A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)

NCT06946797 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: CA209-1533
• Study Type: interventional
• Target: 76
• Locations: 9 countries
• Sites: 38

Brief Summary

The purpose of this study is to evaluate two dosing regimens of subcutaneous Nivolumab in combination with intravenous Ipilimumab and chemotherapy in participants with previously untreated metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC)

Conditions

Non-Small Cell Lung Cancer

Keywords

Nivolumab; Ipilimumab; Checkmate-1533; CA2091533; NSCLC

Outcome Measures

Primary Outcomes (5)

• Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum

  Up to 3 weeks

• Time to peak concentration (Tmax) of subcutaneous Nivolumab in serum

  Up to 3 weeks

• Area under the concentration-time curve within a dosing interval (AUC(TAU)) of subcutaneous Nivolumab in serum

  Up to 3 weeks

• Concentration at the end of a dosing interval (Ctau) of subcutaneous Nivolumab in serum

  Up to 3 weeks

• Trough observed concentration (Ctrough) of subcutaneous Nivolumab

  At Cycle 7 Day 1 (Week 18)

Secondary Outcomes (13)

• Number of participants with adverse events (AEs)

  Up to approximately 2.5 years

• Number of participants with serious adverse events (SAEs)

  Up to approximately 2.5 years

• Number of participants with drug related AEs

  Up to approximately 2.5 years

• Number of participants with Immune Mediated Adverse Events (IMAEs)

  Up to approximately 2.5 years

• Number of participants with AEs leading to discontinuation

  Up to approximately 2.5 years

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Nivolumab; Drug: Ipilimumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin

Arm B

EXPERIMENTAL

Drug: Nivolumab; Drug: Ipilimumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin

Interventions

Ipilimumab DRUG

Specified dose on specified days

Also known as: Yervoy

Arm A; Arm B

Carboplatin DRUG

Specified dose on specified days

Arm A; Arm B

Paclitaxel DRUG

Specified dose on specified days

Arm A; Arm B

Pemetrexed DRUG

Specified dose on specified days

Arm A; Arm B

Cisplatin DRUG

Specified dose on specified days

Arm A; Arm B

Nivolumab DRUG

Specified dose on specified days

Also known as: BMS-986298

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically confirmed stage IV or recurrent non-small cell lung cancer (NSCLC) (as defined by the 9th edition of the IASLC Lung Cancer Staging Guidelines) of squamous or non-squamous histology.
• Participants must have no prior systemic anti-cancer treatment (including EGFR, ALK, ROS-1, BRAF, RET, and NTRK inhibitors) given as primary therapy for advanced or metastatic disease.
• Participants with prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy (whichever was given last) occurred at least 6 months prior to randomization. Participants with locally advanced disease with recurrence after chemoradiation therapy (stage III disease, specifically refers to patients with no curative options) are eligible to enroll.
• Participants with prior adjuvant or neoadjuvant chemotherapy for early-stage lung cancer are permitted if completed at least 6 months prior to randomization.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at screening and confirmed prior to randomization.
• Participants must have measurable disease by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with radiographic tumor assessment performed within 28 days of randomization.

You may not qualify if:

• Participants must not have any prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
• Participants must not have any known driver mutations with available targeted therapy (including but not limited to EGFR mutations, ALK translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with a known activating RET mutations and NTRK fusion gene alterations).
• Participants must not have any untreated central nervous system (CNS) metastases
• Participants must not have leptomeningeal metastases (carcinomatous meningitis).
• Participants must not have any active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to randomization and no additional therapy is required or anticipated to be required during the study period.
• Participants must not have a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Participants must not have any history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (38)

Local Institution - 0032

Anchorage, Alaska, 99508, United States

Location

Local Institution - 0062

Los Angeles, California, 90033, United States

Location

Local Institution - 0063

Boise, Idaho, 83702, United States

Location

Local Institution - 0052

Boise, Idaho, 83706, United States

Location

Local Institution - 0064

Post Falls, Idaho, 83854, United States

Location

Local Institution - 0047

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0033

Cleveland, Ohio, 44109, United States

Location

Local Institution - 0051

Allentown, Pennsylvania, 18103, United States

Location

Local Institution - 0041

Brasília, Federal District, 70200-730, Brazil

Location

Local Institution - 0043

Belo Horizonte, Minas Gerais, 30380-490, Brazil

Location

Local Institution - 0038

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Local Institution - 0037

Barretos, São Paulo, 14784400, Brazil

Location

Local Institution - 0034

São Paulo, 01246-000, Brazil

Location

Local Institution - 0067

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0065

Dijon, Côte-d'Or, 21079, France

Location

Local Institution - 0003

Suresnes, Hauts-de-Seine, 92151, France

Location

Local Institution - 0010

Paris, Île-de-France Region, 75014, France

Location

Local Institution - 0012

Athens, Attikí, 115 27, Greece

Location

Local Institution - 0013

Chaïdári, Attikí, 12462, Greece

Location

Local Institution - 0011

Thessaloniki, Kentrikí Makedonía, 540 07, Greece

Location

Local Institution - 0014

Larissa, Thessalía, 41110, Greece

Location

Local Institution - 0015

Meldola, Emilia-Romagna, 47014, Italy

Location

Local Institution - 0057

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Local Institution - 0020

Bergamo, Lombardy, 24127, Italy

Location

Local Institution - 0019

Florence, Tuscany, 50134, Italy

Location

Local Institution - 0017

Novara, 28100, Italy

Location

Local Institution - 0081

Warsaw, Masovian Voivodeship, 03-411, Poland

Location

Local Institution - 0080

Prabuty, Pomeranian Voivodeship, 82-550, Poland

Location

Local Institution - 0079

Lodz, Łódź Voivodeship, 93-338, Poland

Location

Local Institution - 0073

Bucharest, Bucharest, 022328, Romania

Location

Local Institution - 0076

Florești, Cluj, 407280, Romania

Location

Local Institution - 0077

Craiova, Dolj, 200542, Romania

Location

Local Institution - 0075

Bucharest, 020335, Romania

Location

Local Institution - 0074

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0078

Iași, 700483, Romania

Location

Local Institution - 0031

Soweto, Gauteng, 2013, South Africa

Location

Local Institution - 0009

Sandton, GP, 2196, South Africa

Location

Local Institution - 0084

Rondebosch, Western Cape, 7700, South Africa

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Ipilimumab; Carboplatin; Paclitaxel; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: April 27, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): October 25, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

IT (5); GR (4); CL (1); PL (3); US (8); FR (3); ZA (3); BR (5); RO (6)