Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05078047 En recrutement IDF

Titre

Randomized Phase III Trial of Standard Immunotherapy (IO) by Checkpoint Inhibitors, Versus Reduced Dose Intensity of IO in Patients With Locally Advanced or Metastatic Cancer in Response After 6 Months of Standard IO (MOIO)

Type

Interventional

Pathologie

Carcinome épidermoïde de l'oesophage
Carcinomes
Carcinome basocellulaire
Néphrocarcinome
Métastase tumorale
Tumeurs colorectales
Carcinome à cellules de Merkel
Tumeurs de l'endomètre
Instabilité des microsatellites
Tumeurs du sein triple-négatives

Phase

Phase 3

Promoteur

UNICANCER (Voir sur ClinicalTrials)

Date de début

mars 2022

Date de fin

mars 2025

Dernière mise à jour

20 septembre 2024

Résumé

Immunotherapy (IO), such as treatment with anti-PD-1, PD-L1, or CTLA-4 inhibitors, is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. However, the optimal duration of immunotherapies is currently unknown. Our hypothesis is that a reduced dose intensity of IO could be as effective as the current standard treatment in term of prevention of the disease progression. If proved right, this study will have a positive medico-economic impact by reduction of the costs associated with the treatment and the toxicity, and an increase of the patients' quality of life.

Détail

Voir le détail Immunotherapy (IO) is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. For currently approved immunotherapies such as PD-1 / PD-L1 inhibitors and anti-CTLA-4, the rhythm and duration of treatment are recommended until disease progression or unacceptable toxicity. However, the optimal duration of these treatments is currently unknown. No major dose-dependent effect of anti-PD-1 have been observed and whether the frequency of infusion of IO could improve response or maintain efficacy. Moreover, phase I studies have shown that saturation of the target (PD-1 or PD-L1) can persist far beyond the serum half-life of the IO and 3-monthly infusions of an anti-PD-1 antibody could potentially generate the same level of activity as infusions administered every 2 weeks. In silico modeling studies have suggested that alternate scheduling with IO couldn't compromise the efficacy of the treatment. Indeed, prolonged half-lives of IO drugs, time-varying clearance plus plasma concentrations far above the threshold associated with maximal target-engagement, suggest that the rhythm of administration of IO could be slowed down. Without substantial international data for responding patients, apart metastatic melanoma in complete response, patients and physicians are afraid of stopping treatment, by fear of relapse. Over-treatment with IO may be toxic and inefficient. The rising cost of cancer care in the era of immunotherapy is of great concern for public and private payers around the world. Chronic administration has important consequences for patients and health systems, with multiple medical visits and the risk of chronic, progressive and sometimes fatal toxicities induced by immunotherapy. This is a pragmatic and strategic study challenging the routine practice which compares for the first time in a randomized phase III study, the standard administration of IO versus the same agent administered each three months in patients with metastatic cancer in partial or complete response after 6 months of standard IO ( except melanoma in CR). If our hypothesis of non-inferiority of PFS with a reduced dose intensity of IO is verified, this could replace standard treatment and have a positive medico-economic impact, allowing, on the one hand, a reduction of the costs associated with the treatment and the toxicity, and on the other hand, an increase of the patients' quality of life. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FOCH	Raffaele RATTA	En recrutement IDF	21/10/2024 07:07:23	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Cochin	Jennifer ARRONDEAU	En recrutement IDF		Contact (sur clinicalTrials)
AP-HP - Hôpital Europeen Georges Pompidou		Annulé		Contact (sur clinicalTrials)
AP-HP - Hôpital Henri Mondor-Albert Chenevier	Carolina SALDANA	En recrutement IDF		Contact (sur clinicalTrials)
AP-HP - Hôpital Saint Antoine	Thierry ANDRE	En recrutement IDF		Contact (sur clinicalTrials)
CHI DE CRETEIL	Isabelle MONNET	En recrutement IDF		Contact (sur clinicalTrials)
CLCC INSTITUT CURIE		Annulé		Contact (sur clinicalTrials)
CLCC RENE HUGUENIN INSTITUT CURIE		Annulé		Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Antoine Lacassagne - 06189 - Nice - France	Delphine BORCHIELLINI	En recrutement		Contact (sur clinicalTrials)
Centre Eugene Marquis - 35042 - Rennes - France	Laurence CROUZET	En recrutement		Contact (sur clinicalTrials)
Centre François Baclesse - 14076 - Caen - France	Pierre-Emmanuel BRACHET	En recrutement		Contact (sur clinicalTrials)
Centre Georges François Leclerc - 21079 - Dijon - France	Alice HERVIEU	En recrutement		Contact (sur clinicalTrials)
Centre Gustave Roussy - Villejuif - France	Yohann LORIOT	Recrutement non commencé		Contact (sur clinicalTrials)
Centre Hospitalier de la Côte Basque - 64109 - Bayonne - France	Louis FRANCOIS	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier Mémorial de Saint-Lô - Saint-Lô - France	Dingyu XIAO	En recrutement		Contact (sur clinicalTrials)
Centre Jean Perrin - 63000 - Clermont-Ferrand - France	Maureen BERNADACH	En recrutement		Contact (sur clinicalTrials)
Centre Léon Bérard - Lyon - France	Olivier TREDAN	En recrutement		Contact (sur clinicalTrials)
Centre Oscar Lambret - Lille - France	Alessandra FORESTIER	En recrutement		Contact (sur clinicalTrials)
CH Boulogne sur Mer - Boulogne-sur-Mer - France	Guillaume MARIE	Recrutement non commencé		Contact (sur clinicalTrials)
CHD Vendée - La Roche-sur-Yon - France	Frank PRIOU	Recrutement non commencé		Contact (sur clinicalTrials)
CHI Elbeuf - Saint-Aubin-lès-Elbeuf - France	Pierre-Alexandre HAUSS	En recrutement		Contact (sur clinicalTrials)
CHU Besançon - 25030 - Besançon - France		Annulé		Contact (sur clinicalTrials)
CHU Bordeaux - Hôpial Saint André - Bordeaux - France	Charlotte DOMBLIDES	En recrutement		Contact (sur clinicalTrials)
CHU Bretonneau - 37044 - Tours - France	Mathilde CANCEL	En recrutement		Contact (sur clinicalTrials)
CHU Nîmes/Institut de cancérologie du Gard - Nîmes - France	Nadine HOUEDE	En recrutement		Contact (sur clinicalTrials)
CHU Poitiers - 86000 - Poitiers - France	Nicolas ISAMBERT	En recrutement		Contact (sur clinicalTrials)
Clinique Chenieux - 87000 - Limoges - France	Sabrina FALKOWSKI	En recrutement		Contact (sur clinicalTrials)
Clinique Mutualiste de l'Estuaire - Saint-Nazaire - France	Tifenn L'HARIDON	En recrutement		Contact (sur clinicalTrials)
Clinique Sainte Catherine - 84918 - Avignon - France	Werner HILGERS	En recrutement		Contact (sur clinicalTrials)
GH Mutualiste de Grenoble - Grenoble - France	Valentine RUSTE	Recrutement non commencé		Contact (sur clinicalTrials)
HIA Sainte Anne - Toulon - France	Laurys BOUDIN	En recrutement		Contact (sur clinicalTrials)
Hôpital La Timone -APHM - 13385 - Marseille - France		Annulé		Contact (sur clinicalTrials)
Hôpital Pitié Salpêtrière - 75013 - Paris - France		Annulé		Contact (sur clinicalTrials)
Hôpital Saint Louis - 75010 - Paris - France	Hélène GAUTHIER	En recrutement		Contact (sur clinicalTrials)
Hospices Civils de Lyon - 69310 - Lyon - France	Denis MAILLET	En recrutement		Contact (sur clinicalTrials)
ICANS - 67200 - Strasbourg - France	Philippe BARTHELEMY	En recrutement		Contact (sur clinicalTrials)
Insitut Godinot - 51726 - Reims - France		Annulé		Contact (sur clinicalTrials)
Institut de cancérologie de l'Ouest - 44805 - Saint-Herblain - France	Judith RAIMBOURG	En recrutement		Contact (sur clinicalTrials)
Institut de cancérologie de l'Ouest - 49055 - Angers - France	Elouen BOUGHALEM	En recrutement		Contact (sur clinicalTrials)
IUCT - 31059 - Toulouse - France	Iphigénie KORAKIS	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

1. Patients must have signed a written informed consent form prior to any trial
specific procedures.

2. Patient aged ≥18 years old.

3. Metastatic disease (or locally advanced disease not suitable for local treatment) of
initial tumor histologically confirmed including: lung cancer, renal cell cancer,
head and neck cancer, urothelial carcinoma, triple negative breast cancer, Merkel
cancer, hepatocellular carcinoma, melanoma, colorectal carcinoma with microsatellite
instability [MSI], esophageal squamous cell carcinoma, endometrial
carcinoma,cervical cancer, gastric/gastro-oesophageal junction adenocarcinoma, basal
cell carcinoma or squamous skin carcinoma.

4. Patients in partial or complete response after 6 months of standard immunotherapy
(whatever the line of therapy) according to the RECIST or PERCIST v1.0 criteria
(confirmed by local radiological assessment).

For metastatic melanoma only patients in partial response. Patients with metastatic
or advanced cancer treated by immunotherapy as maintenance therapy can be included
without any lesion at IO initiation. In this case, response after 6 months of
standard immunotherapy will be evaluated by the non-appearance of a new lesion.

5. Eligible to maintain the same standard IO treatment.

6. Patient with Eastern cooperative oncology group (ECOG) performance status ≤1.

7. Patients with brain metastases are allowed, provided they are stable according to
the following definitions: treated with surgery or stereotactic radiosurgery and
without evidence of progression prior to randomization and have no evidence of new
or enlarging brain metastases.

8. Patients treated by IO previously combined with chemotherapy are allowed.

9. Patients with Tyrosine Kinase Inhibitor (TKI)-IO or pemetrexed-IO or bevacizumab-IO
are allowed.

10. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for
pre-menopausal patients.

11. Both sexually active women of childbearing potential and males (and their female
partners) patients must agree to use adequate contraception method for the duration
of the study treatment and after completing treatment according to the most recent
version of the IO Summary of product characteristics (SmPC).

12. Patient is willing and able to comply with the protocol for the duration of the
trial including undergoing treatment and scheduled visits, and examinations
including follow-up.

13. Patient must be affiliated to a Social Security System.

Critère de non inclusion

1. Metastatic melanoma in complete response.

2. Metastatic renal cell carcinoma with International Metastatic Renal Cell Carcinoma
Database (IMDC) favourable-risk treated TKI/IO combination.

3. Hematologic malignancies (leukaemia, myeloma, lymphoma...)

4. Active infection requiring systemic therapy.

5. Patients enrolled in another therapeutic study within 30 days before the inclusion
in and during MOIO study.

6. Patient unable to comply with study obligations for geographic, social, or physical
reasons, or who is unable to understand the purpose and procedures of the study.

7. Person deprived of their liberty or under protective custody or guardianship.

NCT05078047 - Randomized Phase III Trial of Standard Immunotherapy (IO) by Checkpoint Inhibitors, Versus Reduced Dose Intensity of IO in Patients With Locally Advanced or Metastatic Cancer in Response After 6 Months of Standard IO (MOIO)

Informations générales
Etablissements
Critères
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