Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ramucirumab · 1 trial · 4 indications
DLTs are defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The percentage of participants who experience at least one DLT 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. The percentage of participants who discontinued study intervention due to an 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. The percentage of participants who discontinued study intervention 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 Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
| Arm | Type | Description |
|---|---|---|
| Ramucirumab + Paclitaxel | ACTIVE_COMPARATOR | Participants receive ramucirumab at 8mg/kg via intravenous (IV) infusion on days 1 and 15 of each 4-week cycle for up to \~60 weeks plus paclitaxel at 80 mg/M\^2 via IV infusion on Days 1, 8, and 15 of each 4-week cycle (3 weeks on and 1 week off) until discontinuation. |
| Sacituzumab Tirumotecan + Paclitaxel | EXPERIMENTAL | Following a 28-day run-in with sacituzumab tirumotecan at 3 mg/kg and 4 mg/kg IV infusion on Days 1 and 15 of a 6-week cycle plus paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8 and 15 of a 4-week cycle, participants receive paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8, 15 of each 4-week cycle (3 weeks on and 1 week off) plus sacituzumab tirumotecan at selected dose IV infusion on days 1, 15, 29 of every 6-week cycle until discontinuation. |
| HER3-DXd + Ramucirumab | EXPERIMENTAL | Participants receive HER3-DXd via IV infusion on days 1 and 22 of each 6-week cycle plus ramucirumab at 8mg/kg via IV infusion on days 1 and 15 and 29 of each 6-week cycle until discontinuation. |
| Name | Type | Description |
|---|---|---|
| Ramucirumab | BIOLOGICAL | 8 mg/kg IV Infusion |
| Paclitaxel | DRUG | 80 mg/M\^2 IV infusion |
| Sacituzumab Tirumotecan | BIOLOGICAL | 3 mg/kg or 4 mg/kg IV Infusion |
| Rescue Medications | DRUG | Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications for the Sacituzumab Tirumotecan + Paclitaxel arm include antihistamines (histamine-1 and histamine-2 receptor antagonists), acetaminophen or equivalent, dexamethasone or equivalent infusion, and steroid mouth wash (dexamethasone or equivalent) and rescue medications for the HER3-DXd + ramucirumab arm include 5-HT3-receptor antagonist, NK-1 receptor antagonist, and corticosteroids. |
| HER3-DXd | BIOLOGICAL | IV Infusion |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically and/or cytologically confirmed diagnosis of previously treated, second line (2L) (received first line (1L) treatment) gastric adenocarcinoma, gastroesophageal junction adenocarcinoma,...
Ramucirumab is an investigational monoclonal antibody being studied for use in gastroesophageal junction adenocarcinoma. It is currently in Phase 1 clinical development as part of a combination therapy for second-line treatment of this cancer. The drug is being evaluated in a clinical trial enrolling patients with gastroesophageal junction cancer.
Ramucirumab is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gastroesophageal junction adenocarcinoma. Merck is responsible for the ongoing Phase 1 development program for this investigational therapy.
Ramucirumab is currently in Phase 1 clinical development. It is being studied as part of a combination therapy for second-line treatment of gastroesophageal adenocarcinoma. The drug is investigational and has not yet been approved by regulatory authorities. One Phase 1 trial is currently recruiting participants to evaluate this therapy.
Ramucirumab is being evaluated in clinical trial NCT06445972, titled "Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)." This Phase 1 trial is actively recruiting participants and has a target enrollment of 210 patients. The study is being conducted across multiple countries including the United States, Brazil, China, and Germany.
Ramucirumab is being studied in the MK-3475-06D clinical trial, which is part of the Keymaker-U06 program. The trial evaluates combination therapies for gastroesophageal adenocarcinoma, and Ramucirumab is one of the drugs being tested in this study. The trial is sponsored by Merck & Company, Inc.