Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
coformulation pembrolizumab/quavonlimab · 1 trial · 1 indication
DLTs = ≥1 of the following treatment-related toxicities: Grade (G)4 nonhematologic toxicity; G4 hematologic toxicity lasting \>7 days OR G4 platelet count decreased OR G3 platelet count decreased if associated with bleeding; G3 nonhematologic toxicity including G3 fatigue (lasting \>3 days), G3 diarrhea, nausea, vomiting lasting ≥72 hours, G3 rash ≥7 days despite treatment, G3 uncontrolled hypertension; G3/4 nonhematologic laboratory abnormality if requires medical intervention, hospitalization, or persists for \>1 week; G 3/4 febrile neutropenia, alanine aminotransferase, aspartate aminotransferase and/or bilirubin increase; drug-induced liver injury meeting the Hy's law; G4 creatinine increase; G4 electrolyte abnormalities; treatment related adverse event causing study intervention discontinuation during the first 21 days or administration delay \>14 days during the first 21 days; G5 toxicity. The number of participants with ≥1 DLTs in the safety lead-in phase will be presented.
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. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience at least one AE will be presented.
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. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be presented.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 that has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
| Arm | Type | Description |
|---|---|---|
| Coformulation Pembrolizumab/Quavonlimab | EXPERIMENTAL | Participants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation. |
| Coformulation Pembrolizumab/Quavonlimab + Lenvatinib | EXPERIMENTAL | Participants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation. Lenvatinib will be administered orally once-daily (QD) until progressive disease or discontinuation. |
| Coformulation Pembrolizumab/Quavonlimab + MK-4830 | EXPERIMENTAL | Participants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS MK-4830 800 mg. Pembrolizumab/quavonlimab will be administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation. MK-4830 will be administered by IV infusion once every 3 weeks (Q3W) for up to 36 infusions (up to approximately 2 years) or until progressive disease or discontinuation. |
| Coformulation Favezelimab/Pembrolizumab | EXPERIMENTAL | Participants receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg) administered by intravenous (IV) infusion once every 3 weeks (Q3W) for up to 36 infusions (up to approximately 2 years) or until progressive disease or discontinuation. |
| R-DXd | EXPERIMENTAL | Participants receive 5.6 mg/kg R-DXd via IV infusion every three weeks (Q3W) until progressive disease or discontinuation. |
| Name | Type | Description |
|---|---|---|
| coformulation pembrolizumab/quavonlimab | BIOLOGICAL | Intravenous (IV) infusion |
| lenvatinib | DRUG | Oral administration |
| MK-4830 | BIOLOGICAL | IV infusion |
| coformulation favezelimab/pembrolizumab | BIOLOGICAL | IV infusion |
| R-DXd | BIOLOGICAL | IV Infusion |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Arms A-E: * Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of second-line therapy * Has progressed on or after treatment with an anti-programmed cell death 1 (PD-1)/ pro...
Coformulation pembrolizumab/quavonlimab is an investigational monoclonal antibody combination being studied for the treatment of extensive-stage small cell lung carcinoma (ES-SCLC) in patients who need second-line therapy. It is currently in Phase 1 clinical development and has not been approved by the FDA.
Coformulation pembrolizumab/quavonlimab is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK on the New York Stock Exchange. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational combination therapy.
Coformulation pembrolizumab/quavonlimab is currently in Phase 1 clinical development. It is an investigational drug that has not been approved by the FDA. The ongoing trial is active but not recruiting participants, and the drug has received priority review designation from the FDA.
Coformulation pembrolizumab/quavonlimab is being studied in clinical trial NCT04938817, titled MK-3475-B98/KEYNOTE-B98. This Phase 1 trial is evaluating the drug as monotherapy or in combination with pembrolizumab for extensive-stage small cell lung cancer in need of second-line therapy. The trial has an enrollment of 110 participants.
Coformulation pembrolizumab/quavonlimab is a combination product that includes pembrolizumab along with quavonlimab. It is being studied in combination with pembrolizumab in clinical trials. The coformulation is a distinct investigational agent being developed by Merck & Company, Inc.