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Chemotherapy

Immunotherapy + Chemotherapy for Lung Cancer (CheckMate 816 Trial)

Phase 3
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
Lung function capacity capable of tolerating the proposed lung surgery
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to a median of 30 months after randomization.
Awards & highlights

CheckMate 816 Trial Summary

This trial is testing a new way to treat lung cancer that may be more effective and have fewer side effects than the current standard of care.

Who is the study for?
This trial is for people with early-stage IB-IIIA operable non-small cell lung cancer (NSCLC) who have good lung function and can handle surgery. They should be relatively healthy, which means having an ECOG Performance Status of 0-1. Those with advanced inoperable or metastatic disease, autoimmune diseases, or previous treatments targeting T cell pathways cannot join.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of adding Nivolumab to chemotherapy before surgery compared to just chemotherapy alone. It also examines how safe and effective it is to combine Nivolumab with Ipilimumab versus the standard treatment for resectable NSCLC.See study design
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune-related side effects like inflammation in various organs, skin rash, hormone gland problems (like thyroid), fatigue, nausea, breathing difficulties, and potential infusion reactions during administration.

CheckMate 816 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lungs are strong enough for surgery.
Select...
I am fully active or can carry out light work.
Select...
I have a sample of my lung tumor available.
Select...
I am fully active or can carry out light work.
Select...
My lungs are strong enough for surgery.
Select...
My lung cancer is in early stage IB-IIIA and can be operated on.
Select...
My lung cancer is at an early stage (IB-IIIA) and can be operated on.

CheckMate 816 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to a median of 30 months after randomization.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to a median of 30 months after randomization. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-Free Survival (EFS)
Pathologic Complete Response (pCR) Rate
Secondary outcome measures
Major Pathologic Response (MPR) Rate
Overall Survival (OS)
Time to Death or Distant Metastases (TTDM)

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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
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%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
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

CheckMate 816 Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab plus platinum doublet chemotherapyExperimental Treatment6 Interventions
Specified dose on specified days
Group II: Nivolumab plus IpilimumabExperimental Treatment2 Interventions
Specified dose on specified days
Group III: Platinum doublet chemotherapyActive Control7 Interventions
Specified dose on specified days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2640
Paclitaxel
2011
Completed Phase 4
~5380
Nivolumab
2014
Completed Phase 3
~4750
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine
2017
Completed Phase 3
~2070
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,126,031 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
94,158 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02998528 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Platinum doublet chemotherapy, Nivolumab plus platinum doublet chemotherapy, Nivolumab plus Ipilimumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02998528 — Phase 3
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02998528 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other clinical research has been conducted using Nivolumab?

"Nivolumab was first studied in 1997 at City of Hope Comprehensive Cancer Center. 3741 studies have been completed to date, with 2661 more presently underway - a large number of which are based out of Montreal, Quebec."

Answered by AI

What are the most popular conditions that Nivolumab is used to treat?

"Nivolumab is frequently used as an initial treatment, but it can also be useful for patients with metastatic bladder cancer, small cell lung cancer (sclc), or advanced testicular cancer."

Answered by AI

Is this clinical trial limited to a single province in Canada?

"This trial is currently recruiting 100 patients from a total of 103 locations, with Local Institution - 0138 in Montreal, Local Institution - 0017 in High Point, and Local Institution - 0140 in Salt Lake City being just some of the participating sites."

Answered by AI

When was Nivolumab cleared by the FDA?

"Nivolumab's safety was rated a 3 by our team at Power. This is because Phase 3 trials have both efficacy and multiple rounds of data supporting safety."

Answered by AI

Who else is applying?

What site did they apply to?
Hematology-Oncology Associates Of Fredricksburg, Inc
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I am currently undergoing immunotherapy at Fredericksburg Hematology & Oncology.
PatientReceived no prior treatments
~63 spots leftby Mar 2025