A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer
- Conditions
- Advanced Solid TumorsNon-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05543629
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
- Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have a life expectancy of at least 3 months at the time of first dose.
- Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
- Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
- Participants with an active, known, or suspected autoimmune disease.
Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part C: BMS-986442 + Nivolumab + Docetaxel BMS-986442 - Part B1: BMS-986442 + Nivolumab Nivolumab Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC) Part A: BMS-986442 + Nivolumab BMS-986442 - Part A: BMS-986442 + Nivolumab Nivolumab - Part B1: BMS-986442 + Nivolumab BMS-986442 Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC) Part C: BMS-986442 + Nivolumab + Docetaxel Nivolumab - Part B2: BMS-986442 + Nivolumab BMS-986442 Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN) Part B2: BMS-986442 + Nivolumab Nivolumab Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN) Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed BMS-986442 - Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed Nivolumab - Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed Pemexetred - Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel Nivolumab - Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel BMS-986442 - Part C: BMS-986442 + Nivolumab + Docetaxel Docetaxel - Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed Carboplatin - Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel Carboplatin - Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel Paclitaxel -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events From first dose to 100 days post last dose (Approximately 6 Months) Number of Participants with Adverse Events.
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).Number of Participants With Serious Adverse Events From first dose to 100 days post last dose (Approximately 6 Months) A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
* Results in death.
* Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe).
* Requires inpatient hospitalization or causes prolongation of existing hospitalizationNumber of Participants With Adverse Events Leading to Discontinuation From first dose to 100 days post last dose (Approximately 6 Months) Number of Participants with adverse events leading to discontinuation
Number of Participants With Dose Limiting Toxicities From Cycle 1 day 1 to day 28 (28 Days) DLTs will be defined based on the incidence, intensity, and duration of the AEs for which no clear alternative cause is identified and will exclude events clearly related to disease progression or intercurrent illness.
in addition, the following AEs will be DLTs:
* Any death that is not clearly due to the underlying disease or extraneous causes
* Any Grade ≥ 3 non-hematological toxicity
* Any Grade myocarditis
* Any Grade myelitis, encephalitis, myasthenia gravis, or Guillain-Barre syndrome
* Grade 4 neutropenia of \> 7 days duration
* Grade 4 thrombocytopenia.
* Grade 3 thrombocytopenia with clinically significant bleeding.
* Febrile neutropenia
Any AE that is not clearly due to disease progression or extraneous causes that occurs within the 28-day DLT evaluation window and meets criteria for permanent discontinuation will be considered a DLT.Number of Participants Who Died From first dose to 100 days post last dose (Approximately 6 Months) Number of Participants who died
- Secondary Outcome Measures
Name Time Method CMax On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks) Maximum observed serum concentration
Tmax On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks) Time of maximum observed serum concentration
AUC (Tau) On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks) Area under the serum concentration-time curve in 1 dosing interval
Number of Participants With BMS-986442 Anti Drug Antibody (ADA) From first dose to 100 days post last dose (Approximately 6 Months) Number of participants with BMS-986442 Anti Drug Antibody (ADA)
Objective Response Rate (ORR) Per Recist v1.1 by Investigator From first dose to 100 days post last dose (Approximately 6 Months) ORR is defined as the number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated participants.
The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a participant receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).Disease Control Rate (DCR) Per Recist v1.1 by Investigator From first dose to 100 days post last dose (Approximately 6 Months) Disease Control Rate (DCR) is defined as the number of treated participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) (and/or SD \> 6 months), based on investigator assessments divided by the number of all treated participants.
Trial Locations
- Locations (32)
Local Institution - 0019
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0077
🇮🇹Siena, Toscana, Italy
Mayo Clinic in Arizona - Phoenix
🇺🇸Phoenix, Arizona, United States
Local Institution - 0096
🇺🇸Costa Mesa, California, United States
Local Institution - 0075
🇺🇸Orange, California, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Local Institution - 0027
🇺🇸Orlando, Florida, United States
Local Institution - 0029
🇺🇸Fort Wayne, Indiana, United States
Local Institution - 0022
🇺🇸New Orleans, Louisiana, United States
Local Institution - 0005
🇺🇸Grand Rapids, Michigan, United States
Mayo Clinic in Rochester, Minnesota
🇺🇸Rochester, Minnesota, United States
Local Institution - 0003
🇺🇸Hackensack, New Jersey, United States
Carolina BioOncology Institute
🇺🇸Huntersville, North Carolina, United States
Local Institution - 0046
🇺🇸Allentown, Pennsylvania, United States
Local Institution - 0016
🇺🇸Houston, Texas, United States
Local Institution - 0018
🇦🇺Darlinghurst, New South Wales, Australia
Local Institution - 0001
🇦🇺Westmead, New South Wales, Australia
Local Institution - 0086
🇦🇺Southport, Queensland, Australia
Local Institution - 0002
🇦🇺Clayton, Victoria, Australia
Local Institution - 0084
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0065
🇮🇹Milan, Milano, Italy
Local Institution - 0064
🇮🇹Candiolo, Torino, Italy
Local Institution - 0062
🇮🇹Napoli, Italy
Local Institution - 0067
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0073
🇵🇱Gdańsk, Pomorskie, Poland
Local Institution - 0069
🇵🇱Bydgoszcz, Poland
Local Institution - 0080
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0083
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0079
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0082
🇪🇸Málaga, Spain
Local Institution - 0087
🇪🇸Sevilla, Spain
Local Institution - 0081
🇪🇸València, Spain