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 follicular lymphoma and large B-cell lymphoma. It is being evaluated in combination with other therapies, such as R-CHOP and rituximab, for patients with newly diagnosed or relapsed/refractory disease.
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 and survival.
Golcadomide is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy in various lymphoma indications.
Golcadomide is in Phase 1 and Phase 3 clinical trials. Phase 1 studies are evaluating the drug in combination with rituximab and in patients with renal impairment, while Phase 3 studies are comparing Golcadomide plus R-CHOP to placebo plus R-CHOP in large B-cell lymphoma and Golcadomide plus rituximab to investigator's choice in follicular lymphoma.
Golcadomide is being studied in several clinical trials, including NCT06209619 (Phase 1, Golcadomide plus rituximab after CAR T-cell therapy for non-Hodgkin's lymphoma), NCT06356129 (Phase 3, Golcadomide plus R-CHOP for large B-cell lymphoma), NCT06911502 (Phase 3, Golcadomide plus rituximab for follicular lymphoma), and NCT07763418 (Phase 1, pharmacokinetics in renal impairment).
Golcadomide is also known as CC-99282. In clinical trials, the drug has been referred to by both names, with CC-99282 appearing in the title of an early-phase study evaluating it in combination with rituximab for non-Hodgkin's lymphoma.