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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 below
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My head and neck cancer has worsened after treatment with drugs like nivolumab or pembrolizumab.
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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:
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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.
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I haven't had any cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.
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I have not received a live vaccine within the last 30 days, except for the flu shot.
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I have been diagnosed with HIV.
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I have or had lung inflammation not caused by an infection.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

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 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT04099641
34%
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%
Urinary tract infection
8%
Ascites
8%
Dysphagia
8%
Muscular weakness
8%
Rash
7%
Blood creatinine increased
7%
Dyspepsia
7%
Hyponatraemia
7%
Fall
7%
Blood alkaline phosphatase increased
7%
Pleural effusion
5%
Dysuria
5%
Hyperkalaemia
5%
Abdominal discomfort
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%
Obstruction gastric
2%
Disease progression
2%
Respiratory failure
2%
Acute respiratory failure
2%
Large intestinal obstruction
2%
Corona virus infection
2%
Neutrophil count decreased
2%
Facial paralysis
2%
Malignant urinary tract obstruction
2%
Gastrointestinal haemorrhage
2%
Blood cholesterol increased
2%
Acute kidney injury
2%
Hypoxia
2%
Loss of consciousness
2%
Oesophageal cancer metastatic
2%
Multiple organ dysfunction syndrome
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
~3150

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,485 Total Patients Enrolled

Media Library

Bavituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04150900 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Pembrolizumab + Bavituximab
Squamous Cell Carcinoma Clinical Trial 2023: Bavituximab Highlights & Side Effects. Trial Name: NCT04150900 — Phase 2
Bavituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04150900 — Phase 2
~0 spots leftby Jan 2025
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