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Platinum-based Chemotherapy
Immunotherapy + Chemoradiation for Gastroesophageal Cancer
Phase 1
Waitlist Available
Led By Vincent Lam, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate oral intake/nutritional status without the need for enteral or parenteral feeding during chemoradiation or preoperative period
Histologically proven esophageal or gastro-esophageal junction cancer (squamous cell or adenocarcinoma) with core biopsy required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test if giving patients anti-PD-1 or anti-PD1/anti LAG-3 before surgery, along with chemoradiation, is safe and improves survival in patients with resectable distal esophageal/gastroesophageal junction cancer.
Who is the study for?
Adults with resectable esophageal or gastroesophageal junction cancer, who have not undergone certain treatments and do not have autoimmune diseases, active infections, or recent heart issues. Participants must meet specific health criteria like normal organ function tests, be able to undergo surgery, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Nivolumab alone or combined with Relatlimab before chemoradiation therapy in patients preparing for surgery. It aims to see if these drugs can change tumor characteristics to improve survival rates.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, digestive problems such as nausea or diarrhea, blood cell count changes which could increase infection risk and possibly affect lung function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can eat and maintain my weight without special feeding tubes or IV nutrition.
Select...
My cancer in the esophagus or where it meets the stomach has been confirmed by a biopsy.
Select...
I had surgery that allows for my tissue to be tested for specific markers.
Select...
My cancer is at stage II or III.
Select...
I am fully active or can carry out light work.
Select...
My oxygen levels stay above 92% without extra oxygen, even when I walk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcome measures
Approximate quantitation of infused nivolumab bound to PD-1 receptors on the surface of T cells in the peripheral blood and within the resected tumor and lymph node specimens
Changes in Expression of Selected Immune Markers
Feasibility is assessed through the proportion of eligible patients who proceed to surgery without substantial delay (more than 60 days) due to treatment-related reasons
+3 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Neoplasm progression
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment5 Interventions
Nivolumab 240mg administered IV over 30 minutes followed by relatlimab 80mg administered IV over 60 minutes on Day 1 every 2 weeks for 2 cycles and then standard of care chemoradiation (weekly carboplatin/paclitaxel and concurrent radiation).
Group II: Arm AExperimental Treatment4 Interventions
Nivolumab 240mg administered IV over 30 minutes every 2 weeks for 2 cycles and then standard of care chemoradiation (weekly carboplatin/paclitaxel and concurrent radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Relatlimab
2018
Completed Phase 2
~1110
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Radiation
2003
Completed Phase 3
~1020
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,868 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,482 Total Patients Enrolled
Vincent Lam, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
33 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can eat and maintain my weight without special feeding tubes or IV nutrition.I have an autoimmune disease, but it's not one of the exceptions listed.My esophageal cancer is located in the middle or upper part of my esophagus.I do not have an active infection, Hepatitis B/C, HIV/AIDS, or allergies to the study drug.I have certain heart conditions and am participating in the Relatlimab study arm.I have a history of lung scarring or fibrosis.I do not have health issues that could affect how I respond to the study drug.I had surgery that allows for my tissue to be tested for specific markers.My cancer in the esophagus or where it meets the stomach has been confirmed by a biopsy.I've had specific scans within the last 28 days.I have seen a radiation oncologist within the last 28 days.My lung function tests before joining the study are satisfactory.My cancer has spread to my brain.My cancer is at stage II or III.I am fully active or can carry out light work.My tumor extends into my stomach by 5cm or more.My oxygen levels stay above 92% without extra oxygen, even when I walk.My tumor extends above a specific point in my windpipe.My biopsy showed cancer in the lymph nodes above my collarbone.I am not pregnant, nursing, and I am willing to use contraception. I have not had specific antibody therapy before.I have been cancer-free from any previous cancers for at least 1 year.My blood tests and heart function are within normal ranges.I am 18 years old or older.I haven't taken steroids or immunosuppressants in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
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.
How perilous is Nivolumab for individuals undergoing treatment?
"The safety of Nivolumab was appraised with a score of 1 due to its status as a Phase 1 trial, suggesting that there is minimal data attesting to the drug's efficacy and security."
Answered by AI
What medical issues has Nivolumab been confirmed to address?
"Nivolumab is widely used to treat malignant neoplasms, and may also be beneficial for those with high risk of recurrence in cases of unresectable melanoma or squamous cell carcinoma."
Answered by AI
Are there any openings for participants in this experiment right now?
"This trial is not currently enrolling patients. First posted on July 11th, 2017 and last updated April 19th 2022, its recruiting has concluded for now. However, there are 711 clinical trials seeking patients with esophageal neoplasms malignant and 1828 trials actively looking for individuals to participate in Nivolumab assessments."
Answered by AI
How many subjects are being surveyed in this medical experiment?
"The recruitment window for this trial has closed; it was originally posted on July 11th, 2017 and last edited on April 19th, 2022. Alternately, there are currently 711 clinical trials actively seeking patients with esophageal neoplasms malignant as well as 1,828 studies recruiting participants to try Nivolumab."
Answered by AI
Was Nivolumab utilized in any other trials prior to this one?
"Since its first clinical trial in 1997 at City of Hope Comprehensive Cancer Center, nivolumab has been the subject of 1849 completed studies. As of now, there are still 1828 trials that are actively recruiting participants; a number of these experiments originate from Baltimore, Maryland."
Answered by AI
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