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Monoclonal Antibodies
Durvalumab for Squamous Cell Carcinoma
Phase < 1
Waitlist Available
Led By Joseph Curry, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
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 6 months
Awards & highlights
Study Summary
This trial studies how well durvalumab with or without metformin works in treating head and neck squamous cell carcinoma.
Eligible Conditions
- Oral Squamous Cell Carcinoma
- Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immune cell polarization (Th1/Th2; M1/M2)
Secondary outcome measures
Alterations in immunohistochemical (IHC) markers
Alterations in intratumoral immune cell populations
Changes of the intratumoral immunophenotype and metabolism after exposure to durvalumab and metformin
+1 moreOther outcome measures
Assessment of alterations in metabolites produced in different tumor compartments
Assessment of the interactions between the immune and metabolic microenvironments
Circulating Tumor DNA
+1 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (durvalumab)Experimental Treatment1 Intervention
Patients will receive 1500mg durvalumab (MEDI4736) via IV infusion. Participants receive durvalumab as in Arm A in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (durvalumab, metformin)Experimental Treatment2 Interventions
Patients will take Metformin 500mg/day for 3 days. From day 4, 500mg twice daily and then in 3 days (day 7) dose escalation to 1000mg twice daily will be achieved. This will be taken until the day before surgery after dinner.
Patients will receive 1500mg durvalumab (MEDI4736) via IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Metformin
FDA approved
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,873 Total Patients Enrolled
Joseph Curry, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
4 Previous Clinical Trials
105 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer in the mouth, throat, voice box, nose, or sinuses, or a type of skin cancer that can be removed with surgery. If your cancer has come back but can still be treated with surgery, you can still participate.You have cancer in your nose or throat (nasopharyngeal carcinoma) or in your salivary glands.You have had a severe allergic reaction to any kind of antibody medication in the past.You have had an allergic reaction to any of the ingredients in the study drug before.You have received a drug called durvalumab or any other treatment that targets PD-L1 or PD1 in the past.You have diabetes and are currently taking metformin or insulin to manage it.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (durvalumab)
- Group 2: Arm A (durvalumab, metformin)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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.
Is enrollment for this research open to participants at present?
"According to the information posted on clinicaltrials.gov, this investigation is no longer seeking participants. Initially published in November 2018 and most recently updated on August 15th 2022, it has been concluded that recruiting for this trial has ceased; however, there are still 3177 other studies actively accepting volunteers now."
Answered by AI
How many individuals are being included in this clinical trial?
"Unfortunately, applications for this trial have closed. It was initially posted on November 1st 2018 and the last edit occurred August 15th 2022. However, if you are seeking trials to join there are presently 2676 clinical studies enrolling participants with malignant neoplasms and 501 trials recruiting patients for Durvalumab treatment."
Answered by AI
What conditions have been shown to respond positively to Durvalumab?
"Durvalumab is commonly prescribed to encourage physical activity, but it can also have a positive effect on patients affected by type 1 diabetes mellitus, diabetic ketoacidosis, and those in need of advance directives."
Answered by AI
What experimental results have been observed with the application of Durvalumab?
"Durvalumab is currently the subject of 501 active clinical trials, 95 of which are in their last stage. These studies can be found across 14827 sites with a concentration around Seattle, Washington."
Answered by AI
Does Durvalumab present any significant risks to its users?
"Due to limited data surrounding Durvalumab's efficacy and safety, its rating on a 1-3 scale is determined to be a one."
Answered by AI
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