Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-6255 · 1 trial · 2 indications
A DLT is defined as any drug-related AE observed during the DLT evaluation period that meet criteria specified in the protocol. DLTs will be evaluated until 21 days after the first fixed dose during fixed-dose escalation and until 21 days after the first target dose during step-up dose escalation and dose interval extension.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Participants receive MK-6255 once every week (QW). |
| Dose Interval Extension | EXPERIMENTAL | Participants receive MK-6255 at extended interval dosing. |
| Name | Type | Description |
|---|---|---|
| MK-6255 | BIOLOGICAL | During initial dose escalation, participants will receive MK-6255 one weekly (QW). During Dose Interval Extension, participants will receive target doses every 3 weeks (Q3W). |
| CD8 PET Tracer | OTHER | Participants may receive an optional CD8 PET tracer for exploratory imaging assessments. |
| Acetaminophen | DRUG | Participants will receive acetaminophen (or similar antipyretic) as premedication. |
| Diphenhydramine | DRUG | Participants will receive diphenhydramine (or similar antihistamine) as premedication. |
| Dexamethasone | DRUG | Participants will receive dexamethasone as premedication. |
| Tocilizumab | BIOLOGICAL | Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration. |
| Tocilizumab biosimilar | BIOLOGICAL | Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration. |
| Siltuximab | BIOLOGICAL | Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has one of the following diagnoses: * Recurrent, pathologically documented epithelial OC, primary peritoneal cancer, or fallopian tube cancer that is either (1) platinum resistant or (2) platinum sen...