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.
Eligible Conditions
- Squamous Cell Carcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: through study completion, an average of 1 year
Month 100
Survival
Month 100
CR+PR
Progression
Week 100
Time
Year 1
Number of participants with laboratory correlates of resposne
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Group 2 (CPI Relapse)
47%Constipation
32%Fatigue
26%Myalgia
26%Dyspnoea
26%Nausea
26%Diarrhoea
21%Decreased appetite
21%Headache
21%Abdominal pain
16%Gastric cancer
16%Oedema peripheral
16%Cough
16%Anaemia
16%Vomiting
16%Ascites
16%Dysphagia
16%Weight decreased
11%Arthralgia
11%Sepsis
11%Dysuria
11%Pyrexia
11%Pleural effusion
11%Abdominal pain upper
11%Abdominal distention
11%Dyspepsia
11%Aspartate aminotransferase increased
11%Blood alkaline phosphatase increased
11%Blood bilirubin increased
11%Insomnia
11%Oropharyngeal pain
11%Dry skin
5%Emphysematous cholecystitis
5%Gastrointestinal pain
5%Generalized oedema
5%Swelling
5%Obstructive nephropathy
5%Pollakiuria
5%Hyponatraemia
5%Injury
5%Muscular weakness
5%Hyperkalaemia
5%Infusion related reaction
5%Pneumothorax
5%Urinary tract infection
5%Muscle spasms
5%Tumour haemorrhage
5%Asthenia
5%Cystitis
5%Hypophosphataemia
5%Arthritis
5%Myositis
5%Upper respiratory tract infection
5%Non-cardiac chest pain
5%Cholangitis
5%Dilatation intrahepatic duct acquired
5%Neutrophil count decreased
5%Pelvic pain
5%Blood cholesterol increased
5%Hypokalaemia
5%Coagulopathy
5%Alanine aminotransferase increased
5%Liver function test increased
5%Weight increased
5%Peripheral sensory neuropathy
5%Dysgeusia
5%Tremor
5%Rhinorrhoea
5%Hypertension
5%Hypotension
5%Vision blurred
5%Oesophageal haemorrhage
5%Pancreatitis
5%Toothache
5%Abdominal discomfort
Trial Design
1 Treatment Group
Pembrolizumab + Bavituximab
1 of 1
Experimental Treatment
29 Total Participants · 1 Treatment Group
Primary Treatment: Bavituximab · No Placebo Group · Phase 2
Pembrolizumab + BavituximabExperimental Group · 2 Interventions: Pembrolizumab, Bavituximab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Bavituximab
Not yet FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
617 Previous Clinical Trials
355,969 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a medical condition that can be measured using the RECIST 1.1 criteria.
You are able to perform daily activities without significant limitations or with some slight limitations.
Your organs are working properly, as determined by recent lab tests. These tests must have been done within 10 days before starting the treatment.
If you are a woman who could become pregnant, you must provide a negative pregnancy test result (either a urine or blood test) within 72 hours before starting the study medication.
If you are a woman capable of having children, you must agree to use birth control during the study and for 120 days after finishing the study.
It's okay if you choose to not have sex as a form of birth control, as long as it's your usual choice.
You have head and neck cancer that has spread or come back after treatment with certain medicines called immune checkpoint inhibitors. You must also have shown progression after treatment with platinum therapy or within 6 months of treatment with cisplatin and radiation.
You are able and willing to sign a document saying you agree to participate in the study.
You must be at least 18 years old when you agree to participate in the study.
You need to provide a fresh tissue sample from a tumor that is 6 weeks old or less. If you cannot provide a fresh sample, you may submit an older sample only if the study doctor agrees.
References
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Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer