Immunotherapy + Chemotherapy for Lung Cancer

(CheckMate 816 Trial)

No longer recruiting at 279 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Checkpoint inhibitors

Disqualifiers: Metastatic disease, Autoimmune disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatment options for individuals with resectable non-small cell lung cancer (NSCLC) that can be surgically removed. Researchers compare the safety and effectiveness of a combination of nivolumab (an immunotherapy drug) and chemotherapy against chemotherapy alone, and they also examine nivolumab with ipilimumab (another immunotherapy drug). Individuals with early-stage NSCLC that can be operated on and whose lungs are healthy enough for surgery might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering access to potentially groundbreaking treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using nivolumab with platinum-doublet chemotherapy is generally safe and well-tolerated. The FDA has already approved this combination for treating resectable non-small cell lung cancer (NSCLC). Studies indicate it significantly improves survival rates without causing unexpected side effects.

The combination of nivolumab with ipilimumab has also undergone extensive study. Results over five years suggest this treatment helps NSCLC patients live longer. However, some patients experienced immune-related side effects, such as lung inflammation, occurring in about 9% of cases. Despite these side effects, this combination has proven effective for many patients.

Overall, these treatments are being tested to ensure safety and effectiveness. While side effects can occur, healthcare teams usually manage and closely monitor them. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for lung cancer because they combine powerful immunotherapies with traditional chemotherapy, aiming for a stronger attack on cancer cells. Unlike standard chemotherapy alone, Nivolumab and Ipilimumab are immunotherapy drugs that work by unleashing the immune system to better recognize and destroy cancer cells. The combination of Nivolumab with platinum doublet chemotherapy could enhance the effectiveness of existing chemo treatments, while the Nivolumab plus Ipilimumab duo offers a novel approach by focusing solely on boosting immune response. These combinations hold promise for improving outcomes by potentially extending survival and enhancing the quality of life for patients.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that combining nivolumab with platinum-based chemotherapy, one of the treatment arms in this trial, can lead to better results for patients with resectable non-small-cell lung cancer (NSCLC). Studies have found that this combination improves long-term outcomes compared to chemotherapy alone. Nivolumab helps the immune system attack cancer cells more effectively.

Another treatment arm in this trial involves the combination of nivolumab and ipilimumab. Evidence suggests this combination offers lasting survival benefits for NSCLC patients. In some studies, patients experienced significantly better survival rates compared to past data. Ipilimumab works with nivolumab to enhance the immune system's response against cancer cells. ^{1 2 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My lungs are strong enough for surgery.

I have a sample of my lung tumor available.

I am fully active or can carry out light work.

Exclusion Criteria

I have been treated with drugs that boost the immune system.

You have a known autoimmune disease that is currently active or suspected.

My cancer cannot be removed by surgery and may have spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either nivolumab plus ipilimumab, nivolumab plus platinum doublet chemotherapy, or platinum doublet chemotherapy alone

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Ipilimumab
• Nivolumab
• Paclitaxel
• Pemetrexed

Trial Overview

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.

How Is the Trial Designed?

Group I: Nivolumab plus platinum doublet chemotherapy Experimental Treatment 6 Interventions

Specified dose on specified days

Group II: Nivolumab plus Ipilimumab Experimental Treatment 2 Interventions

Specified dose on specified days

Group III: Platinum doublet chemotherapy Active Control 7 Interventions

Specified dose on specified days

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Ono Pharmaceutical Co. Ltd

Industry Sponsor

Trials

182

Recruited

97,100+

Shinji Takai

Ono Pharmaceutical Co. Ltd

Chief Medical Officer since 2023

MD from an unspecified institution

Gyo Sagara

Ono Pharmaceutical Co. Ltd

Chief Executive Officer since 2024

PhD in Pharmaceutical Sciences from Kyoto University

Citations

1.

esmoopen.com

esmoopen.com/article/S2059-7029(25)00992-5/fulltext

final, 6-year outcomes from CheckMate 9LA

The 6-year DOR rate was 19% with nivolumab plus ipilimumab with chemotherapy; all patients in the chemotherapy arm were censored or stopped ...

2.

opdivohcp.com

opdivohcp.com/efficacy/nsclc/opdivo-yervoy

OPDIVO® (nivolumab) + YERVOY® (ipilimumab) Efficacy ...

In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 ( ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9937094/

Five-Year Survival Outcomes With Nivolumab Plus Ipilimumab ...

Patients with metastatic non–small-cell lung cancer (mNSCLC) have historically had a 5-year survival rate of only 7%, but more recently, immune check point ...

4.

news.bms.com

news.bms.com/news/details/2023/Six-Year-Outcomes-from-Phase-3-CheckMate--227-Trial-Show-Durable-Long-Term-Survival-with-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-in-the-First-Line-Treatment-of-Patients-with-Metastatic-Non-Small-Cell-Lung-Cancer/default.aspx

Six-Year Outcomes from Phase 3 CheckMate -227 Trial ...

Six-Year Outcomes from Phase 3 CheckMate -227 Trial Show Durable, Long-Term Survival with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in the ...

5.

opdivo.com

opdivo.com/nsclc/clinical-trial-results/advanced-pd-l1-positive-immunotherapy-combination

Non-small cell lung cancer (NSCLC)

See how OPDIVO® (nivolumab) + YERVOY® (ipilimumab) performed in a clinical trial as first-line treatment for adults with stage 4 or recurrent advanced ...

6.

ejcancer.com

ejcancer.com/article/S0959-8049(24)00952-3/fulltext

Five-year outcomes with first-line nivolumab plus ...

Five-year progression-free survival and DOR rates in 5-year survivors were 55% versus 38% and 59% versus 46%, respectively. No new safety ...

7.

jto.org

jto.org/article/S1556-0864(24)02355-4/fulltext

Long-Term Survival Outcomes With First-Line Nivolumab ...

In patients with squamous NSCLC, median OS was 16.2 versus 8.2 months with nivolumab plus ipilimumab with or without chemotherapy versus ...

8.

news.bms.com

news.bms.com/news/details/2022/Landmark-Five-Year-Data-from-Phase-3-CheckMate--227-Trial-Demonstrate-Long-Term-Durable-Survival-Outcomes-with-Opdivonivolumab-Plus-Yervoy-ipilimumab-in-First-Line-Treatment-of-Patients-with-Metastatic-Non-Small-Cell-Lung-Cancer/default.aspx

Landmark Five-Year Data from Phase 3 CheckMate -227 ...

Opdivo plus Yervoy nearly doubled overall survival rate at five years compared to chemotherapy in patients with metastatic non-small cell lung cancer (mNSCLC)