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BMS-Symbol für "Aktive Studie, für die noch nicht rekrutiert wird"

Active, Not Recruiting

Studien-Nr. CA233-0000  |   NCT06544655

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

Warnsymbol
In diese Studie werden leider keine neuen Patient:innen aufgenommen, sie ist aber weiterhin aktiv.
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Zusammenfassung

  • Phase 1
  • Symbol für männliches und weibliches Geschlecht
  • 18+
    Altersgruppe
  • BMS-Symbol für "Aktive Studie, für die noch nicht rekrutiert wird"
    Active, Not Recruiting

Überblick

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).

Wichtigste Einschlusskriterien

Einschlusskriterien

Symbol für Einschlusskriterien 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.

        Ausschlusskriterien

        Symbol für Ausschlusskriterien
        :
        • 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.
                Zusätzliche Informationen*
                • Other protocol-defined Inclusion/Exclusion criteria apply.

                  Behandlungsmöglichkeiten

                  Studienarme

                  ZUGEWIESENE BEHANDLUNG

                  Studienarme

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

                  ZUGEWIESENE BEHANDLUNG
                  • Drug: BMS-986484
                  • Biological: Nivolumab

                  Studienarme

                  Experimental: Part 1A: BMS-986484 Dose Escalation

                  ZUGEWIESENE BEHANDLUNG
                  • Drug: BMS-986484

                  Studienarme

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

                  ZUGEWIESENE BEHANDLUNG
                  • Drug: BMS-986484
                  • Biological: Nivolumab

                  Studienarme

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

                  ZUGEWIESENE BEHANDLUNG
                  • Drug: Oxaliplatin, Capecitabine, Fluorouracil, Calcium folinate, BMS-986484
                  • Biological: Nivolumab

                  Studienarme

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

                  ZUGEWIESENE BEHANDLUNG
                  • Drug: BMS-986484

                  Studienarme

                  Experimental: Part 2A: BMS-986484 Dose Expansion

                  ZUGEWIESENE BEHANDLUNG
                  • Drug: BMS-986484

                  Studienarme

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

                  ZUGEWIESENE BEHANDLUNG
                  • Drug: BMS-986484
                  • Biological: Nivolumab

                  Studienarme

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

                  ZUGEWIESENE BEHANDLUNG
                  • Drug: Oxaliplatin, Capecitabine, Fluorouracil, Calcium folinate, BMS-986484
                  • Biological: Nivolumab

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