Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06946797

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)

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0041, Brasília, Federal District, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Nivolumab

Drug

Specified dose on specified days

Other names: BMS-986298

Ipilimumab

Drug

Specified dose on specified days

Other names: Yervoy

carboplatin

Drug

Specified dose on specified days

paclitaxel

Drug

Specified dose on specified days

Pemetrexed

Drug

Specified dose on specified days

Cisplatin

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum

    Time frame: Up to 3 weeks

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

    Time frame: Up to 3 weeks

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

    Time frame: Up to 3 weeks

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

    Time frame: Up to 3 weeks

  5. Trough observed concentration (Ctrough) of subcutaneous Nivolumab

    Time frame: At Cycle 7 Day 1 (Week 18)

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 2.5 years

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to approximately 2.5 years

  3. Number of participants with drug related AEs

    Time frame: Up to approximately 2.5 years

  4. Number of participants with Immune Mediated Adverse Events (IMAEs)

    Time frame: Up to approximately 2.5 years

  5. Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 2.5 years

  6. Number of deaths

    Time frame: Up to approximately 2.5 years

  7. Number of participants with anti-nivolumab antibodies

    Time frame: Up to approximately 2.5 years

  8. Number of participants with anti-ipilimumab antibodies

    Time frame: Up to approximately 2.5 years

  9. Number of participants with neutralizing antibodies

    Time frame: Up to approximately 2.5 years

  10. Cmax of intravenous Ipilimumab in serum

    Time frame: Up to 6 weeks

  11. Tmax of intravenous Ipilimumab in serum

    Time frame: Up to 6 weeks

  12. AUC(TAU) of intravenous Ipilimumab in serum

    Time frame: Up to 6 weeks

  13. Ctau of intravenous Ipilimumab in serum

    Time frame: Up to 6 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 2, Open-label, Randomized Trial to Evaluate Two Dosing Regimens of Subcutaneous Formulation of Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent NSCLC

Acronym: CheckMate-1533

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 27, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.