Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06136559 | A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011) | PHASE3 | RECRUITING | 1,200 | — | — | Dec 13, 2023 | Sep 7, 2032 | May 28, 2026 | 198 | United States, Australia +27 |
| NCT05624554 | A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008) | PHASE3 | ACTIVE NOT_RECRUITING | 300 | — | — | Mar 16, 2023 | Mar 17, 2031 | Mar 16, 2026 | 97 | United States, Australia +19 |
ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per iwCLL Criteria 2018 as assessed by BICR.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per iwCLL Criteria 2018 as assessed by BICR.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by blinded independent central review (BICR).
| Arm | Type | Description |
|---|---|---|
| Nemtabrutinib | EXPERIMENTAL | Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met. |
| Ibrutinib/Acalabrutinib | ACTIVE_COMPARATOR | Participants will receive investigator's choice of ibrutinib or acalabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met. |
| FCR or BR | ACTIVE_COMPARATOR | Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar. |
| Name | Type | Description |
|---|---|---|
| Nemtabrutinib | DRUG | Administered orally |
| Ibrutinib | DRUG | Administered orally |
| Acalabrutinib | DRUG | Administered orally |
| Fludarabine | DRUG | 25 mg/m\^2 administered via intravenous (IV) infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles. |
| Cyclophosphamide | DRUG | 250 mg/m\^2 administered via IV infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles. |
| Bendamustine | DRUG | Administered via IV infusion on Days 1 and 2 of each 28-day cycle up to 6 cycles. The first dose is given as 70 to 90 mg/m\^2. Subsequent doses may be escalated up to 90 mg/m\^2, if applicable and as per local guidelines. |
| Rituximab | BIOLOGICAL | Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles. |
| Truxima | BIOLOGICAL | Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles. |
| Ruxience | BIOLOGICAL | Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles. |
| Riabni | BIOLOGICAL | Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy. * Has at least 1 marker of disease burden. * Has an Eastern Cooperative Oncology Group (ECOG) per...