Status:
ACTIVE_NOT_RECRUITING
Durvalumab With or Without Tremelimumab in Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
AstraZeneca
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Oral Cavity Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a randomized, open-label, prospective, pilot phase I/II study with focus on translational research and on the evaluation of the biological changes that are observed in sequential tumor tissue ...
Detailed Description
Durvalumab has shown activity in squamous cell carcinoma of the head and neck. Locally advanced resectable cancers of this type represent a challenge, as the majority of these patients still die from ...
Eligibility Criteria
Inclusion
- Resectable locally advanced oral cavity SCC stage IV
- Newly diagnosed disease
- Age ≥18 years at the time of screening
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- No active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix
- No prior chemotherapy, radiotherapy or targeted therapy including PD-1, PD-L1 or CTLA-4 antibodies for SCCHN, including durvalumab or tremelimumab
- Availability of blood samples for Translational research
- Negative pregnancy test
- Normal organ function
- No participation in another interventional clinical trial in the preceding 30 days prior to randomization
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
- Body weight \> 30 kg
Exclusion
- Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck
- Receipt of other treatments for cancer within 30 days prior to first dose of study treatment
- Previous radiotherapy in the head and neck region
- Previous systemic therapy for SCCHN
- Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned IP.
- History of allogeneic organ transplantation
- Active or prior documented autoimmune or inflammatory
- Uncontrolled intercurrent illness
- Active relevant second malignancy during the last five years
- Mean QT interval corrected for heart rate ≥470 ms
- History of active primary immunodeficiency
- Active infection Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP.
- Female patients of childbearing potential who are pregnant or breast-
- Known allergy or hypersensitivity to IP or any IP excipient
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study results
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP
- Metastatic disease
Key Trial Info
Start Date :
August 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03784066
Start Date
August 27 2018
End Date
March 24 2026
Last Update
July 3 2024
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000