Advanced Cancer Clinical Trial
Official title:
A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
| Verified date | May 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.
| Status | Active, not recruiting |
| Enrollment | 494 |
| Est. completion date | May 14, 2025 |
| Est. primary completion date | June 28, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies Exclusion Criteria: - Active, known or suspected autoimmune disease - Active malignancy requiring concurrent intervention - Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0008 | ABB | Distrito Federal |
| Argentina | Local Institution - 0016 | Buenos Aires | |
| Argentina | Local Institution - 0017 | Buenos Aires | |
| Argentina | Local Institution - 0074 | Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Argentina | Local Institution - 0012 | Caba | Distrito Federal |
| Argentina | Local Institution - 0011 | Ciudad Autónoma De Buenos Aires | Buenos Aires |
| Argentina | Local Institution - 0014 | Córdoba | Cordoba |
| Argentina | Local Institution - 0013 | Río Cuarto | Cordoba |
| Canada | Local Institution - 0046 | Montreal | Quebec |
| Canada | Local Institution - 0042 | Montréal | Quebec |
| Canada | Local Institution - 0006 | Toronto | Ontario |
| Chile | Local Institution - 0009 | Santiago | Metropolitana |
| Chile | Local Institution - 0019 | Santiago | Metropolitana |
| Chile | Local Institution - 0035 | Santiago | Región Metropolitana De Santiago |
| Chile | Local Institution - 0036 | Santiago | Región Metropolitana De Santiago |
| Chile | Local Institution - 0010 | Viña del Mar | Valparaiso |
| France | Local Institution - 0034 | Bordeaux | Gironde |
| France | Local Institution - 0018 | Bron Cedex | |
| France | Local Institution - 0026 | Marseille | |
| France | Local Institution - 0015 | Paris | |
| France | Local Institution - 0022 | Saint-Herblain | Loire-Atlantique |
| France | Centre Hospitalier intercommunal de Toulon La Seyne sur Mer | Toulon | |
| Italy | Local Institution - 0028 | Ancona | |
| Italy | Local Institution - 0033 | Catanzaro | |
| Italy | Local Institution - 0031 | Milan | |
| Italy | Local Institution - 0040 | Milan | Lombardia |
| Italy | Local Institution - 0038 | Padova | Veneto |
| Italy | Local Institution - 0039 | Roma | |
| Spain | Local Institution - 0054 | Barcelona | Catalunya [Cataluña] |
| Spain | Local Institution - 0056 | Barcelona | Barcelona [Barcelona] |
| Spain | Local Institution - 0023 | Madrid | |
| Spain | Local Institution - 0024 | Majadahonda | |
| Spain | Local Institution - 0055 | Sevilla | |
| Spain | Local Institution - 0025 | València | |
| United States | Local Institution - 0005 | Aurora | Colorado |
| United States | Local Institution - 0002 | Baltimore | Maryland |
| United States | Local Institution - 0075 | Costa Mesa | California |
| United States | Local Institution - 0001 | Hackensack | New Jersey |
| United States | Local Institution - 0050 | Orange | California |
| United States | Local Institution - 0004 | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Canada, Chile, France, Italy, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | Up to 2 years | ||
| Primary | Incidence of Serious Adverse Events (SAEs) | Up to 2 years | ||
| Primary | Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria | Up to 2 years | ||
| Primary | Incidence of AEs leading to discontinuation | Up to 2 years | ||
| Primary | Incidence of AEs leading to death | Up to 2 years | ||
| Primary | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review | Part 2C | Up to 2 years | |
| Secondary | Maximum Observed Concentration (Cmax) of BMS-986288 | Up to 2 years | ||
| Secondary | Time of Maximum Observed Concentration (Tmax) of BMS-986288 | Up to 2 years | ||
| Secondary | Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288 | Up to 2 years | ||
| Secondary | Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288 | Up to 2 years | ||
| Secondary | Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288 | Up to 2 years | ||
| Secondary | Trough Observed Concentrations (Ctrough) of BMS-986288 | Up to 2 years | ||
| Secondary | Total Body Clearance (CLT) of BMS-986288 | Up to 4 months | ||
| Secondary | Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288 | Up to 4 months | ||
| Secondary | Accumulation Index (AI) of BMS-986288 | Up to 4 months | ||
| Secondary | Terminal Half-Life (T-HALF) of BMS-986288 | Up to 4 months | ||
| Secondary | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment | Up to 4 years | ||
| Secondary | Duration of Response (DOR) by RECIST v1.1 by Investigator Assessment | Up to 4 years | ||
| Secondary | Progression-Free Survival (PFS) by RECIST v1.1 by Investigator Assessment | Up to 4 years | ||
| Secondary | Time to Response (TTR) by RECIST v1.1 by Investigator Assessment | Up to 4 years | ||
| Secondary | DOR by RECIST v1.1 by blinded independent central review | Up to 4 years | ||
| Secondary | PFS by RECIST v1.1 by blinded independent central review | Up to 4 years | ||
| Secondary | Overall Survival (OS) by RECIST v1.1 by blinded independent central review | Up to 4 years | ||
| Secondary | Incidence of Adverse Events (AEs) | Up to 100 days following last dose of study treatment | ||
| Secondary | Incidence of Serious Adverse Events (SAEs) | Up to 100 days following last dose of study treatment | ||
| Secondary | Incidence of AEs meeting protocol-defined Dose Limiting Toxicities (DLT) criteria | Up to 100 days following last dose of study treatment | ||
| Secondary | Incidence of AEs leading to discontinuation | Up to 100 days following last dose of study treatment | ||
| Secondary | Incidence of AEs leading to death | Up to 100 days following last dose of study treatment |
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