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Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study | Clinical Trials | Clareo Health

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Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study

Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study.

NCT04095208•Institut Bergonié

View on ClinicalTrials.gov

Summary

This is a multicenter study assessing the efficacy of nivolumab in association with relatlimab.

Detailed Description

This multicenter, prospective, open-labeled 2-arm, randomized non-comparative phase II trial. This phase II trial is based on a 2-stage Simon's optimal design. Randomization 1:1 with 1 patient randomized in experimental arm A (association of nivolumab plus relatlimab) and 1 patient randomized in arm B (treatment by nivolumab alone).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histology: participant with soft tissue sarcoma histologically confirmed and reviewed by the RRePS Network as recommended by the French NCI (Inca),
•2. Presence of mature tertiary lymphoid structures (TLS). Except if presence of TLS have been already confirmed by Biopathological platform at Bergonié Institute, presence of TLS should be confirmed by central review based on FFPE (Formalin-Fixed Paraffin-Embedded) tumor tissue sample (archived or newly obtained by biopsy for research purpose). Note that the presence of TLS could be determined by central analysis if not available before,
•3. Deleted MSA5
•4. For research purpose, have provided tissue of a tumor lesion from \< 3 months old archival tissue sample (both frozen or FFPE) obtained on locally advanced disease, or metastasis, with no subsequent treatment since or presence of tumor lesion that can be biopsied,
•5. Advanced non resectable / metastatic disease,
•6. Documented progression according to RECIST criteria, unless the participant has no received prior systemic treatment for advanced disease. Progression on the last line of treatment should be confirmed by central review with two radiological assessments identical (CT scans or MRI) obtained at less than 6 months interval within the 12 months before inclusion.
•7. At least one tumor site that can be biopsied for research purpose,
•8. Previous treatment: no more than 2 previous lines of systemic therapy for advanced or metastatic disease
•9. Participant must have advanced disease and must not be a candidate for other approved therapeutic regimen known to provide significant clinical benefit based on investigator judgement,
•10. Age ≥ 18 years,
+22 more criteria

Exclusion Criteria

•1. Previous treatment with an PD1/PDL1, LAG-3
•2. Previous enrolment in the present study,
•3. Evidence of progressive or symptomatic central nervous system (CNS) or leptomeningeal metastases,
•4. Women who are pregnant or breast feeding,
•5. Participant unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons,
•6. Known hypersensitivity to any involved study drug or of its formulation components,
•7. Participation to a study involving a medical or therapeutic intervention in the last 30 days,
•8. Uncontrolled cardiac arrhythmia or hypertension, as per investigator discretion,
•9. Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
•1. Myocardial infarction or stroke/transient ischemic attack within the 6 months prior to study entry.
+25 more criteria

Locations (5)

Institut Bergonié

Bordeaux, France

Centre Léon Bérard

Lyon, France

Institut de Cancérologie de l'Ouest - Site René Gauducheau

Nantes, France

Hôpital Cochin

Paris, France

Institut Gustave Roussy

Villejuif, France

Key Dates

Start Date

February 27, 2020

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

October 2, 2025

Enrollment

ESTIMATED participants

Conditions

Soft Tissue Sarcoma AdultAdvanced Cancer

Interventions

Association of Nivolumab + Relatlimab

DRUG

Nivolumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study

Inclusion Criteria

Exclusion Criteria

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