Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03022409

A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
A Clinical Trial to Investigate Biomarker Effects of Pre-Surgical Treatment With DDR Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) Who Are Planned to Undergo Surgery That is Likely to be Followed by Radiotherapy and/or Chemotherapy.

Clinical Trial Summary

This biomarker study has been designed to assess the effects of different agents in both tumour tissue and peripheral samples to help inform the best combinations of DDR agents with immuno-oncology (IO) therapies. In the first instance 2 DDR agents will be assessed separately as monotherapy. Additional arms may be added later to evaluate other DDR agents and/or DDR and immunotherapy agents in combination or in sequence. The primary objective of the study is to investigate immune activation due to DDR inhibition by assessing tumour and blood samples of patients treated with study investigational agent(s).

Clinical Trial Description

Patients are dosed for a minimum of nine days with drug. Surgery or biopsy can then take place at any time between Day 10 and Day 21 (depending on when it can be scheduled), but must occur with 24 hrs following three consecutive treatment days. During the treatment period, safety assessments must be completed at least weekly. Follow-up will be completed after surgical resection or biopsy has been completed and can be part of standard post-surgery follow-up. If this follow-up visit occurs prior to 30 days after the final dose, a further visit or telephone call must be conducted to assess that any toxicity has resolved and to check for late toxicity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03022409
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date September 18, 2017
Completion date January 20, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT03317327 - REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors Phase 1/Phase 2
Terminated NCT02892201 - Pembrolizumab in HNSCC With Residual Disease After Radiation Phase 2
Active, not recruiting NCT04854499 - Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma Phase 2
Terminated NCT04110249 - Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer N/A
Terminated NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Recruiting NCT05338905 - Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial N/A
Recruiting NCT04045496 - A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors Phase 1
Completed NCT04452214 - A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors Phase 1
Recruiting NCT04096638 - Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT03070366 - Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC Phase 2
Recruiting NCT02661152 - DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC. Phase 3
Terminated NCT02488629 - Study of SCB01A in Patient With Head and Neck Cancer Phase 2
Completed NCT01697800 - A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract Phase 2
Completed NCT01427478 - Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck Phase 3
Recruiting NCT05437380 - Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC N/A
Recruiting NCT05065086 - Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
Recruiting NCT04567056 - Specific Methylation Profiles in HNSCC
Active, not recruiting NCT04555837 - Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer Phase 1/Phase 2