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Monoclonal Antibodies
Nivolumab for Small Cell Lung 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose date to the date of first documented disease progression (up to 97 months)
Awards & highlights
Study Summary
This trial is testing a new drug, BMS-986012, to see if it is safe and effective at treating relapsed or refractory small cell lung cancer, either alone or in combination with another drug, nivolumab.
Eligible Conditions
- Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose to the last tumor assessment prior to subsequent therapy (up to 97 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to the last tumor assessment prior to subsequent therapy (up to 97 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Died
Number of Participants With Abnormal Hepatic Test
Number of Participants With Adverse Events (AEs)
+2 moreSecondary outcome measures
BMS-986012 Accumulation Index (AI_AUC)
BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
+15 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%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
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
12Treatment groups
Experimental Treatment
Group I: Dose Expansion (Monotherapy)- Cohort A (Refractory)Experimental Treatment1 Intervention
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Group II: Dose Expansion (Monotherapy) Cohort D (Sensitive)Experimental Treatment1 Intervention
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Group III: Dose Expansion (Monotherapy) Cohort C (Sensitive)Experimental Treatment1 Intervention
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Group IV: Dose Expansion (Monotherapy) Cohort B (Refractory)Experimental Treatment1 Intervention
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Group V: Dose Expansion (Combination)- (Refractory and Sensitive)Experimental Treatment2 Interventions
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
Group VI: Dose Escalation (Monotherapy) Dose 4Experimental Treatment1 Intervention
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Group VII: Dose Escalation (Monotherapy) Dose 3Experimental Treatment1 Intervention
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Group VIII: Dose Escalation (Monotherapy) Dose 2Experimental Treatment1 Intervention
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Group IX: Dose Escalation (Monotherapy) Dose 1Experimental Treatment1 Intervention
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Group X: Dose Escalation (Monotherapy) Dose -1Experimental Treatment1 Intervention
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
Group XI: Dose Escalation (Combination) Dose 2Experimental Treatment2 Interventions
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
Group XII: Dose Escalation (Combination) Dose 1Experimental Treatment2 Interventions
BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986012 (anti-fucosyl-GM1)
2014
Completed Phase 2
~110
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,394 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participation rate of this experiment?
"This trial is no longer recruiting; it was first posted on November 14th 2014 and its last update occurred on September 28th 2022. Nevertheless, there are 1577 studies looking to enrol patients with small cell lung carcinoma and 718 trials searching for participants taking Nivolumab."
Answered by AI
In what medical scenarios is Nivolumab commonly prescribed?
"Nivolumab is a common treatment for malignancies, and can also be used to address unresectable melanoma, squamous cell carcinoma, metastatic esophageal adenocarcinoma."
Answered by AI
Has Nivolumab been utilized in any prior research efforts?
"Nivolumab was initially researched in 2012 at Local Institution. There have since been 253 concluded trials and 718 clinical studies actively recruiting patients, with a notable concentration of these investigations taking place in Durham, North carolina."
Answered by AI
Is this experiment a pioneering endeavor in the field of medicine?
"Since 2012, clinical trials have been conducted to assess the efficacy of Nivolumab. The initial experiment was sponsored by Ono Pharmaceutical Co. Ltd and included 659 patients; afterwards, it received Phase 1 & 2 drug approval. At present, 718 active studies are being carried out in 2354 cities spread across 49 different countries worldwide."
Answered by AI
How many medical facilities have been enlisted to conduct this research?
"There are 13 sites participating in this trial, with notable locations including Local Institution - 0001 from Durham, North carolina; Juravinski Cancer Centre based out of Hamilton, Alberta; and Duke University Medical Center located in Edmonton, Nova Scotia."
Answered by AI
Is there an ongoing recruitment process for this clinical trial?
"Presently, this clinical trial is not recruiting. It was first posted on November 14th 2014 and its last modification occurred on September 28th 2022. If you are in search of other trials, there are 1577 studies related to small cell lung carcinoma looking for participants as well as 718 studies involving Nivolumab which are actively enrolling patients."
Answered by AI
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