BridgeMD
Study comparing the standard administration of immunotherapy (IO) versus the same agent administered each three months in patients with locally advanced or metastatic cancer in response after 6 months of standard IO
EU CTIS ID: 2024-513707-14-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must have signed a written informed consent form prior to any trial specific procedures.
- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for premenopausal patients
- 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.
- 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.
- Patient must be affiliated to a Social Security System
- Patient aged ≥18 years old.
You likely can't join if
- Metastatic melanoma in complete response
- Hematologic malignancies (leukaemia, myeloma, lymphoma…)
- Active infection requiring systemic therapy.
- Patients enrolled in another therapeutic study within 30 days before the inclusion in and during MOIO study
- 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.
- Person deprived of their liberty or under protective custody or guardianship
See the full eligibility criteria
Who can join
- Patients must have signed a written informed consent form prior to any trial specific procedures.
- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for premenopausal patients
- 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.
- 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.
- Patient must be affiliated to a Social Security System
- Patient aged ≥18 years old.
- 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, squamous skin carcinoma or biliary tract cancer.
- Patients in partial or complete response after 6 months of standard immunotherapy (whatever the line of therapy) according to the RECIST v1.1 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 nonappearance of a new lesion.
- Eligible to maintain the same standard IO treatment
- Patient with ECOG performance status ≤1.
- 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.
- Patients treated by IO previously combined with chemotherapy are allowed
- Patients with TKI-IO or pemetrexed-IO or bevacizumab-IO are allowed
What rules you out
- Metastatic melanoma in complete response
- Hematologic malignancies (leukaemia, myeloma, lymphoma…)
- Active infection requiring systemic therapy.
- Patients enrolled in another therapeutic study within 30 days before the inclusion in and during MOIO study
- 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.
- Person deprived of their liberty or under protective custody or guardianship
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.