Advanced Cancer
Conditions
Keywords
Immunotherapy, Relatlimab, Nivolumab, Ipilimumab, BMS-986205
Brief summary
The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.
Interventions
BIOLOGICALRelatlimab
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
DRUGBMS-986205
Specified dose on specified days
BIOLOGICALIpilimumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1 * Available tumor tissue for biomarker analysis * Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1
Exclusion criteria
* Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease * History of interstitial lung disease / pneumonitis * Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer * Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 3/Grade 4 Laboratory Test Results | From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months) | Laboratory test results are graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Grade 3 = Severe or medically significant but not immediately life-threatening. Grade 4 = Life-threatening or disabling. |
| Number of Participants With Adverse Events and Deaths | From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months) | Adverse events are any unfavorable or unintended signs, symptoms, or diseases occurring in study participants during a clinical trial, regardless of whether they are related to the intervention. They include all-cause mortality, serious adverse events, and other events exceeding a set frequency threshold. Serious adverse events are a subset that result in significant outcomes such as death, life-threatening conditions, hospitalization or its prolongation, persistent or significant disability/incapacity, or other medically important conditions. |
| Number of Participants With Dose Limiting Toxicities | From first dose (Day 1) and up to 42 days post first dose | Dose-Limiting Toxicities (DLTs) are treatment-related adverse events occurring during the first cycle (typically Days 1-28) that meet predefined severity criteria per NCI CTCAE v4.03. Hematologic DLTs include Grade 4 neutropenia \>5 days, Grade 3 neutropenia with fever, Grade 4 thrombocytopenia or Grade 3 with bleeding, and Grade 4 anemia. Non-hematologic DLTs include any toxicity ≥Grade 3 (except alopecia or controlled nausea) or treatment interruption ≥2 weeks due to adverse events. |
| Objective Response Rate (ORR) | From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months) | Objective Response Rate (ORR) is the percentage of participants whose best overall response is Complete Response (CR) or Partial Response (PR) per RECIST v1.1. CR is the disappearance of all target lesions and reduction of pathological lymph nodes to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. ORR is calculated as: (Number of participants with CR or PR ÷ Total participants) × 100. Confidence intervals are typically estimated using the Clopper-Pearson method. |
| Disease Control Rate (DCR) | From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months) | Disease Control Rate (DCR) is the percentage of participants whose Best Overall Response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1. CR is the disappearance of all target lesions and reduction of any pathological lymph nodes to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum diameters while on study. DCR is calculated as: (Number of participants with CR, PR, or SD ÷ Total participants) × 100. |
| Duration of Response (DoR) | From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months) | Duration of Response (mDOR) is the median time from the first documented occurrence of Complete Response (CR) or Partial Response (PR) until disease progression or death, assessed per RECIST v1.1. CR is the disappearance of all target lesions and reduction of pathological lymph nodes to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. Progression is defined as at least a 20% increase in the sum of diameters of target lesions or appearance of new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | From the date of first dose (Day 1) to up to the date of the first documented disease progression or death (up to approximately 80 months) | Progression-Free Survival (PFS) is the time from randomization or treatment start until the first documented disease progression or death from any cause, whichever occurs first, assessed per RECIST v1.1. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions (minimum 5 mm absolute increase) or appearance of new lesions. Participants without progression or death are censored at the date of last adequate tumor assessment. PFS is typically analyzed using Kaplan-Meier estimates and reported in months. |
| Progression Free Survival Rate at 6 and 12 Months | Month 6 and 12 | Progression-Free Survival Rate (PFSR) is the percentage of participants who remain alive without disease progression, assessed per RECIST v1.1. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions (minimum 5 mm absolute increase) or appearance of new lesions. Participants without progression or death by the time point are considered event-free |
Countries
Australia, France, Italy, Spain, Switzerland, United Kingdom, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 137 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 26 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Not reported | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 2 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 3 | 2 / 3 | 5 / 7 | 3 / 6 | 35 / 45 | 21 / 54 | 46 / 65 | 15 / 46 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 7 / 7 | 6 / 6 | 36 / 45 | 52 / 54 | 63 / 65 | 43 / 46 |
| serious Total, serious adverse events | 1 / 3 | 1 / 3 | 6 / 7 | 4 / 6 | 29 / 45 | 21 / 54 | 38 / 65 | 27 / 46 |
Outcome results
None listed