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Monoclonal Antibodies
Anti-LAG-3 + Anti-PD-1 Immunotherapy for Cancer
Phase 1 & 2
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
ECOG performance status between 0 and 2
For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2.3 years
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of an experimental medication, BMS-986016, either alone or in combination with nivolumab, in patients with solid tumors that have spread and/or cannot be removed by surgery.
Who is the study for?
This trial is for adults with certain solid tumors (like lung, stomach, liver cancer and more) that have spread or can't be surgically removed. Participants must not have tried immuno-oncology drugs before, except for specific cases in melanoma and lung cancer. They should be relatively healthy otherwise and have at least one measurable tumor.Check my eligibility
What is being tested?
The study tests BMS-986016 alone or combined with nivolumab to see how safe they are and how well they work against various advanced cancers. It's looking at different doses to find the right amount that's effective but also tolerable.See study design
What are the potential side effects?
Potential side effects may include typical immune therapy reactions like fatigue, skin issues, inflammation of organs (like lungs or intestines), hormonal gland problems, infusion-related reactions, and possibly others depending on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I meet all previous criteria except for having cervical, ovarian, or colorectal cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2.3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2.3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate (DCR)
Number of AEs in the Broad Scope MedDRA Anaphylactic Reaction SMQ
Objective response rate (ORR)
+7 moreSecondary outcome measures
Accumulation index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with nivolumab
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab
Best overall response (BOR)
+19 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%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
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%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
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%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
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%
Malaise
5%
Pain
5%
Musculoskeletal chest 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%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
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
3Treatment groups
Experimental Treatment
Group I: Relatlimab + NivolumabExperimental Treatment2 Interventions
Relatlimab (BMS-986016) + Nivolumab (BMS-936558) specified dose on specified days
Group II: RelatlimabExperimental Treatment1 Intervention
Relatlimab (BMS-986016) specified dose on specified days
Group III: BMS-986213Experimental Treatment1 Intervention
Relatlimab (BMS-986016) + Nivolumab (BMS-936558)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986213
2018
Completed Phase 2
~280
Relatlimab
2018
Completed Phase 2
~1110
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,015 Total Patients Enrolled
12 Trials studying Tumors
2,128 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My only active cancer is in my brain.I have specific cancer types and am new to or have specific treatment histories with immuno-oncology agents.I have tried at least one standard treatment without success or could not tolerate it.I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.My cancer has spread to my brain and is not under control.I can take care of myself and am up and about more than half of my waking hours.There may be additional criteria that need to be met or avoided as specified in the study guidelines.I meet all previous criteria except for having cervical, ovarian, or colorectal cancer.You have a disease where your immune system mistakenly attacks your own body.
Research Study Groups:
This trial has the following groups:- Group 1: BMS-986213
- Group 2: Relatlimab
- Group 3: Relatlimab + Nivolumab
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are taking part in this experiment?
"This particular trial has wrapped up recruitment, however there are 749 other clinical trials recruiting patients that might be of interest. These 25 studies have an active need for participants with neoplasms and Nivolumab specifically."
Answered by AI
How can eligible patients sign up for this clinical trial?
"Unfortunately, this clinical trial is not presently searching for candidates. According to the data on clinicaltrials.gov, this study was initially posted on 11/5/2013 and was last updated on 2/10/2022. However, there are other studies that may be of interest; currently, 25 clinical trials enrolling participants with neoplasms by site and 749 trials for Nivolumab are actively looking for participants."
Answered by AI
What are some of the conditions that Nivolumab is commonly used to treat?
"While Nivolumab is most commonly used to treat cancer, it has also been shown to be effective against other conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
How many different geographical areas are included in this research project?
"The trial is based out of CHU de Quebec - Universite Laval in Quebec, Illinois, Advocate Health and Hospitals Corporation in Park Ridge, Texas, and University Of Chicago Medical Center in Chicago, Oregon. Additionally, there are 18 other potential locations for the study."
Answered by AI
What else is known about Nivolumab's effects?
"Nivolumab's first clinical trial was completed in 2010 at H. Lee Moffitt Cancer Center and Research Institute. To date, there have been a total of 249 similar studies completed with 749 more active trials recruiting patients as we speak. A large number of these new studies are based in Quebec and Illinois."
Answered by AI
Is this a novel clinical trial?
"Nivolumab has been under research for a decade now, with the first study completed in 2010 by Medarex. After Phase 1 drug approval was received, there are now 749 live studies involving Nivolumab happening in 2348 cities across 50 nations."
Answered by AI
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