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Also known as Varlilumab
Combination of varlilumab and nivolumab · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| Varlilumab and Nivolumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Combination of varlilumab and nivolumab | DRUG | Phase I: Varlilumab dosing will be dependent on the cohort assigned in combination with 3 mg/kg of nivolumab every two weeks. Phase II: Patients with CRC, RCC or GBM enrolled in Phase ll will receive 3.0 mg/kg of varlilumab in combination with 240 mg of nivolumab every 2 weeks. Patients with SCCHN or ovarian cancer will receive varlilumab at a dose of either 3 mg/kg every 2 weeks, 3 mg/kg every 12 weeks, or 0.3 mg/kg every 4 weeks, in combination with 240 mg of nivolumab every 2 weeks. Patients may be discontinued from receiving study treatment based on the results of disease assessments or if experiencing intolerable side effects. |
Key Inclusion Criteria: 1. Histologically-diagnosed advanced (unresectable and/or metastatic) Non-small Cell Lung Cancer (Phase l only), Melanoma (Phase l only), Colorectal, Head and Neck SCC (squamous cell carcinoma), Ovarian Cancer, Glioblastoma or Renal Cell Carcinoma. * 1a. Head and Neck ...
The combination of varlilumab and nivolumab is being studied for the treatment of squamous cell carcinoma of the head and neck (SCCHN). It is an investigational combination therapy in Phase 1 clinical development, evaluated in patients with advanced refractory solid tumors.
The combination targets CD27 and PD-1. Varlilumab is an anti-CD27 antibody, and nivolumab is an anti-PD-1 antibody. By targeting these immune checkpoint and costimulatory molecules, the combination aims to modulate the immune response against tumors.
The combination of varlilumab and nivolumab is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CLDX.
The combination of varlilumab and nivolumab is in Phase 1 clinical development. It is investigational and not yet approved by regulatory authorities. The Phase 1 study has been completed.
The combination is being studied in clinical trial NCT02335918, titled "A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors." This Phase 1 trial, conducted in the United States, has been completed and enrolled 175 participants.
Varlilumab is a component of the combination therapy. The combination consists of varlilumab, an anti-CD27 antibody, and nivolumab, an anti-PD-1 antibody. Varlilumab alone is not the same as the combination, which includes both agents.