Table of contents
- Trial overview
- Endometrial cancer study
- Head and neck cancer study
- Study design and endpoints
- Who may participate
Trial overview
Two authorised Phase 2 studies are investigating Tuparstobart in people with advanced cancers.[1][2] These studies are interventional, which means the research team gives study treatment and then measures how the cancer responds.[1][2]
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.[1][2]
Endometrial cancer study
The first study is the POD1UM-204 umbrella study in advanced or metastatic endometrial cancer.[1] An umbrella study is a study that looks at several treatment groups within one trial.[1]
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.[1] The study has 157 planned participants and is authorised.[1]
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.[1] Complete response means the tumor cannot be seen on scans, and partial response means the tumor has shrunk by a meaningful amount.[1]
The brief study goal is to evaluate the antitumor activity of INCMGA00012 in Group A.[1] The trial also lists other study drugs in combination arms, including Pemazyre, INCAGN02385, and INCAGN02390.[1]
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.[2] 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.[2]
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.[2] The study plans to enroll 176 participants and is authorised.[2]
The study compares retifanlimab plus INCAGN02385, and retifanlimab plus INCAGN02385 plus INCAGN02390, against retifanlimab alone in the overall study population.[2] The brief summary says the goal is to determine the efficacy of these combinations, which means how well they work against the cancer.[2]
Study design and endpoints
The endometrial cancer study measures ORR as its primary outcome for Group A.[1] This endpoint helps show whether the treatment can shrink tumors in a meaningful way.[1]
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.[2] This endpoint helps show how long the treatment can keep the disease under control.[2]
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.[1][2]
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.[1]
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.[2]
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.[1][2]
