Clinical trial NCT05407675: A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
Official title: A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Keywords: Cancer
Oncology
Phase 1
Solid Tumor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.


Eligibility criteria: Inclusion Criteria:

* Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
* Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
* Participants must have experienced radiographically documented progressive disease on or after the most recent therapy

Exclusion Criteria:

* An active, known or suspected autoimmune disease
* Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
* Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
* Untreated central nervous system (CNS) metastases or leptomeningeal metastasis

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of participants with Dose-Limiting Toxicities (DLTs)
timeFrame: Up to 28 days
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 29 months
measure: Number of deaths
timeFrame: Up to 50 months
Secondary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: Up to 27 months
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 27 months
measure: Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T))
timeFrame: Up to 27 months
measure: Objective Response Rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to 50 months
measure: Duration of Response (DOR) assessed by RECIST v1.1
timeFrame: Up to 50 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Local Institution - 0010
state: Massachusetts
city: Hackensack
country: United States
facility: Local Institution - 0001
state: New Jersey
city: Houston
country: United States
facility: Local Institution - 0003
state: Texas
city: Edmonton
country: Canada
facility: Local Institution - 0007
state: Alberta
city: Hamilton
country: Canada
facility: Local Institution - 0011
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution - 0005
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0006
state: Ontario
city: Bordeaux
country: France
facility: Local Institution - 0015
state: Aquitaine
city: Villejuif
country: France
facility: Local Institution - 0014
state: Paris
city: Marseille
country: France
facility: Local Institution - 0018
city: Toulouse
country: France
facility: Local Institution - 0019
city: Málaga
country: Spain
facility: Local Institution - 0024
state: Andalucía
city: Madrid
country: Spain
facility: Local Institution - 0025
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Local Institution - 0022
city: Madrid
country: Spain
facility: Local Institution - 0023
city: st.Gallen
country: Switzerland
facility: Local Institution - 0021
state: Sankt Gallen
city: Basel
country: Switzerland
facility: Local Institution - 0012
city: Geneva
country: Switzerland
facility: Local Institution - 0020
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: