A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Melanoma | Cervical Cancer | Ovarian Neoplasms | Pancreatic Adenocarcinoma | Non-Small-Cell Lung...The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
Inclusion Criteria:
* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Radiographically documented progressive disease on or after the most recent therapy
* Received standard-of-care therapies, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant
Exclusion Criteria:
* Women who are pregnant or breastfeeding
* Primary central nervous system (CNS) malignancy
* Untreated CNS metastases
* Leptomeningeal metastases
* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
* Active, known, or suspected autoimmune disease
* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
* Prior organ or tissue allograft
* Uncontrolled or significant cardiovascular disease
* Major surgery within 4 weeks of study drug administration
* History of or with active interstitial lung disease or pulmonary fibrosis
Other protocol-defined inclusion/exclusion criteria apply
Lieu de l'étude
Local Institution - 0009
Local Institution - 0009Toronto, Ontario
Canada
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Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton Health Sciences-Juravinski Cancer CentreHamilton, Ontario
Canada
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Sebastien Hotte, Site 0029
9053170886Cross Cancer Institute
Cross Cancer InstituteEdmonton, Alberta
Canada
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Quincy Chu, Site 0027
7804328248Centre Hospitalier de luniversite de Montreal
Centre Hospitalier de luniversite de MontrealMontreal, Quebec
Canada
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Rahima Jamal, Site 0015
51489080008444BC Cancer Vancouver
BC Cancer VancouverVancouver, British Columbia
Canada
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Anna Tinker, Site 0030
604-877-6000- Étude parrainée par
- Bristol-Myers Squibb
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT04895709