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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
Patients must have progressed on prior platinum therapy either in the recurrent setting or within 6 months of treatment with cisplatin and radiation in the potentially curative setting
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 below
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My head and neck cancer has worsened after treatment with drugs like nivolumab or pembrolizumab.
Select...
My cancer got worse after platinum therapy or within 6 months of cisplatin and radiation treatment.
Select...
I agree to use birth control during and up to 120 days after the study.
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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.
Select...
I am 18 years old or older.
Select...
I agree to provide a recent biopsy sample or, if not possible, an older sample with the doctor's approval.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My organ functions are within the required range for treatment.

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

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 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT04099641
34%
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%
Dizziness
15%
Pyrexia
13%
Abdominal pain upper
13%
Aspartate aminotransferase increased
13%
Alanine aminotransferase increased
13%
Chills
11%
Hypertension
11%
Headache
11%
Hypothyroidism
11%
Gastric cancer
11%
Myalgia
11%
Arthralgia
10%
Abdominal distention
10%
Asthenia
10%
Hypoalbuminaemia
10%
Back pain
8%
Depression
8%
Insomnia
8%
Ascites
8%
Dysphagia
8%
Urinary tract infection
8%
Muscular weakness
8%
Rash
7%
Pleural effusion
7%
Dyspepsia
7%
Fall
7%
Blood alkaline phosphatase increased
7%
Blood creatinine increased
7%
Hyponatraemia
5%
Dysuria
5%
Hypotension
5%
Infusion related reaction
5%
Hyperkalaemia
5%
Dry skin
5%
Abdominal discomfort
3%
Dehydration
3%
Upper gastrointestinal haemorrhage
3%
Peripheral sensory neuropathy
3%
Vision blurred
3%
Death
3%
Generalized oedema
3%
Blood bilirubin increased
3%
Hypokalaemia
3%
Hypophosphataemia
3%
Cough
2%
Malignant urinary tract obstruction
2%
Biliary tract infection
2%
Acute kidney injury
2%
Facial paralysis
2%
Respiratory failure
2%
Encephalopathy
2%
Transient ischaemic attack
2%
Gastrointestinal haemorrhage
2%
Loss of consciousness
2%
Cancer pain
2%
Large intestinal obstruction
2%
Obstruction gastric
2%
Disease progression
2%
Multiple organ dysfunction syndrome
2%
Corona virus infection
2%
Acute myocardial infarction
2%
Atrioventricular block
2%
Cardiac arrest
2%
Malignant ascites
2%
Metastatic gastric cancer
2%
Oesophageal cancer metastatic
2%
Urinary tract obstruction
2%
Benign prostatic hyperplasia
2%
Acute respiratory failure
2%
Hypoxia
2%
Pneumonia aspiration
2%
Pneumonitis
2%
Upper respiratory tract infection
2%
Blood cholesterol increased
2%
Neutrophil count decreased
2%
Pelvic pain
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
~1950

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
684 Previous Clinical Trials
373,102 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

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
Recent research and studies
~1 spots leftby Jan 2025