Table of Contents
- Overview of Avelumab trials
- Cancer types studied
- Trial designs, phases, and who can join
- Main endpoints and what they mean
- Key trial highlights
- Special populations and biomarker studies
Overview of Avelumab trials
Clinical trials with Avelumab are testing it in many cancer settings, often together with other treatments such as chemotherapy, targeted therapy, or another immunotherapy drug.[1][2]
Across the trials, the main goals are to check safety, tolerability, survival, tumor response, and whether treatment can help after earlier therapy or as part of first-line treatment.[1][3]
Cancer types studied
The trials cover a wide range of cancers, including urothelial cancer, bladder cancer, muscle invasive bladder cancer, head and neck squamous cell carcinoma, penile squamous cell carcinoma, colorectal cancer, gastric cancer, gastroesophageal junction cancer, renal cell carcinoma, gastrointestinal stromal tumor, neuroendocrine neoplasias, breast cancer, CNS tumors in children, and HPV-related cancers.[1][2][4]
Some studies are focused on very specific groups, such as patients with HPV-16 positive disease, patients with RAS/BRAF wild type metastatic colorectal cancer, or patients with a specific immune profile or gene change.[2][5][6]
Trial designs, phases, and who can join
Most Avelumab studies in this set are Phase 2 or Phase 3 trials, which means they are testing how well the treatment works and continuing to track safety in larger groups.[1][3]
There is also a Phase 1 study in children with primary CNS tumors, where the main focus is safety, tolerability, and dose finding.[4]
Many studies enroll adults with advanced, metastatic, recurrent, or unresectable disease, meaning the cancer cannot be removed by surgery or has come back or spread.[1][3]
Some trials study Avelumab as maintenance treatment, which means treatment given after initial therapy if the cancer has not progressed.[1][7]
Main endpoints and what they mean
Several trials measure overall survival (OS), which is the time from study entry or randomization until death from any cause.[2][7]
Many studies use progression-free survival (PFS), which means the time before the cancer gets worse or the patient dies.[1][3]
Other trials measure disease-free survival (DFS), objective response rate (ORR), disease control rate (DCR), and pathological complete response (pCR).[1][2][8]
Some studies also measure quality of life, safety events, and immune blood markers, especially when the goal is to understand treatment burden or immune-related toxicity.[3][9]
Key trial highlights
The PULSE trial (NCT03774901) is a Phase 2 study in locally advanced or metastatic squamous cell penile carcinoma. It tests maintenance Avelumab after first-line platinum-based chemotherapy and measures disease-free progression, with the disease-free survival time counted from the start of Avelumab until progression or death.[1]
The metastatic colorectal cancer trial (NCT05291156) is a Phase 2 randomized study of Avelumab plus cetuximab versus cetuximab alone in pre-treated RAS/BRAF wild-type patients. Its main outcome is overall survival.[2]
The AVETUX-HN study (2025-521738-27-00) compares two cycles versus four cycles of combination therapy with cetuximab, Avelumab, cisplatin, and docetaxel in recurrent metastatic head and neck cancer. The main endpoint is quality of life at 18 weeks, measured with the QLQ-C30 questionnaire.[3]
The DEPECA-1 trial (NCT07110038) studies first-line enfortumab vedotin plus Avelumab in locally advanced or metastatic penile squamous cell carcinoma. It measures objective response rate using RECIST 1.1, a standard scan-based response system.[10]
The A-Brave study (NCT02926196) tested one year of adjuvant Avelumab after curative-intent treatment for high-risk triple negative breast cancer. Its main outcome was disease-free survival.[8]
The AVESEC trial (2025-524077-16-00) is a Phase 2 maintenance study in metastatic urothelial carcinoma after second-line platinum-based chemotherapy and progression on earlier pembrolizumab plus enfortumab vedotin. It compares Avelumab with best supportive care and uses blinded independent central review for progression-free survival.[11]
Special populations and biomarker studies
Some studies focus on special groups, such as children with primary CNS tumors, where the trial looks at safety, dose-limiting toxicities, and progression-free survival in an expansion part.[4]
Other trials use biomarkers, which are measurable signs in the body, to understand who may benefit most or who may have toxicity. One study in solid tumors looks at immune blood markers and autoantibodies to explore immune-related toxicities of checkpoint inhibitors, including Avelumab.[9]
The REGOMUNE study (NCT03475953) is a Phase 1/2 trial in advanced or metastatic solid tumors. In Phase 1 it studies safety, dose-limiting toxicities, and the recommended Phase 2 dose, while Phase 2 measures different activity endpoints across several tumor cohorts.[6]
The ProTarget study (NCT04341181) uses genomic profiling, which means looking at tumor genes to guide treatment choice. In this trial, Avelumab is one of several approved targeted or immune treatments being studied for anti-tumor activity and safety in advanced cancer.[5]
