Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Golcadomide · 7 trials · 20 indications
Metabolic response as assessed by PET/CT and defined by Lugano criteria; toxicities as defined by CTCAE v5
Golcadomide + Rituximab arms only
Will describe frequency and nature of adverse events associated with CC-99282 + rituximab post CD19 chimeric antigen receptor (CAR) -T cell therapy using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Will use Bayesian Optimal Interval design to define the maximum tolerated dose.
| Arm | Type | Description |
|---|---|---|
| Golcadomide + Rituximab | EXPERIMENTAL | - |
| Rituximab + Lenalidomide/Chemotherapy | ACTIVE_COMPARATOR | Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine |
| Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) | EXPERIMENTAL | - |
| Placebo + R-CHOP | PLACEBO_COMPARATOR | - |
| Arm A- Golcadomide + Rituximab | EXPERIMENTAL | Rituximab 375mg/m2 IV infusion Q4W + golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction |
| Arm B- Nivolumab + golcadomide + Rituximab | EXPERIMENTAL | Nivolumab 480mg IV infusion Q4W, Rituximab 375mg/m2 IV infusion Q4W and golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction |
| Rituximab + Chemotherapy | EXPERIMENTAL | R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine |
| Golcadomide Dose 1 + Rituximab | EXPERIMENTAL | - |
| Golcadomide Dose 2 + Rituximab | EXPERIMENTAL | - |
| Treatment (rituximab, CC-99282) | EXPERIMENTAL | Patients receive rituximab intravenously (IV) on day 1 of each cycle and CC-99282 orally (PO) once daily (QD) on days 1-14 of each cycle. Treatment repeats every 28 days for up to 6 cycles of rituximab and up to 26 cycles of CC-99282 in the absence of disease progression or unacceptable toxicity. Patients also undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the trial. Patients may undergo biopsy at screening. |
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | EXPERIMENTAL | - |
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Golcadomide | DRUG | Specified dose on specified days |
| Rituximab | DRUG | Specified dose on specified days |
| Lenalidomide | DRUG | Specified dose on specified days |
| Cyclophosphamide | DRUG | Specified dose on specified days |
| Doxorubicin | DRUG | Specified dose on specified days |
| Vincristine | DRUG | Specified dose on specified days |
| Prednisone/Prednisolone | DRUG | Specified dose on specified days |
| Bendamustine | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on specified days |
| Prednisone | DRUG | Specified dose on specified days |
| Nivolumab 10 MG/ML | DRUG | Nivolumab is a fully humanised IgG4 blocking monoclonal antibody against PD-1. |
| Biopsy | PROCEDURE | Undergo biopsy |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Computed Tomography | PROCEDURE | Undergo PET/CT |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| Itraconazole | DRUG | Specified dose on specified days. |
| Rifampin | DRUG | Specified dose on specified days |
Inclusion Criteria: \- Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with corresponding pathology report for retrospective central pathology ...
Golcadomide is an investigational small molecule being studied for the treatment of B-cell non-Hodgkin lymphomas, including large B-cell lymphoma and follicular lymphoma. It is also being evaluated in healthy volunteers and in patients with chronic kidney failure. Its development is focused on oncology indications.
Golcadomide is a cereblon-modulating agent, belonging to the -domide class of drugs. It works by binding to cereblon, a component of the E3 ubiquitin ligase complex, which leads to the degradation of specific proteins involved in cancer cell growth. This mechanism is being studied in lymphoma.
Golcadomide is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various lymphoma indications.
Golcadomide is in clinical development, with trials ranging from Phase 1 to Phase 3. It is not FDA approved and remains investigational. Active trials include a Phase 3 study in large B-cell lymphoma and a Phase 3 study in follicular lymphoma, along with earlier-phase trials.
Golcadomide is being studied in several trials. NCT06356129 is a Phase 3 trial comparing Golcadomide plus R-CHOP to placebo plus R-CHOP in large B-cell lymphoma. NCT06425302 is a Phase 2 trial in follicular lymphoma. NCT06911502 is a Phase 3 trial in relapsed/refractory follicular lymphoma. NCT06363630 is a completed Phase 1 drug interaction study.
Golcadomide is also known as BMS-986369. In clinical trials, the drug is referred to by both names, with BMS-986369 being the compound identifier used by Bristol-Myers Squibb. Both names refer to the same investigational drug.