Study of the efficacy of nivolumab + ipilimumab versus pazopanib alone in patients with metastatic or unresectable advanced sarcoma of rare subtype

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002821-28-FR

Enrollment

Registered

2020-10-23

Start date

2020-12-24

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic or unresectable advanced rare sarcomas

Interventions

Trade Name: Opdivo Product Name: Nivolumab Pharmaceutical Form: Solution for injection INN or Proposed INN: NIVOLUMAB CAS Number: NIVOLUMAB Current Sponsor code: ET20-128 Other descriptive name: NIVOL

Eligibility

Sex/Gender

All

Inclusion criteria

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 : - 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 ; 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) ; ...See the protocol 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48

Exclusion criteria

Exclusion criteria: E1. Concurrent use of any other approved or investigational antineoplastic agent ; 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 médications ; ...See the protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: Secondary objectives will include the following clinical and translational objectives: • To determine in both study arms: • The Best Overall Response (BOR), the Objective Response Rate (ORR) and the duration of response (DOR); • The Time to Treatment Failure (TTF); • The Overall Survival (OS); • The Quality of Life (QoL); • The profile of tolerance. • To determine in the experimental arm The Progression-Free Survival using the iRECIST (immune Response Evaluation Criteria for Solid Tumours). • Translational objectives will be to: i) Quantify tumour PD-L1 expression and Combined Positive Score (CPS) in patients in both arms ii) Identify the predictive biomarkers of treatment response;Primary end point(s): The primary endpoint will be Progression-Free Survival.;Timepoint(s) of evaluation of this end point: Progression-Free Survival : defined as the time from the date of randomisation to the date of first documented progression or death due to any cause. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: Secondary objectives will include the following clinical and translational objectives: • To determine in both study arms: • The Best Overall Response (BOR), the Objective Response Rate (ORR) and the duration of response (DOR); • The Time to Treatment Failure (TTF); • The Overall Survival (OS); • The Quality of Life (QoL); • The profile of tolerance. • To determine in the experimental arm The Progression-Free Survival using the iRECIST (immune Response Evaluation Criteria for Solid Tumours). • Translational objectives will be to: i) Quantify tumour PD-L1 expression and Combined Positive Score (CPS) in patients in both arms ii) Identify the predictive biomarkers of treatment response;Primary end point(s): The primary endpoint will be Progression-Free Survival.;Timepoint(s) of evaluation of this end point: Progression-Free Survival : defined as the time from the date of randomisation to the date of first documented progression or death due to any cause. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints : Best Overall Response Objective Response Rate Duration of response Time to Treatment Failure Overall Survival Quality of Life Tolerance profile Progression-Free Survival ;Timepoint(s) of evaluation of this end point: Throughout the study Each tumor assessment	—

Countries

France

Contacts

Public ContactDRCI

Centre Léon Bérard

severine.metzger@lyon.unicancer.fr+33478 78 27 86

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026