A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.

Phase 3

Recruiting

• Conditions: Relapsed/Refractory Follicular Lymphoma; Refractory Follicular Lymphoma; Follicular Lymphoma
• Interventions: Drug: Placebo oral tablet; Drug: Tazemetostat; Combination Product: Lenalidomide; Combination Product: Rituximab

• Registration Number: NCT04224493
• Lead Sponsor: Epizyme, Inc.

Brief Summary

The participants of this study would have relapsed/refractory follicular lymphoma.

Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works.

Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed.

Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment.

Detailed Description

Stage 1 is a safety run-in phase, was designed to evaluate the safety of the combination of tazemetostat and R2, as well as to establish the RP3D for Stage 2, which is now completed.

Stage 2 is an efficacy and safety phase for an assessment of the FL population with the enhancer of zeste homolog 2 (EZH2) gain-of-function (GOF) mutation (EZH2 mutant-type \[MT\]) and without the EZH2 GOF mutation (EZH2 wild-type \[WT\]). In Stage 2, EZH2 WT and EZH2 MT patients will be randomly assigned in a 1:1 ratio to tazemetostat + R2 or placebo + R2. There will be 1 futility interim analysis (IA) and 1 efficacy IA for WT population and 1 efficacy IA for MT population.

Stage 3 is a long-term follow-up of patients for assessment of response and overall survival. All patients will be followed for survival until 5 years post last patient enrolled in the study.

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-06-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Primary Completion: 2026-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 612

Inclusion Criteria

1. Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.

2. Males or females are ≥18 years of age at the time of providing voluntary written informed consent.

3. Life expectancy ≥3 months before enrollment.

4. Meet requirement for hepatitis and human immunodeficiency virus (HIV) infection as follows

   • Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection Note: Participants whose HBV infection status could not be determined by serologic test results have to be negative for HBV-DNA by PCR to be eligible for study participation. Participants seropositive for HBV with undetectable HBV DNA by PCR are permitted with appropriate antiviral prophylaxis.
   • Negative test results for hepatitis C virus (HCV) Note: Participants who are positive for HCV antibody must be negative for HCV RNA by PCR to be eligible for study participation
   • If HIV positive, HIV infection is controlled

5. Have histologically confirmed FL, Grades 1 to 3A.

6. Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:

   a. Systemic therapy includes treatments such as:

   i. Rituximab monotherapy

   ii. Chemotherapy given with or without rituximab

   iii. Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab.

   b. Systemic therapy does not include, for example:

   i. Local involved field radiotherapy for limited-stage disease

   ii. Helicobacter pylori eradication

   c. Prior investigational therapies will be allowed provided the subject has received at least 1 prior systemic therapy as discussed in Inclusion Criterion #6a.

   d. Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed.

   e. Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed.

7. Must have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression <6 months after last dose).

8. Have measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

10. Within 7 days prior to randomization, all clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy must have either resolved to Grade 1 per NCI CTCAE Version 5.0 OR are clinically stable and no longer clinically significant.

11. Have provided sufficient tumor tissue block or unstained slides for EZH2 mutation testing in all subjects to allow for stratification

    a. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled. Tumor tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than 24 months prior to the anticipated administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections mounted on slides are also acceptable.

    NOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor's or Designee Medical Monitor.

12. Time between prior anticancer therapy and first dose of tazemetostat as follows:

    1. Cytotoxic chemotherapy - At least 21 days.
    2. Noncytotoxic chemotherapy (eg, small molecule inhibitor) - At least 14 days.
    3. Nitrosoureas - At least 6 weeks.
    4. Monoclonal and/or bispecific antibodies or CAR T - At least 28 days.
    5. Radiotherapy - At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.

13. Adequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula.

14. Adequate bone marrow function:

    a. Absolute neutrophil count (ANC) ≥1000/mm3 (≥1.0 × 10^9/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥75 × 10^9/L) with bone marrow infiltration

    • Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days.

      b. Platelets ≥75,000/mm3 (≥75 × 10^9/L)

    • Evaluated at least 7 days after last platelet transfusion.

      c. Hemoglobin ≥9.0 g/dL

    • May receive transfusion

15. Adequate liver function:

    1. Total bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.
    2. Alkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver infilration).

16. International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended.

17. Females of childbearing potential (FCBP) must have a negative urine or serum pregnancy tests (beta-human chorionic gonadotropin [β-hCG] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening within 10 to 14 days prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic [amenorrhea following cancer therapy does not rule out childbearing potential] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing).

18. Females of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception:

    Examples of highly effective methods:

    • Intrauterine device (IUD)
    • Hormonal (ovulation inhibitory combined [estrogen and progesterone] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrel-releasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel]) NOTE: There is a potential for tazemetostat interference with hormonal contraception methods due to enzymatic induction.
    • Bilateral tubal ligation
    • Partner's vasectomy (if medically confirmed [azoospermia] and sole sexual partner).

    Examples of additional effective methods:

    • Male latex or synthetic condom,
    • Diaphragm,
    • Cervical Cap

    NOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.

19. All study participants enrolled must be registered into the applicable pregnancy prevention program (e.g. REVLIMID REMS in the US, Pregnancy Prevention Programme [PPP] in Europe, RevAid in Canada) for lenalidomide to be administered and be willing and able to comply with the requirements of the applicable program as appropriate for the country in which the drug is being used.

    a. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in theapplicable pregnancy prevention program. During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, at days 14 and 28 following the last dose of lenalidomide and at overall treatment discontinuation (at the End-of-Treatment/30-day safety Follow-up visit). Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR have had a total hysterectomy and/or bilateral oophorectomy.

20. Male subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.

NOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.

Exclusion Criteria

All Subjects

1. Prior exposure to tazemetostat or other inhibitor(s) of EZH2.

2. Prior exposure to lenalidomide or drugs of the same class.

3. Grade 3b, mixed histology, or FL that has histologically transformed to diffuse large B-cell lymphoma (DLBCL) (subjects transformed from DLBCL to FL may be enrolled).

4. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE Version 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN).

5. Has a prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL) or B-cell acute lymphoblastic leukemia (B-ALL).

6. Subjects with uncontrolled leptomeningeal metastases or brain metastases or history of previously treated brain metastases.

7. Subjects taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers (including St. John's wort).

8. Are unwilling to exclude grapefruit juice, Seville oranges, and grapefruits from the diet and/or consumed within 1 week of the first dose of study drug and for the duration of the study.

9. Major surgery within 4 weeks before the first dose of study drug.

   a. Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment.

10. Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat.

11. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia.

12. Prolongation of corrected QT interval using Fridericia's formula (QTcF) to ≥480 msec at screening or history of long QT syndrome.

13. Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat.

    a. Note: Participants who have experienced deep vein thrombosis/pulmonary embolism more than 3 months before enrollment are eligible but are recommended to receive prophylaxis.

14. Have an active infection requiring systemic therapy.

15. Known hypersensitivity to any component of tazemetostat or lenalidomide; known severe hypersensitivity to any component of rituximab requiring hospitalization or resuscitation.

16. Active viral infection with or seropositive for HBV: HBV surface antigen (HBsAg) positive OR HBsAg negative, anti-HBs positive and/or anti-HBc positive with detectable HBV DNA.

    NOTE: Subjects who are HBsAg negative, anti-HBs positive and/or anti-HBc positive, but with undetectable viral DNA and normal ALT are eligible. Subjects who are seropositive due to HBV vaccination (HBsAg negative, HBV surface antibody [anti-HBs] positive, and HBV core antibody [anti-HBc] negative) are eligible.

17. Active viral infection with hepatitis C virus (as measured by positive HCV antibody and detectable viral RNA, HIV), or known active infection with human T-cell lymphotropic virus.

    NOTE: Subjects with a history of hepatitis C infection (HCV antibody reactive) who have normal ALT and undetectable HCV RNA are eligible.

18. Any other medical or social condition that, in the Investigator's judgment, will interfere with a participant's ability to provide informed consent, to receive study drugs, or meet study demands, or that substantially increases the risk associated with the subject's participation in the study, or that may interfere with interpretation of results.

19. Female subjects who are pregnant or lactating/breastfeeding.

20. Subjects who have undergone a solid organ transplant.

21. Subjects with malignancies other than FL. a. Exception: Subjects with another malignancy who have been disease-free for 3 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Tazemetostat + R2 arm	Rituximab	Stage 1 (Phase 1b): This phase is now completed. * Tazemetostat was escalated from a starting dose of 400 mg PO twice daily to 600 mg PO twice daily to 800 mg PO twice daily in 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administred PO QD on days 1 to 21 for 12 cycles. Stage 2: * Tazemetostat 800 mg administered PO twice daily in continuous 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), PO QD on days 1 to 21 for 12 cycles. Maintenance Therapy (Stages 1 and 2): Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Placebo + R2 Arm	Placebo oral tablet	Stage 2: * Placebo administered PO twice daily in continuous 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles. Maintenance Therapy (Stage 2): Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. During maintenance, placebo will be continued until disease progression or unacceptable toxicity, or participant withdraws consent.
Placebo + R2 Arm	Lenalidomide	Stage 2: * Placebo administered PO twice daily in continuous 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles. Maintenance Therapy (Stage 2): Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. During maintenance, placebo will be continued until disease progression or unacceptable toxicity, or participant withdraws consent.
Tazemetostat + R2 arm	Lenalidomide	Stage 1 (Phase 1b): This phase is now completed. * Tazemetostat was escalated from a starting dose of 400 mg PO twice daily to 600 mg PO twice daily to 800 mg PO twice daily in 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administred PO QD on days 1 to 21 for 12 cycles. Stage 2: * Tazemetostat 800 mg administered PO twice daily in continuous 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), PO QD on days 1 to 21 for 12 cycles. Maintenance Therapy (Stages 1 and 2): Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.
Placebo + R2 Arm	Rituximab	Stage 2: * Placebo administered PO twice daily in continuous 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles. Maintenance Therapy (Stage 2): Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. During maintenance, placebo will be continued until disease progression or unacceptable toxicity, or participant withdraws consent.
Tazemetostat + R2 arm	Tazemetostat	Stage 1 (Phase 1b): This phase is now completed. * Tazemetostat was escalated from a starting dose of 400 mg PO twice daily to 600 mg PO twice daily to 800 mg PO twice daily in 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administred PO QD on days 1 to 21 for 12 cycles. Stage 2: * Tazemetostat 800 mg administered PO twice daily in continuous 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), PO QD on days 1 to 21 for 12 cycles. Maintenance Therapy (Stages 1 and 2): Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.

Primary Outcome Measures

Name	Time	Method
Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)	Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 was selected at the end of Stage 1	The safety and tolerability of tazemetostat in combination with R2 in subjects with R/R FL will be evaluated. RP3D of tazemetostat for further evaluation in phase 3 will be selected as assessed by the occurrence of treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs).
Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) population	Stage 2: Up to 72 months	PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators.
PFS in the Intent-to-treat mutant-type (ITT-MT) population	Stage 2: Up to 72 months	PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators.

Secondary Outcome Measures

Name	Time	Method
OS in the ITT-MT population	Stage 2: Up to 96 months
PFS in the ITT-WT population, assessed by a blinded IRC	Stage 2: Up to 96 months
Percentage of study drug taken by participants	Up to 36 months
PK of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit: Time to Maximum Observed Drug Concentration (Tmax)	Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration [AUC(0-t)],	Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to infinity [AUC(0-∞)]	Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
The apparent terminal elimination half-life (t1/2) of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit	Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
Complete Response Rate (CRR) in ITT-WT population	Stage 2: Up to 96 months	CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded Independent Review Committee (IRC).
Pharmacokinetics (PK) of tazemetostat: Maximum (peak) Observed Plasma Drug Concentration (Cmax).	Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)	Cmax will be recorded from the PK blood samples collected.
CRR in ITT-MT population	Stage 2: Up to 96 months	CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.
CRR in the Relapsed/Refractory (R/R) Follicular Lymphoma (FL) population regardless of mutation status	Stage 2: Up to 96 months	CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.
Objective Response Rate (ORR) in the ITT-WT population	Stage 2: Up to 96 months	ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.
OS in the R/R FL population regardless of mutation status	Stage 2: Up to 96 months
ORR in the ITT-MT population	Stage 2: Up to 96 months	ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.
ORR in the R/R FL population regardless of mutation status	Stage 2: Up to 96 months	ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.
DOCR in the R/R FL population regardless of mutation status	Stage 2: Up to 96 months	DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.
Population PK parameters of oral volume of distribution (Vd/F) of tazemetostat.	Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)
Population PK parameters of first-order absorption rate constant (Ka) for tazemetostat.	Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)
Overall Survival (OS) in the ITT-WT population	Stage 2: Up to 96 months	OS is defined as the time from the date of randomization until death due to any cause.
PFS in the ITT-MT population, assessed by a blinded IRC	Stage 2: Up to 96 months
PFS in the R/R FL population regardless of mutation status, assessed by the Investigator	Stage 2: Up to 96 months
DOCR in the ITT-MT population	Stage 2: Up to 96 months	DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.
PFS in the R/R FL population regardless of mutation status, assessed by a blinded IRC	Stage 2: Up to 96 months
Duration Of Response (DOR) in the ITT-WT population	Stage 2: Up to 96 months	DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC.
DOR in the ITT-MT population	Stage 2: Up to 96 months	DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC.
DOR in the R/R FL population regardless of mutation status	Stage 2: Up to 96 months	DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC.
Duration Of Complete Response (DOCR) in the ITT-WT population	Stage 2: Up to 96 months	DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.
Disease Control Rate (DCR) in the ITT-WT population	Stage 2: Up to 96 months	DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC.
DCR in the ITT-MT population	Stage 2: Up to 96 months	DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC.
DCR in the R/R FL population regardless of mutation status	Stage 2: Up to 96 months	DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC.
Population PK parameters of oral clearance (CL/F) of tazemetostat	Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)	CL/F will be used to generate estimates of tazemetostat AUC
Percentage of Participants Experiencing Adverse Events (AEs)	Up to 36 months	An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of Participants with Clinically Significant Changes in Physical Examination	Up to 36 months	Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
Percentage of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Readings	Up to 72 months	Percentage of participants with clinically significant changes in ECG Readings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.
Performance status evaluated by Eastern Cooperation Oncology Group (ECOG)	Up to 72 months	ECOG is a 6-point performance status scale used to assess performance using PA as a key indicator (e.g., 0 = fully active, 2 = up and about more than 50% of walking hours, 5 = dead) Performance status will be assessed per usual clinical practice and will be recorded in the medical record.
Duration of Study Drug Exposure	Up to 36 months	Duration of exposure to study drug will be reported.
Quality of life questionnaires evaluation	Up to 36 months	Evaluate and compare health-related quality of life as measured by the EuroQOL 5-Dimension 5-Level (EQ-5D-5L) instrument and the Functional Assessment of Cancer Therapy -Lymphoma (FACT-Lym)
Percentage of Participants with Clinically Significant Changes in Vital Signs	Up to 36 months	Percentage of participants with clinically significant changes in vital signs findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.

Trial Locations

Locations (203)

Centre Hospitalier Docteur Schaffner; 🇫🇷 Lens, France

L'Hôpital Privé Confluent; 🇫🇷 Nantes, France

L'hôpital Privé du Concluent; 🇫🇷 Nantes, France

Hopital Saint Louis; 🇫🇷 Paris, France

IEO - Istituto Europeo di Oncologia, IRCCS; 🇮🇹 Milano, Italy

Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda; 🇮🇹 Milano, Italy

Ospedale Niguarda, ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italy

Ospedale San Gerardo, ASST di Monza; 🇮🇹 Monza, Italy

Texas Oncology; 🇺🇸 Plano, Texas, United States

Ospedale Civile S.Spirito, PO di Pescara, AUSL Pescara; 🇮🇹 Pescara, Italy

Southern Cancer Center; 🇺🇸 Mobile, Alabama, United States

Arizona Oncology Associates - Tuscon-Rusadill Road; 🇺🇸 Tucson, Arizona, United States

TOI - Clinical Research; 🇺🇸 Cerritos, California, United States

UCSF Fresno; 🇺🇸 Clovis, California, United States

UC San Diego Health Sciences; 🇺🇸 La Jolla, California, United States

UCLA Clinical Research Unit Hematology/Oncology; 🇺🇸 Santa Monica, California, United States

Rocky Mountain Cancer Centers (RMCC) - Boulder; 🇺🇸 Boulder, Colorado, United States

St. Mary's Hospital and Regional Medical Center - St. Mary's; 🇺🇸 Grand Junction, Colorado, United States

SCL Health Lutheran Medical Center; 🇺🇸 Greeley, Colorado, United States

Cancer Specialists of North Florida; 🇺🇸 Fleming Island, Florida, United States

Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center; 🇺🇸 Fort Myers, Florida, United States

Mayo Clinic - Cancer Clinical Research Office; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

Miami Cancer Institute; 🇺🇸 Miami, Florida, United States

Florida Cancer Affiliates/Ocala Oncology - Clinic; 🇺🇸 Ocala, Florida, United States

BRCR Medical Center, INC; 🇺🇸 Plantation, Florida, United States

Florida Cancer Specialists; 🇺🇸 Saint Petersburg, Florida, United States

Florida Cancer Specialists - Panhandle; 🇺🇸 Tallahassee, Florida, United States

H Lee Moffitt Cancer Center and Research Institute I; 🇺🇸 Tampa, Florida, United States

Florida Cancer Specialists & Research Institute (FCS) - Atlantis; 🇺🇸 West Palm Beach, Florida, United States

Kaiser Permanente Hawaii Moanalua Medical Center; 🇺🇸 Honolulu, Hawaii, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Illinois Cancer Specialists; 🇺🇸 Niles, Illinois, United States

June E. Nylen Cancer Center; 🇺🇸 Sioux City, Iowa, United States

The University of Kansas Cancer Center; 🇺🇸 Overland Park, Kansas, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

The office of Frederick P. Smith, MD, P.C.; 🇺🇸 Chevy Chase, Maryland, United States

Mass General Cancer Center at Newton-Wellesley; 🇺🇸 Newton, Massachusetts, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

St. Joseph Mercy Hospital; 🇺🇸 Ypsilanti, Michigan, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States

Saint Louis University Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

University Of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Astera Cancer Care; 🇺🇸 East Brunswick, New Jersey, United States

Astera Cancer Center; 🇺🇸 East Brunswick, New Jersey, United States

Regional Cancer Care Associates-Freehold; 🇺🇸 Freehold, New Jersey, United States

Hackensack University Medical John Theurer Cancer Center; 🇺🇸 Hackensack, New Jersey, United States

Regional Cancer Care Associates LLC - Howell; 🇺🇸 Howell, New Jersey, United States

Regional Cancer Care Associates LLC - Little Silver; 🇺🇸 Little Silver, New Jersey, United States

New Mexico Cancer Care Alliance; 🇺🇸 Albuquerque, New Mexico, United States

New York Oncology Hematology, P.C.; 🇺🇸 Albany, New York, United States

Northwell Health/Monter Cancer Center; 🇺🇸 Lake Success, New York, United States

Weill Cornell Medicine-New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Columbia U - Herbert Irving Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Hematology Oncology Associates of Rockland, P.C.; 🇺🇸 Nyack, New York, United States

Messino Cancer Center; 🇺🇸 Asheville, North Carolina, United States

Levine Cancer Institute - Concord; 🇺🇸 Concord, North Carolina, United States

FirstHealth of the Carolinas; 🇺🇸 Pinehurst, North Carolina, United States

Gabrail Cancer Center Research; 🇺🇸 Canton, Ohio, United States

Oncology Hematology Care (OHC), Inc. - Kenwood Office; 🇺🇸 Cincinnati, Ohio, United States

Willamette Valley Cancer Institute and Research Center - Oncology; 🇺🇸 Eugene, Oregon, United States

University of Pittsburgh Medical Center - Oncology; 🇺🇸 Pittsburgh, Pennsylvania, United States

Western Pennsylvania Hospital Hematology & Cellular Therapy; 🇺🇸 Pittsburgh, Pennsylvania, United States

Tennessee Oncology, PLLC; 🇺🇸 Chattanooga, Tennessee, United States

University of Tennessee Medical Center - Cancer Institute; 🇺🇸 Knoxville, Tennessee, United States

CHU de Clermont-Ferrand, site Estaing; 🇫🇷 Clermont-Ferrand, France

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Texas Oncology - Amarillo; 🇺🇸 Amarillo, Texas, United States

Texas Oncology-Austin Midtown; 🇺🇸 Austin, Texas, United States

Texas Oncology - Medical City Dallas Pediatric Hematology; 🇺🇸 Dallas, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Millennium Physicians - Oncology; 🇺🇸 Houston, Texas, United States

Mays Cancer Center; 🇺🇸 San Antonio, Texas, United States

UT Health East Texas HOPE Cancer Center - Tyler; 🇺🇸 Tyler, Texas, United States

USO Texas Oncology - Tyler; 🇺🇸 Tyler, Texas, United States

Texas Oncology- Weslaco; 🇺🇸 Weslaco, Texas, United States

Utah Cancer Specialists/ IHO Corp; 🇺🇸 Salt Lake City, Utah, United States

Huntsman Cancer Institute; The University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Peninsula Cancer Institute; 🇺🇸 Chesapeake, Virginia, United States

Virginia Cancer Specialists; 🇺🇸 Gainesville, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia Inc.; 🇺🇸 Roanoke, Virginia, United States

MC Rockwood Cancer Bl Specialty Ctr - North; 🇺🇸 Spokane, Washington, United States

Yakima Valley Memorial Hospital - North Star Lodge Cancer Center; 🇺🇸 Yakima, Washington, United States

Wheeling Hospital; 🇺🇸 Wheeling, West Virginia, United States

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Monash Health; 🇦🇺 Clayton, Victoria, Australia

Barwon Health, University Hospital Geelong; 🇦🇺 Geelong, Victoria, Australia

Hollywood Private Hospital; 🇦🇺 Nedlands, Western Australia, Australia

GenesisCare - St Andrew's; 🇦🇺 Adelaide, Australia

Peninsula Health - Frankston; 🇦🇺 Frankston, Australia

Gold Coast University Hosptial; 🇦🇺 Southport, Australia

CHU Dinant Godinne UCL Namur; 🇧🇪 Yvoir, Namur, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

UZ Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Vlaams Brabant, Belgium

University Health Network Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM); 🇨🇦 Montréal, Quebec, Canada

Sir Mortimer B Davis/Jewish General Hospital; 🇨🇦 Montréal, Quebec, Canada

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

The Affiliated Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Zhejiang, Hangzhou, China

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

The First Bethune Hospital of Jilin University; 🇨🇳 Changchun, Jinlin, China

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanxi Bethune Hospital; 🇨🇳 Taiyuan, Shanxi, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Tongji Hospital of Tongji Medical College of HUST; 🇨🇳 Hangzhou, China

Sichuan Provincial People's Hospital; 🇨🇳 Sichuan, China

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, China

Centre Hospitalier Universitaire de Bordeaux-Hopital du Haut Leveque; 🇫🇷 Pessac Cedex, Aquitaine, France

CHRU Brest Hôp Morvan; 🇫🇷 Brest, Bretagne, France

Institut Bergonie; 🇫🇷 Bordeaux, Gironde, France

Centre Hosp Mulh Hop Emile Muller; 🇫🇷 Mulhouse, Haut-Rhin, France

Centre Henri Becquerel; 🇫🇷 Rouen, Haute-Normandie, France

CHU de Limoges Dupuytren; 🇫🇷 Limoges, Haute-Vienne, France

CHU de Grenoble - Hopital Albe; 🇫🇷 La Tronche, Isere, France

CHU de Nantes - Hematologie; 🇫🇷 Nantes, Loire-Atlantique, France

CHRU de Lille Hop Claude Huriez; 🇫🇷 Lille, Nord, France

Centre Hospitalier Le Mans; 🇫🇷 Le Mans, Sarthe, France

Centre Hospitalier Universitaire D'Angers - Hématologie Clinique; 🇫🇷 Angers, France

CHRU de Besançon- Hopital Jean Minjoz; 🇫🇷 Besancon, France

CHU Caen; 🇫🇷 Caen, France

Centre Hospitalier Universitaire de Poitiers; 🇫🇷 Poitiers, France

Centre Hospitalier - Hôpital de jour d'Hématologie; 🇫🇷 Périgueux, France

CHU de Nancy Brabois; 🇫🇷 Vandœuvre-lès-Nancy, France

Centre Hospitalier Bretagne Atlantique; 🇫🇷 Vannes, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Hopital Henri Mondor - Hemopathies Lymphoides; 🇫🇷 Créteil, Île-de-France, France

Diakoneo Diak Schwaebisch Hall gGmbH; 🇩🇪 Schwäbisch Hall, Baden-Württemberg, Germany

Klinikum Der Universität München AöR; 🇩🇪 München, Bayern, Germany

Klinikum rechts der Isar der Technischen Universitat Muenche; 🇩🇪 München, Bayern, Germany

Universitätsmedizin Mainz; 🇩🇪 Mainz, Hessen, Germany

Universitaetsklinikum Bonn AöR; 🇩🇪 Bonn, Nordrhein-Westfalen, Germany

Kliniken Maria Hilf GmbH; 🇩🇪 Moenchengladbach, Nordrhein-Westfalen, Germany

Städt. Krankenhaus Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Vivantes Klinikum am Urban Hämatologie und Onkologie; 🇩🇪 Berlin, Germany

University Medical Center Schleswig Holstein; 🇩🇪 Kiel, Germany

Debreceni Egyetem Klinikai Központ; 🇭🇺 Debrecen, Hajdú-Bihar, Hungary

Semmelweis Egyetem Általános Orvostudományi Kar; 🇭🇺 Budapest, Hungary

Országos Onkológiai Intézet; 🇭🇺 Budapest, Hungary

Del-pesti Centrumkorhaz Orszagos Hematologiai és Infektologiai Intezet; 🇭🇺 Budapest, Hungary

AOU Federico II; 🇮🇹 Napoli, Campania, Italy

Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS; 🇮🇹 Meldola, Forli-Cesena, Italy

ASST Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

PO Garibaldi-Nesima, ARNAS Garibaldi; 🇮🇹 Catania, Italy

AOU Careggi; 🇮🇹 Firenze, Italy

Ospedale Vito Fazzi, ASL Lecce; 🇮🇹 Lecce, Italy

Ospedale Infermi di Rimini, AUSL Rimini, Distretto di Rimini, Presidio di Rimini, Santarcangelo di Romagna e Novafeltria; 🇮🇹 Rimini, Italy

Catholic University Of Sacred Heart; 🇮🇹 Roma, Italy

PU Campus Bio-Medico di Roma; 🇮🇹 Roma, Italy

Regina Elena, Istituto Nazionale dei Tumori , IFO, IRCCS; 🇮🇹 Roma, Italy

Azienda Ospedaliera Santa Maria di Terni; 🇮🇹 Terni, Italy

Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I di Torino; 🇮🇹 Torino, Italy

Ospedale S.Giacomo Apostolo, PO Castelfranco Veneto, AULSS 2 Marca Trevigiana; 🇮🇹 Treviso, Italy

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Ospedale Maggiore; 🇮🇹 Trieste, Italy

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy; 🇵🇱 Warszawa, Mazowieckie, Poland

Centrum Medyczne Pratia Poznan; 🇵🇱 Skorzewo, Wielkopolskie, Poland

Pratia Onkologia Katowice; 🇵🇱 Katowice, Poland

Pratia MCM Krakow; 🇵🇱 Kraków, Poland

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.; 🇵🇱 Słupsk, Poland

MICS Centrum Medyczne Torun; 🇵🇱 Torun, Poland

MTZ Clinical Research powered by Pratia; 🇵🇱 Warszawa, Poland

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu; 🇵🇱 Wroclaw, Poland

Beatson West of Scotland Cancer Centre; 🇬🇧 Glasgow, United Kingdom

Hospital Universitari Vall d'Hebrón; 🇪🇸 Barcelona, Cataluny, Spain

Hospital Costa del Sol; 🇪🇸 Marbella, Málaga, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Hospital Univ. Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

C.H. de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Nuestra Señora de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen De La Macarena; 🇪🇸 Sevilla, Spain

Buddihist Tzu Chi Medical Foundation- Hualien Tzu Chi Hospital; 🇨🇳 Hualien City, Taiwan

Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology; 🇨🇳 Kaohsiung, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Ankara University Medical Faculty - Hematology; 🇹🇷 Ankara, Turkey

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research; 🇹🇷 Ankara, Turkey

Gazi University Medical Faculty; 🇹🇷 Ankara, Turkey

Medipol Bagcilar Mega Hospital; 🇹🇷 Istanbul, Turkey

Ondokuz Mayis University Medical Faculty - Hematology; 🇹🇷 Samsun, Turkey

Western General Hospital - Haematology; 🇬🇧 Edinburgh, Edinburgh, City Of, United Kingdom

Imperial College Healthcare NHS Trust - Hammersmith Hospital; 🇬🇧 London, London City, United Kingdom

St Bartholomew's Hospital Barts Health NHS Trust; 🇬🇧 London, London, City Of, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust - Clatterbridge Cancer Centre; 🇬🇧 Bebington, United Kingdom

Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital; 🇬🇧 Cornwell, United Kingdom

Northwick Park Hospital Middlesex, United Kindgom, HA1 3UJ; 🇬🇧 Middlesex, United Kingdom