Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CDX-301, Recombinant Human Flt3 Ligand
Flt3L · 4 trials · 7 indications
DLTs recorded and graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03, within DLT evaluation window of 63 days (end of cycle 1 of pembrolizumab) from initiation of in situ vaccine.
An AE is any event that either occurs after the initiation of study drug, having been absent at baseline, or, if present at baseline, appears to have worsened in severity or frequency, regardless of its relation to the drug. An SAE is any AE that suggests a significant hazard, contraindication, side effect, or untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded. The AE row includes all participants who experienced at least one AE, including SAEs.
Based on the CTEP Active Version (version 5.0) of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Highest dose of CDX-301 that did not cause a dose limiting toxicity
The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX301.
| Arm | Type | Description |
|---|---|---|
| Combination therapy | EXPERIMENTAL | Vaccination with Flt3L, Radiation, and Poly ICLC combined with Pembrolizumab |
| Cohort A: NKTR-214 + Nivolumab | EXPERIMENTAL | - |
| Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab | EXPERIMENTAL | - |
| Cohort C: CDX-301 + INO-5151 + Nivolumab | EXPERIMENTAL | - |
| CDX-301 + Neovax + Nivolumab | EXPERIMENTAL | * Participants will have vaccine made from tissue collected from metastatic tumor biopsy or surgical resection, or from previously collected archival biopsy or surgical tissue. * Participants will receive Nivolumab at a flat dose every 4 weeks up to two years. * Participants will receive CDX-301 at a predetermined dose dependent on the number of participants previously enrolled for 5 days starting 2 days before the initiation of NeoVax. CDX-301 will then be administered at a predetermined dose dependent on the number of participants previously enrolled 2 days before and for 5 days coinciding with the administration of NeoVax on days 50 and 78. |
| CDX-301 + Neovax + Pembrolizumab | EXPERIMENTAL | * Participants will have vaccine made from tissue collected from tumor biopsy, or from previously collected archival biopsy or surgical tissue. * Participants will receive neoadjuvant Pembrolizumab for 3 doses every 3 weeks, then undergo standard-of-care surgical resection. * Participants will receive adjuvant NeoVax and CDX-301. CDX-301 will be administered at a predetermined dose, dependent on the number of participants previously enrolled, for 5 days starting 2 days before the initiation of NeoVax. CDX-301 will then be administered at a predetermined dose dependent on the number of participants previously enrolled 2 days before and for 5 days coinciding with the administration of NeoVax on days 50 and 78. * Participants will receive adjuvant Pembrolizumab for 15 doses every 6 weeks. |
| CDX-301 | EXPERIMENTAL | CDX-301 (rhuFlt3L), administered to healthy patients. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | 200 mg administered as an IV infusion over 30 minutes Q3W |
| Flt3L | DRUG | an immune cell growth factor. CDX-301 drug product is formulated as a sterile solution intended for single-use parenteral administration. Each vial contains a nominal 2.5 mg/mL CDX-301 protein in a 1 mL volume of buffered solution composed of sodium phosphate and sodium chloride, with a pH of 7.0. |
| Radiation | RADIATION | The target site will get 2 small treatments of radiation. |
| Poly ICLC | DRUG | an immune cell activating factor. vials containing 1 ml of 2 mg/mL |
| NKTR-214 (Cohort A) | DRUG | NKTR-214 will be administered intravenously every 3 weeks for up to 2 years |
| Nivolumab (Cohort A, B and C) | DRUG | Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C. |
| Stereotactic body radiation therapy (SBRT) (Cohort B) | RADIATION | Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1 |
| CDX-301 (Cohort B and C) | DRUG | CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C. |
| Poly-ICLC (Cohort B) | DRUG | Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1 |
| INO-5151 (Cohort C) | DRUG | INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter |
| Cellectra 2000 | DEVICE | Electroporation device |
| CDX-301 | DRUG | Administered as an injection given underneath the skin |
| NEOVAX | BIOLOGICAL | Personalized neoantigen vaccine administered as an injection given underneath the skin |
| Nivolumab | DRUG | Administered intravenously (IV) |
Inclusion Criteria: * Have pathologically confirmed iNHL, MBC or HNSCC * Lymphoma subtypes that may be enrolled include small lymphocytic lymphoma Exclusion Criteria: * Is currently participating and receiving an investigational therapy (not standard therapies) or has participated in a study of a...