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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

Must not have

Active, known, or suspected autoimmune disease except for specific conditions

Esophageal tumors located in the mid esophagus or higher

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I can eat and maintain my weight without special feeding tubes or IV nutrition.

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

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I had surgery that allows for my tissue to be tested for specific markers.

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My cancer is at stage II or III.

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I am fully active or can carry out light work.

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My oxygen levels stay above 92% without extra oxygen, even when I walk.

Exclusion Criteria

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

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I have an autoimmune disease, but it's not one of the exceptions listed.

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My esophageal cancer is located in the middle or upper part of my esophagus.

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I do not have an active infection, Hepatitis B/C, HIV/AIDS, or allergies to the study drug.

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I have a history of lung scarring or fibrosis.

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My cancer has spread to my brain.

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My tumor extends into my stomach by 5cm or more.

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My tumor extends above a specific point in my windpipe.

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My biopsy showed cancer in the lymph nodes above my collarbone.

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I am not pregnant, nursing, and I am willing to use contraception. I have not had specific antibody therapy before.

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I have been cancer-free from any previous cancers for at least 1 year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary study objectives

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 more

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 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

Radiation

2003

Completed Phase 2

~780

Nivolumab

2014

Completed Phase 3

~5220