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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
Must not have
Has a known history of active TB (Bacillus Tuberculosis)
Has an active infection requiring systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of active tuberculosis.
Select...
I am currently being treated for an infection.
Select...
I stopped a cancer treatment due to an immune system side effect.
Select...
I haven't had any cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.
Select...
I have not received a live vaccine within the last 30 days, except for the flu shot.
Select...
I have been diagnosed with HIV.
Select...
I have or had lung inflammation not caused by an infection.
Select...
I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CR+PR
Secondary study objectives
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%
Diarrhoea
26%
Constipation
25%
Vomiting
23%
Anaemia
21%
Abdominal pain
18%
Dyspnoea
16%
Oedema peripheral
16%
Weight decreased
15%
Pyrexia
15%
Dizziness
13%
Aspartate aminotransferase increased
13%
Abdominal pain upper
13%
Alanine aminotransferase increased
13%
Chills
11%
Arthralgia
11%
Myalgia
11%
Gastric cancer
11%
Headache
11%
Hypertension
11%
Hypothyroidism
10%
Asthenia
10%
Back pain
10%
Abdominal distention
10%
Hypoalbuminaemia
8%
Insomnia
8%
Depression
8%
Ascites
8%
Urinary tract infection
8%
Dysphagia
8%
Muscular weakness
8%
Rash
7%
Fall
7%
Dyspepsia
7%
Blood creatinine increased
7%
Hyponatraemia
7%
Blood alkaline phosphatase increased
7%
Pleural effusion
5%
Hyperkalaemia
5%
Abdominal discomfort
5%
Dysuria
5%
Infusion related reaction
5%
Dry skin
5%
Hypotension
3%
Death
3%
Generalized oedema
3%
Hypophosphataemia
3%
Blood bilirubin increased
3%
Peripheral sensory neuropathy
3%
Hypokalaemia
3%
Cough
3%
Vision blurred
3%
Upper gastrointestinal haemorrhage
3%
Dehydration
2%
Encephalopathy
2%
Upper respiratory tract infection
2%
Facial paralysis
2%
Obstruction gastric
2%
Gastrointestinal haemorrhage
2%
Neutrophil count decreased
2%
Disease progression
2%
Respiratory failure
2%
Malignant urinary tract obstruction
2%
Acute respiratory failure
2%
Multiple organ dysfunction syndrome
2%
Large intestinal obstruction
2%
Corona virus infection
2%
Acute kidney injury
2%
Hypoxia
2%
Oesophageal cancer metastatic
2%
Loss of consciousness
2%
Blood cholesterol increased
2%
Pelvic pain
2%
Biliary tract infection
2%
Transient ischaemic attack
2%
Acute myocardial infarction
2%
Atrioventricular block
2%
Cardiac arrest
2%
Cancer pain
2%
Malignant ascites
2%
Metastatic gastric cancer
2%
Urinary tract obstruction
2%
Benign prostatic hyperplasia
2%
Pneumonia aspiration
2%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (CPI Naïve)
Group 2 (CPI Relapse)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~2810
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
711 Previous Clinical Trials
379,232 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.
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