Tolerability and efficacy of treating locally advanced Resectable Oral Cancer with neoadjuvant INtratumoral anti-CTLA4 ImmunoTherapy combined with systemic anti-PD-1 (ROCinIT).

Conditions

Oral cavity squamous cell carcinoma

Brief summary

To evaluate the tolerability, and efficacy of neoadjuvant intratumoral anti-CTLA-4 combined with systemic anti-PD-1 immunotherapy prior to surgery for locally advanced oral cancer.

Detailed description

To compare clinical outcome and toxicity data to Nivolumab alone and systemic anti-CTLA-4 + anti-PD-1., To investigate immune activation in peripheral blood pre-, on- and post-treatment between patients with a CR/MPR and non-responders., To investigate immune activation in the tumor in pre- on- and post-treatment biopsies, and post treatment tdLNs between patients with a CR/MPR and non-responders, To investigate the molecular profile of the tumor (e.g. presence of copy number alterations) in relation to response to the treatment and immune parameters., To assess whether baseline, and/or on treatment MRI perfusion patterns, and treatment induced changes, relate to pathological response and to CD8 T cell infiltration patterns (T-cell excluded versus T-cell inflamed tumor microenvironments), The circulating cell free DNA or RNA kinetics of longitudinal plasma samples at baseline, during neoadjuvant immunotherapy and post-surgery will be linked to pathological response

Related papers

No related papers found yet.

Interventions

DRUGNIVOLUMAB

DRUGIPILIMUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate the tolerability, and efficacy of neoadjuvant intratumoral anti-CTLA-4 combined with systemic anti-PD-1 immunotherapy prior to surgery for locally advanced oral cancer.	—

Secondary

Measure	Time frame
To compare clinical outcome and toxicity data to Nivolumab alone and systemic anti-CTLA-4 + anti-PD-1., To investigate immune activation in peripheral blood pre-, on- and post-treatment between patients with a CR/MPR and non-responders., To investigate immune activation in the tumor in pre- on- and post-treatment biopsies, and post treatment tdLNs between patients with a CR/MPR and non-responders, To investigate the molecular profile of the tumor (e.g. presence of copy number alterations) in relation to response to the treatment and immune parameters., To assess whether baseline, and/or on treatment MRI perfusion patterns, and treatment induced changes, relate to pathological response and to CD8 T cell infiltration patterns (T-cell excluded versus T-cell inflamed tumor microenvironments), The circulating cell free DNA or RNA kinetics of longitudinal plasma samples at baseline, during neoadjuvant immunotherapy and post-surgery will be linked to pathological response	—

Measure

Time frame

To compare clinical outcome and toxicity data to Nivolumab alone and systemic anti-CTLA-4 + anti-PD-1., To investigate immune activation in peripheral blood pre-, on- and post-treatment between patients with a CR/MPR and non-responders., To investigate immune activation in the tumor in pre- on- and post-treatment biopsies, and post treatment tdLNs between patients with a CR/MPR and non-responders, To investigate the molecular profile of the tumor (e.g. presence of copy number alterations) in relation to response to the treatment and immune parameters., To assess whether baseline, and/or on treatment MRI perfusion patterns, and treatment induced changes, relate to pathological response and to CD8 T cell infiltration patterns (T-cell excluded versus T-cell inflamed tumor microenvironments), The circulating cell free DNA or RNA kinetics of longitudinal plasma samples at baseline, during neoadjuvant immunotherapy and post-surgery will be linked to pathological response

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Outcome results

None listed