Phase I/Ib trial of durvalumab (MEDI4736), tremelimumab + cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (OBERON)

The Christie NHS Foundation Trust0 sites36 target enrollmentNovember 8, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: The Christie NHS Foundation Trust
Enrollment: 36
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 8, 2018

End Date

November 9, 2020

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

The Christie NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

•1\. Histologically confirmed recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) not amenable to local curative therapy with surgery or radiation therapy progressed beyond standard of care
•2\. Previous immunotherapy or cetuximab is permitted for part A (dose escalation) but not required. For Part B (expansion cohort), all patients must have progressed beyond treatment including immune checkpoint blockade (e.g. including but not limited to previous treatment targeting PD1/PDL1/CTLA4\)
•3\. Able and willing to give valid written consent to provide newly acquired tumour tissue (preferred) or archival tissue. Determination of adequate tumour cell content to provide 25 slides will be undertaken by local site pathologist. Patients who do not meet this criteron may be considered eligible following discussion with the sponsor
•4\. For patients with oropharyngeal cancer (OPC) only: confirmed HPV status by p16 IHC, HPV PCR or ISH
•5\. Measurable disease by RECIST 1\.1 (previously irradiated lesions must have progressed if to be used as marker lesions)
•6\. Written informed consent and any locally\-required authorsation (e.g. HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol\-related procedures, including screening evaluations
•7\. Age \= 18 years at time of study entry
•8\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•9\. Life expectancy of \= 12 weeks
•10\. Body weight \> 30 kg

Exclusion Criteria

•Full exclusion criteria with exceptions is located in the current study protocol.
•1\. Involvement in the planning and/or conduct of the study
•2\. Participation in another clinical study with an investigational product during the last 4 weeks
•3\. Concurrent enrolment in another clinical study, unless it is an observational clinical study or during the follow\-up period of an interventional study
•4\. Receipt of the last dose of anti\-cancer therapy \< \= 28 days prior to the first dose of study drug. If sufficient wash\-out time has not occurred due to the schedule or PK properties of an agent, a longer wash\-out period will be required, as agreed by AstraZeneca/MedImmune and the investigator
•5\. Any unresolved toxicity NCI CTCAE Grade \> \= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
•6\. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non\-cancer\-related conditions is acceptable
•7\. Major surgical procedure within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
•8\. History of allogeneic organ transplantation
•9\. Active or prior documented autoimmune or inflammatory disorders