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Clinical Trial 20026

Cancer Type: Thoracic
Interventions:Alimta (Pemetrexed); BMS-936558 (Nivolumab); NBTXR3; Nivolumab; Pembrolizumab (Keytruda); Pemetrexed

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Jessica Frakes

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase I/II Study of NBTXR3 Activated by SABR for Patients with Advanced HNSCC or NSCLC Treated with an Anti-PD-1 Antibody

Summary

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

Objective

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).

Inclusion Criteria

  • Age 18 or older
  • Histologically-proven inoperable loco- regional recurrent HNSCC with tumor in previously irradiated Head Neck field which is amenable to re-irradiation with SABR
  • Histologically-proven recurrent AND metastatic HNSCC with tumor in previously irradiated Head Neck field which is amenable to re-irradiation with SABR
  • Histologically-proven lung metastasis, accessible to intratumoral injection, not previously irradiated, from HNSCC not amenable to re-irradiation if synchronous locoregional recurrence and metastasis, or from NSCLC (squamous and non squamous types),
  • Histologically-proven liver metastasis, accessible to intratumoral injection, not previously irradiated, from HNSCC not amenable to re-irradiation if synchronous locoregional recurrence and metastasis, or from NSCLC (squamous and non squamous types),
  • Known status of human papillomavirus infection, in participants with oropharyngeal SCC HNSCC with prior irradiation, concurrent or not with platin-based chemotherapy or cetuximab
  • Non symptomatic CNS metastasis is elegible
  • NSCLC previously treated or not with a platinum based-regimen
  • Participants with NSCLC tumors with EGFR or ALK genomic aberrations must have had disease progression under approved molecular targeted therapy
  • Metastatic participants must have received an approved anti-PD1 with SD for at least for 12 weeks or with confirmed PD at 12 weeks
  • Karnofsky performance status ≥60
  • Life expectancy >12 weeks
  • Adequate function of bone marrow
  • Adequate liver function
  • Adequate kidney function:
  • Non-childbearing potential: All female participants of childbearing potential must have a negative serum pregnancy test within the 7 days prior to NBTXR3 administration. Female participants of childbearing potential must agree and use at least 2 forms of highly effective methods of contraception, including at least 1 barrier method starting with the first dose of study therapy through 150 days after the last dose of study therapy. Male participants and their sexual partner(s) of childbearing potential must agree and use at least 2 forms of highly effective methods of contraception, including at least 1barrier method starting with the first dose of study therapy through 150 days after the last dose of study therapy.

  • Exclusion Criteria

  • Written Informed Consent not obtained, signed and dated
  • Hypersensitivity to anti-PD1 monoclonal antibody
  • History of severe immune-related adverse event requiring treatment discontinuation
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy in excess of physiologic dose within 7 days prior to treatment start
  • Active autoimmune disease requiring systemic treatment in the past year
  • History of non-infectious pneumonitis or HIV
  • Active hepatitis B or hepatitis C
  • Peripheral neuropathy >grade 2
  • Loco-regional recurrent HNSCC with ulceration
  • Target lung metastatic lesion > Metastatic lesion not easily accessible for intratumoral/intralesional injection.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heartfailure, acute coronary syndrome, etc.
  • Medical history of life-threatening ventricular arrhythmia
  • Concurrent treatment with any other anticancer therapy not determined by the study treatment or planning to receive these treatments during the study
  • Participants unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
  • Participants participating in another clinical investigation at the time of signature of the informed consent