Patient with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) who are not eligible to standard first line chemotherapy
Conditions
Interventions
Trade Name: Durvalumab
Product Name: MEDI4736
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DURVALUMAB
CAS Number: 1428935-60-7
Current Sponsor
Sponsors
Centre Léon Bérard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years at the time of study entry; 2. Histological or cytological confirmation of the diagnosis of Squamous Cell Carcinoma of the Head and Neck; 3. Primary tumor located in one of the following : oral cavity, larynx, oropharynx or hypopharynx Nota Bene: sinuses and nasopharynx locations are not allowed; isolated cervical lymphnodes with unknown primary site may be discussed with the sponsor on a cases by case basis. 4. Archival tumor sample available at the time of inclusion with sufficient material to achieve the translational research program; 5. Disease must be in metastatic (Stage IVc) or recurrent setting; 6. Documented progression of measurable disease as per the RECIST (Appendix 1); Nota Bene: in case of a single metastatic lesion, the tumor size must be > 20mm to allow tumor biopsy. 7. Patients must fulfil at least one of the following frailty criteria: 8. Eastern Cooperative Oncology Group performance status of 0, 1 or 2 (Appendix 2); ...See the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of another primary malignancy except for • Malignancy treated with curative intent and with no known active disease =5 years before the first dose of IP and of low potential risk for recurrence • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease • Adequately treated carcinoma in situ without evidence of disease 2. Prior anticancer therapy in metastatic or recurrent setting. In case patient received neoadjuvant or adjuvant anti-cancer treatment, it must have been completed for at least 6 months prior to study drugs initiation and patient must have no unresolved toxicity NCI CTCAE Grade =2 with the exception of alopecia, vitiligo and laboratory values defined as inclusion criteria. Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician. 3. Patient whom disease progressed within 6 months after the start date of the previous chemotherapy (faster progressors) 4. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab. 5. Symptomatic or active leptomeningial or parenchymal brain metastases. Patients with previously treated brain metastases (either by surgery, radiotherapy or radiosurgery) may be enrolled if stable, off steroids, on imaging and clinically, for at least 4 weeks. ...See the Protocol?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the efficacy and safety of a combination of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy.;Secondary Objective: Secondary objectives will be to determine the following in the whole study population (tolerance study and both cohorts in phase II) : • Progression-Free Survival (PFS) • Time to Treatment Failure (TTF) • Overall survival (OS) • Objective Response Rate (ORR) • Best Response Rate (BRR) • Duration of response • Quality of life • The tolerance profile ;Primary end point(s): Feasibility will be determined as the onset of limiting adverse events before the end of the first cycle of chemotherapy. ;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression-Free Survival (PFS) • Time to Treatment Failure (TTF) • Overall survival (OS) • Objective Response Rate (ORR) • Best Response Rate (BRR) • Duration of response • Quality of life • The tolerance profile;Timepoint(s) of evaluation of this end point: • Time from the date of the first study drug administration to the date of first documented progression or death due to any cause; • Time from the date of inclusion to the date of permanent study treatment discontinuation; • Patients with a best overall response of Complete Response or Partial Response; • Patients who achieve a best response of CR, PR, SD or PD; • Date of first documented response (CR or PR) to the date of the first documented subsequent progression or death due to any cause; • EORTC QLQ-C30 and the QLQ-H&N35 module; • Incidence of Treatment Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and death assessed according to the NCI-CTC AE version 5. | — |
Countries
France
Contacts
Public ContactDRCI
Centre Léon Bérard
Outcome results
None listed