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Monoclonal Antibodies

Bavituximab for Gastroesophageal Cancer

Phase 2
Waitlist Available
Research Sponsored by OncXerna Theraputics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose through 30 days after last dose. maximum exposure: 567 days.
Awards & highlights

Study Summary

This trial is testing a combination of two drugs, bavituximab and pembrolizumab, to treat gastric and gastroesophogeal cancer.

Eligible Conditions
  • Gastroesophageal Cancer
  • Stomach Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose through 30 days after last dose. maximum exposure: 567 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose through 30 days after last dose. maximum exposure: 567 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Treatment Emergent Adverse Events (TEAE)
Objective Response Rate (ORR)
Severity of Treatment Emergent Adverse Events (TEAE)

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%
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: bavituximab and pembrolizumabExperimental Treatment2 Interventions
Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bavituximab
2011
Completed Phase 2
~300
Pembrolizumab Injection
2019
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

OncXerna Theraputics, Inc.Lead Sponsor
2 Previous Clinical Trials
580 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,884 Previous Clinical Trials
5,054,306 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical condition is Bavituximab typically prescribed?

"Bavituximab is typically prescribed to combat malignant neoplasms, yet it can also be used for other medical conditions including unresectable melanoma, microsatellite instability high and chemotherapy-resistant disease progression."

Answered by AI

How many medical centers are engaged in conducting this trial?

"Currently, this clinical trial is recruiting participants from 9 distinct sites. These facilities are located in Nashville, Weston as well as New Haven and another 6 cities. To minimize travel needs, one should select the closest clinic if they decide to participate in the study."

Answered by AI

How many participants are actively engaging in this experiment?

"At this moment, no additional candidates are being sought for the study. The trial's initial posting was on September 11th 2019 and it has most recently been updated June 14th 2022. If you are looking to join other trials, 643 medical studies concerning gastroesophageal cancer patients and 961 clinical investigations involving Bavituximab participants remain in need of applicants."

Answered by AI

Has Bavituximab been tested in any other scientific investigations?

"Bavituximab was first tested in 2010 at City of Hope and now has 260 documented trials. At present, there are 961 experiments running worldwide with a high concentration occurring in Nashville, Tennessee."

Answered by AI

Is this trial currently accepting participants?

"The trial in question, initially posted on September 11th 2019 and last edited June 14th 2022, is not accepting new candidates at this time. However, according to the clinicaltrials.gov database, 1604 other trials are actively seeking enrolment."

Answered by AI

Is Bavituximab a reliable therapeutic for patients?

"Although Bavituximab has not been proven to be efficacious, there is some evidence suggesting it may have a safe profile. Thus, our team at Power assigned it a rating of 2 on the safety scale from 1-3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
2019. "An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04099641.
~14 spots leftby Apr 2025
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