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Trial ID CA233-0000  |   NCT06544655

A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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).
    1. Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
      1. Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • History of or with active interstitial lung disease or pulmonary fibrosis.
          1. Active, known, or suspected autoimmune disease.
            1. Serious uncontrolled medical disorders.
              1. New onset, non-catheter-associated venous thromboembolism within the past 6 months.
                Additional Information *
                • Other protocol-defined Inclusion/Exclusion criteria apply.

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part 1 Co-Admin: BMS-986484 + Nivolumab

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986484
                  • Biological: Nivolumab

                  Study Arms

                  Experimental: Part 1A: BMS-986484 Dose Escalation

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986484

                  Study Arms

                  Experimental: Part 1B: BMS-986484 + Nivolumab Dose Escalation

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986484
                  • Biological: Nivolumab

                  Study Arms

                  Experimental: Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation

                  ASSIGNED INTERVENTION
                  • Drug: Oxaliplatin, Capecitabine, Fluorouracil, Calcium folinate, BMS-986484
                  • Biological: Nivolumab

                  Study Arms

                  Experimental: Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986484

                  Study Arms

                  Experimental: Part 2A: BMS-986484 Dose Expansion

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986484

                  Study Arms

                  Experimental: Part 2B: BMS-986484 + Nivolumab Dose Expansion

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986484
                  • Biological: Nivolumab

                  Study Arms

                  Experimental: Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion

                  ASSIGNED INTERVENTION
                  • Drug: Oxaliplatin, Capecitabine, Fluorouracil, Calcium folinate, BMS-986484
                  • Biological: Nivolumab

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