Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ipilimumab · 1 trial · 5 indications
Defined as the proportion of subjects for whom the best overall response at week 12 is confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). Point estimates of ORR and 95% confidence intervals will be provided. Only participants with confirmed response are included in this analysis.
| Arm | Type | Description |
|---|---|---|
| Treatment (pembrolizumab, ipilimumab, aspirin) | EXPERIMENTAL | Patients receive pembrolizumab IV over 30 minutes on day 1, ipilimumab IV over 60 minutes on day 1 for courses 1-4, and aspirin PO BID (orally, twice a day) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Aspirin | DRUG | Given PO |
| Ipilimumab | BIOLOGICAL | Given IV |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Pembrolizumab | BIOLOGICAL | Given IV |
Inclusion Criteria: * Patients must have histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Leukocytes \>= 3,00...
Ipilimumab is a monoclonal antibody being studied for the treatment of Stage III Cutaneous Melanoma, including Stage IIIA, IIIB, and IIIC subtypes. It is currently in Phase 2 clinical development and is being investigated as part of a combination approach with prostaglandin inhibition and immune checkpoint blockade.
Ipilimumab is a monoclonal antibody that targets CTLA-4, an immune checkpoint protein. By blocking CTLA-4, it enhances T-cell activation and anti-tumor immune responses. In the context of the Phase 2 trial, it is combined with a prostaglandin inhibitor to potentially improve immune-mediated tumor destruction in melanoma.
Ipilimumab is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Stage III Cutaneous Melanoma.
Ipilimumab is currently in Phase 2 clinical development for Stage III Cutaneous Melanoma. It is an investigational drug and has not yet been approved by regulatory authorities for this indication. The Phase 2 trial has been completed, and the drug remains under evaluation for potential further development.
Ipilimumab is associated with one completed Phase 2 clinical trial, identified as NCT03396952, titled 'Prostaglandin Inhibition and Immune Checkpoint Blockade in Melanoma.' The trial enrolled 27 participants with Stage III or IV Cutaneous Melanoma in the United States and was not randomized or blinded.
Ipilimumab is the generic name for the drug marketed as Yervoy. In the context of this Phase 2 trial, it is being studied in combination with a prostaglandin inhibitor for the treatment of Stage III Cutaneous Melanoma. The trial focuses on evaluating the safety and efficacy of this combination approach.