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RAR-Immune: A randomised, comparative, prospective, multicentre study of the efficacy of nivolumab + ipilimumab versus pazopanib alone in patients with metastatic or unresectable advanced sarcoma of rare subtype
EU CTIS ID: 2024-513982-38-00
What this study is testing
The primary objective is to compare the efficacy (Progression-Free Survival) of nivolumab + ipilimumab versus pazopanib in the treatment of patients with metastatic or unresectable advanced rare sarcomas.
- 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
- I1. Age ≥ 18 years at the day of consenting to the study ;
- I10. Ability to understand and willingness for follow-up visits;
- I11. Covered by a medical insurance;
- I12. Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
- I2. Only histologically confirmed sarcoma of rare subtype, defined as one of the following subtypes: - AS (Angiosarcoma) - ASPS (Alveolar Soft Part Sarcoma) - CCSA (Clear Cell Sarcoma) - DSRCT (Desmoplastic Small Round Cell Tumour) - SEF (Sclerosing Epithelioïd Fibrosarcoma) - PEComa (Perivascular Epithelioid Cell Tumour) - IS (Intimal sarcoma) - EMC (Extraskeletal Myxoid Chondrosarcoma) - SFT (Solitary Fibrous Tumour) - EHE (Epithelioid HemangioEndothelioma) - IMT (Inflammatory Myofibroblastic Tumour) - ES (Epithelioïd sarcoma) - FS (FibroSarcoma) - SMARCA-4 deficient sarcoma - MPNST (Malign Peripheral Nerve Sheath Tumours) - Chordoma; - MC (Mesenchymal Chondrosarcoma) - LGFMS (Low Grade FibroMyxoid sarcoma) - KS (Kaposi’s Sarcoma)
- 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 ;
You likely can't join if
- E1. Concurrent use of any other approved or investigational antineoplastic agent;
- E10. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan;
- E11. Patients with a high-risk of hemorrhage or history of coagulopathy;
- E12. Any contraindication to nivolumab, to ipilimumab or to pazopanib according to the Summary of Product Characteristics of each drug;
- E13. History of other malignancy other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of disease for at least 3 years;
- E14. Patient under tutorship or curatorship of deprived of liberty;
See the full eligibility criteria
Who can join
- I1. Age ≥ 18 years at the day of consenting to the study ;
- I10. Ability to understand and willingness for follow-up visits;
- I11. Covered by a medical insurance;
- I12. Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
- I2. Only histologically confirmed sarcoma of rare subtype, defined as one of the following subtypes: - AS (Angiosarcoma) - ASPS (Alveolar Soft Part Sarcoma) - CCSA (Clear Cell Sarcoma) - DSRCT (Desmoplastic Small Round Cell Tumour) - SEF (Sclerosing Epithelioïd Fibrosarcoma) - PEComa (Perivascular Epithelioid Cell Tumour) - IS (Intimal sarcoma) - EMC (Extraskeletal Myxoid Chondrosarcoma) - SFT (Solitary Fibrous Tumour) - EHE (Epithelioid HemangioEndothelioma) - IMT (Inflammatory Myofibroblastic Tumour) - ES (Epithelioïd sarcoma) - FS (FibroSarcoma) - SMARCA-4 deficient sarcoma - MPNST (Malign Peripheral Nerve Sheath Tumours) - Chordoma; - MC (Mesenchymal Chondrosarcoma) - LGFMS (Low Grade FibroMyxoid sarcoma) - KS (Kaposi’s Sarcoma)
- 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. ECOG Performance Status of 0 or 1;
- I7. Patients must have an adequate organ and bone marrow function at baseline;
- I8. Women of childbearing potential must have a negative serum pregnancy test within 7 days before C1D1
- I9. Women of childbearing potential must agree to use 1 highly effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drugs.
What rules you out
- E1. Concurrent use of any other approved or investigational antineoplastic agent;
- E10. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan;
- E11. Patients with a high-risk of hemorrhage or history of coagulopathy;
- E12. Any contraindication to nivolumab, to ipilimumab or to pazopanib according to the Summary of Product Characteristics of each drug;
- E13. History of other malignancy other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of disease for at least 3 years;
- E14. Patient under tutorship or curatorship of deprived of liberty;
- E15. Pregnant or breast-feeding woman
- E2. Prior or concurrent treatment with any antibody targeting PD1, PDL1, PDL2 or CTLA4;
- E3. Prior treatment with pazopanib;
- E4. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Note: Asymptomatic patients with treated CNS lesions are eligible,
- E5. . Patients using, or requirement to use while on the study, or not respecting the minimal wash-out period of medications listed below:...See the protocol
- E6. History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis with the following exceptions: • patients with a history of autoimmune-related hypothyroidism who are on stable thyroid replacement hormone therapy, • patients with controlled Type 1 diabetes mellitus, • patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are eligible provided that they meet the following conditions: o Rash must cover less than 10% of body surface area (BSA). o Disease is well controlled at baseline and only requiring low potency topical steroids. o no acute exacerbations of underlying condition within the previous 12 months requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids;
- E7. Patients with HIV, active B or C hepatitis infection, or any other active infection.
- E8. Patients with active tuberculosis;
- E9. Prior allogeneic bone marrow transplantation or solid organ transplant for another malignancy in the past;
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.