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A Phase 1b/2 Study of BMS-986442 in Combination with Nivolumab or Nivolumab and Chemotherapies in Participants with Advanced Solid Tumors and Non-small Cell Lung Cancer

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-503108-26-00
Acronym
CA115-001
Enrollment
106
Registered
2023-07-19
Start date
2023-11-06
Completion date
2024-09-04
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer, Solid Tumor

Brief summary

Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation, and death (per CTCAE v5.0).

Detailed description

Summary measures of BMS-986442 PK parameters (such as, but not limited to, Cmax, Tmax, and AUC), Incidence of ADAs, and anti tumor efficacy parameters (ORR, DOR, DCR, and PFSR at 6 months and 12 months per RECIST v1.1 by Investigator)

Interventions

DRUGDOCETAXEL
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGPACLITAXEL
DRUGAGEN1777
DRUGCARBOPLATIN
DRUGPEMETREXED DISODIUM

Sponsors

Bristol-Myers Squibb Services Unlimited Company, Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation, and death (per CTCAE v5.0).—

Secondary

MeasureTime frame
Summary measures of BMS-986442 PK parameters (such as, but not limited to, Cmax, Tmax, and AUC), Incidence of ADAs, and anti tumor efficacy parameters (ORR, DOR, DCR, and PFSR at 6 months and 12 months per RECIST v1.1 by Investigator)—

Countries

Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026