A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced Tumors

A Phase 1 Study for Safety and Tolerability of BMS-986205 Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223603

Enrollment

Registered

2017-07-28

Start date

2017-07-14

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Advanced Cancer

Interventions

investigational material(s) Generic name etc : BMS-986205 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational mater

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must have histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) Participants must have received, and then progressed or been intolerant to standard treatment regimen in the advanced or metastatic setting Eastern Cooperative Oncology Group performance status of ≤ 1

Exclusion criteria

Exclusion criteria: Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded History of congenital or autoimmune hemolytic disorders History or presence of hypersensitivity or idiosyncratic reaction to methylene blue

Design outcomes

Primary

Measure	Time frame
safety Incidence of Adverse Events (AEs) [ Time Frame: 15 months ] Incidence of Serious Adverse Events (SAEs) [ Time Frame: 15 months ] Incidence of Death [ Time Frame: 15 months ] Incidence of Laboratory Abnormalities [ Time Frame: 15 months ] Incidence of AEs leading to discontinuation [ Time Frame: Up to one year ]	—

Secondary

Measure	Time frame
efficacy pharmacokinetics pharmacodynamics Maximum observed plasma concentration (Cmax) [ Time Frame: Up to one year ] Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to one year ] Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to one year ] Trough observed plasma concentration at the end of the dosing interval (Ctrough) [ Time Frame: Up to one year ] Apparent total body clearance (CLT/F) [ Time Frame: Up to one year ] Apparent volume of distribution at steady-state (Vss/F) [ Time Frame: Up to one year ] Percent urinary recovery over 24 hours (%UR24) [ Time Frame: Up to 24 hours ] Biomarker Availability [ Time Frame: Up to one year ] Incidence of anti-drug antibody (ADA) [ Time Frame: Up to one year ] Best Overall Response (BOR) [ Time Frame: Up to one year ] Duration of Response (DOR) [ Time Frame: Up to one year ]	—

Measure

Time frame

efficacy pharmacokinetics pharmacodynamics Maximum observed plasma concentration (Cmax) [ Time Frame: Up to one year ] Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to one year ] Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to one year ] Trough observed plasma concentration at the end of the dosing interval (Ctrough) [ Time Frame: Up to one year ] Apparent total body clearance (CLT/F) [ Time Frame: Up to one year ] Apparent volume of distribution at steady-state (Vss/F) [ Time Frame: Up to one year ] Percent urinary recovery over 24 hours (%UR24) [ Time Frame: Up to 24 hours ] Biomarker Availability [ Time Frame: Up to one year ] Incidence of anti-drug antibody (ADA) [ Time Frame: Up to one year ] Best Overall Response (BOR) [ Time Frame: Up to one year ] Duration of Response (DOR) [ Time Frame: Up to one year ]

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026