In short
Clinical trials investigating Tuparstobart are studying how it performs in people with advanced cancers. The trials look at outcomes such as tumor response and progression-free survival, and they include patients with endometrial cancer and recurrent or metastatic squamous cell carcinoma of the head and neck.
Key points
- Clinical trials investigating Tuparstobart are focused on advanced cancers, especially endometrial cancer and recurrent or metastatic squamous cell carcinoma of the head and neck. Both studies are Phase 2 and are authorised. One trial looks at tumor response in people with endometrial cancer after platinum-based chemotherapy, while the other measures progression-free survival in PD-L1-positive head and neck cancer. The studies include both single-treatment and combination-treatment approaches. Together, they aim to learn how well these Tuparstobart-based regimens work in different patient groups.
Trial overview
Two authorised Phase 2 studies are investigating Tuparstobart in people with advanced cancers. These studies are interventional, which means the research team gives study treatment and then measures how the cancer responds.
The trials focus on different patient groups: one is for advanced or metastatic endometrial cancer after platinum-based chemotherapy, and the other is for PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck.
Endometrial cancer study
The first study is the POD1UM-204 umbrella study in advanced or metastatic endometrial cancer. An umbrella study is a study that looks at several treatment groups within one trial.
This study includes participants who have progressed on or after platinum-based chemotherapy, which means their cancer got worse during or after treatment with a platinum medicine. The study has 157 planned participants and is authorised.
The main result being measured in Group A is objective response rate (ORR), which is the share of patients whose tumors have a complete response or partial response according to RECIST v1.1, a standard way to measure tumors in cancer trials. Complete response means the tumor cannot be seen on scans, and partial response means the tumor has shrunk by a meaningful amount.
The brief study goal is to evaluate the antitumor activity of INCMGA00012 in Group A. The trial also lists other study drugs in combination arms, including Pemazyre, INCAGN02385, and INCAGN02390.
Head and neck cancer study
The second study is a randomized, double-blind, multicenter Phase 2 trial in recurrent or metastatic squamous cell carcinoma of the head and neck. Randomized means participants are assigned by chance to different groups, and double-blind means the patient and study team do not know which group is being given.
This study is for people with PD-L1-positive disease and who are systemic therapy-naive, meaning they have not yet received body-wide treatment such as chemotherapy or immunotherapy. The study plans to enroll 176 participants and is authorised.
The study compares retifanlimab plus INCAGN02385, and retifanlimab plus INCAGN02385 plus INCAGN02390, against retifanlimab alone in the overall study population. The brief summary says the goal is to determine the efficacy of these combinations, which means how well they work against the cancer.
Study design and endpoints
The endometrial cancer study measures ORR as its primary outcome for Group A. This endpoint helps show whether the treatment can shrink tumors in a meaningful way.
The head and neck cancer study measures progression-free survival (PFS), which is the time from randomization until the cancer gets worse or the patient dies from any cause. This endpoint helps show how long the treatment can keep the disease under control.
Both studies are designed to learn more about Tuparstobart-based treatment strategies in different cancer settings, but they use different patient groups and different main outcomes.
Who may participate
In the endometrial cancer study, the key group is people with advanced or metastatic endometrial cancer who have already had platinum-based chemotherapy and whose disease has progressed.
In the head and neck cancer study, the key group is people with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck who have not had systemic therapy before.
These eligibility rules matter because clinical trials often focus on a specific stage of cancer or a specific test result so the results are easier to interpret.