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Advanced Solid TumorPhase 2CAIRENCT04705818

Combining Epigenetic And Immune Therapy to Beat Cancer.

A Phase 2 study testing Durvalumab and Tazemetostat in people with Advanced Solid Tumor and Advanced Colorectal Carcinoma, run by Institut Bergonié at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Durvalumab and Tazemetostat
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
3 sitesFrance
Study dates
23 Jul 2021to 17 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Note: for cohort C, IFNG gene expression and/or presence of tertiary lymphoid structure will be centrally assessed. Cohort D, diagnosis must be confirmed and reviewed by the RRePS Network.as recommended by the French NCI (Inca).
  • 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,
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  • 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,
  • Adequate hematological, renal, metabolic and hepatic functions
  • No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
  • At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and/or radiotherapy,
  • Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment, excluding alopecia of any grade and non-painful peripheral neuropathy grade ≤ 2
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to inclusion.
  • Both women and men must agree to use a highly effective method of contraception throughout the treatment period and for at least nine months after discontinuation of treatment for women and six months after discontinuation of treatment for men.
  • Voluntary signed and dated written informed consents prior to any specific study procedure,
  • Participants with a social security in compliance with the French law.

Who cannot join

  • 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,
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  • 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,
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment,
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan or interstitial lung disease with ongoing signs and symptoms at inclusion. History of radiation pneumonitis in the radiation field (fibrosis) is permitted,
  • Has known active tuberculosis, hepatitis B or hepatitis C,
  • Has a known history of Human Immunodeficiency Virus or known acquired immunodeficiency syndrome,
  • Persistent proteinuria > 3.5 g/24 hours measured by urine protein-creatinine ratio from a random urine sample (≥ Grade 3, NCI-CTCAE v5),
  • Major surgical procedure or significant traumatic injury within 28 days before inclusion,
  • Non-healing wound, non-healing ulcer, or non-healing bone fracture,
  • Participants with evidence or history of any bleeding diathesis, irrespective of severity,
  • Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to inclusion,
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before inclusion (except for adequately treated catheter-related venous thrombosis occurring more than one month before inclusion),
  • Ongoing infection > Grade 2 as per NCI CTCAE v5,
  • Uncontrolled hypertension (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg) despite optimal medical management,
  • Congestive heart failure ≥ New York Heart Association class 2,
  • Unstable angina, new-onset angina (begun within the last 3 months),
  • Myocardial infarction less than 6 months before inclusion,
  • Uncontrolled cardiac arrhythmias,
  • Pregnant or breast-feeding participants,
  • Individuals deprived of liberty or placed under legal guardianship,
  • Prior organ transplantation, including allogeneic stem cell transplantation,
  • Known alcohol or drug abuse,
  • Participants with any condition that impairs their ability to swallow and retain tablets,
  • Other severe acute or chronic medical conditions including immune inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study,
  • Participant with anti-Vitamine K oral anticoagulation therapy,
  • Suspected or known intraabdominal fistula,
  • Screening QTc interval > 480 msec is excluded,
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment.
  • Participants with a prior history of myeloid malignancies, including myelodysplastic syndromes (MDS), acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN),
  • Participants with a prior history of T-cell lymphoblastic lymphoma (T-LBL) / T-cell lymphoblastic leukemia (T-ALL).

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Institut Bergonie

    Bordeaux, 33076

  • CHRU Brest

    Brest, 29200

  • CHU Poitiers

    Poitiers, 86000

Other trials in France

About this study

Official title: Combining Epigenetic And Immune Therapy to Beat Cancer. CAIRE Study

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

Read the detailed description

4 independant, multicenter, prospective, signle-arm phase II trials, based on 2-stage Simon's optimal design, will be conducted in parallel to assess the efficacy of durvalumab when prescribed with tazemetostat, separately, in distinct cohorts of solid tumors:

  • cohort A: patients with pancreatic cancer
  • cohort B: patients with colorectal cancer not MSI-H or MMR-deficient
  • cohort C: patients with metastatic solid tumors with positive interferon gamma signature and/or tertiary lymphoid structure positive
  • cohort D: patients with soft-tissue sarcoma
Being tested
Durvalumab, Tazemetostat
Keywords
tertiary lymphoid structure, pancreatic cancer, soft-tissue sarcoma, immunotherapy, colorectal cancer, solid tumor, epigenetic
Medical subject headings
Tertiary Lymphoid Structures, Pancreatic Neoplasms, Sarcoma, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    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)

  • TazemetostatDrug

    Tazemetostat will be administered per-os, twice daily (800 mg x 2), continuously. Treatment by tazemetostat will start on day 1 (of cycle1).

Study groups in NCT04705818
Study groupRoleWhat they receive
Cohort A: pancreatic cancerExperimentalPatients with pancreatic cancer will be treated by durvalumab prescribed in association with tazemetostat
Receives: Drug: Durvalumab; Drug: Tazemetostat
Cohort B: not MSI-H or MMR-deficient colorectal cancerExperimentalPatients with colorectal cancer will be treated bydurvalumab prescribed in association with tazemetostat
Receives: Drug: Durvalumab; Drug: Tazemetostat
Cohort C: metastatic solid tumorExperimentalPatients with metastatic solid with positive interferon gamma signature and/or presence of tertiary lymphoid structurestumor will be treated bydurvalumab prescribed in association with tazemetostat
Receives: Drug: Durvalumab; Drug: Tazemetostat
Cohort D: soft-tissue sarcomaExperimentalPatients with soft-tissue sarcoma will be treated by durvalumab prescribed in association with tazemetostat
Receives: Drug: Durvalumab; Drug: Tazemetostat

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Antitumor activity will be assessed in terms of disease control rate, defined as complete response (CR), partial response (PR) and stable disease (SD) as per RECIST v1.1 criteria

    Measured: Within 6 months of treatment onset

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

    Antitumor activity will be assessed in terms of disease control rate, defined as CR, PR and SD as per RECIST v1.1 criteria

    Measured: Within 6 months of treatment onset

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

    Antitumor activity will be assessed in terms of objective response rate, defined as CR and PR as per RECIST v1.1 criteria

    Measured: Within 6 months of treatment onset

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

    Antitumor activity will be assessed in terms of 6-months progression-free rate, defined as CR, PR and SD as per RECIST v1.1 criteria

    Measured: 6 months

Secondary outcomes (13)

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

    Antitumor activity will be assessed in terms of objective response rate, defined as CR and PR as per RECIST v1.1 criteria

    Measured: Within 6 months of treatment onset

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

    Antitumor activity will be assessed in terms of 6-months progression-free rate, defined as CR, PR and SD as per RECIST v1.1 criteria

    Measured: 6 months

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

    Antitumor activity will be assessed in terms of 6-months progression-free rate, defined as CR, PR and SD as per RECIST v1.1 criteria

    Measured: 6 months

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

    Antitumor activity will be assessed in terms of 6-months progression-free rate, defined as CR, PR and SD as per RECIST v1.1 criteria

    Measured: 6 months

  5. 6-month objective response (OR) independently for each population

    Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed at 6 months, based on RECIST 1.1 criteria

    Measured: 6 months

  6. Best overall response, independently for each population

    Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determinded once all the data for the patient is known (RECIST 1.1)

    Measured: Throughout the treatment period, an expected average of 6 months

  7. 1-year progression-free survival, independently for each population

    Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first

    Measured: 1 year

  8. 1-year overall survival, independently for each population

    Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause)

    Measured: 1 year

  9. Safety profile, independently for each population: Common Terminology Criteria for adverse events version 5

    Toxicity graded using the Common Terminology Criteria for Adverse Events vers 5

    Measured: Throughout the treatment period, an expected average of 6 months

  10. Tumor immune cell levels

    Levels of immune cells in tumors will be measured by immunohistochemistry

    Measured: before treatment onset, cycle 2 day 1 and cycle 3 day 1 (each cycle is 21 days)

  11. Blood cytokines level

    Levels of cytokines in blood will be measured by ELISA

    Measured: before treatment onset, cycle 2 day 1, cycle 3 day 1 and treatment discontinuation (each cycle is 21 days)

  12. Blood lymphocytes level

    Levels of lymphocytes in blood will be measured by flow cytometry

    Measured: before treatment onset, cycle 2 day 1, cycle 3 day 1 and treatment discontinuation (each cycle is 21 days)

  13. Blood kynurenin level

    Levels of kynurenin in blood will be measured by ELISA

    Measured: before treatment onset, cycle 2 day 1, cycle 3 day 1 and treatment discontinuation (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2021
  2. Study start23 Jul 2021
  3. Primary completion7 Jan 2024
  4. Study completion17 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
4 independant single-arm, phase II trials, based on 2-stage Simon's optimal design: * cohort A: pancreatic cancer * cohort B: not MSI-H or MMR-deficient colorectal cancer * cohort C: metastatic solid tumor with positive interferon gamma signature and/or prensece of tertiary lymphoid structure * cohort D: soft-tissue sarcoma
Masking
None (open label)
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04705818
Sponsor's protocol ID
IB2019-04
Other IDs
2019-003303-35, 2019
Acronym
CAIRE
Status last verified
Mar 2026
First submitted
11 Jan 2021
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab and Tazemetostat in people with Advanced Solid Tumor and Advanced Colorectal Carcinoma, run by Institut Bergonié at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort A (time frame: Within 6 months of treatment onset). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04705818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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