Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Prostatic Neoplasms

Head and Neck Neoplasms

Uterine Cervical Neoplasms

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Vinorelbine

Immunomodulating Agents

Durvalumab

Tremelimumab

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

Patients presenting advanced refractory breast cancer

Patients presenting advanced refractory head and neck cancer

Patients presenting advanced refractory cervix cancer

Patients presenting advanced refractory prostate cancer

Patients presenting advanced refractory solid tumour with high mutational load

Patient will be treated by metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy

Durvalumab + Tremelimumab + metronomic Vinorelbine

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.

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.

This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative 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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours	NCT03518606	Advanced Solid ... Breast Cancer Head and Neck C... Cervix Cancer Prostate Cancer	Durvalumab + Tr...	18 Years -	UNICANCER
Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours	NCT03518606	Advanced Solid ... Breast Cancer Head and Neck C... Cervix Cancer Prostate Cancer	Durvalumab + Tr...	18 Years -	UNICANCER

Spots Global Cancer Trial Database for high mutational load malignancies