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Monoclonal Antibodies
Bavituximab + Pembrolizumab for Head and Neck Cancer
Phase 2
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients will have recurrent/metastatic head and neck cancer and will have radiographic evidence of progression on prior immune checkpoint inhibitor therapy, including nivolumab, pembrolizumab, durvalumab and atezolizumab
Be > or equal to 18 years of age on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing if bavituximab, when combined with a PD-1 inhibitor, can help people with squamous cell head and neck cancer that has gotten worse despite treatment with a PD-1 inhibitor.
Who is the study for?
This trial is for adults over 18 with recurrent/metastatic squamous cell head and neck cancer who've seen their cancer progress after platinum therapy and PD-1 inhibitor treatment. They must have measurable disease, provide a recent tumor tissue sample, have good performance status (0 or 1), adequate organ function, agree to use contraception, and not be pregnant.Check my eligibility
What is being tested?
The study tests if bavituximab can enhance the immune response when combined with pembrolizumab in patients whose cancers progressed on prior PD-1 inhibitors. It's a phase II single-arm trial where all participants receive both drugs.See study design
What are the potential side effects?
Potential side effects include typical reactions to monoclonal antibodies such as infusion-related reactions, fatigue, possible autoimmune responses due to immune system activation by the drugs, liver enzyme elevations indicating potential liver damage, and an increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My head and neck cancer has worsened after treatment with drugs like nivolumab or pembrolizumab.
Select...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CR+PR
Secondary outcome measures
Number of participants with laboratory correlates of resposne
Progression
Survival
+1 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0409964134%
Decreased appetite
33%
Fatigue
30%
Nausea
26%
Constipation
26%
Diarrhoea
25%
Vomiting
23%
Anaemia
21%
Abdominal pain
18%
Dyspnoea
16%
Oedema peripheral
16%
Weight decreased
15%
Pyrexia
15%
Dizziness
13%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
13%
Abdominal pain upper
13%
Chills
11%
Gastric cancer
11%
Hypothyroidism
11%
Headache
11%
Hypertension
11%
Myalgia
11%
Arthralgia
10%
Asthenia
10%
Hypoalbuminaemia
10%
Abdominal distention
10%
Back pain
8%
Depression
8%
Insomnia
8%
Ascites
8%
Dysphagia
8%
Urinary tract infection
8%
Muscular weakness
8%
Rash
7%
Dyspepsia
7%
Fall
7%
Hyponatraemia
7%
Pleural effusion
7%
Blood alkaline phosphatase increased
7%
Blood creatinine increased
5%
Dysuria
5%
Hyperkalaemia
5%
Hypotension
5%
Dry skin
5%
Infusion related reaction
5%
Abdominal discomfort
3%
Upper gastrointestinal haemorrhage
3%
Dehydration
3%
Death
3%
Hypokalaemia
3%
Generalized oedema
3%
Cough
3%
Vision blurred
3%
Peripheral sensory neuropathy
3%
Blood bilirubin increased
3%
Hypophosphataemia
2%
Multiple organ dysfunction syndrome
2%
Atrioventricular block
2%
Biliary tract infection
2%
Cancer pain
2%
Metastatic gastric cancer
2%
Disease progression
2%
Acute myocardial infarction
2%
Corona virus infection
2%
Oesophageal cancer metastatic
2%
Encephalopathy
2%
Acute respiratory failure
2%
Facial paralysis
2%
Loss of consciousness
2%
Transient ischaemic attack
2%
Acute kidney injury
2%
Malignant urinary tract obstruction
2%
Gastrointestinal haemorrhage
2%
Pneumonia aspiration
2%
Pneumonitis
2%
Hypoxia
2%
Respiratory failure
2%
Upper respiratory tract infection
2%
Pelvic pain
2%
Neutrophil count decreased
2%
Blood cholesterol increased
2%
Large intestinal obstruction
2%
Obstruction gastric
2%
Cardiac arrest
2%
Malignant ascites
2%
Urinary tract obstruction
2%
Benign prostatic hyperplasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (CPI Naïve)
Group 2 (CPI Relapse)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + BavituximabExperimental Treatment2 Interventions
Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bavituximab
2011
Completed Phase 2
~300
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
691 Previous Clinical Trials
376,719 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of active tuberculosis.I am currently being treated for an infection.I have stable brain metastases, not using steroids for 7 days, and no carcinomatous meningitis.I stopped a cancer treatment due to an immune system side effect.I haven't had any cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.I haven't had cancer treatment in the last 2 weeks and have recovered from past treatments, except for mild neuropathy.I have not received a live vaccine within the last 30 days, except for the flu shot.My head and neck cancer has worsened after treatment with drugs like nivolumab or pembrolizumab.My cancer got worse after platinum therapy or within 6 months of cisplatin and radiation treatment.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I agree to use birth control during and up to 120 days after the study.I have been diagnosed with HIV.I am a man who can father children and will use birth control as required, starting with the first dose of the study therapy until 120 days after the last dose.I am 18 years old or older.I have or had lung inflammation not caused by an infection.I am eligible regardless of my gender or ethnicity.I agree to provide a recent biopsy sample or, if not possible, an older sample with the doctor's approval.I am fully active or restricted in physically strenuous activity but can do light work.I have another cancer besides skin or in situ cervical cancer that needs treatment.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.My organ functions are within the required range for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Bavituximab
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.
Is there an ongoing recruitment of participants for this experiment?
"This experiment, which was initially advertised on January 13th 2020 and has recently been updated (March 17th 2022), is still recruiting volunteers."
Answered by AI
What is the current size of this clinical trial's cohort?
"Correct. Clinicaltrials.gov reveals that this medical trial, which was initially posted on January 13th 2020, is actively searching for participants. The goal is to enlist 29 individuals from a single centre."
Answered by AI
Could you provide an overview of other Bavituximab experiments?
"At this time, there are 961 Bavituximab clinical trials in progress; 122 of which are at Phase 3. Houston Texas has a high concentration of these studies but the drug is studied all over with 35727 locations hosting such tests."
Answered by AI
Has Bavituximab been sanctioned by the FDA?
"There is some evidence of Bavituximab's safety, warranting it a score of 2 on our scale. However, there are no studies that support the efficacy of this medication yet."
Answered by AI
What pathologies is Bavituximab commonly employed to address?
"Bavituximab has been clinically proven to treat malignant tumors, unresectable melanoma, and cases of microsatellite instability high."
Answered by AI
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