Efficacy of the Combination of Nivolumab and Ipilimumab as a Treatment in Patients With Sarcoma o… (NCT04741438) | Clinical Trial Compass
UnknownPhase 3
Efficacy of the Combination of Nivolumab and Ipilimumab as a Treatment in Patients With Sarcoma of Rare Subtype
France96 participantsStarted 2021-03-30
Plain-language summary
This is a randomized open label study, with 2 arms treatments conducted in patients with metastatic or unresectable advanced sarcoma of rare subtype; previously treated by anthracycline-based regimen except for whom standard therapy does not exist or is not considered appropriate by the Investigator.
In the experimental arm, patients will receive the combination of Nivolumab + Ipilimumab for a maximum of 24 months, whereas in the control arm, patients will receive Pazopanib alone.
The purpose of the study is to know if the combination of nivolumab + ipilimumab can be more efficient than Pazopanib in terms of Progression-Free Survival.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
I1. Age ≥ 18 years at the day of consenting to the study;
I2. Only histologically confirmed sarcoma of rare subtype, defined as one of the following subtypes:
* Angiosarcoma (AS)
* Alveolar Soft Part Sarcoma (ASPS)
* Clear Cell Sarcoma (CCSA)
* Desmoplastic Small Round Cell Tumour (DSRCT)
* Sclerosing Epithelioid Fibrosarcoma (SEF)
* Perivascular Epithelioid Cell Tumour (PEComa)
* Intimal sarcoma (IS)
* Extraskeletal Myxoid Chondrosarcoma (EMC)
* Solitary Fibrous Tumour (SFT)
* Epithelioid HemangioEndothelioma (EHE)
* Inflammatory Myofibroblastic Tumour (IMT)
* Epithelioid sarcoma (ES)
* FibroSarcoma (FS)
* SMARCA-4 deficient sarcoma
* Malign Peripheral Nerve Sheath Tumours (MPNST)
* Chordoma;
I3. Metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator;
I4. Measurable disease as per the RECIST version 1.1;
I5. Previously treated with anthracycline-based regimen except for whom standard therapy does not exist or is not considered appropriate by the Investigator: inclusion in first line is allowed (randomisation will be stratified according to the number of previous treatment lines);
I6. Performance Status (ECOG) of 0 or 1;
I7. Patients must have an adequate organ and bone marrow function at baseline;
* Absolute neutrophil count (ANC) ≥ 1.0 x 10 G/L
* Platelets ≥ 100 x 10 G/L
* Haemoglobin ≥ 9 g…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.