Solid tumors MedDRA version: 19.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent 2) Target Population a) Subjects must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable):for Cohort Expansion part 2 Head and Neck Squamous Cell Carcinoma (SCCHN) (oral cavity, pharynx, larynx) ii. Subjects must have = 5 prior treatment regimens. The following are not considered separate lines of treatment: addition of a compound to an on-going regimen, re-starting the same regimen after a drug holiday, or switching from intravenous to oral therapy b) Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment. c) ECOG status of 0 or 1. fd Life expectancy of = 12 weeks. 3) Age, Sex, and Reproductive Status a) Men and women, ages > 18. 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 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1) Target Disease Exceptions 2) Medical History and Concurrent Diseases a. Subjects with a prior malignancy are excluded, except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, or in situ ductal or lobular carcinoma of the breast. b. Subjects with any active autoimmune disease or history of known or suspected autoimmune disease, with the exception of subjects with isolated vitiligo, resolved childhood asthma/atopy, and controlled thyroid disorders. 3) Prohibited Prior Treatments and/or Therapies a. Prior therapy with an anti-KIR, anti-PD-1, or anti-PD-L1, antibody. b. Prior treatment regimens with any immune cell modulating antibody such as anti-CD137 and anti-OX40. c. Exposure to any other investigational drug within 4 weeks prior to the first dose of study drug (within 101 days for anti-CTLA4 therapy). d. Any anti-cancer therapy (e.g., chemotherapy, biologics, vaccines, radiotherapy with curative intent, or hormonal treatment) within 4 weeks prior to the first dose of study drug administration (within 101 days for anti-CTLA4 therapy), with the exception of GnRH agonist therapy for subjects with prostate cancer. 4) Physical and Laboratory Test Findings 5) Sex and Reproductive Status a) Women who are pregnant or are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -) To assess the safety and tolerability of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination, in subjects with advanced (metastatic and/or unresectable) solid tumors. -) To assess the preliminary anti-tumor activity of the combination of lirilumab (BMS 986015) and nivolumab (BMS-936558) in subjects with advanced solid tumors.;Secondary Objective: -) To characterize the pharmacokinetics (PK) of lirilumab (BMS-986015) and nivolumab (BMS-936558) when co-administered. -) To monitor immunogenicity of lirilumab (BMS-986015) and nivolumab (BMS-936558) administered as combination therapy. -) To assess the pharmacodynamic effect in tumor tissue on tumor infiltrating lymphocyte (TIL) subsets from melanoma (MEL), and head and neck squamous cell carcinoma (SCCHN) subjects treated with lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558).;Primary end point(s): Safety is the primary endpoint in this Phase I/II study. The primary objective (to assess the safety and tolerability of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination) will be measured by the following primary endpoints: a) Incidence of adverse events. b) Incidence of clinical laboratory test abnormalities including hematology and serum chemistry, and thyroid panel abnormalities.;Timepoint(s) of evaluation of this end point: Incidence of adverse events will be collected from Day 1 until 100 days after the subject’s last dose of study drug or until they discontinue the study as per protocol. Incidence of clinical laboratory test abnormalities will be assessed at specified time points as designated in the Time and Events Section (5.1) of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoint: The secondary objective of assessing preliminary anti-tumor activity will be based on endpoints described below using RECIST v1.1: 1) Best overall response (BOR) is the best response designation recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation, based on RECIST v1.1 criteria. 2) Objective response rate (ORR) is defined as the total number of subjects whose BOR is either CR or PR divided by the total number of subjects in the population of interest. 3) Duration of Response (DOR) 4) Progression-Free Survival Rate (PFSR) is defined as the probability of a subject remaining progression-free and surviving to 24 weeks Pharmacokinetics (PK) Immunogenicity Biomarkers;Timepoint(s) of evaluation of this end point: BOR will be determined based on tumor measurements occurring every 8 weeks during the Treatment period (Cycle 1 Day 1 through Cycle 12 Day 56), and once during the Clinical Follow-up period. DOR defined as the number of days between the date of first response and the subsequent date of objectively documented disease progression based on the criteria (RECIST v1.1) or death PFSR is 24 weeks | — |
Countries
Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed