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A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated with an Anti-PD1 Therapy
The purpose of this research study is to determine the safe recommended dose/s and the effectiveness of intratumoral/intralesional injection of NBTXR3 activated by radiotherapy in combination with an anti-PD1 Antibody
To determine the Maximum Tolerated Dose/s and the early Dose Limiting Toxicities (DLT) of intratumoral/intralesional injection of NBTXR3 activated by SABR in combination with an anti-PD1 antibody. To determine the Recommended Dose/s of NBTXR3 given as intratumoral/Intralesional injection and activated by SABR in combination with an anti-PD1 antibody, in patients with: o Locoregionally recurrent or metastatic HNSCC amenable to re-irradiation (RD1), o Lung metastasis from HNSCC (not amenable to reirradiation if synchronous locoregional recurrence and metastasis) or NSCLC (not previously irradiated) (RD2), o Liver metastasis from HNSCC (not amenable to reirradiation if synchronous locoregional recurrence and metastasis) or NSCLC (not previously irradiated) (RD3).
Immunotherapy; Radiotherapy; Therapy (NOS)
Alimta (Pemetrexed); BMS-936558 (Nivolumab); NBTXR3 (); Nivolumab (Opdivo); Pembrolizumab (Keytruda); Pemetrexed ()
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