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HNSCC clinical trials

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NCT ID: NCT03944915 Recruiting - Clinical trials for Squamous Cell Carcinoma

De-Escalation Therapy for Human Papillomavirus Negative Disease

DEPEND
Start date: August 26, 2019
Phase: Phase 2
Study type: Interventional

This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the subject's cancer.

NCT ID: NCT03917537 Recruiting - HNSCC Clinical Trials

WGA in Platinum-refractory HNSCC Underwent Nivolumab

Start date: April 1, 2018
Phase:
Study type: Observational

To choose a subgroup who could clearly benefit from Nivolumab, we are proposing a prospective observational study. Whole-genome study (WGS) analysis will be performed on archived cancer tissues from patients who were (1) cisplatin-refractory and subsequently (2) received Nivolumab (at least 4 doses) and (3) had completed imaging response evaluation at 3-4 month after Nivolumab. The estimated sample size was designed to be 80, including 20 responders and 60 non-responders (1:3 design) after Nivolumab alone at a dosage of 2-3mg/kg every 2 weeks (+/- 7 days could be allowed), given the minimal requirement of statistical significance. The specific bio-signature(s) found in this prospective observational study could possibly greatly contribute to precision immuno-oncology medicine, especially Nivolumab.

NCT ID: NCT03740100 Terminated - HNSCC Clinical Trials

Single-arm Study With Bimiralisib in Patients With HNSCC Harboring NOTCH1 Loss of Function Mutations

HNSCC
Start date: January 25, 2019
Phase: Phase 2
Study type: Interventional

Preclinical data and limited clinical evidence suggest that Head and Neck Squameous Cell Carcinoma tumors harboring certain mutations may respond well to PI3K/mTOR inhibition (phosphatidylinositol-3-kinase/ mammalian target of rapamycin inhibition). The current study enrolls patients with refractory and / or metastatic Head and Neck Squameous Cell Carcinoma based on the mutational status of their disease to assess the response to treatment with bimiralisib, an orally available pan-PI3K/mTOR inhibitor (phosphatidylinositol-3-kinase/ mammalian target of rapamycin inhibitor).

NCT ID: NCT03726775 Active, not recruiting - HNSCC Clinical Trials

Trial Evaluating the Tolerance and Safety of Durvalumab - RT Combination for Treatment in SCCHN

REWRITe
Start date: July 17, 2019
Phase: Phase 2
Study type: Interventional

This study evaluate the regional (neck) nodal control of durvalumab in combination with RT restricted to the primary tumor and the immediately adjacent nodal level (i.e. without prophylactic neck irradiation) in N0 patients with SCCHN.

NCT ID: NCT03719690 Completed - HNSCC Clinical Trials

Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy

AIM-HN/SEQ-HN
Start date: March 15, 2019
Phase: Phase 2
Study type: Interventional

An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

NCT ID: NCT03652142 Recruiting - HNSCC Clinical Trials

Predictive Biomarkers for Response to Nivolumab in Head and Neck Squamous Cell Carcinoma

Start date: May 1, 2018
Phase:
Study type: Observational

Nivolumab is FDA-approved for the treatment of patients with recurrent/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). HNSCC whose disease has progressed within 6 months after platinum-based chemotherapy. The development of predictive biomarkers is needed to optimize patient benefit, minimize risk of toxicities and guide combination strategies.

NCT ID: NCT03625323 Active, not recruiting - NSCLC Clinical Trials

Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC

TACTI-002
Start date: February 18, 2019
Phase: Phase 2
Study type: Interventional

Evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in non-small cell lung carcinoma and head and neck carcinoma patients.

NCT ID: NCT03526835 Recruiting - Colorectal Cancer Clinical Trials

A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

Start date: May 2, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the RP2D of MCLA-158 single agent in patients with mCRC. The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer. The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158.

NCT ID: NCT03480672 Recruiting - HNSCC Clinical Trials

Postoperative aRCH With Cisplatin Versus aRCH With Cisplatin and Pembrolizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma

Start date: August 6, 2018
Phase: Phase 2
Study type: Interventional

This trial evaluates the addition of pembrolizumab to standard postoperative adjuvant radiochemotherapy in the treatment of patients with locally advanced intermediate and high risk head and neck squamous cell carcinoma (HNSCC).

NCT ID: NCT03422536 Completed - Clinical trials for Head and Neck Cancer

Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma

Start date: December 5, 2017
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well ficlatuzumab with or without cetuximab works in treating patients with head and neck squamous cell carcinoma that has come back or spread to other places in the body and resistant to cetuximab treatment. Monoclonal antibodies, such as ficlatuzumab and cetuximab, may block growth signals that lets a tumor cell survive and reproduce, and helps the immune system recognize and fight head and neck squamous cell carcinoma.