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Checkpoint Inhibitor

Nivolumab +/- Ipilimumab for Lung Cancer

Phase 3

Waitlist Available

Led By Vassiliki Papadimitrakopoulou

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity

Patients must not have had prior treatment with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing nivolumab with or without ipilimumab to see if it can treat patients with squamous cell lung cancer that has come back after previous treatment.

Who is the study for?

This trial is for patients with stage IV squamous cell lung cancer that has returned after treatment. Participants must not have allergies to nivolumab or ipilimumab, no recent steroids or immunosuppressants, no HIV/AIDS, and should be free of certain heart conditions. They can't have had prior treatments targeting immune checkpoints and must not suffer from active autoimmune diseases.Check my eligibility

What is being tested?

The study compares the effectiveness of two monoclonal antibodies: nivolumab alone versus nivolumab combined with ipilimumab in treating recurrent lung cancer. It's a phase III trial for those who didn't qualify for other biomarker-driven studies.See study design

What are the potential side effects?

Nivolumab and Ipilimumab may cause immune-related side effects such as inflammation in various organs, potential lung issues (pneumonitis), skin reactions, hormone gland problems (like thyroid dysfunction), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have lung disease that causes symptoms or could affect lung toxicity treatment.

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I have not received treatments targeting immune checkpoints.

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I am not allergic to nivolumab or ipilimumab.

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I do not have HIV or AIDS.

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I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.

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I have a history of heart issues or am at risk, and have had heart function tests.

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I do not have severe heart disease or recent serious heart issues.

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I have had a heart condition and undergone tests like EKG and echocardiogram.

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I do not have active hepatitis B or C.

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I do not have an active autoimmune disease, except for allowed conditions like vitiligo or controlled hypothyroidism.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival

Secondary outcome measures

Investigator-assessed Progression-free Survival (IA-PFS)

Pharmaceutical Preparations

Objective Response Rate

Other outcome measures

Screen success rate

Treatment arm randomization acceptance rate

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (nivolumab, ipilimumab)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (nivolumab)Active Control4 Interventions

Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Ipilimumab

2014

Completed Phase 3

~2670

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

264,895 Total Patients Enrolled

Southwest Oncology GroupLead Sponsor

388 Previous Clinical Trials

261,536 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,878 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02785952 — Phase 3

Lung Cancer Research Study Groups: Arm II (nivolumab), Arm I (nivolumab, ipilimumab)

Lung Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02785952 — Phase 3

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02785952 — Phase 3

Frequently Asked Questions

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

Why is Laboratory Biomarker Analysis used?

"Cancerous neoplasms, unresectable melanomas, and other diseases that present with anti-angiogenic symptoms can be treated by Laboratory Biomarker Analysis."

Answered by AI

What risks are inherent in Laboratory Biomarker Analysis?

"There is some evidence for efficacy and extensive safety data available for Laboratory Biomarker Analysis, so it received a score of 3."

Answered by AI

Could you please explain the objectives of this clinical trial?

"The goal of this trial is to improve Investigator-assessed progression-free survival in Solid Tumors patients. Secondary outcomes include Objective Response Rate and Response rate in patients with measurable disease. Toxicity frequencies will also be monitored."

Answered by AI

Is this trial offered at many locations within the city?

"The trial is based in Danbury Hospital, Christiana Gynecologic Oncology LLC, and Decatur Memorial Hospital but is also running in 100 other hospitals."

Answered by AI

Would you please share if other research teams have looked into Laboratory Biomarker Analysis before?

"Currently, 801 clinical trials related to laboratory biomarker analysis are ongoing, with 87 of them in phase 3. Most of the trials for this topic are based in Pittsburgh, Pennsylvania, but there are 43516 locations across the globe conducting trials on this topic."

Answered by AI

Recent research and studies

JAMA OncologyJournal

Nivolumab Plus Ipilimumab Vs Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer

Gettinger, Scott N., Mary W. Redman, Lyudmila Bazhenova, Fred R. Hirsch, Philip C. Mack, Lawrence H. Schwartz, Jeffrey D. Bradley, et al.. 2021. “Nivolumab Plus Ipilimumab Vs Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2021.2209.

JAMA OncologyJournal

Nivolumab Plus Ipilimumab Vs Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer

clinicaltrials.govStudy

Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers

2015. "Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02785952.