A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors

Study Overview
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Brief Summary
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The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.

Official Title
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A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: BMS-986360
* Drug: Docetaxel
* Drug: Nivolumab
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in Part 1 must have histologic or cytologic confirmation of non-small cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or sarcoma, that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease per RECIST v1.1. In Part 2, only participants with histologic confirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 are eligible. In Part 2, archival biopsy collected within 3 months of screening with no intervening therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of 20 freshly cut unstained FFPE slides with an associated pathological report) or fresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1 (C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional at progression. Therefore, the participant in Part 2 must have a suitable tumor lesion for the biopsy procedure, as judged by the investigator, in order to be eligible for the study. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Participants resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit (in addition, participants with NSCLC must be resistant or refractory to anti-PD-(L)1-based immunotherapy) Exclusion Criteria: Participants with primary central nervous system (CNS) disease, or tumors with CNS metastases as the only disease site, will be excluded. Participants with controlled brain metastases, however, will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), no longer taking steroids for at least 2 weeks prior to first dose of study intervention, and with no new or progressive neurological signs and symptoms. Participants with a condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Participants with concurrent malignancy or history of prior malignancy active within 2 years (except history of early-stage basal/squamous cell skin cancer or non-invasive or in situ cancers who have undergone definitive treatment) are excluded unless treatment was completed at least 2 years before randomization and the participant has no evidence of disease. Participants with NSCLC with known or not tested for epidermal growth factor receptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E mutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1) translocations sensitive to available targeted inhibitor therapy Other protocol-defined inclusion/exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986360<br> | Drug: BMS-986360<br>* Specified dose on specified days<br>* Other names: CC-90001;|
| Experimental: BMS-986360 + Docetaxel<br> | Drug: BMS-986360<br>* Specified dose on specified days<br>* Other names: CC-90001;Drug: Docetaxel<br>* Specified dose on specified days<br>* Other names: Taxotere®;|
| Experimental: BMS-986360 + Nivolumab<br> | Drug: BMS-986360<br>* Specified dose on specified days<br>* Other names: CC-90001;Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|
| Experimental: BMS-986360 + Capecitabine<br> | Drug: BMS-986360<br>* Specified dose on specified days<br>* Other names: CC-90001;Drug: Capecitabine<br>* Specified dose on specified days<br>* Other names: Xeloda®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events (AEs) |  | Up to approximately 2 years | 
| Number of participants with Serious Adverse Events (SAEs) |  | Up to approximately 2 years | 
| Number of participants with Dose-Limiting Toxicities (DLTs) |  | Up to approximately 2 years | 
| Number of participants with AEs leading to discontinuation |  | Up to approximately 2 years | 
| Number of deaths |  | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to approximately 2 years | 
| Time of maximum observed plasma concentration (Tmax) |  | Up to approximately 2 years | 
| Area under the plasma concentration-time curve (AUC) |  | Up to approximately 2 years | 
| Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator |  | Up to approximately 2 years | 
| Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment |  | Up to approximately 2 years | 
| Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator |  | Up to approximately 2 years | 
| Part 2: DOR based on RECIST v1.1 by BICR assessment |  | Up to approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumors, Nivolumab, Chemotherapy, BMS-986360, CC-90001