In short
Clinical trials are studying Vibostolimab in several cancer settings, often as part of combination treatment plans. These studies look at safety, how well the treatment works, and measures such as response rate and survival. The trials include adults, and in one study, pediatric and young adult participants.
Key points
- Clinical trials of Vibostolimab are studying several cancers, especially melanoma and different types of lung cancer. The source data also includes studies in bladder cancer, renal cell carcinoma, colorectal cancer, prostate cancer, and advanced solid tumors. These trials range from Phase 1 to Phase 4, so they include early safety testing as well as larger studies that look at survival and tumor response. Many studies test Vibostolimab in combination with other cancer treatments. The main outcomes often include safety, response rate, progression-free survival, recurrence-free survival, and overall survival.
Clinical trial overview
The source data shows that Vibostolimab is being studied in cancer clinical trials, mostly as part of combination treatment plans. These studies are looking at whether the treatment is safe and whether it helps control cancer better than the comparison treatment.
The trials include different cancer settings, such as melanoma, lung cancer, bladder cancer, renal cell carcinoma, colorectal cancer, prostate cancer, and advanced solid tumors. Some studies are completed, some are authorised, and some were withdrawn.
Who the studies include
Each trial focuses on a specific patient group, so participation depends on the cancer type and other study details. For example, some studies include people with PD-1 refractory melanoma, which means melanoma that did not respond well to earlier treatment with a PD-1 drug.
Other studies include people with metastatic non-small cell lung cancer, extensive-stage small-cell lung cancer, high-risk non-muscle invasive bladder cancer, or renal cell carcinoma. One withdrawn study also included pediatric and young adult participants with hematologic malignancies or solid tumors.
Trial phases and main endpoints
The Vibostolimab studies in the data range from Phase 1 to Phase 4. Phase 1 studies usually focus on safety and tolerability, while later phases often measure how well the treatment works in larger groups.
Common endpoints include adverse events, objective response rate, progression-free survival, overall survival, recurrence-free survival, disease-free survival, and pathological complete response. Some studies also measured dose-limiting toxicities and treatment stopping because of side effects.
Several studies used blinded independent central review, which means expert reviewers checked the results without knowing which treatment each person received. This helps make the results more reliable.
Cancer types studied
Melanoma was studied in several trials, including studies in stage IIIB/IIIC/IIID melanoma, PD-1 refractory melanoma, and high-risk resected melanoma. The melanoma trials looked at safety, objective response rate, pathological complete response, and recurrence-free survival.
Non-small cell lung cancer (NSCLC) was another major area of study. Trials included metastatic NSCLC, stage IV NSCLC, treatment-naïve NSCLC, and stage III lung cancer that could not be treated with surgery. These studies looked mainly at overall survival, progression-free survival, and objective response rate.
Other cancer types included small-cell lung cancer, bladder cancer, renal cell carcinoma, colorectal cancer, and metastatic castration-resistant prostate cancer. In these studies, the main focus was usually how well the treatment worked and how safe it was.
Study designs and treatment combinations
Most of the trials are interventional studies, which means the research team gives a treatment and then measures the results. Vibostolimab is often tested with other cancer drugs, such as pembrolizumab, chemotherapy, or other investigational agents.
Some studies compare a Vibostolimab-containing treatment with a control treatment such as pembrolizumab alone, placebo plus docetaxel, or other standard approaches listed in the trial records. Several studies also included a safety lead-in phase, which is an early step used to check if a new combination can be tested safely before moving on.
In the pediatric and young adult study, the source data also included drug level testing, such as area under the curve, maximum concentration, and trough concentration. These are measures of how much of the study drug is in the blood over time.
Trial status and enrollment
The data includes trials with a wide range of enrollment numbers, from 52 participants to 1,806 participants. This shows that some studies were small early-phase trials, while others were large late-phase trials.
Several studies are marked Completed, meaning the planned study work has finished. Others are marked Authorised, meaning they are allowed to run, and a few are marked Withdrawn, meaning they were stopped before completion.
Key patient-focused points
- Vibostolimab is being studied in many different cancers, not just one disease.
- Most trials test Vibostolimab together with other treatments, so the results reflect combination therapy.
- The studies measure both safety and benefit, using outcomes like side effects, tumor response, and survival.
- Trial phases range from early safety testing to larger studies that compare survival outcomes.
- Eligibility depends on the exact cancer type and the rules written for each trial.