Description:
The purpose of this study is to evaluate the treatment of solid tumors with various
immunotherapy combinations. The treatment will be determined based upon a broad biomarker
assessment.
Title
- Brief Title: An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment
- Official Title: ADaptiVe Biomarker Trial That InformS Evolution of Therapy
Clinical Trial IDs
- ORG STUDY ID:
CA028-001
- NCT ID:
NCT03335540
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | BMS-936558 | Arm B |
| Relatlimab | BMS-986016 | Arm B |
| Cabiralizumab | BMS-986227, FPA008 | Arm C |
| Ipilimumab | BMS-734016 | Arm D |
| IDO1 Inhibitor | BMS-986205 | Arm F |
Purpose
The purpose of this study is to evaluate the treatment of solid tumors with various
immunotherapy combinations. The treatment will be determined based upon a broad biomarker
assessment.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm B | Experimental | Combination therapy determined by biomarker assessment | |
| Arm C | Experimental | Combination therapy determined by biomarker assessment | |
| Arm D | Experimental | Combination therapy determined by biomarker assessment | |
| Arm F | Experimental | Combination therapy determined by biomarker assessment | |
| Arm G | Experimental | Combination therapy determined by biomarker assessment | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Participants must have an ECOG performance status of less than or equal to 1
- Participants must have had prior therapy;Participants who have received adjuvant or
neoadjuvant anti-PD(L)1 therapy andprogressed within 6 months of completing therapy
will be considered IO refractory.
- Participants must have at least 2 lesions with measurable disease as defined by RECIST
Version 1.1
Exclusion Criteria:
- Participants with suspected, known, or progressive CNS metastases, have untreated CNS
metastases, or have the CNS as the only site of disease
- Participants with carcinomatous meningitis
- Participants with other active malignancy requiring concurrent intervention
Other protocol defined inclusion/exclusion criteria could apply
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of participants with qualified tumor biopsy specimen at baseline |
| Time Frame: | Up to 28 days |
| Safety Issue: | |
| Description: | An adequate quality tumor biopsy providing sufficient information prior to choosing a combination immunotherapy/Stereotactic Body Radiation Therapy (SBRT) |
Secondary Outcome Measures
| Measure: | Percent of change from baseline in histopathologic features |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Percent of change from baseline in biomarker expression patterns |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Adverse Events (AEs) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Serious Adverse Events (SAEs) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Laboratory Abnormalities |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | Any laboratory test result that is clinically significant or meets the definition of an SAE, requires the participant to have study treatment discontinued, or receive specific corrective therapy |
| Measure: | Number of Adverse Events(AEs) leadind to discontinutaion |
| Time Frame: | up to 4 years |
| Safety Issue: | |
| Description: | Number of Adverse Events leadind to discontinutaion |
| Measure: | Number of Deaths |
| Time Frame: | up to 4 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
May 18, 2020
