FRAIL-IMMUNE (GORTEC 2018-03) - Combination of Durvalumab With Carboplatin/Paclitaxel

NCT03723967 | Completed Phase 2 DMC

• 1 other identifier: ET18-023 FRAIL-IMMUNE
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

Squamous Cell Carcinoma of the Head and Neck; Recurrent / metastatic SCCHN; Frail patients; GORTEC

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months after study treatment initiation

Secondary Outcomes (9)

• Progression-Free Survival

  12 months after study treatment initiation

• Time to Treatment Failure

  12 months after study treatment initiation

• Overall survival

  Up to 36 months

• Objective Response Rate

  12 months after study treatment initiation

• Best Response Rate

  12 months after study treatment initiation

Other Outcomes (22)

• Determination as predictive & prognostic factors of efficacy: Time to recurrence

  Inclusion, Day 1 cycle 2 (each cycle is 28 days), First documented radiological progression

• Determination as predictive & prognostic factors of efficacy : Site of recurrence

  Inclusion, Day 1 cycle 2 (each cycle is 28 days), First documented radiological progression

• Determination as predictive & prognostic factors of efficacy: Level of expression of PD-L1

  Inclusion, Day 1 cycle 2 (eachy cycle is 28 days), First documented radiological progression

Study Arms (1)

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

Drug: Durvalumab with Carboplatin/Paclitaxel

Interventions

Durvalumab with Carboplatin/Paclitaxel DRUG

Durvalumab associated with Carboplatin / Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy

Also known as: Combination of Durvalumab with Carboplatin/Paclitaxel

Durvalumab with Carboplatin/Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)
• 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

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (17)

CHU d'Amiens

Amiens, 80054, France

Location

ICO - Centre Paul Papin

Angers, 59055, France

Location

Institut Sainte-Catherine

Avignon, 84918, France

Location

Centre Georges-François Leclerc

Dijon, 21079, France

Location

Clinique des Ormeaux

Le Havre, 76600, France

Location

Groupe hospitalier Bretagne Sud

Lorient, 56322, France

Location

Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Hôpital de la Timone

Marseille, 13005, France

Location

ICM - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Hôpital Privé du Confluent

Nantes, 44277, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

ICO - Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, 44600, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut de Cancérologie de Lorraine Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Recurrence

Interventions

durvalumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Jérôme FAYETTE, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, prospective, single arm phase II study (a run-in tolerance study will be first performed on a limited number of patients: maximum 9)

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 30, 2018
• Study Start: May 16, 2019
• Primary Completion: May 16, 2020
• Study Completion: March 9, 2024
• Last Updated: April 22, 2024

Record last verified: 2022-09

Locations

FR (17)