Actively Recruiting
Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO
Led by UNICANCER · Updated on 2025-06-05
646
Participants Needed
40
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Metastatic or locally advanced cancer not suitable for local treatment, including lung cancer, renal cell cancer, head and neck cancer, urothelial carcinoma, triple negative breast cancer, Merkel cell carcinoma, hepatocellular carcinoma, melanoma, colorectal carcinoma with microsatellite instability, esophageal squamous cell carcinoma, endometrial carcinoma, cervical cancer, gastric/gastro-esophageal junction adenocarcinoma, basal cell carcinoma, or squamous skin carcinoma
- Partial or complete response after 6 months of standard immunotherapy according to RECIST or PERCIST v1.0 criteria (confirmed by local radiological assessment)
- For metastatic melanoma, only patients in partial response are eligible
- Eligible to continue the same standard immunotherapy treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patients with stable brain metastases treated with surgery or stereotactic radiosurgery and no progression prior to randomization
- Patients previously treated with immunotherapy combined with chemotherapy, Tyrosine Kinase Inhibitor (TKI)-IO, pemetrexed-IO, or bevacizumab-IO are allowed
- Evidence of post-menopausal status or negative pregnancy test for pre-menopausal women
- Agree to use adequate contraception during the study and after treatment if sexually active and of childbearing potential
- Willing and able to comply with study procedures and follow-up
- Affiliated with a Social Security System
You will not qualify if you...
- Metastatic melanoma in complete response
- Metastatic renal cell carcinoma with favorable-risk treated with TKI/IO combination
- Hematologic malignancies such as leukemia, myeloma, or lymphoma
- Active infection requiring systemic therapy
- Participation in another therapeutic clinical trial within 30 days before or during this study
- Inability to comply with study requirements due to geographic, social, or physical reasons
- Inability to understand the study purpose and procedures
- Being under legal protective custody, guardianship, or deprived of liberty
AI-Screening
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Trial Site Locations
Total: 40 locations
1
Institut de cancérologie de l'Ouest
Angers, France, 49055
Actively Recruiting
2
Clinique Sainte Catherine
Avignon, France, 84918
Actively Recruiting
3
Centre Hospitalier de la Côte Basque
Bayonne, France, 64109
Actively Recruiting
4
CHU Besançon
Besançon, France, 25030
Withdrawn
5
CHU Bordeaux - Hôpial Saint André
Bordeaux, France
Actively Recruiting
6
CH Boulogne sur Mer
Boulogne-sur-Mer, France
Not Yet Recruiting
7
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
8
Centre Jean Perrin
Clermont-Ferrand, France, 63000
Actively Recruiting
9
Centre Hospitalier Intercommunal
Créteil, France, 94010
Actively Recruiting
10
CHU Henri Mondor
Créteil, France, 94010
Actively Recruiting
11
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
12
GH Mutualiste de Grenoble
Grenoble, France
Not Yet Recruiting
13
CHD Vendée
La Roche-sur-Yon, France
Not Yet Recruiting
14
Centre Oscar Lambret
Lille, France
Actively Recruiting
15
Clinique Chenieux
Limoges, France, 87000
Actively Recruiting
16
Hospices Civils de Lyon
Lyon, France, 69310
Actively Recruiting
17
Centre Léon Bérard
Lyon, France
Actively Recruiting
18
Hôpital La Timone -APHM
Marseille, France, 13385
Withdrawn
19
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
20
CHU Nîmes/Institut de cancérologie du Gard
Nîmes, France
Actively Recruiting
21
Institut Curie
Paris, France, 75005
Withdrawn
22
Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
23
Hôpital Pitié Salpêtrière
Paris, France, 75013
Withdrawn
24
Hôpital Européen Georges Pompidou
Paris, France, 75015
Withdrawn
25
Hôpital Cochin APHP
Paris, France
Actively Recruiting
26
Hôpital Saint Antoine APHP
Paris, France
Actively Recruiting
27
CHU Poitiers
Poitiers, France, 86000
Actively Recruiting
28
Insitut Godinot
Reims, France, 51726
Withdrawn
29
Centre Eugene Marquis
Rennes, France, 35042
Actively Recruiting
30
CHI Elbeuf
Saint-Aubin-lès-Elbeuf, France
Actively Recruiting
31
Institut Curie
Saint-Cloud, France, 92210
Withdrawn
32
Institut de cancérologie de l'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
33
Centre Hospitalier Mémorial de Saint-Lô
Saint-Lô, France
Actively Recruiting
34
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France
Actively Recruiting
35
ICANS
Strasbourg, France, 67200
Actively Recruiting
36
Hôpital Foch
Suresnes, France, 92151
Actively Recruiting
37
HIA Sainte Anne
Toulon, France
Actively Recruiting
38
IUCT
Toulouse, France, 31059
Actively Recruiting
39
CHU Bretonneau
Tours, France, 37044
Actively Recruiting
40
Centre Gustave Roussy
Villejuif, France
Not Yet Recruiting
Research Team
C
Clotilde SIMON
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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