A Study of Subcutaneous Nivolumab plus Intravenous Ipilimumab and Chemotherapy in Participants with Previously Untreated Metastatic or Recurrent NSCLC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

5 Nov 2025 → ongoing

Decision date (initial)

2025-08-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-520108-25-00

WHO UTN

U1111-1316-6409

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic

To study how the body processes (pharmacokinetics or PK) the nivolumab SC when given in two different doses along with ipilimumab IV and chemotherapy.

Secondary objectives 3

1. To evaluate the safety of the nivolumab SC when used with ipilimumab IV and chemotherapy,
2. To assess the body's immune response to the nivolumab SC and ipilimumab IV.
3. To study the PK of ipilimumab IV when given with nivolumab SC and chemotherapy.

Conditions and MedDRA coding

Non-small cell lung cancer (NSCLC)

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Females and males ≥18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at time of ICF signature.
2. Histologically confirmed stage IV or recurrent NSCLC (as defined by the 9th edition of the IASLC Lung Cancer Staging Guidelines) of squamous or non-squamous histology.
3. 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.
4. 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.
5. Prior adjuvant or neoadjuvant chemotherapy for early-stage lung cancer is permitted if completed at least 6 months prior to randomization.
6. ECOG Performance Status ≤ 1 at screening and confirmed prior to randomization.
7. Measurable disease by CT or MRI per RECIST 1.1 criteria with radiographic tumor assessment performed within 28 days of randomization.

Exclusion criteria 8

1. 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 costimulation or checkpoint pathways.
2. 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). - Positive, unknown, or indeterminate EGFR mutation status in participants of non-squamous histology are excluded.
3. Participants with untreated CNS metastases are excluded. - Participants are eligible if CNS metastases are asymptomatic and do not require immediate treatment or have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
4. Participants with leptomeningeal metastases (carcinomatous meningitis).
5. Participants with 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.
6. 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.
7. Participants with 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.
8. Participants who have history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Measuring various PK parameters of nivolumab SC in the blood during the first treatment cycle.
2. Measuring the amount of nivolumab SC left in the body just before the next dose is given on the first day of the seventh treatment cycle.

Secondary endpoints 3

1. Recording the incidence of side effects (adverse events or AEs), serious adverse events (SAEs), drug-related AEs, immune-mediated AEs (IMAEs), specific AEs, AEs leading to discontinuation, and deaths until 100 days post end of treatment.
2. Measuring the incidence of antibodies against nivolumab SC and ipilimumab IV, including neutralizing antibodies if applicable, until 100 days post end of treatment.
3. Evaluating the PK parameters of ipilimumab IV in the blood when given with nivolumab SC and chemotherapy during the first treatment cycle.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT Representative

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT Representative

Third parties 8

Locations

5 EU/EEA countries · 21 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 5 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 45 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications