CompletedPhase 2

Combining Epigenetic And Immune Therapy to Beat Cancer.

France164 participantsStarted 2021-07-23

Plain-language summary

Umbrella study structure to independently and simultaneously assess the effects of the association of durvalumab and tazemetostat in multiple solid tumors.

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.

Inclusion criteria

✓. Histology: histologically confirmed solid tumors including pancreatic cancer (cohort A), non MSI-H or MMR-deficient colorectal cancer (cohort B), solid tumor with positive IFNG gene expression signature and/or tertiary lymphoid structure positive (cohort C), soft-tissue sarcomas (Cohort D). Other solid tumor types may be included through future amendment of the current version of the study protocol.
✓. For cohort C, availability of archived FFPE tumor tissue sample for IFNG gene expression assessment and/or determination of the presence of tertiary lymphoid structure,
✓. Advanced disease defined as metastatic or unresectable locally advanced disease,
✓. Age ≥ 18 years,
✓. ECOG, Performance status ≤ 1,
✓. Measurable disease according to RECIST
✓. Life expectancy \> 3 months,
✓. 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 judgment,

Exclusion criteria

✕. Previous treatment with durvalumab or tazemetostat,
✕. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody,
✕. EGFR/ALK/ROS mutated NSCLC,
✕. Evidence of progressive or symptomatic central nervous system or leptomeningeal metastases,
✕. Participation to a study involving a medical or therapeutic intervention in the last 30 days,
✕. Previous enrolment in the present study,
✕. 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,

What they're measuring

Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort A

Timeframe: Within 6 months of treatment onset

Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort B

Timeframe: Within 6 months of treatment onset

Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort C

Timeframe: Within 6 months of treatment onset

Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort D

Timeframe: 6 months

Trial details

NCT IDNCT04705818

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-07

View on ClinicalTrials.gov More Advanced Solid Tumor trials

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.

Inclusion criteria

✓. Histology: histologically confirmed solid tumors including pancreatic cancer (cohort A), non MSI-H or MMR-deficient colorectal cancer (cohort B), solid tumor with positive IFNG gene expression signature and/or tertiary lymphoid structure positive (cohort C), soft-tissue sarcomas (Cohort D). Other solid tumor types may be included through future amendment of the current version of the study protocol.
✓. For cohort C, availability of archived FFPE tumor tissue sample for IFNG gene expression assessment and/or determination of the presence of tertiary lymphoid structure,
✓. Advanced disease defined as metastatic or unresectable locally advanced disease,
✓. Age ≥ 18 years,
✓. ECOG, Performance status ≤ 1,
✓. Measurable disease according to RECIST
✓. Life expectancy \> 3 months,
✓. 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 judgment,

Exclusion criteria

✕. Previous treatment with durvalumab or tazemetostat,
✕. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody,
✕. EGFR/ALK/ROS mutated NSCLC,
✕. Evidence of progressive or symptomatic central nervous system or leptomeningeal metastases,
✕. Participation to a study involving a medical or therapeutic intervention in the last 30 days,
✕. Previous enrolment in the present study,
✕. 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,

What they're measuring

Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort A

Timeframe: Within 6 months of treatment onset

Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort B

Timeframe: Within 6 months of treatment onset

Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort C

Timeframe: Within 6 months of treatment onset

Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort D

Timeframe: 6 months