What side effects are associated with this type of intervention?

Common side effects of cancer treatments involving PD-1 inhibitors like Nivolumab and Pembrolizumab include fatigue, rash, pruritus (itching), diarrhea, and pneumonitis (lung inflammation). When combined with Ipilimumab, these treatments can lead to higher toxicity, with additional side effects such as colitis (inflammation of the colon), hepatitis (liver inflammation), and endocrinopathies (hormonal imbalances). These immune-related adverse events (irAEs) often require management with steroids or other immunosuppressive agents.

What prior FDA approvals exist?

Nivolumab, a PD-1 inhibitor, has been approved by the FDA for various cancers, including metastatic melanoma, non-small cell lung cancer (NSCLC), and malignant pleural mesothelioma. Other similar PD-1 inhibitors include Pembrolizumab, approved for advanced melanoma, NSCLC, and cervical cancer, and Avelumab, approved for metastatic urothelial carcinoma. These drugs work by blocking the PD-1 pathway, enhancing the immune system's ability to fight cancer.

What other types of research exist?

Promising alternatives to Nivolumab for cancer patients include: 1) Pembrolizumab (another PD-1 inhibitor) often used in combination with other agents like Axitinib or Lenvatinib, 2) Atezolizumab (a PD-L1 inhibitor) combined with Bevacizumab, 3) Ipilimumab (CTLA-4 inhibitor) used in combination with Nivolumab or other agents, and 4) Relatlimab (LAG-3 inhibitor) combined with Nivolumab. These alternatives have shown efficacy in various cancers and are being actively studied in clinical trials.

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Checkpoint Inhibitor

Nivolumab for Esophageal Cancer (CheckMate 577 Trial)

Phase 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection

Completed pre-operative chemo radiotherapy followed by surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to 1, 2 and 3 years later

Awards & highlights

Pivotal Trial

Summary

This trial is testing if Nivolumab, a drug that helps the immune system fight cancer, can help cancer patients stay free of the disease longer. Nivolumab has been shown to improve survival in various cancers, including melanoma and esophageal cancer.

Who is the study for?

This trial is for people who've had surgery for Stage II/III esophageal or gastroesophageal junction cancer and still have some signs of the disease. They must have finished chemo radiotherapy before surgery. It's not open to those with other conditions that could interfere.

What is being tested?

The study is testing if Nivolumab, an immune therapy drug, can keep cancer from coming back better than a placebo (a treatment with no active drug). Participants will be randomly assigned to receive either Nivolumab or the placebo.

What are the potential side effects?

Nivolumab may cause immune-related side effects such as inflammation in various organs, skin rash, endocrine disorders like thyroid issues, fatigue, and infusion reactions.

Eligibility Criteria

Inclusion Criteria

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

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I had surgery for cancer with clear margins but still have some disease left.

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I finished chemo and radiation before surgery.

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My cancer is in the esophagus or where the stomach meets the esophagus, and it's at an advanced stage but not the most severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to 1, 2 and 3 years later

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to 1, 2 and 3 years later

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 1, 2 and 3 years later for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease

Secondary study objectives

Overall Survival (OS)

Overall Survival Rate

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NivolumabExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immune checkpoint inhibitors, such as Nivolumab, work by blocking the PD-1 pathway, which cancer cells often exploit to evade the immune system. By inhibiting PD-1, these drugs enhance the body's immune response against cancer cells, allowing T-cells to recognize and destroy them more effectively. This mechanism is crucial for cancer patients as it offers a targeted approach to treatment, potentially leading to improved survival rates and durable responses. However, it also comes with unique immune-related side effects that require careful management. Understanding these mechanisms helps patients and healthcare providers make informed decisions about incorporating immunotherapy into cancer treatment plans.

Understanding Immune Checkpoint Inhibitors for Effective Patient Care.