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Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

A Phase I/II Basket Trial Evaluating a Combination of Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumour

NCT03518606•UNICANCER

View on ClinicalTrials.gov

Summary

This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.

Detailed Description

Methodology: The study divided in two parts: * Phase I part: dose escalation study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy, * Phase II part: activity study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy. Indication: Patient eligible to the study are patients with histologically confirmed locally advanced or metastatic solid tumours, resistant to conventional therapies, and candidate to experimental therapy by local clinical board, from the following primary tumours: head and neck, prostate, cervix, and breast cancers, as well as miscellaneous malignancies with high mutational load.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient must have signed a written informed consent form prior to any study specific procedures.
•2. Histologically confirmed locally advanced or metastatic solid tumours, resistant to conventional therapies, and candidate to experimental therapy by local clinical board, from the following primary tumours:
•* Head and neck squamous cell carcinomas,
•* Breast cancer,
•* Prostate cancer,
•* Cervical cancer,
•* Miscellaneous primary tumours (except melanoma, non-small cell lung cancer \[NSCLC\], and renal cell cancer) with a high mutational load, as defined by a molecular clinical board after next-generation sequencing (comprehensive cancer gene panel or whole genome/exome sequencing) analysis.
•3. Patients aged ≥18 years at registration.
•4. Life expectancy ≥3 months.
•5. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
+17 more criteria

Exclusion Criteria

•1. Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix, or basal cell or squamous cell carcinoma of the skin. Patients who have had potentially curative therapy for a prior malignancy are eligible provided there has been no evidence of disease for ≥5 years and the risk of recurrence is considered low.
•2. Active brain metastases, spinal cord compression, or leptomeningeal disease. Patients whose brain metastases have been treated may participate if the brain metastases are stable by imagery (defined as 2 brain images, both obtained after treatment of the brain metastases and at least four weeks apart, and showing no evidence of intracranial progression). In addition, any neurologic symptoms caused by the brain metastases or their treatment must be resolved or stable, without steroidal treatment or with a dose of steroid ≤10 mg/day of prednisone or its equivalent and an anticonvulsants, for at least 14 days prior to the start of treatment.
•3. Previous treatment with an anti-PD1/PD-L1 including durvalumab or an anti-CTLA-4 therapy including tremelimumab or vinorelbine.
•4. Patients with known allergy or severe hypersensitivity to any of the study treatments or any of the study treatment excipients.
•5. History of active primary immunodeficiency.
•6. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion:
•* Patients with vitiligo or alopecia.
•* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement therapy.
•* Any chronic skin condition that does not require systemic therapy.
•* Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
+13 more criteria

Locations (9)

Institut de Cancérologie de l'Ouest - Site Paul Papin

Angers, France

Centre François Baclesse

Caen, France

Centre Georges-François Leclerc

Dijon, France

Institut Paoli-Calmettes

Marseille, France

Centre Antoine Lacassagne

Nice, France

Institut Curie

Paris, France

Centre Eugène Marquis

Rennes, France

Institut de Cancérologie de l'Ouest - Site René Gauducheau

Saint-Herblain, France

Gustave Roussy

Villejuif, France

Key Dates

Start Date

June 20, 2018

Primary Completion Date

April 1, 2022

Completion Date

December 19, 2024

Last Updated

January 15, 2025

Enrollment

126

ACTUAL participants

Conditions

Advanced Solid TumoursBreast CancerHead and Neck CancerCervix CancerProstate Cancer

Interventions

Durvalumab + Tremelimumab + metronomic Vinorelbine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

Inclusion Criteria

Exclusion Criteria

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