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Checkpoint Inhibitor
Immunotherapy + Radiation for Gastroesophageal Cancer (REACTION Trial)
Phase 1 & 2
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
Either a formalin fixed paraffin block or a minimum of ten 5-micron tissue section's (slides) of tumor biopsy sample must be available for biomarker evaluation
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
REACTION Trial Summary
This trial is testing if it's safe to use immunotherapy after SBRT in people with recurrent or metastatic gastroesophageal cancer.
Who is the study for?
Adults aged 18+ with recurrent or metastatic gastroesophageal cancer who haven't had systemic chemotherapy for metastatic disease can join. They need good heart function, normal blood counts and organ function, no severe heart issues or autoimmune diseases, and must not be pregnant or nursing. Participants should agree to use contraception and have a performance status of 0-1.Check my eligibility
What is being tested?
The trial is testing the safety of Nivolumab alone or combined with other immuno-oncology agents after targeted radiation in patients with advanced esophagogastric cancer. It's an early-phase study focusing on how well patients tolerate this treatment approach.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that could affect various organs, infusion-related responses, fatigue, possible changes in liver enzymes and blood cell counts. Specific risks will depend on individual patient factors.
REACTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a sample of my tumor for testing.
Select...
I am fully active or can carry out light work.
Select...
My organs are functioning well.
Select...
My heart's electrical activity is normal according to my last ECG.
Select...
I can provide a sample of my tumor for testing.
Select...
My cancer in the esophagus or stomach has been confirmed by a biopsy.
Select...
My heart's electrical activity is normal according to my last ECG.
REACTION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the infiltrating CD8+ T cell density units after systemic treatment with radiation plus nivolumab +/- Relatlimib
Secondary outcome measures
Efficacy of PD-1 inhibition +/- Relatlimib as determined by number of participants without evidence of disease progression
Safety profile of nivolumab +/- Relatlimib plus systemic radiation as determined by number of drug-related adverse events
Side 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%
Hyponatraemia
14%
Rash
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%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
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%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
1%
Superior vena cava syndrome
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
REACTION Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B Nivolumab + RelatlimabExperimental Treatment2 Interventions
stereotactic body radiation (SBRT) 8G x 3 followed by Nivolumab 240mg administered IV over 30 minutes every 2 weeks and Relatlimab (anti-LAG3) every 2 weeks for one year or until evidence of disease progression or unresolved toxicity.
Group II: Arm A Nivolumab OnlyExperimental Treatment1 Intervention
stereotactic body radiation (SBRT) 8G x 3 followed by Nivolumab 240mg administered IV over 30 minutes every 2 weeks for one year or until evidence of disease progression or unresolved toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Relatlimab
2018
Completed Phase 2
~1120
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,811 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
561 Previous Clinical Trials
33,078 Total Patients Enrolled
Vincent Lam, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
44 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is normal, confirmed by a heart test within the last 6 months.I have never had myocarditis.I am 18 years old or older.I agree to use birth control during and after the study as required.My cancer has returned or is in stage IV, and I chose not to have chemotherapy as the first treatment.I agree to use contraception during and after treatment as required.I agree not to donate sperm during the trial.My heart markers are within acceptable limits for the Relatlimab arm.I do not have brain metastasis.I do not have significant heart problems or recent serious heart events.I can provide a sample of my tumor for testing.I am fully active or can carry out light work.My organs are functioning well.I had cancer before, but it's been in complete remission for over 2 years, and I don't need treatment now.I have a history of lung disease but don't need constant oxygen.I am currently being treated for an infection or have tested positive for Hepatitis B or C.I am 18 years old or older.I agree to use contraception and not donate sperm during and after the study as required.I understand the study, its risks, and am willing to follow its requirements.I understand the study, its risks, and I'm willing to sign the consent form.I do not have an active autoimmune disease or a history that required immune-suppressing drugs, except for vitiligo or resolved childhood asthma.I agree to use birth control during and after the study as required.My heart's electrical activity is normal according to my last ECG.I have tested positive for HIV/AIDS.I can provide a sample of my tumor for testing.My cancer has come back or is stage IV, and I chose not to have chemotherapy as the first treatment.I haven't had any vaccines in the last 4 weeks.My cancer in the esophagus or stomach has been confirmed by a biopsy.I need to take corticosteroids through pills or injections, but I can use inhalers.I am not pregnant or nursing.My female partner and I are not willing to use birth control.My heart's electrical activity is normal according to my last ECG.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A Nivolumab Only
- Group 2: Arm B Nivolumab + Relatlimab
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.
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