Advanced Cancer Clinical Trial
— ADVISEOfficial title:
ADaptiVe Biomarker Trial That InformS Evolution of Therapy
| Verified date | September 2022 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | August 25, 2021 |
| Est. primary completion date | March 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution - 0002 | Baltimore | Maryland |
| United States | Local Institution - 0001 | Chicago | Illinois |
| United States | University of Chicago | Chicago | Illinois |
| United States | Local Institution - 0003 | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with qualified tumor biopsy specimen at baseline | An adequate quality tumor biopsy providing sufficient information prior to choosing a combination immunotherapy/Stereotactic Body Radiation Therapy (SBRT) | Up to 28 days | |
| Secondary | Percent of change from baseline in histopathologic features | Up to 4 years | ||
| Secondary | Percent of change from baseline in biomarker expression patterns | Up to 4 years | ||
| Secondary | Number of Adverse Events (AEs) | Up to 4 years | ||
| Secondary | Number of Serious Adverse Events (SAEs) | Up to 4 years | ||
| Secondary | Number of Laboratory Abnormalities | 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 | Up to 4 years | |
| Secondary | Number of Adverse Events(AEs) leadind to discontinutaion | Number of Adverse Events leadind to discontinutaion | up to 4 years | |
| Secondary | Number of Deaths | up to 4 years |
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