> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-bms-986484-alone-and-combination-therapy-in-c710e5c2-c540-482b-b55c-5a7881dfa32e > Record changed: 2026-10-13 # A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors NCT06544655 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) Participants 213 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) Start date 2024-10-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) Number of sites 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Title and summary **Summary** The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Short title** A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Official title** A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Dates **Completion date** 2027-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **First posted** 2024-08-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Registry last updated** 2026-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Primary completion date** 2027-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Start date** 2024-10-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Size and sites **Participants** 213 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Planned participants** 213 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Number of sites** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Identifiers **Registry ID** NCT06544655 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **ClinicalTrials.gov ID** NCT06544655 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Outcomes ### Primary outcomes 1. Incidence of adverse events (AEs) Timeframe: Up to approximately 2 years 2. Incidence of serious adverse events (SAEs) Timeframe: Up to approximately 2 years 3. Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria Timeframe: Up to approximately 28 days 4. Incidence of AEs leading to discontinuation Timeframe: Up to approximately 2 years 5. Incidence of AEs leading to death Timeframe: Up to approximately 2 years ### Secondary outcomes 1. Maximum observed concentration (Cmax) Timeframe: Up to approximately 2 years 2. Time of maximum observed concentration (Tmax) Timeframe: Up to approximately 2 years 3. Area under the concentration-time curve (AUC) Timeframe: Up to approximately 2 years 4. Incidence of anti-drug antibodies (ADAs) Timeframe: Up to approximately 2 years 5. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Timeframe: Up to approximately 2 years 6. Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Timeframe: Up to approximately 2 years 7. Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Timeframe: Up to approximately 2 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN). - Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). - Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. ### Exclusion criteria - History of or with active interstitial lung disease or pulmonary fibrosis. - Active, known, or suspected autoimmune disease. - Serious uncontrolled medical disorders. - New onset, non-catheter-associated venous thromboembolism within the past 6 months. - Other protocol-defined Inclusion/Exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Sites - Local Institution - 0003Tucson, United States - Local Institution - 0007Los Angeles, United States - Local Institution - 0011Grand Rapids, United States - Local Institution - 0004Sioux Falls, United States - Local Institution - 0013San Antonio, United States - Local Institution - 0021Darlinghurst, Australia - Local Institution - 0019Elizabeth Vale, Australia - Local Institution - 0017Toronto, Canada - Local Institution - 0016Montreal, Canada Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06544655.html) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06544655) ## Related records ### Drugs (5) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Levoleucovorin calcium](https://trialight.com/data/asset/levoleucovorin-calcium-21e918a4-89ff-4c55-aafc-3b4fd0086bc6.md) - [Nivolumab](https://trialight.com/data/asset/nivolumab-d2e207ca-a7d1-43d0-987f-43ef7eef8f1b.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (3) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) ### Targets (2) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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