NBTXR3 Activated by SABR for Patients With Advanced HNSCC or NSCLC Treated With an Anti-PD1 Antibody

  • Interventional
  • Not Recruiting
  • NCT03589339
Eligibility Details Visit Clinicaltrials.gov

A Phase I/II Study of NBTXR3 Activated by SABR for Patients With Advanced HNSCC or NSCLC Treated With an Anti-PD1 Antibody

The study is an open label Phase I/II prospective clinical trial, non randomized, which consists of two consecutive steps, a dose escalation and a subsequent dose expansion part. The phase I and II parts include different patient population.

Escalation dose part:

     Elegible patients will receive a single intratumoral injection of NBTXR3 concurrently with an approved anti-PD1 and will receive external beam radiotherapy starting 24 hours after the injection up to completion of 15 days of treatment.

     Expansion dose part:

     Elegible patients will receive a single intratumoral injection of NBTXR3 concurrently with an approved anti-PD1 and will receive external beam radiotherapy starting 24 hours after the injection up to completion of 15 days of treatment at recommended NBTXR3 dose and recommended radiotherapy dose.

     A visit of end of treatment will take place approximately 3-4 weeks after last radiotherapy fraction. Patients will be followed for evaluation of their disease status and adverse event until the end of the study.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Age ≥ 18

         - 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 patients 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

         - Patients with NSCLC tumors with EGFR or ALK genomic aberrations must have had disease progression under approved molecular targeted therapy

         - Metastatic patients 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 patients of childbearing potential must have a negative serum pregnancy test within the 7 days prior to NBTXR3 administration.

             - Female patients 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 patients 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 <2 cm

         - 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

         - Patients 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

         - Patients participating in another clinical investigation at the time of signature of the informed consent

At a Glance

National Government IDNCT03589339

IRB#IRB18-0603

Lead SponsorNanobiotix

Lead PhysicianAlexander Pearson

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting