Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma
Oral Squamous Cell CarcinomaThe purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced oral squamous cell carcinoma.
Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
Squamous Cell Carcinoma of Head and NeckFor dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab. For dose expansion cohorts, the co-primary objectives are: To assess the preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by objective response rate (ORR) To assess the preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy, as measured by intratumoral Glucocorticoid-Induced Tumor necrosis factor receptor-Related (GITR)+ Treg depletion Secondary Objectives are: For dose escalation cohorts: To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by ORR, disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) To characterize the pharmacokinetics (PK) of REGN6569 alone and in combination with cemiplimab To assess the immunogenicity of REGN6569 and cemiplimab For expansion cohorts: To characterize the safety profile in each expansion cohort To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by DCR, DOR, PFS, and OS To characterize the PK of REGN6569 alone and in combination with cemiplimab To assess the immunogenicity of REGN6569 and cemiplimab
Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors
Solid TumorMicrosatellite Stable Colorectal Cancer7 moreTo determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) or intravenously and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).
Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic...
Metastatic Head and Neck CancerRecurrent Head and Neck Cancer3 moreVERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
Small Cell Lung CancerNon-small Cell Lung Cancer9 moreThis trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.
A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours
Advanced Solid TumorHead and Neck Squamous Cell Carcinoma12 moreThis first-in-human study evaluates safety, tolerability and distribution of [225Ac] FPI-1966, [111In]-FPI-1967, and vofatamab in patients with FGFR3-expressing solid tumors.
Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer
Head and Neck CancerHead and Neck Squamous Cell Carcinoma11 moreThis study will examine the combination of pembrolizumab and tadalafil for safety and efficacy in advanced head and neck cancer.
Atezolizumab and Bevacizumab in Patients With Recurrent or Metastatic Squamous-cell Carcinoma of...
Head and Neck NeoplasmsThis proof-of-concept study aims to assess the clinical and biological effects of Atezolizumab combined with Bevacizumab in advanced previously treated squamous-cell carcinoma of the head and neck (HNSCC).
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma...
Head and Neck Squamous Cell CarcinomaThis is a single-centre feasibility study designed to assess the safety, tolerability and engraftment of MET-4 bacterial strains when given in combination with chemoradiotherapy (CRT). The study will involve a prospective cohort of 30 patients diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (LA-OPSCC) to be treated with CRT as per standard of care at Princess Margaret Cancer Centre. All patients enrolled will receive MET-4 in addition to standard CRT. MET-4 is administered orally as an initial daily loading dose over 2 days followed by a daily maintenance dose of MET-4 and will be administered until week 4 of CRT or unacceptable toxicity whichever occurs earlier and in the absence of criteria to discontinue MET-4. This protocol does not determine eligibility to receive treatment with concurrent CRT. It is anticipated that patient accrual will be completed within 12 months.
SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas
Squamous Cell Carcinoma of the Head and NeckMelanoma11 moreThis is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas.