E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent and/or metastatic head and neck cancer |
|
E.1.1.1 | Medical condition in easily understood language |
Recurrent and/or metastatic head and neck cancer |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the confirmed Overall Response Rate (CR/PR) rate according to RECIST V 1.1, in patients treated with cetuximab plus paclitaxel for recurrent and/or metastatic SCCHN after pembrolizumab based first-line therapy |
|
E.2.2 | Secondary objectives of the trial |
- To describe Best Overall Response categories (CR, PR, SD, PD) according to RECIST V 1.1, in patients treated with cetuximab in combination with paclitaxel in patients diagnosed with recurrent and/or metastatic SCCHN after pembrolizumab based first-line therapy · To describe duration of response · To evaluate changes in health-related quality-of-life assessments from baseline in patients with R/M SCCHN using the EORTC QLQ C-30 and EORTC QLQ-H&N35 questionnaires. · To assess median Overall Survival (OS) and Progression Free Survival (PFS) in this patient population · To evaluate the safety of cetuximab in combination with paclitaxel in patients diagnosed with recurrent and/or metastatic SCCHN. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The patient has provided written informed consent prior to any study-related procedure. · The patient is at least 18 years of age - Histologically proven locally advanced unresectable, recurrent and/or metastatic squamous cell carcinoma of the oropharynx, hypopharynx, larynx or oral cavity not amenable for salvage surgery · p16 status has to be determined for oropharyngeal carcinomas · Documented progressive disease based on investigator assessment according to RECIST 1.1, following receipt of a pembrolizumab based regimen given as first line therapy in the platinum sensitive setting (i.e. ≥ 6 months since last platinum exposure) for recurrent and/or metastatic SCCHN · Measurable disease according to RECIST 1.1. · The patient has a life expectancy of at least 3 months. · Has a performance status of 0, 1 or 2 on the ECOG Performance Scale · Female patient of childbearing potential should have a negative Urine or serum pregnancy 24 hours prior to treatment initiation If the Urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. · Female patients of childbearing potential smust agree to use highly effective contraception or be surgically sterile, or abstain from heterosexual activity for the course of the study until 120 days after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. · Male patients must agree to use an adequate method of contraception (Condom) starting with the first dose of study therapy until 120 days after the last dose of study therapy. · Demonstrate adequate organ function as defined in table 1, all screening labs should be performed within 14 days of Treatment Initiation. |
|
E.4 | Principal exclusion criteria |
- Prior taxane therapy is not allowed except as part of induction therapy for locally advanced disease (completed at least 6 months before study entry) · Prior cetuximab therapy is not allowed except as part of either induction therapy or in combination with radiotherapy treatment for locally advanced disease (completed at least 6 months before study entry) · Patients with nasopharyngeal carcinomas or salivary glands cancers · Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment. · Has a diagnosis of immunodeficiency including a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). · Has known active Hepatitis A/B or Hepatitis C · Has had prior pembrolizumab within 1 week prior to study day 1 or who has not recovered (i.e., recovery to ≤ Grade 1 or baseline grade prior to pembrolizumab) from (immune- related) adverse events other than endocrine side effects. · Has had prior chemotherapy or radiation therapy within 2 weeks Prior to study day 1 or who has not recovered (i.e., recovery to ≤ Grade 1 or baseline grade prior to pembrolizumab) from adverse events due to a previously administered agent. · Has had chemotherapy, targeted therapy or investigational drugs after checkpoint inhibitor failure for second line therapy. - Has had prior pembrolizumab in the platinum resistant setting (<6 months after last platinum exposure). · Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the Skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. · Has an active infection requiring systemic therapy. · Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. · Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. · Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit until 120 days after the last dose of trial treatment · Any direct relationship to the sponsor, the investigator or the trial site · Placement in an institution on the basis of a judicial or administrative order |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety, response assessment and duration, EORTC QLQ-C30 and EORTC QLQ-H&N35 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |