All > Chordoma

Nivolumab for Unresectable Chordoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, CAUnresectable Chordoma+3 MoreNivolumab - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Unresectable Chordoma
  • Chordoma
  • Metastatic Chordoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Topotecan
1
Nivolumab
1
Nivolumab

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 2 years

Month 6
Progress free survival (PFS) time
Up to 2 years
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
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
Response rate by Choi criteria

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Topotecan
1
Nivolumab
1
Nivolumab

Side Effects for

Investigator Choice of Chemotherapy
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%Neutropenia
21%Pyrexia
19%Hypomagnesaemia
19%Headache
18%Arthralgia
16%Asthenia
16%Dizziness
16%Neutrophil count decreased
15%Thrombocytopenia
15%Insomnia
14%Weight decreased
14%Hyponatraemia
14%Rash
14%Platelet count decreased
13%Blood creatinine increased
13%White blood cell count decreased
12%Pain in extremity
12%Pruritus
12%Hypokalaemia
12%Abdominal pain
11%Alanine aminotransferase increased
11%Aspartate aminotransferase increased
11%Myalgia
10%Pneumonia
10%Muscular weakness
10%Productive cough
10%Alopecia
10%Dry skin
10%Chest pain
10%Hypoalbuminaemia
10%Dysgeusia
9%Abdominal pain upper
9%Mucosal inflammation
9%Hypothyroidism
9%Upper respiratory tract infection
9%Peripheral sensory neuropathy
8%Lacrimation increased
8%Non-cardiac chest pain
8%Nasopharyngitis
8%Dysphonia
8%Epistaxis
8%Haemoptysis
8%Stomatitis
7%Hyperkalaemia
7%Dehydration
7%Bronchitis
7%Anxiety
7%Hypertension
7%Chills
7%Blood alkaline phosphatase increased
7%Hyperglycaemia
7%Lymphocyte count decreased
6%Pneumonitis
6%Neuropathy peripheral
6%Oropharyngeal pain
6%Pleural effusion
6%Hypophosphataemia
6%Leukopenia
5%Dry mouth
5%Malaise
5%Pain
5%Urinary tract infection
5%Muscle spasms
5%Gamma-glutamyltransferase increased
5%Depression
5%Hypotension
5%Rash maculo-papular
5%Dyspepsia
5%Musculoskeletal chest pain
4%Fall
4%Pulmonary embolism
3%Myocardial infarction
3%Metastases to central nervous system
3%Musculoskeletal pain
3%Chronic obstructive pulmonary disease
3%Febrile neutropenia
2%Adrenal insufficiency
2%Atrial fibrillation
2%Sepsis
2%Malignant pleural effusion
2%Embolism
2%Cardiac failure
2%General physical health deterioration
1%Lung cancer metastatic
1%Neoplasm progression
1%Small intestinal haemorrhage
1%Gastrointestinal haemorrhage
1%Colitis
1%Appendicitis
1%Respiratory tract infection
1%Bone pain
1%Ataxia
1%Syncope
1%Bronchial obstruction
1%Pneumothorax
1%Circulatory collapse
1%Superior vena cava syndrome
1%Respiratory failure
1%Seizure
1%Pancytopenia
1%Atrial flutter
1%Pericardial effusion
1%Ileus
1%Small intestinal obstruction
1%Performance status decreased
1%Skin infection
1%Femur fracture
1%Hypercalcaemia
1%Cancer pain
1%Pericardial effusion malignant
1%Confusional state
1%Tumour pain
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the Investigator Choice of Chemotherapy ARM group. Side effects include: Nausea with 57%, Anaemia with 54%, Fatigue with 51%, Decreased appetite with 39%, Malignant neoplasm progression with 36%.

Trial Design

1 Treatment Group

Treatment (nivolumab and relatlimab)
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 2

Treatment (nivolumab and relatlimab)Experimental Group · 2 Interventions: Nivolumab, Relatlimab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Relatlimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
21,734 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,510 Previous Clinical Trials
3,944,333 Total Patients Enrolled
Arun SinghPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You or your legal guardian must agree in writing before any testing or treatment can be done.
You cannot be breastfeeding if you're a woman.
You are expected to live for at least 12 more weeks.
You understand what the study is about and agree to follow the study's rules.
You must be in good physical condition with minimal limitations to your daily activities.
You have been diagnosed with chordoma through a tissue biopsy.
The researchers need a piece of your tumor tissue that is at least 0.8 x 0.1 cm in size or has at least 50 tumor cells. If they don't have it, they will need to perform a biopsy to get it.
You have a type of cancer called chordoma that has spread and gotten worse, either based on imaging scans or loss of nerve function, within the past 6 months.
You have a tumor that can be measured using a specific set of guidelines called RECIST 1.1.
Women must not be pregnant or able to become pregnant during the study. You must have gone through menopause for at least a year, had surgery to prevent pregnancy, or use effective birth control methods like pills, implants, intrauterine devices, or barrier methods with spermicide.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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