
Febrile neutropenia
32%
Hypertension
27%
Pain
27%
Alkaline phosphatase increased
27%
Aspartate aminotransferase increased
23%
Hypomagnesemia
23%
Infections and infestations
23%
Dysphagia
23%
Arthralgia
23%
Esophagitis
23%
Hiccups
18%
Dehydration
18%
Hypoxia
18%
Abdominal pain
18%
Allergic rhinitis
18%
Dyspnea
18%
Generalized muscle weakness
18%
Hemorrhoids
14%
Infusion related reaction
14%
INR increased
14%
Immune system disorders
14%
Bloating
14%
Paresthesia
14%
Pleural effusion
14%
Dyspepsia
14%
Hypermagnesemia
14%
Rectal pain
9%
Upper respiratory infection
9%
Sore throat
9%
Blood bilirubin increased
9%
Bone pain
9%
Cholesterol high
9%
Creatinine increased
9%
Nasal congestion
9%
Papulopustular rash
9%
Arthritis
9%
Back pain
9%
Dry skin
9%
Dysgeusia
9%
Flushing
9%
General disorders and administration site conditions
9%
Hypernatremia
9%
Hyperuricemia
9%
Non-cardiac chest pain
9%
Renal and urinary disorders
9%
Skin ulceration
5%
Hypoglycemia
5%
Lymph node pain
5%
Tremor
5%
Hypothyroidism
5%
Lung infection
5%
Thromboembolic event
5%
Urinary tract pain
5%
Vascular disorders
5%
Weight gain
5%
Lymphocyte count increased
5%
Myalgia
5%
Urinary tract infection
5%
Urinary frequency
5%
Lung
5%
Eye disorders
5%
Gastroesophageal reflux disease
5%
Mucosal infection
5%
Metabolism and nutrition disorders
5%
Musculoskeletal and connective tissue disorder
5%
Peripheral motor neuropathy
5%
Prostatic obstruction
5%
Pulmonary edema
5%
Rash acneiform
5%
Respiratory failure
5%
Acute kidney injury
5%
Ear pain
5%
Edema face
5%
Encephalopathy
5%
Endocrine disorders
5%
Atelectasis
5%
Atrial fibrillation
5%
Bladder infection
5%
Epistaxis
5%
Flatulence
5%
Gastrointestinal pain
5%
Hematuria
5%
Hemorrhoidal hemorrhage
5%
Hypercalcemia
5%
Neck pain
5%
Nervous system disorders
5%
Pain in extremity
5%
Restlessness
5%
Sinus bradycardia
5%
Sinusitis
5%
Skin and subcutaneous tissue disorder
5%
Skin hyperpigmentation
5%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment2 Interventions
Anti-OX40 antibody administration 1 week prior to surgical resection
Group II: Group 2Experimental Treatment2 Interventions
Anti-OX40 antibody administration 2 weeks prior to surgical resection
Group III: Group 1Experimental Treatment2 Interventions
Anti-OX40 antibody administration 3 weeks prior to surgical resection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anti-OX40 antibody administration
2014
Completed Phase 1
~20
Surgical Resection
2018
Completed Phase 2
~420
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,518 Total Patients Enrolled
MedImmune LLCIndustry Sponsor
347 Previous Clinical Trials
793,892 Total Patients Enrolled
Richard B. Bell, MDPrincipal InvestigatorProvidence Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your cancer has spread to other parts of your body and cannot be removed by surgery.You need to take more than 5mg of prednisone (or a similar steroid) every day for a long time.You are not currently experiencing any bleeding in your digestive system.You have a specific type of cancer in the mouth, throat, or voice box that can be removed with surgery and then treated with additional therapy.You have been diagnosed with head and neck cancer, and there is no evidence of the cancer spreading to other parts of your body. Even if the cancer has invaded bones or cartilage, you can still participate in the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
- Group 3: Group 3
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical trial represent a groundbreaking approach?
"Research into Surgical Resection was initiated in 2014, with a clinical trial funded by MedImmune LLC. After 17 participants had been examined, it passed the Phase 1 drug approval stage and is now undergoing further examination via an active study sponsored again by MedImmune LLC."
Answered by AI
Is the Surgical Resection procedure sanctioned by the FDA?
"Our team evaluated the safety of Surgical Resection and assigned it a score of 1 due to its Phase 1 status, indicating limited evidence for efficacy and security."
Answered by AI
Have other experiments examining Surgical Resection been conducted?
"Currently, there is one ongoing Surgical Resection trial. This research effort has not yet reached Phase 3 and its sites of operation are primarily located in Portland, Oregon with a single alternate site."
Answered by AI
Can you tell me if there are any vacancies available for this medical experiment?
"Unfortunately, at this moment in time, enrollment into the study is not possible. It was initially posted on October 1st 2014 with its last update being recorded as July 13th 2022. However, for those seeking other trials to enroll in, there are 480 studies which require participants suffering from head neoplasms and one trial dedicated to Surgical Resection currently recruiting patients."
Answered by AI
What is the intake capacity of this research project?
"This investigation is no longer recruiting patients. Initially posted on October 1st 2014, the study was last modified on July 13th 2022. Nevertheless, 480 studies are presently seeking participants with head neoplasms and one surgical resection trial has vacancies available."
Answered by AI
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