A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 (anti-ICOS mAb) Alone or in Combination with Nivolumab or Ipilimumab in Patients with Advanced Solid Tumors

Phase 1

• Conditions: Advanced Solid Tumor; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864

• Registration Number: EUCTR2017-000238-73-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-09
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

_Advanced solid tumors;
_Histological or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1;
_At least 1 lesion accessible for biopsy in addition to the target lesion;
_Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen;
_Eastern Cooperative Oncology Group (ECOG) performance status =2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 94

Exclusion Criteria

_Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded (controlled brain metastases will be allowed to enroll);
_Participants with carcinomatous meningitis;
_Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in
situ of the prostate, cervix, or breast;
_Active, known, or suspected autoimmune disease;
_Uncontrolled or significant cardiovascular disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified