Combining Epigenetic And Immune Therapy to Beat Cancer.

Sponsor
Institut Bergonié
Study ID
NCT04705818
Phase
PHASE2
Status
Completed

Conditions

  • Adult Solid Tumor
  • Advanced Colorectal Carcinoma
  • Advanced Pancreatic Adenocarcinoma
  • Advanced Soft-tissue Sarcoma
  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab will be administered by intraveinous infusion (1120 mg) on day 1, every 3 weeks. Treatment by durvalumab will start on Day 22 (i.e., day 1 of cycle 2)
  • Tazemetostat — DRUG
    Tazemetostat will be administered per-os, twice daily (800 mg x 2), continuously. Treatment by tazemetostat will start on day 1 (of cycle1).

Study Details

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

Key Dates

Start date
Jul 23, 2021
Status verified
Mar 2026
Primary completion
Jan 7, 2024
Completion
Jul 17, 2025

Study Design

Enrollment
164 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: pancreatic cancer
    Patients with pancreatic cancer will be treated by durvalumab prescribed in association with tazemetostat
  • Experimental: Cohort B: not MSI-H or MMR-deficient colorectal cancer
    Patients with colorectal cancer will be treated bydurvalumab prescribed in association with tazemetostat
  • Experimental: Cohort C: metastatic solid tumor
    Patients with metastatic solid with positive interferon gamma signature and/or presence of tertiary lymphoid structurestumor will be treated bydurvalumab prescribed in association with tazemetostat
  • Experimental: Cohort D: soft-tissue sarcoma
    Patients with soft-tissue sarcoma will be treated by durvalumab prescribed in association with tazemetostat

Primary Outcome Measure

Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort A [ Time Frame: Within 6 months of treatment onset ]

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