Head and Neck Neoplasms Clinical Trial
Official title:
ImmunoModulation by the Combination of Ipilimumab and Nivolumab Neoadjuvant to Surgery In Advanced Or Recurrent Head and Neck Carcinoma. Subtitle: Hypoxia as a Determinant for the Effect of Nivolumab With or Without Ipilimumab on Intra-tumoral T Cell Capacity
This is a phase IB/II trial to examine feasibility and safety of checkpoint blockade (aPD1 with or without aCTLA4) neoadjuvant to standard of care (SOC) in advanced stage head and neck squamous cell carcinoma (HNSCC), a patient population in need for improved clinical outcome and in tumors likely to respond to neoadjuvant aPD1 and aCTLA4. In addition, with this research protocol the potential impact of intratumoral hypoxia on tumor infiltrating lymphocyte (TIL) abundance, differentiation and effector function will be assessed, and the potentially divergent effects of T cell checkpoint blockade in areas of hypoxia and normoxia.
The phase Ib is designed as 3 + 3, with primary objective feasibility and toxicity. Of Note: endpoints must be reached in all 6 patients of cohort 1 and 2, before start of the next cohort. The phase II is designed as a single arm design with primary endpoint efficacy. In phase Ib, two cohorts will be used (cohort 1: nivolumab only and cohort 2: nivolumab and ipilimumab neoadjuvant to surgery) to define which neoadjuvant immunotherapy regimen will be taken towards the expansion cohort 3. Thirty-two patients will be treated with nivolumab (240 mg flat dose, week 1 and week 3, twice in total) as a single agent OR the combination of ipilimumab (1 mg/kg) + nivolumab (240mg flat dose) in week 1, and nivolumab 240mg flat dose in week 3, neoadjuvant to SOC (surgery with or without adjuvant (C)RT). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05980598 -
TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02548377 -
Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial
|
N/A | |
Active, not recruiting |
NCT02229656 -
Olaparib and Radiotherapy in Head and Neck Cancer
|
Phase 1 | |
Terminated |
NCT02975739 -
Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors
|
N/A | |
Recruiting |
NCT00982436 -
Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01025518 -
DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
|
N/A | |
Active, not recruiting |
NCT00248235 -
Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer
|
Phase 2/Phase 3 | |
Terminated |
NCT00073450 -
Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)
|
Phase 2 | |
Completed |
NCT00135161 -
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
|
Phase 1 | |
Completed |
NCT05269342 -
Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05544136 -
A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer
|
Phase 2 | |
Terminated |
NCT03286972 -
PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning
|
||
Recruiting |
NCT04435938 -
A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck
|
Phase 2 | |
Recruiting |
NCT03678649 -
A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC
|
Phase 2 | |
Recruiting |
NCT03975465 -
EMST and Swallowing in Long-Term Survivors of HNCA
|
N/A | |
Completed |
NCT03292250 -
Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]
|
Phase 2 | |
Completed |
NCT02284802 -
Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy
|
N/A | |
Recruiting |
NCT03981068 -
DAHANCA 37. Re-irradiation With Proton Radiotherapy
|
N/A | |
Completed |
NCT02254018 -
Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
|
Phase 1 | |
Withdrawn |
NCT03875833 -
Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest
|
N/A |