Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anti-CD40 Agonist Monoclonal Antibody CDX-1140 · 1 trial · 15 indications
Evaluated according to National Cancer Institute Common Terminology Criteria for adverse events (NCI CTCAE) version (v)5.0. Will be summarized by cohort and grade using frequencies and relative frequencies.
Will be summarized by cohort (with or without CDX 1140) using frequencies and relative frequencies, with the ORR estimated using 90% confidence intervals obtained by Jeffrey's prior method. The final analysis will be performed on all n=80 (40 in each cohort) evaluable patients; and if the p-value is less than or equal to 0.10, then the triplet regimen will be considered superior with respect to response.
| Arm | Type | Description |
|---|---|---|
| Arm I (pembrolizumab, bevacizumab) | ACTIVE_COMPARATOR | Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity. |
| Arm II (pembrolizumab, bevacizumab, CDX-1140) | EXPERIMENTAL | Patients receive pembrolizumab IV over 30 minutes, bevacizumab IV over 30-90 minutes, and CDX-1140 IV over 90 minutes on day 1. Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Anti-CD40 Agonist Monoclonal Antibody CDX-1140 | BIOLOGICAL | Given IV |
| Bevacizumab | BIOLOGICAL | Given IV |
| Pembrolizumab | BIOLOGICAL | Given IV |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
| Questionnaire Administration | OTHER | Ancillary studies |
Inclusion Criteria: * Age \>= 18 years of age. * Recurrent serous (low grade or high grade), endometrioid, or clear cell recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. * Participant can be either platinum-sensitive or platinum-resistant, no more than 4 prior lines of tr...
Anti-CD40 Agonist Monoclonal Antibody CDX-1140 is an investigational monoclonal antibody being studied for the treatment of ovarian clear cell adenocarcinoma and other recurrent ovarian, fallopian tube, and primary peritoneal cancers. It is currently in Phase 2 clinical development for these oncology indications.
Anti-CD40 Agonist Monoclonal Antibody CDX-1140 targets the CD40 receptor, a protein found on immune cells. As an agonist antibody, it is designed to activate CD40 signaling, which may help stimulate an anti-tumor immune response in patients with certain gynecologic cancers.
Anti-CD40 Agonist Monoclonal Antibody CDX-1140 is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR.
Anti-CD40 Agonist Monoclonal Antibody CDX-1140 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is actively recruiting patients.
Anti-CD40 Agonist Monoclonal Antibody CDX-1140 is being evaluated in the Phase 2 clinical trial NCT05231122. This active, randomized trial combines pembrolizumab and bevacizumab with or without CDX-1140 for patients with recurrent ovarian cancer and related gynecologic malignancies. The trial is enrolling 80 female patients in the United States.
Yes, Anti-CD40 Agonist Monoclonal Antibody CDX-1140 is the same drug as CDX-1140. The full name describes the drug's mechanism and target, while CDX-1140 is the shorter designation used in clinical trial documentation and research.