CompletedPhase 2

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

France68 participantsStarted 2020-02-27

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histology: participant with soft tissue sarcoma histologically confirmed and reviewed by the RRePS Network as recommended by the French NCI (Inca),
✓. 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,
✓. Deleted MSA5
✓. 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,
✓. Advanced non resectable / metastatic disease,
✓. 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.
✓. At least one tumor site that can be biopsied for research purpose,
✓. Previous treatment: no more than 2 previous lines of systemic therapy for advanced or metastatic disease

✕. Previous treatment with an PD1/PDL1, LAG-3
✕. Previous enrolment in the present study,
✕. Evidence of progressive or symptomatic central nervous system (CNS) or leptomeningeal metastases,
✕. Women who are pregnant or breast feeding,
✕. Participant unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons,
✕. Known hypersensitivity to any involved study drug or of its formulation components,
✕. Participation to a study involving a medical or therapeutic intervention in the last 30 days,
✕. Uncontrolled cardiac arrhythmia or hypertension, as per investigator discretion,

Assessment of the antitumor activity of nivolumab in association with relatlimab independently for each arm

Timeframe: 6 months

NCT IDNCT04095208

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-29

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histology: participant with soft tissue sarcoma histologically confirmed and reviewed by the RRePS Network as recommended by the French NCI (Inca),
✓. 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,
✓. Deleted MSA5
✓. 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,
✓. Advanced non resectable / metastatic disease,
✓. 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.
✓. At least one tumor site that can be biopsied for research purpose,
✓. Previous treatment: no more than 2 previous lines of systemic therapy for advanced or metastatic disease

✕. Previous treatment with an PD1/PDL1, LAG-3
✕. Previous enrolment in the present study,
✕. Evidence of progressive or symptomatic central nervous system (CNS) or leptomeningeal metastases,
✕. Women who are pregnant or breast feeding,
✕. Participant unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons,
✕. Known hypersensitivity to any involved study drug or of its formulation components,
✕. Participation to a study involving a medical or therapeutic intervention in the last 30 days,
✕. Uncontrolled cardiac arrhythmia or hypertension, as per investigator discretion,