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Monoclonal Antibodies
Trastuzumab Deruxtecan + Nivolumab for Esophageal Cancer
Phase 2
Recruiting
Led By Howard Safran, MD
Research Sponsored by Brown University
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 first dose of study treatment until time of cancer recurrence or death from any cause, whichever occurs first, maximum of 36 months
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to see if it is safe and effective in treating esophagogastric adenocarcinoma.
Who is the study for?
This trial is for adults who've had surgery after chemoradiation for HER2+ esophageal or gastroesophageal junction cancer but didn't have a complete response. They must be 4-12 weeks post-surgery, with certain stages of disease pre-treatment, and agree to contraception if applicable. Excluded are those previously treated with similar drugs, having significant heart issues, other cancers within 3 years (some exceptions), uncontrolled infections, or severe allergies to study drugs.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of Trastuzumab Deruxtecan (Enhertu) combined with Nivolumab in patients who are disease-free post-trimodality treatment for HER2+ esophagogastric cancer. It's an open-label phase II study where all participants receive the drug combination for one year.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, immune-related effects like inflammation in organs due to Nivolumab, potential heart problems from Trastuzumab Deruxtecan, as well as general symptoms such as fatigue and digestive issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose of study treatment until time of cancer recurrence or death from any cause, whichever occurs first, maximum of 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose of study treatment until time of cancer recurrence or death from any cause, whichever occurs first, maximum of 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of the addition of adjuvant trastuzumab deruxtecan with nivolumab for patients with esophagogastric cancer who have completed trimodality treatment
Secondary outcome measures
Disease-free survival with adjuvant trastuzumab deruxtecan & nivolumab after completion of trimodality treatment for HER2+ esophageal cancer.
Side effects data
From 2024 Phase 2 trial • 79 Patients • NCT0401407565%
Nausea
44%
Vomiting
42%
Fatigue
38%
Anaemia
37%
Diarrhoea
35%
Weight Decreased
33%
Decreased Appetite
29%
Constipation
24%
Alopecia
18%
Platelet Count Decreased
16%
Neutrophil Count Decreased
16%
Aspartate Aminotransferase Increased
16%
Hypokalaemia
15%
Asthenia
14%
Abdominal Pain
11%
Pyrexia
11%
Cough
11%
White Blood Cell Count Decreased
11%
Blood Alkaline Phosphatase Increased
10%
Neutropenia
10%
Hypoalbuminaemia
10%
Epistaxis
10%
Gastrooesophageal Reflux Disease
10%
Alanine Aminotransferase Increased
9%
Back Pain
9%
Dyspnoea
9%
Headache
8%
Hyponatraemia
8%
Hypotension
8%
Dizziness
6%
Urinary Retention
6%
Ascites
6%
Pneumonitis
6%
Abdominal Pain Upper
6%
Dysphagia
6%
Covid-19
6%
Insomnia
6%
Thrombocytopenia
6%
Weight Increased
6%
Blood Bilirubin Increased
5%
Acute Kidney Injury
5%
Interstitial Lung Disease
5%
Device Related Infection
5%
Hypophosphataemia
5%
Depression
5%
Flatulence
5%
Mucosal Inflammation
5%
Blood Creatinine Increased
5%
Urinary Tract Infection
5%
Oedema Peripheral
3%
Pneumonia
3%
Disease Progression
3%
Malignant Neoplasm Progression
1%
Wound Infection
1%
Colitis
1%
Covid-19 Pneumonia
1%
Hyperpyrexia
1%
Staphylococcal Infection
1%
Haematemesis
1%
Bacterial Sepsis
1%
Intestinal Obstruction
1%
Animal Bite
1%
Enteritis
1%
Basal Ganglia Infarction
1%
Cerebrovascular Accident
1%
Generalised Tonic-Clonic Seizure
1%
Pulmonary Embolism
1%
Lymphangiosis Carcinomatosa
1%
Tumour Haemorrhage
1%
Bile Duct Stenosis
1%
Hepatotoxicity
1%
Hydronephrosis
1%
Urinary Tract Obstruction
1%
Exposure To Communicable Disease
1%
Device Occlusion
1%
Catheter Site Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab Deruxtecan
Trial Design
3Treatment groups
Experimental Treatment
Group I: Starting Trastuzumab Deruxtecan DoseExperimental Treatment2 Interventions
Trastuzumab deruxtecan, 6.4 mg/kg IV every 3 weeks for 17 doses (12 months)
Group II: Second Trastuzumab Deruxtecan Dose ReductionExperimental Treatment2 Interventions
Trastuzumab deruxtecan, 4.4 mg/kg IV every 3 weeks for 17 doses (12 months)
Group III: First Trastuzumab Deruxtecan Dose ReductionExperimental Treatment2 Interventions
Trastuzumab deruxtecan, 5.4 mg/kg IV every 3 weeks for 17 doses (12 months)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Trastuzumab deruxtecan
2022
Completed Phase 2
~580
Find a Location
Who is running the clinical trial?
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,259 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,275 Previous Clinical Trials
288,613,576 Total Patients Enrolled
Howard Safran, MDPrincipal InvestigatorLifespan Cancer Institute
30 Previous Clinical Trials
908 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who can father children and will use a condom with spermicide.My cancer shows high levels of HER2.I am not planning to receive other cancer treatments not specified by this trial.I have not received a live vaccine in the last 30 days.I do not have an active primary immunodeficiency or uncontrolled HIV, hepatitis B, or C.I have an autoimmune or inflammatory condition affecting my lungs.I will not donate eggs or breastfeed from enrollment until 7 months after my last treatment.I am post-menopausal or not pregnant and sexually active with a man who is not sterilized.I have or had lung inflammation that needed steroids.I am allergic to the medication or ingredients in this study.I haven't taken steroids or immunosuppressants in the last 14 days.I have a significant lung condition besides my cancer.I had chemoradiation and surgery for esophageal cancer but still have some cancer cells.It has been 4 to 12 weeks since my esophagus surgery.I am fully active or can carry out light work.I am using a reliable form of non-hormonal birth control.I have had more than one type of cancer in the last 3 years.I do not have an infection needing IV drugs.I have had a lung removed.My cancer originates from the esophagus, esophagogastric junction, or stomach.I need a procedure to remove fluid buildup in my chest or abdomen.I am 18 years old or older.My cancer was at an early stage before receiving combined treatments.My recent tests show my organs and bone marrow are functioning well.I am using a reliable birth control method.I still have side effects from cancer treatment that are not mild.I haven't received nivolumab, HER2 treatments, or experimental cancer drugs for esophageal cancer.I haven't had a heart attack or severe heart failure in the last 6 months.I have a history of irregular heartbeats or uncontrolled heart rhythm problems.I have an active autoimmune disease or a history of one that could come back.
Research Study Groups:
This trial has the following groups:- Group 1: Starting Trastuzumab Deruxtecan Dose
- Group 2: First Trastuzumab Deruxtecan Dose Reduction
- Group 3: Second Trastuzumab Deruxtecan Dose Reduction
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree does Trastuzumab deruxtecan pose a hazard to individuals?
"The safety of Trastuzumab deruxtecan was evaluated and given a score of 2 - signifying that there is clinical evidence supporting its safety but none proving efficacy."
Answered by AI
Is there currently an opportunity to join this experiment?
"As confirmed on clinicaltrials.gov, this medical research project is not accepting patients at the moment as it last updated its status on July 28th 2022. Nonetheless, there are 421 other trials that require enrollment currently active across various sites."
Answered by AI
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