Arm 5-Tazemetostat plus mosunetuzumab (CD20/CD3 BsAb) in subjects with R/R follicular lymphoma for Relapsed/Refractory Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Relapsed/Refractory DiseasePomalidomide 4 MG - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at the safety of using the drug tazemetostat with other treatments for blood cancer. Tazemetostat has been found to be a safe and effective drug for patients with relapsed refractory follicular lymphoma. Giving tazemetostat in combination with other treatments may work better in treating patients with blood cancer and may improve disease response and durability of response.

Eligible Conditions
  • Relapsed/Refractory Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Time from the date of first dose of study drug to the time of response, assessed up to 24 months

Evaluated for DLTs during the first 28-day cycle. The RP2D for Phase 2 for each arm will be selected at the end of that arm's experience in Phase 1b
Phase 1b: Recommended Phase 2 Dose (RP2D) of tazemetostat in combination with each partner drug
Month 24
Phase 2: Duration of Response (DOR)
Phase 2: Overall Survival (OS)
Month 24
Phase 2: Objective Response Rate (ORR)
Phase 2: Progression Free Survival (PFS)

Trial Safety

Trial Design

9 Treatment Groups

Arm 5-Tazemetostat plus mosunetuzumab (CD20/CD3 BsAb) in subjects with R/R folli...
1 of 9
Arm 1-Tazmetostat plus CD19 Ab (tafasitamab-cxix) lenalidomide in subjects with ...
1 of 9
Arm 4- Taz plus Daratumumab/ pomalidomide/ dexamethasone in subjects with R/R mu...
1 of 9
Arm 3-Tazemetostat plus acalabrutinib in subjects with R/R mantle cell lymphoma
1 of 9
Arm 2-Tazemetostat plus lenalidomide in subjects with R/R DLBCL
1 of 9
Arm 4-Tazemetostat plus daratumumab/pomalidomide/dexamethasone in subjects with ...
1 of 9
Arm 1-Tazemetostat plus tafasitamab-cxix (CD19 Ab)/lenalidomide in subjects with...
1 of 9
Arm 3 -Tazemetostat plus Bruton tyrosine kinase inhibitor in subjects with R/R m...
1 of 9
Arm 2 -Tazemetostat plus lenalidomide in subjects with R/R DLBCL
1 of 9

Active Control

156 Total Participants · 9 Treatment Groups

Primary Treatment: Arm 5-Tazemetostat plus mosunetuzumab (CD20/CD3 BsAb) in subjects with R/R follicular lymphoma · No Placebo Group · Phase 1 & 2

Arm 5-Tazemetostat plus mosunetuzumab (CD20/CD3 BsAb) in subjects with R/R follicular lymphomaActiveComparator Group · 2 Interventions: Mosunetuzumab, Tazemetostat · Intervention Types: Drug, Drug
Arm 1-Tazmetostat plus CD19 Ab (tafasitamab-cxix) lenalidomide in subjects with R/R DLBCLActiveComparator Group · 3 Interventions: Tafasitamab, Tazemetostat, Lenalidomide · Intervention Types: Drug, Drug, Drug
Arm 4- Taz plus Daratumumab/ pomalidomide/ dexamethasone in subjects with R/R multiple myeloma.ActiveComparator Group · 6 Interventions: Pomalidomide 4 MG, Dexamethasone 20mg, Hyaluronidase-Fihj, Dexamethasone 40mg, Tazemetostat, Daratumumab · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Arm 3-Tazemetostat plus acalabrutinib in subjects with R/R mantle cell lymphomaActiveComparator Group · 2 Interventions: Acalabrutinib, Tazemetostat · Intervention Types: Drug, Drug
Arm 2-Tazemetostat plus lenalidomide in subjects with R/R DLBCLActiveComparator Group · 2 Interventions: Tazemetostat, Lenalidomide · Intervention Types: Drug, Drug
Arm 4-Tazemetostat plus daratumumab/pomalidomide/dexamethasone in subjects with R/R multiple myelomaActiveComparator Group · 6 Interventions: Daratumumab (Intravenously), Pomalidomide, Dexamethasone 20mg, Daratumumab (Subcutaneously), Hyaluronidase-Fihj, Tazemetostat · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Arm 1-Tazemetostat plus tafasitamab-cxix (CD19 Ab)/lenalidomide in subjects with R/R DLBCLActiveComparator Group · 3 Interventions: Tafasitamab, Tazemetostat, Lenalidomide · Intervention Types: Drug, Drug, Drug
Arm 3 -Tazemetostat plus Bruton tyrosine kinase inhibitor in subjects with R/R mantle cell lymphomaActiveComparator Group · 2 Interventions: Acalabrutinib, Tazemetostat · Intervention Types: Drug, Drug
Arm 2 -Tazemetostat plus lenalidomide in subjects with R/R DLBCLActiveComparator Group · 2 Interventions: Tazemetostat, Lenalidomide · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from the date of first dose of study drug to the time of response, assessed up to 24 months

Who is running the clinical trial?

Epizyme, Inc.Lead Sponsor
30 Previous Clinical Trials
2,788 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Results of the test are negative for acute or chronic HBV infection, HCV infection and HIV infection.
You have documented relapsed, refractory, or progressive disease after 2 lines of treatment with systemic therapy.