Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
UNICANCER (Voir sur ClinicalTrials)
mars 2022
mai 2029
19 juillet 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Natacha NAOUN | 07/08/2026 13:00:05 | Contacter | ||
| HOPITAL FOCH | Raffaele RATTA | 11/05/2026 07:26:15 | 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 | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Saint Antoine | Contact (sur clinicalTrials) | ||||
| CHI DE CRETEIL | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugene Marquis - 35042 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la Côte Basque - 64109 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - 63000 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux - Hôpial Saint André - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Clinique Mutualiste de l'Estuaire - Saint-Nazaire - France | Contact (sur clinicalTrials) | ||||
| GH Mutualiste de Grenoble - Grenoble - France | Contact (sur clinicalTrials) | ||||
| HIA Sainte Anne - Toulon - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - 69310 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Institut de cancérologie de l'Ouest - 44805 - Saint-Herblain - France | 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 | Contact (sur clinicalTrials) | ||||
| Centre François Baclesse - 14076 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Gustave Roussy - Villejuif - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Mémorial de Saint-Lô - Saint-Lô - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - Lille - France | Contact (sur clinicalTrials) | ||||
| CH Boulogne sur Mer - Boulogne-sur-Mer - France | Contact (sur clinicalTrials) | ||||
| CHD Vendée - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| CHI Elbeuf - Saint-Aubin-lès-Elbeuf - France | Contact (sur clinicalTrials) | ||||
| CHU Bretonneau - 37044 - Tours - France | Contact (sur clinicalTrials) | ||||
| CHU Nîmes/Institut de cancérologie du Gard - Nîmes - France | Contact (sur clinicalTrials) | ||||
| Clinique Chenieux - 87000 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Clinique Sainte Catherine - 84918 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| ICANS - 67200 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| IUCT - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
Exclusion Criteria:
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.