In short
Clinical trials of Spartalizumab are studying this treatment in several cancer types, including advanced, metastatic, and resectable tumors. These studies look at safety, tolerability, and how well the treatment works in different patient groups. They include phase 1 and phase 2 trials in adults and, in one study, children and adults.
Key points
- Clinical trials of Spartalizumab are being done in several cancer settings, including metastatic anal cancer, resectable gastric cancer, advanced cancer, metastatic disease, and refractory or recurrent solid tumors. The studies include both phase 1 and phase 2 trials, so they are looking at safety, dose finding, and early signs of benefit. Some trials focus on adults only, while one includes both pediatric and adult groups. The trial goals include progression-free survival, pathologic complete response, adverse events, overall response rate, disease control rate, and maximum tolerated dose. Trial statuses vary, with some authorised, some completed, and one suspended.
Trial overview
The available studies of Spartalizumab are interventional clinical trials, which means researchers give a study treatment and then measure what happens. The trials include both phase 1 and phase 2 designs and are focused on cancer research.
Across the listed studies, Spartalizumab is being tested alone or with other cancer treatments, depending on the trial. The main goal is to learn more about safety, tolerability, and early signs that the treatment may help control cancer.
Cancer types being studied
One phase 2 study is looking at people with metastatic squamous cell anal carcinoma, which is anal cancer that has spread to other parts of the body.
Another phase 2 study is in people with resectable gastric cancer, meaning stomach cancer that can be removed with surgery.
A phase 1 rollover study includes subjects with different types of advanced cancer and is designed for continued safety and tolerability follow-up in people already treated with Spartalizumab.
One phase 2 study looks at patients with metastatic disease and high PD1 biomarker expression, meaning the cancer has spread and the study is focused on a selected tumor feature.
The SPARTO study is in people with refractory or recurrent solid tumor, which means a solid cancer that has not responded well to treatment or has returned after treatment.
Trial phases and participants
The studies are mainly in phase 1 and phase 2, which are common early research stages for learning about safety and possible benefit.
Most trials are in adults, but the SPARTO study includes both a pediatric cohort and an adult cohort, so it is designed for children and adults with the right cancer type.
The trial sizes vary from 34 to 184 enrolled participants, showing that these studies range from smaller focused trials to larger phase 2 research.
What the trials measure
The main endpoint in the metastatic anal cancer study is Progression-Free Survival (PFS) at 1 year, measured by RECIST v1.1. This means researchers check how many patients are alive without their cancer getting worse after one year.
In the gastric cancer study, the main endpoint is pathologic complete response (pCR) in the primary tumor. This means the removed tissue from surgery is checked for any remaining tumor cells, and the goal is to see whether no tumor is found.
The rollover study focuses on adverse events, serious adverse events, dose interruptions, and dose reductions. These are ways to track safety and how well the treatment is tolerated over time.
The metastatic disease study measures Overall Response Rate (ORR), which counts complete response and partial response according to RECIST 1.1.
In the SPARTO study, the pediatric cohort looks for the Maximum Tolerated Dose (MTD), and the adult cohort looks at the 6-month disease control rate. Disease control means the cancer shrinks or stays stable for 6 months after treatment starts.
Study status and size
The listed studies have different statuses: two are authorised, two are completed, and one is suspended.
The trial with metastatic squamous cell anal carcinoma plans to enroll 34 participants, the gastric cancer study enrolled 68, the rollover safety study enrolled 119, the metastatic disease study enrolled 184, and the SPARTO study enrolled 74.