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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

Must not have

(Relatlimab arm only) Participants must not have a history of myocarditis

Subjects with known brain metastasis are excluded from this study. Patients with suspected brain metastasis must have brain imaging (either MRI brain or CT brain with contrast) prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can provide a sample of my tumor for testing.

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I am fully active or can carry out light work.

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My organs are functioning well.

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My heart's electrical activity is normal according to my last ECG.

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I can provide a sample of my tumor for testing.

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My cancer in the esophagus or stomach has been confirmed by a biopsy.

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My heart's electrical activity is normal according to my last ECG.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had myocarditis.

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I do not have brain metastasis.

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I do not have significant heart problems or recent serious heart events.

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I have a history of lung disease but don't need constant oxygen.

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I am currently being treated for an infection or have tested positive for Hepatitis B or C.

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I have tested positive for HIV/AIDS.

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I am not pregnant or nursing.

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My female partner and I are not willing to use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the infiltrating CD8+ T cell density units after systemic treatment with radiation plus nivolumab +/- Relatlimib

Secondary study objectives

Safety profile of nivolumab +/- Relatlimib plus systemic radiation as determined by number of drug-related adverse events

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Relatlimab

2019

Completed Phase 2

~1150

Nivolumab

2015

Completed Phase 3

~4010