Phase
Condition
Neoplasm Metastasis
Head And Neck Cancer
Basal Cell Carcinoma
Treatment
Reduced dose intensity of IO
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have signed a written informed consent form prior to any trialspecific procedures.
Patient aged ≥18 years old.
Metastatic disease (or locally advanced disease not suitable for local treatment) ofinitial tumor histologically confirmed including: lung cancer, renal cell cancer,head and neck cancer, urothelial carcinoma, triple negative breast cancer, Merkelcancer, hepatocellular carcinoma, melanoma, colorectal carcinoma with microsatelliteinstability [MSI], esophageal squamous cell carcinoma, endometrialcarcinoma,cervical cancer, gastric/gastro-oesophageal junction adenocarcinoma, basalcell carcinoma or squamous skin carcinoma.
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 metastaticor advanced cancer treated by immunotherapy as maintenance therapy can be includedwithout any lesion at IO initiation. In this case, response after 6 months ofstandard immunotherapy will be evaluated by the non-appearance of a new lesion.
Eligible to maintain the same standard IO treatment.
Patient with Eastern cooperative oncology group (ECOG) performance status ≤1.
Patients with brain metastases are allowed, provided they are stable according tothe following definitions: treated with surgery or stereotactic radiosurgery andwithout evidence of progression prior to randomization and have no evidence of newor enlarging brain metastases.
Patients treated by IO previously combined with chemotherapy are allowed.
Patients with Tyrosine Kinase Inhibitor (TKI)-IO or pemetrexed-IO or bevacizumab-IOare allowed.
Evidence of post-menopausal status, or negative urinary or serum pregnancy test forpre-menopausal patients.
Both sexually active women of childbearing potential and males (and their femalepartners) patients must agree to use adequate contraception method for the durationof the study treatment and after completing treatment according to the most recentversion of the IO Summary of product characteristics (SmPC).
Patient is willing and able to comply with the protocol for the duration of thetrial including undergoing treatment and scheduled visits, and examinationsincluding follow-up.
Patient must be affiliated to a Social Security System.
Exclusion
Exclusion Criteria:
Metastatic melanoma in complete response.
Metastatic renal cell carcinoma with International Metastatic Renal Cell CarcinomaDatabase (IMDC) favourable-risk treated TKI/IO combination.
Hematologic malignancies (leukaemia, myeloma, lymphoma...)
Active infection requiring systemic therapy.
Patients enrolled in another therapeutic study within 30 days before the inclusionin and during MOIO study.
Patient unable to comply with study obligations for geographic, social, or physicalreasons, or who is unable to understand the purpose and procedures of the study.
Person deprived of their liberty or under protective custody or guardianship.
Study Design
Study Description
Connect with a study center
Institut de cancérologie de l'Ouest
Angers, 49055
FranceActive - Recruiting
Clinique Sainte Catherine
Avignon, 84918
FranceActive - Recruiting
Centre Hospitalier de la Côte Basque
Bayonne, 64109
FranceActive - Recruiting
CHU Besançon
Besançon, 25030
FranceSite Not Available
CHU Bordeaux - Hôpial Saint André
Bordeaux,
FranceActive - Recruiting
CH Boulogne sur Mer
Boulogne-sur-Mer,
FranceSite Not Available
Centre François Baclesse
Caen, 14076
FranceActive - Recruiting
Centre Jean Perrin
Clermont-Ferrand, 63000
FranceActive - Recruiting
CHU Henri Mondor
Créteil, 94010
FranceActive - Recruiting
Centre Hospitalier Intercommunal
Créteil, 94010
FranceActive - Recruiting
Centre Georges François Leclerc
Dijon, 21079
FranceActive - Recruiting
GH Mutualiste de Grenoble
Grenoble,
FranceSite Not Available
CHD Vendée
La Roche-sur-Yon,
FranceSite Not Available
Centre Oscar Lambret
Lille,
FranceActive - Recruiting
Clinique Chenieux
Limoges, 87000
FranceActive - Recruiting
Centre Léon Bérard
Lyon,
FranceActive - Recruiting
Hospices Civils de Lyon
Lyon, 69310
FranceActive - Recruiting
Hôpital La Timone -APHM
Marseille, 13385
FranceSite Not Available
Centre Antoine Lacassagne
Nice, 06189
FranceActive - Recruiting
CHU Nîmes/Institut de cancérologie du Gard
Nîmes,
FranceActive - Recruiting
Hôpital Cochin APHP
Paris,
FranceActive - Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
FranceSite Not Available
Hôpital Pitié Salpêtrière
Paris, 75013
FranceSite Not Available
Hôpital Saint Antoine APHP
Paris,
FranceActive - Recruiting
Hôpital Saint Louis
Paris, 75010
FranceActive - Recruiting
Institut Curie
Paris, 75005
FranceSite Not Available
CHU Poitiers
Poitiers, 86000
FranceActive - Recruiting
Insitut Godinot
Reims, 51726
FranceSite Not Available
Centre Eugene Marquis
Rennes, 35042
FranceActive - Recruiting
CHI Elbeuf
Saint-Aubin-lès-Elbeuf,
FranceActive - Recruiting
Institut Curie
Saint-Cloud, 92210
FranceSite Not Available
Institut de cancérologie de l'Ouest
Saint-Herblain, 44805
FranceActive - Recruiting
Centre Hospitalier Mémorial de Saint-Lô
Saint-Lô,
FranceActive - Recruiting
Clinique Mutualiste de l'Estuaire
Saint-Nazaire,
FranceActive - Recruiting
ICANS
Strasbourg, 67200
FranceActive - Recruiting
Hôpital Foch
Suresnes, 92151
FranceActive - Recruiting
HIA Sainte Anne
Toulon,
FranceActive - Recruiting
IUCT
Toulouse, 31059
FranceActive - Recruiting
CHU Bretonneau
Tours, 37044
FranceActive - Recruiting
Centre Gustave Roussy
Villejuif,
FranceSite Not Available
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