Oncologic metastatic tumour (lung cancer (K), renal cell K (except IMDC favorable-risk treated TKI / immunotherapy [IO] combination), head and neck K, bladder K, triple negative breast K, Merkel K and melanoma, or hepatocellular carcinoma) in PR or CR (except for melanoma, only patients in partial response) after 6 months of standard IO treatment (monotherapy or previously in combination with other immunotherapy or chemotherapy or continuous combination with pemetrexed or bevacizumab or TKI).
Conditions
Sponsors
UNICANCER
Eligibility
Sex/Gender
All
Inclusion criteria
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. Initial metastatic disease histologically confirmed including : lung cancer, renal cell cancer, head and neck cancer, bladder cancer, triple negative breast cancer, Merkel cancer, hepatocellular carcinoma and melanoma. 4. Patients in partial or complete response after 6 months of standard immunotherapy (whatever the line of therapy) according to the RECIST (confirmed by local radiological assessment). For metastatic melanoma only patients in partial response. 5. Eligible to maintain the same standard IO treatment. 6. Patient with 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 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 396
Exclusion criteria
Exclusion criteria: 1. Metastatic melanoma in complete response. 2. Metastatic renal cell carcinoma with 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority in term of PFS of administration of reduced dose intensity of IO versus standard IO for patients in response after 6 months of standard IO.;Secondary Objective: To evaluate in both arms : 1.Cost-effectiveness, 2.Immune progression-free survival using iRECIST, 3.Objective response rate at 12 and 24 months post-randomization, 4.Overall survival, 5.Duration of response at 12 months post-randomization 6.Quality of life (self-reported EORTC QLQ-C30, and the EQ-5D-5L questionnaires), 7.Anxiety and fear of relapse using specific questionnaires, 8.Safety profile. ANCILLARY OBJECTIVES: Pharmacokinetics study: •To measure the IO’s residual concentrations in plasma (trough levels). Immune monitoring: •To identify immune biomarkers of long-term response allowing IO dose reduction.;Primary end point(s): Progression-free survival (PFS) is calculated from the date of randomization to the date of first progression or death from any cause, whichever occurs first. Progression will be determined locally by the investigator through the use of RECIST v1.1 in case of lesions identified at baseline. For patients without any evidence of disease at inclusion, the progression will be defined as an appearance of a new lesion (measurable or not measurable). Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last RECIST 1.1 assessment. ;Timepoint(s) of evaluation of this end point: see above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incremental cost-effectiveness ratio (ICER) expressed as a cost per quality-adjusted life year (QALY) gained at 36 months. 2. Immune progression-free survival (iPFS) calculated from the date of randomization to the date of disease progression criteria (iPD) or death from to any cause, whichever occurs first. Immune progression (iPD) will be determined locally by the investigator through the use of iRECIST in case of lesions identified at baseline. 3. Objective response rate (ORR) defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator using RECIST v1.1 at 12 and 24 months post-randomization considering patients who switch from study treatment to any other cancer treatment within 12 and 24 months post-randomization as failures. 4. Overall survival calculated from the date of randomization to the date of death from any cause. 5. Duration of response (DoR) defined as the time from randomization to first documented response until progression disease progression or death, whichever occurs first. 6. Quality of life mean score of self-reported EORTC QLQ-C30, and the EQ-5D-5L questionnaires at inclusion visit (pre-randomization), 3, 6, 9, 12, 15, 18, 24 and 36 months post-randomization. 7. Evaluation of anxiety and fear of relapse using specific questionnaires at 3, 6, 9, 12, 15, 18, 24 and 36 months post-randomization. 8. Number, frequency and severity of adverse events according to CTCAE v5.0 at 12 months and 3 years post-randomization.;Timepoint(s) of evaluation of this end point: see above | — |
Countries
France
Contacts
Public ContactProject Manager
UNICANCER
Outcome results
None listed