Non-Small Cell Lung CancerPhase 2CheckMate-1533NCT06946797
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)
A Phase 2 study testing Nivolumab, Ipilimumab and Carboplatin in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 38 sites in 9 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Nivolumab, Ipilimumab and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 38 sitesin 9 countries
- Study dates
- 19 Sep 2025to 25 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
38 sites in 9 countries.
38 sites in 9 countries
United States8 sites
Local Institution - 0051
Allentown, Pennsylvania, 18103
Local Institution - 0032
Anchorage, Alaska, 99508
Local Institution - 0063
Boise, Idaho, 83702
Local Institution - 0052
Boise, Idaho, 83706
Local Institution - 0047
Cleveland, Ohio, 44106
Local Institution - 0033
Cleveland, Ohio, 44109
Local Institution - 0062
Los Angeles, California, 90033
Local Institution - 0064
Post Falls, Idaho, 83854
Romania6 sites
Local Institution - 0073
Bucharest, Bucharest, 022328
Local Institution - 0075
Bucharest, 020335
Local Institution - 0074
Cluj-Napoca, 400015
Local Institution - 0077
Craiova, Dolj, 200542
Local Institution - 0076
Florești, Cluj, 407280
Local Institution - 0078
Iași, 700483
Brazil5 sites
Local Institution - 0037
Barretos, São Paulo, 14784400
Local Institution - 0043
Belo Horizonte, Minas Gerais, 30380-490
Local Institution - 0041
Brasília, Federal District, 70200-730
Local Institution - 0038
Porto Alegre, Rio Grande do Sul, 90035-903
Local Institution - 0034
São Paulo, 01246-000
Italy5 sites
Local Institution - 0020
Bergamo, Lombardy, 24127
Local Institution - 0019
Florence, Tuscany, 50134
Local Institution - 0015
Meldola, Emilia-Romagna, 47014
Local Institution - 0017
Novara, 28100
Local Institution - 0057
Udine, Friuli Venezia Giulia, 33100
Greece4 sites
Local Institution - 0012
Athens, Attikí, 115 27
Local Institution - 0013
Chaïdári, Attikí, 12462
Local Institution - 0014
Larissa, Thessalía, 41110
Local Institution - 0011
Thessaloniki, Kentrikí Makedonía, 540 07
France3 sites
Local Institution - 0065
Dijon, Côte-d'Or, 21079
Local Institution - 0010
Paris, Île-de-France Region, 75014
Local Institution - 0003
Suresnes, Hauts-de-Seine, 92151
Poland3 sites
Local Institution - 0079
Lodz, Łódź Voivodeship, 93-338
Local Institution - 0080
Prabuty, Pomeranian Voivodeship, 82-550
Local Institution - 0081
Warsaw, Masovian Voivodeship, 03-411
South Africa3 sites
Local Institution - 0084
Rondebosch, Western Cape, 7700
Local Institution - 0009
Sandton, GP, 2196
Local Institution - 0031
Soweto, Gauteng, 2013
About this study
Official 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
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
- Being tested
- Nivolumab, Ipilimumab, Carboplatin, Paclitaxel, Pemetrexed
- Keywords
- Nivolumab, Ipilimumab, Checkmate-1533, CA2091533, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called BMS-986298
Specified dose on specified days
IpilimumabDrug
Also called Yervoy
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
PaclitaxelDrug
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin |
| Arm B | Experimental | Not described Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum
Measured: Up to 3 weeks
Time to peak concentration (Tmax) of subcutaneous Nivolumab in serum
Measured: Up to 3 weeks
Area under the concentration-time curve within a dosing interval (AUC(TAU)) of subcutaneous Nivolumab in serum
Measured: Up to 3 weeks
Concentration at the end of a dosing interval (Ctau) of subcutaneous Nivolumab in serum
Measured: Up to 3 weeks
Trough observed concentration (Ctrough) of subcutaneous Nivolumab
Measured: At Cycle 7 Day 1 (Week 18)
Secondary outcomes (13)
Number of participants with adverse events (AEs)
Measured: Up to approximately 2.5 years
Number of participants with serious adverse events (SAEs)
Measured: Up to approximately 2.5 years
Number of participants with drug related AEs
Measured: Up to approximately 2.5 years
Number of participants with Immune Mediated Adverse Events (IMAEs)
Measured: Up to approximately 2.5 years
Number of participants with AEs leading to discontinuation
Measured: Up to approximately 2.5 years
Number of deaths
Measured: Up to approximately 2.5 years
Number of participants with anti-nivolumab antibodies
Measured: Up to approximately 2.5 years
Number of participants with anti-ipilimumab antibodies
Measured: Up to approximately 2.5 years
Number of participants with neutralizing antibodies
Measured: Up to approximately 2.5 years
Cmax of intravenous Ipilimumab in serum
Measured: Up to 6 weeks
Tmax of intravenous Ipilimumab in serum
Measured: Up to 6 weeks
AUC(TAU) of intravenous Ipilimumab in serum
Measured: Up to 6 weeks
Ctau of intravenous Ipilimumab in serum
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start19 Sep 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion25 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946797
- Sponsor's protocol ID
- CA209-1533
- Acronym
- CheckMate-1533
- Status last verified
- May 2026
- First submitted
- 25 Apr 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06946797
- Acronym / sponsor ID
- CheckMate-1533 / CA209-1533
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Nivolumab, Ipilimumab, Checkmate-1533, CA2091533, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 25 Oct 2028 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-986298Specified dose on specified days | Drug | Arm A, Arm B |
| IpilimumabAlso: YervoySpecified dose on specified days | Drug | Arm A, Arm B |
| CarboplatinSpecified dose on specified days | Drug | Arm A, Arm B |
| PaclitaxelSpecified dose on specified days | Drug | Arm A, Arm B |
| PemetrexedSpecified dose on specified days | Drug | Arm A, Arm B |
| CisplatinSpecified dose on specified days | Drug | Arm A, Arm B |
Primary outcome
Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum
Time frame: Up to 3 weeks
Time to peak concentration (Tmax) of subcutaneous Nivolumab in serum
Time frame: Up to 3 weeks
Area under the concentration-time curve within a dosing interval (AUC(TAU)) of subcutaneous Nivolumab in serum
Time frame: Up to 3 weeks
Concentration at the end of a dosing interval (Ctau) of subcutaneous Nivolumab in serum
Time frame: Up to 3 weeks
Trough observed concentration (Ctrough) of subcutaneous Nivolumab
Time frame: At Cycle 7 Day 1 (Week 18)
13 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to approximately 2.5 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 2.5 years
Number of participants with drug related AEs
Time frame: Up to approximately 2.5 years
Number of participants with Immune Mediated Adverse Events (IMAEs)
Time frame: Up to approximately 2.5 years
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 2.5 years
Number of deaths
Time frame: Up to approximately 2.5 years
Number of participants with anti-nivolumab antibodies
Time frame: Up to approximately 2.5 years
Number of participants with anti-ipilimumab antibodies
Time frame: Up to approximately 2.5 years
Number of participants with neutralizing antibodies
Time frame: Up to approximately 2.5 years
Cmax of intravenous Ipilimumab in serum
Time frame: Up to 6 weeks
Tmax of intravenous Ipilimumab in serum
Time frame: Up to 6 weeks
AUC(TAU) of intravenous Ipilimumab in serum
Time frame: Up to 6 weeks
Ctau of intravenous Ipilimumab in serum
Time frame: Up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
38 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Ipilimumab and Carboplatin in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 38 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Romania, Brazil, Italy, Greece and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum (time frame: Up to 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.