What is the mechanism of action of this treatment?

The most common treatments for Chordoma, particularly those being studied like Nivolumab and Relatlimab, work by enhancing the body's immune response against cancer cells. Nivolumab blocks the PD-1 receptor, preventing tumor cells from evading the immune system. Relatlimab targets the LAG-3 protein, reducing inhibitory signals that dampen the immune response. This combination is crucial for Chordoma patients as it aims to boost the immune system's ability to recognize and attack tumor cells, potentially improving disease control.

What side effects are associated with this type of intervention?

Common side effects of treatments for Chordoma, particularly those involving immune checkpoint inhibitors like Nivolumab (PD-1 inhibitor) and Relatlimab (LAG-3 inhibitor), include immune-related adverse events. These can manifest as pneumonitis, colitis, hepatitis, endocrinopathies (such as hypothyroidism and adrenal insufficiency), and skin reactions like rash and pruritus. Severe but less common side effects may include myocarditis and nephritis.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Chordoma that involve immune checkpoint inhibitors like Nivolumab (PD-1 inhibitor) and Relatlimab (LAG-3 inhibitor). However, immune checkpoint inhibitors have been approved for various other cancers, such as melanoma and non-small cell lung cancer, where drugs like Nivolumab and Pembrolizumab (another PD-1 inhibitor) have shown efficacy. The ongoing trial studying Nivolumab and Relatlimab for Chordoma aims to explore the potential of these drugs in enhancing the immune response against this rare cancer.

What other types of research exist?

Promising novel alternatives for Chordoma patients in 2024 may include other PD-1/PD-L1 inhibitors such as Pembrolizumab or Atezolizumab, CTLA-4 inhibitors like Ipilimumab, and emerging therapies targeting new immune checkpoints such as TIM-3 or TIGIT. Combination therapies involving these agents or novel small molecules could also be considered.

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Checkpoint Inhibitor

Nivolumab + Relatlimab for Advanced Chordoma

Phase 2

Waitlist Available

Led By Arun Singh

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1

Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and agree to continue use for 6 months after the final dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is studying nivolumab and relatlimab to see how well they work in treating chordoma that has spread to other places in the body.

Who is the study for?

This trial is for adults with advanced chordoma, a type of bone cancer. Participants must have tumors that can be measured, not be pregnant or breastfeeding, and agree to use effective contraception. They should have good physical function (ECOG PS 0-1) and adequate organ function. Those with recent surgery, certain heart conditions, previous anti-LAG3 antibody treatment, active infections or other serious health issues cannot join.Check my eligibility

What is being tested?

The study tests nivolumab and relatlimab—monoclonal antibodies designed to stop tumor growth in patients with chordoma that has spread. It's a phase II trial aiming to see how well these drugs work together against this rare cancer type.See study design

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in various organs, skin rash or endocrine disorders; infusion-related symptoms like fever or chills; fatigue; possible liver enzyme changes; and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I am using two effective birth control methods during and for 6 months after the study.

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My cancer is confirmed to be chordoma.

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I have a recent tumor sample large enough for testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR) defined as the number of subjects with a best objective response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of subjects

Secondary outcome measures

Clinical benefit rate as defined by adding CR, PR, and stable disease (SD)

Incidence of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Progress free survival (PFS) time

+1 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

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

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Nasopharyngitis

Lacrimation increased

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Hyperkalaemia

Hypertension

Bronchitis

Dehydration

Blood alkaline phosphatase increased

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Pain

Malaise

Musculoskeletal chest pain

Rash maculo-papular

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Pericardial effusion malignant

Pneumothorax

Atrial flutter

Bone pain

Small intestinal haemorrhage

Bronchial obstruction

Femur fracture

Syncope

Hypercalcaemia

Confusional state

Cancer pain

Neoplasm progression

Circulatory collapse

Superior vena cava syndrome

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab and relatlimab)Experimental Treatment2 Interventions

Participants receive nivolumab intravenously (IV) over 60 minutes and relatlimab via infusion over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable 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

0 / 4Eligibility 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

The most common treatments for Chordoma, particularly those being studied like Nivolumab and Relatlimab, work by enhancing the body's immune response against cancer cells. Nivolumab blocks the PD-1 receptor, preventing tumor cells from evading the immune system. Relatlimab targets the LAG-3 protein, reducing inhibitory signals that dampen the immune response. This combination is crucial for Chordoma patients as it aims to boost the immune system's ability to recognize and attack tumor cells, potentially improving disease control.

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