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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 belowSelect...
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.
Select...
My cancer is confirmed to be chordoma.
Select...
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
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 moreSide 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%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
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%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Hypertension
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
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%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
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
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
~1110
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,065 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,504 Total Patients Enrolled
4 Trials studying Chordoma
546 Patients Enrolled for Chordoma
Arun SinghPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medications that may affect my heart's rhythm.I have or had inflammatory bowel disease or a primary immunodeficiency.My side effects from previous cancer treatments are mild or gone, except for hair loss.I am fully active or can carry out light work.I am currently being treated for a serious infection.I have not been treated with anti-LAG3 antibodies before, but may have had PD-1/PD-L1 antibodies.I am using two effective birth control methods during and for 6 months after the study.My cancer is confirmed to be chordoma.My chordoma is advanced, can't be surgically removed, and has worsened in the last 6 months.I cannot become pregnant or am using reliable birth control methods.I haven't had palliative surgery or radiation, nor taken steroids, in the last 28 days.My heart condition or high blood pressure is not under control.My heart's pumping ability is confirmed to be normal.I am not on cancer treatment but may be on hormones for other conditions.I have a history of tuberculosis.I do not have active hepatitis B or C, nor HIV.I haven't taken strong immune-weakening medicines in the last 28 days, except for small doses or certain types.I have had an autoimmune disease in the last 3 years.I have had an organ transplant and take drugs to suppress my immune system.I haven't had any live vaccines in the last 30 days.I do not have significant heart problems or recent serious heart issues.I agree to provide samples for biopsy and understand the requirements for the biopsy site.I have been cancer-free for over 2 years, except for certain skin or superficial cancers.I haven't taken any cancer treatment drugs in the last 7 days.I have a recent tumor sample large enough for testing.You are expected to live for at least 12 more weeks.I am unable to understand or sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab and 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.
Chordoma Patient Testimony for trial: Trial Name: NCT03623854 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical issues can be addressed with the administration of Nivolumab?
"Nivolumab is prescribed most frequently to combat malignant neoplasms, though it has also been used in the treatment of various other illnesses like metastatic esophageal adenocarcinoma and unresectable melanoma."
Answered by AI
What adverse effects may be associated with the administration of Nivolumab?
"Based on the available evidence, our team has determined Nivolumab to be moderately safe and thus assigned it a 2. Even though Phase 2 indicates that there is some data regarding its safety, no clinical trials have been conducted to evaluate efficacy yet."
Answered by AI
Is this study pioneering a new protocol for treatment?
"At present, there are 720 active Nivolumab trials spanning 49 nations and 2355 cities. The pioneering study of this drug, conducted by Ono Pharmaceutical Co. Ltd in 2012, involved 659 participants; it successfully completed its Phase 1 & 2 approval stage. Since then, 252 further research studies have been undertaken on the subject matter."
Answered by AI
What is the capacity of this trial in terms of participants?
"Affirmative. According to clinicaltrials.gov, the trial is still in recruitment mode, having been posted on April 3rd 2019 and modified as of September 16th 2022. 20 participants are sought from a single medical facility."
Answered by AI
Are there vacancies available for individuals to partake in this experiment?
"Affirmative. According to the information from clinicaltrials.gov, this trial is presently seeking participants and was first listed on April 3rd 2019 with the last update occurring September 16th 2022. The study requires 20 individuals to be recruited across a single medical site."
Answered by AI
Are there other investigations that have utilized Nivolumab?
"There are presently 720 clinical trials for Nivolumab underway, and 82 of them have reached the third phase. Although most investigations originate in Zürich, BE, there are over 40 thousand sites conducting research on this drug."
Answered by AI
Who else is applying?
What site did they apply to?
UCLA / Jonsson Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I have tried surgery and some medication and not responce , I hope your staff can help me .
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Do I have to pay for the treatment?
How long will my treatment process take?
PatientReceived 2+ prior treatments
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