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Checkpoint Inhibitor

nivolumab for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Matthew Hellmann, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 every 6 weeks (+/- 1 week) until week 48
Awards & highlights

Study Summary

This trial is looking at why some patients with lung cancer respond to treatment with nivolumab and ipilimumab, and why some patients do not.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks (+/- 1 week) until week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks (+/- 1 week) until week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best overall response rate (confirmed partial + complete response) will be assessed as part of this study. Tumor response will be assessed using RECIST 1.1)

Side effects data

From 2021 Phase 3 trial • 1844 Patients • NCT03068455
38%
Fatigue
37%
Diarrhoea
37%
Pruritus
29%
Headache
28%
Rash
24%
Hypothyroidism
24%
Nausea
20%
Hyperthyroidism
18%
Arthralgia
18%
Cough
18%
Asthenia
15%
Alanine aminotransferase increased
13%
Lipase increased
13%
Pyrexia
12%
Constipation
12%
Aspartate aminotransferase increased
12%
Decreased appetite
12%
Nasopharyngitis
11%
Abdominal pain
11%
Dry mouth
11%
Vomiting
11%
Myalgia
10%
Hypophysitis
10%
Insomnia
10%
Back pain
9%
Amylase increased
8%
Dyspnoea
8%
Upper respiratory tract infection
7%
Dizziness
6%
Adrenal insufficiency
6%
Abdominal pain upper
6%
Infusion related reaction
6%
Hyperglycaemia
6%
Oropharyngeal pain
6%
Blood creatine phosphokinase increased
6%
Influenza like illness
5%
Vitiligo
5%
Hypertension
5%
Pain in extremity
3%
Colitis
3%
Anxiety
2%
Immune-mediated enterocolitis
2%
Autoimmune hepatitis
2%
Basal cell carcinoma
2%
Malignant neoplasm progression
1%
Squamous cell carcinoma
1%
Autoimmune colitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Erysipelas
1%
Pneumonia
1%
Melanoma recurrent
1%
Pneumonitis
1%
Sarcoidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Ipi
Arm B: Nivo

Trial Design

1Treatment groups
Experimental Treatment
Group I: NivolumabExperimental Treatment2 Interventions
Patients will begin treatment with nivolumab IV 3mg/kg and ipilimumab 1mg/kg. Treatment with nivolumab will continue every 2 weeks (+/- 3 days) thereafter and treatment with ipilimumab will continue every 6 weeks (+/- 3 days) thereafter. Treatment will continue until protocol-defined toxicity, confirmed progression of disease*, withdrawal of consent, or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~4960
pilimumab
2015
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,853 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,642 Previous Clinical Trials
4,130,094 Total Patients Enrolled
Matthew Hellmann, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02350764 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Nivolumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02350764 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02350764 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned nivolumab for therapeutic use?

"Despite the lack of efficacy data, our team at Power rated nivolumab's safety as a 2 due to its Phase 2 status."

Answered by AI

What is the aggregate participation for this experiment?

"This clinical trial is no longer recruiting patients. Initially posted on January 1st 2015, the last edit to this listing was done on December 6th 2021. If you are interested in other studies that meet your criteria, there are 1360 trials actively enrolling people with advance directives and 718 for nivolumab treatments currently open for enrolment."

Answered by AI

What prior research has been documented about the utilization of nivolumab?

"Presently, there are 718 active clinical trials assessing nivolumab's efficacy. Of those studies, 82 have progressed to Phase 3 with the main concentration of these triaal sites located in Basel, BE and 40237 other locations running related research."

Answered by AI

Is there still availability for individuals to participate in this investigation?

"According to the information present on clinicaltrials.gov, this medical trial is not presently accepting new patients; however, it was posted in January 2015 and last updated in December 2021. There are currently 2,078 other trials recruiting participants at the moment."

Answered by AI

Is this research initiative unique to the field?

"Ever since 2012, when the very first trial for nivolumab was conducted by Ono Pharmaceutical Co. Ltd., this medication has been heavily studied with 718 ongoing trials in 2354 cities and 49 different countries. After Phase 1 & 2 drug approval were granted, Nivolumab is now available to many patients worldwide."

Answered by AI

In what treatments is nivolumab frequently employed?

"Nivolumab is utilized to treat malignant neoplasms and certain other afflictions, such as metastatic esophageal adenocarcinoma, squamous cell carcinoma of the skin or unresectable melanomas."

Answered by AI
~3 spots leftby May 2025