Squamous Cell Carcinoma of the Head and NeckPhase 2FRAIL-IMMUNENCT03723967
FRAIL-IMMUNE (GORTEC 2018-03) - Combination of Durvalumab With Carboplatin/Paclitaxel
A Phase 2 study testing Durvalumab with Carboplatin/Paclitaxel in people with Squamous Cell Carcinoma of the Head and Neck, run by Centre Leon Berard at 17 sites in France.
Trial summary
The primary objective of the phase II trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Durvalumab with Carboplatin/Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 17 sitesFrance
- Study dates
- 16 May 2019to 9 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of study entry;
- Histological or cytological confirmation of the diagnosis of Squamous Cell Carcinoma of the Head and Neck;
- Primary tumor located in one of the following : oral cavity, larynx, oropharynx or hypopharynx (NB: sinuses and nasopharynx locations are not allowed; isolated cervical lymphnodes with unknown primary site may be discussed with the coordinating investigator on a case by case basis)
- Archival tumor sample available at the time of inclusion with sufficient material to achieve the translational research program. Archival material must have been collected 3 months before inclusion at the latest, unless a new tumor sample must be collected.
- Disease must be in metastatic (Stage IVc) or recurrent setting;
- Documented progression of measurable disease as per the RECIST 1.1 (NB: in case of a single metastatic lesion, the tumor size must be > 20mm to allow tumor biopsy)
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- Patients must be ineligible to standard therapies, including cisplatin. Ineligibility is defined as at least one of the following criteria:
- Creatinine clearance (CrCl) : 40 < CrCl < 60ml/min
- Any severe comorbidity rendering the patient ineligible to standard chemotherapy, as per investigator's judgment.
- Eastern Cooperative Oncology Group performance status of 0, 1 or 2
- Must have a life expectancy of at least 12 weeks
- Body weight > 30Kg;
- Adequate organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dl
- Absolute Neutrophils Count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Creatinine clearance ≥ 40 ml/min using the following appropriate formulae:
- Cockroft-Gault formula for female : 0.85 x weight (Kg) x (140-age) / 72 x serum creatinine (mg/dL)
- Cockroft-Gault formula for male : weight (Kg) x (140-age) / 72 x serum creatinine (mg/dL)
- MDRD for patients older than 65 years: 186.3 x (serum creatinine (µmol/L / 88.4) -1.154 x Age -0.203 x (0.742 if female) x (1.212 if black patient [African origin]).
- AST/ALT ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5 x ULN
- Serum total bilirubin ≤ 1.5 x ULN (in the absence of Gilbert's syndrome)
- Coagulation panel : INR or PT ≤ 1.5 x ULN
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Patient (male or female) using a highly effective contraception as defined in appendix 9 during the study treatment period and until 6 months after the last administration of carboplatin and/or paclitaxel or until 90 days after the last administration of durvalumab, whichever is longer. Prior to dispensing study drugs, the investigator must confirm and document the patient's (and his/her partner) use of highly effective contraceptive methods, dates of negative pregnancy tests, and confirm the patient's understanding of the teratogenic potential of study drugs.
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Covered by a medical insurance.
- Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment
Who cannot join
- 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
- 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 coordinating investigator.
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- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the coordinating investigator.
- Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
- Patient whom tumor lesion is hemorrhagic or at risk of bleeding
- Patient whom disease progressed within 6 months after the start date of the previous chemotherapy (faster progressors)
- Symptomatic or active leptomeningial or parenchymal brain metastases. Patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment ot the brain metastases; these Imaging scans should both be obtained at least 4 weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of <=10mg/day of prednisone or its equivalent and anticonvulsant for at least 14 days prior to the start of treatment.
- Active or prior/history of disease/medical condition listed below:
- Inflammatory or interstitial lung disease
- Documented autoimmune or inflammatory disease (including inflammatory bowel disease [e.g., Crohn's disease, ulcerative colitis], systemic lupus erythematosus, sarcoidosis syndrome or Wegener syndrome, granulomatosis with polyangitis, Grave's disease, rheumatoid arthritis, hypophysitis, uveitis, etc) within the past 2 years except for autoimmune hypothyroidism on a stable dose of thyroid supplementation and patients with type 1 diabetes mellitus on a stable dose of insulin.
- Note: Subjects with alopecia, vitiligo, psoriasis not requiring systemic treatment (within the past 2 years) or chronic skin condition that does not require systemic therapy, are not excluded, as well as patients without active disease in the last 5 years (after consultation with the study physician) and patients with celiac disease controlled by diet alone.
- Mean QT interval corrected for heart rate (QTc) ≥470 ms using Fredericia's Correction.
- Clinically significant cardiac disease or congestive heart failure > New York Heart Association (NYHA) class 2. Patients must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.
- History of primary immunodeficiency
- Allogeneic organ transplantation
- Documented hypersensitivity to the active substance or excipient of the study drugs
- Any uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Active peptic ulcer disease or gastritis,
- Active bleeding diatheses including any subject known to have evidence of acute risk,
- Serious chronic gastrointestinal conditions associated with diarrhea
- Any psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- Current or prior use, or need for the following concomitant medications/interventions not permitted during the study treatment period :
- Any concurrent chemotherapy or radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug (except palliative radiotherapy on a non-target lesion after discussion with the coordinating investigator), immunotherapy, biologic or hormonal therapy for cancer treatment, other than any stated in the protocol (Note: concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable)).
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab including, but not limited to systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent, methotrexate, azathioprine, and TNF-α blockers. Use of immunosuppressive medications for the management of investigational product-related AEs or in subjects with contrast allergies is acceptable.
- Phenytoin given in a prophylactic intent
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP (Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP).
- Strong inhibitors and inducers of CYP3A4
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- Participation in another clinical study with an investigational product during the last 28 days prior to first study drug administration
- Pregnant or breastfeeding women (Women of childbearing potential are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. A positive urine test must be confirmed by a serum pregnancy test).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CHU d'Amiens
Amiens, 80054
ICO - Centre Paul Papin
Angers, 59055
Institut Sainte-Catherine
Avignon, 84918
Centre Georges-François Leclerc
Dijon, 21079
Clinique des Ormeaux
Le Havre, 76600
Groupe hospitalier Bretagne Sud
Lorient, 56322
Hôpital de la Croix-Rousse
Lyon, 69004
Centre Léon Bérard
Lyon, 69008
Hôpital de la Timone
Marseille, 13005
ICM - Centre Val d'Aurelle
Montpellier, 34298
Hôpital Privé du Confluent
Nantes, 44277
Centre Henri Becquerel
Rouen, 76038
ICO - Centre René Gauducheau
Saint-Herblain, 44805
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44600
Centre Paul Strauss
Strasbourg, 67065
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Multicenter Prospective Single Arm Phase II Study Evaluating Efficacy & Safety of Durvalumab With Carboplatin/Paclitaxel as First Line Treatment in Patients With Recurrent/Metastatic SCCHN Not Eligible to Standard Chemotherapy
The primary objective of the phase II trial 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.
Read the detailed description
For recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN), the standard first-line treatment is chemotherapy by cisplatin-fluorouracil and cetuximab which allows a median overall survival of 10.1 months. Due to its toxicity, this combination could be proposed only to patients younger than 70 years, good PS (ECOG PS0 or PS1) and adequate renal function.
In routine practice it is estimated that the proportion of eligible patients is about two third. One third of patients were ineligible to first-line chemotherapy by cisplatin-fluorouracil-cetuximab. Among them, 25% due to PS2 and the others for various reasons (older than 70 years, renal insufficiency….). For these ineligible patients, an alternative chemotherapy should be proposed. The carboplatin-paclitaxel scheme with weekly paclitaxel is safe for poor population and demonstrated efficacy in head and neck cancers with overall survival varying from 4.9 months to 12.8 months in first line. The response rate varies from 20% to 52% and is about 25% in our experience. Even for frail patients it should be a safe and active treatment.
Nivolumab, a monoclonal antibody targeting PD1 demonstrated survival benefit compared with chemotherapy in patients with SCCHN who progressed after platinum-based first line (median OS of 7.5 months versus 5.1 months and 12-month OS rate of 36.0% versus 16.6%). Safety data confirm these antibodies are of interest in a population of frail patients. Only 58.9% of patients experienced treatment-related adverse events with nivolumab arm and 13% of grade 3/4. Durvalumab, an anti-PDL1 antibody is currently tested in SCCHN with promising results.
Head and neck cancers are rapidly progressive and due to the delayed action of immunotherapy, and the recent demonstration that immunotherapy with anti-PD1 or anti-PDL1 can be responsible of hyperprogression, patients will probably benefit from addition of chemotherapy to immunotherapy, mostly for patients unfit for cisplatin-fluorouracil because their poor condition is often related to the cancer and a rapid response is needed.
This trial proposes to study the addition of Durvalumab to chemotherapy in first line treatment for frail patients with recurrent/metastatic SCCHN.
Prior to this evaluation, a run-in tolerance study in a limited number of patients to ensure that the experimental treatment combination is safe.
- Being tested
- Durvalumab with Carboplatin/Paclitaxel
- Keywords
- Squamous Cell Carcinoma of the Head and Neck, Recurrent / metastatic SCCHN, Frail patients, GORTEC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab with Carboplatin/PaclitaxelDrug
Also called Combination of Durvalumab with Carboplatin/Paclitaxel
Durvalumab associated with Carboplatin / Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab with Carboplatin/Paclitaxel | Experimental | Combination of Durvalumab with Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy Receives: Drug: Durvalumab with Carboplatin/Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of efficacy and safety of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy
Number of patients still alive 12 months after the first study drug administration (overall survival)
Measured: 12 months after study treatment initiation
Secondary outcomes (9)
Progression-Free Survival
Defined as the time from the date of the first study drug administration to the date of first documented progression or death due to any cause
Measured: 12 months after study treatment initiation
Time to Treatment Failure
Defined as the time from the date of inclusion to the date of permanent study treatment discontinuation
Measured: 12 months after study treatment initiation
Overall survival
Defined as the time from the date of inclusion to the date of death due to any cause
Measured: Up to 36 months
Objective Response Rate
Defined as the proportion of patients with a best overall response of Complete or Partial Response
Measured: 12 months after study treatment initiation
Best Response Rate
Defined as proportion of patients who achieve a best response of CR, PR, SD or PD
Measured: 12 months after study treatment initiation
Duration of response
Defined as the time from the date of first documented response (CR or PR) to the date of the first documented subsequent progression or death due to any cause
Measured: 12 months after study treatment initiation
Quality of life using European Organisation for Research and Treatment of Cancer (EORTC) questionnaire
Using the EORTC QLQ-C30 (Quality of Life Questionnaire) - Scale range: 1 (better outcome) to 4 (worse outcome) for 28 variables and from 1 (better outcome) to 7 (worse outcome) for 2 variables
Measured: 12 months after study treatment initiation
Quality of life using European Organisation for Research and Treatment of Cancer (EORTC) questionnaire
Using the EORTC QLQ-H\&N35 questionnaire (Quality of Life Questionnaire) - Scale range: 1 (better outcome) to 4 (worse outcome) for 30 variables and from 1 (better outcome) to 2 (worse outcome) for 5 variables
Measured: 12 months after study treatment initiation
Tolerance profile: Incidence of treatment emergent adverse events and serious adverse events
Incidence of Treatment Emergent Adverse Events, Serious Adverse Events (SAE) and death assessed according to the NCI-CTC AE version 5
Measured: 12 months after study treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start16 May 2019
- Primary completion16 May 2020
- Study completion9 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter, prospective, single arm phase II study (a run-in tolerance study will be first performed on a limited number of patients: maximum 9)
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme FAYETTE, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723967
- Sponsor's protocol ID
- ET18-023 FRAIL-IMMUNE
- Acronym
- FRAIL-IMMUNE
- Status last verified
- Sep 2022
- First submitted
- 18 Oct 2018
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Single Arm Phase II Study Evaluating Efficacy & Safety of Durvalumab With Carboplatin/Paclitaxel as First Line Treatment in Patients With Recurrent/Metastatic SCCHN Not Eligible to Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT03723967
- Acronym / sponsor ID
- FRAIL-IMMUNE / ET18-023 FRAIL-IMMUNE
- Keywords
- Squamous Cell Carcinoma of the Head and Neck, Recurrent / metastatic SCCHN, Frail patients, GORTEC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 16 May 2020 (actual)
- Study completion
- 9 Mar 2024 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the phase II trial 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.
Detailed description
For recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN), the standard first-line treatment is chemotherapy by cisplatin-fluorouracil and cetuximab which allows a median overall survival of 10.1 months. Due to its toxicity, this combination could be proposed only to patients younger than 70 years, good PS (ECOG PS0 or PS1) and adequate renal function.
In routine practice it is estimated that the proportion of eligible patients is about two third. One third of patients were ineligible to first-line chemotherapy by cisplatin-fluorouracil-cetuximab. Among them, 25% due to PS2 and the others for various reasons (older than 70 years, renal insufficiency….). For these ineligible patients, an alternative chemotherapy should be proposed. The carboplatin-paclitaxel scheme with weekly paclitaxel is safe for poor population and demonstrated efficacy in head and neck cancers with overall survival varying from 4.9 months to 12.8 months in first line. The response rate varies from 20% to 52% and is about 25% in our experience. Even for frail patients it should be a safe and active treatment.
Nivolumab, a monoclonal antibody targeting PD1 demonstrated survival benefit compared with chemotherapy in patients with SCCHN who progressed after platinum-based first line (median OS of 7.5 months versus 5.1 months and 12-month OS rate of 36.0% versus 16.6%). Safety data confirm these antibodies are of interest in a population of frail patients. Only 58.9% of patients experienced treatment-related adverse events with nivolumab arm and 13% of grade 3/4. Durvalumab, an anti-PDL1 antibody is currently tested in SCCHN with promising results.
Head and neck cancers are rapidly progressive and due to the delayed action of immunotherapy, and the recent demonstration that immunotherapy with anti-PD1 or anti-PDL1 can be responsible of hyperprogression, patients will probably benefit from addition of chemotherapy to immunotherapy, mostly for patients unfit for cisplatin-fluorouracil because their poor condition is often related to the cancer and a rapid response is needed.
This trial proposes to study the addition of Durvalumab to chemotherapy in first line treatment for frail patients with recurrent/metastatic SCCHN.
Prior to this evaluation, a run-in tolerance study in a limited number of patients to ensure that the experimental treatment combination is safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, prospective, single arm phase II study (a run-in tolerance study will be first performed on a limited number of patients: maximum 9)
| Arm | Type | Receives |
|---|---|---|
| Durvalumab with Carboplatin/Paclitaxel | Experimental | Drug: Durvalumab with Carboplatin/PaclitaxelCombination of Durvalumab with Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Age ≥ 18 years at the time of study entry;
- Histological or cytological confirmation of the diagnosis of Squamous Cell Carcinoma of the Head and Neck;
- Primary tumor located in one of the following : oral cavity, larynx, oropharynx or hypopharynx (NB: sinuses and nasopharynx locations are not allowed; isolated cervical lymphnodes with unknown primary site may be discussed with the coordinating investigator on a case by case basis)
- Archival tumor sample available at the time of inclusion with sufficient material to achieve the translational research program. Archival material must have been collected 3 months before inclusion at the latest, unless a new tumor sample must be collected.
- Disease must be in metastatic (Stage IVc) or recurrent setting;
Key exclusion criteria (35 listed)
- History of another primary malignancy except for:
- 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 coordinating investigator.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the coordinating investigator.
- Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Durvalumab with Carboplatin/PaclitaxelAlso: Combination of Durvalumab with Carboplatin/PaclitaxelDurvalumab associated with Carboplatin / Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy | Drug | Durvalumab with Carboplatin/Paclitaxel |
Primary outcome
Evaluation of efficacy and safety of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy
Time frame: 12 months after study treatment initiation
Number of patients still alive 12 months after the first study drug administration (overall survival)
9 secondary outcomes
Progression-Free Survival
Time frame: 12 months after study treatment initiation
Time to Treatment Failure
Time frame: 12 months after study treatment initiation
Overall survival
Time frame: Up to 36 months
Objective Response Rate
Time frame: 12 months after study treatment initiation
Best Response Rate
Time frame: 12 months after study treatment initiation
Duration of response
Time frame: 12 months after study treatment initiation
Quality of life using European Organisation for Research and Treatment of Cancer (EORTC) questionnaire
Time frame: 12 months after study treatment initiation
Quality of life using European Organisation for Research and Treatment of Cancer (EORTC) questionnaire
Time frame: 12 months after study treatment initiation
Tolerance profile: Incidence of treatment emergent adverse events and serious adverse events
Time frame: 12 months after study treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme FAYETTE, MD principal investigator
Centre Leon Berard
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab with Carboplatin/Paclitaxel in people with Squamous Cell Carcinoma of the Head and Neck, run by Centre Leon Berard at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of efficacy and safety of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy (time frame: 12 months after study treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.