Bavencio (avelumab)

P1, N=32, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2025 --> Jan 2026

P1/2, N=50, Recruiting, Ariceum Therapeutics GmbH

A post hoc analysis displayed higher frequency of M-MDSCs (p = 0.020) and lower frequency of CD4+ (p < 0.005) at pretreatment in EC patients as compared to healthy donors. In conclusion, the peripheral evaluation of MDSCs and Tregs correlated with molecular features in EC treated with CP/CPA and may add insights in identifying EC patients responder to first-line chemo/chemo-immunotherapy.

P2, N=57, Completed, Ludwig-Maximilians - University of Munich | Active, not recruiting --> Completed

The scores were assessed for patients with LARC enrolled in the Averectal study (NCT03503630), who received five fractions of short-course radiotherapy, followed by six cycles of mFOLFOX-6 plus avelumab, and total mesorectal excision... The IS can supplement the mrTRG to better predict TNT outcomes, along with the use of the NAR score. This combination could potentially help with patient selection for non-operative management and guide treatment strategies for those with different recurrence risks.

A literature search was conducted on PubMed of programmed cell death protein 1 (nivolumab, pembrolizumab), PD-L1 (atezolizumab, avelumab, durvalumab), and CTLA-4 inhibitors (ipilimumab, tremelimumab) along with previously noted conjunctival and periocular tumors. Our overall review presents promising results with the usage of ICI for patients, noting an increased overall survival rate, clinical control of local and metastatic disease and decreased surgical morbidity, while avoiding orbital exenteration. These improvements have not come without considerations for adverse immune-related side effects and clinicians needs to be judicious is deciding between the overall efficacy and side effects.

These findings highlight the clinical potential of regorafenib and avelumab in GEP-NENs, emphasizing the need for predictive biomarkers and validation in future randomized trials. Clinical Trial registration: NCT03475953 .

P2, N=18, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2025 --> Mar 2026

ICIs, such as anti-PD-1 (e.g. nivolumab, pembrolizumab), anti-PD-L1 (e.g. atezolizumab, avelumab), and anti-CTLA-4 (e.g. ipilimumab), enhance T cell-mediated anti-tumor responses but can also trigger immune-related adverse events (irAEs). However, in our review, we mention the potential role of CXCL10 and CXCL13 as biomarkers of n-irAEs and describe the current evidence, as well as the need for further studies, on the use of cytokines in guiding selection of second-line therapies for n-irAEs. Finally, no specific microbiome-related microbial signature has been proven to be linked to n-irAEs specifically, leading to the need of more future research on the topic.

P2, N=122, Active, not recruiting, Melanoma and Skin Cancer Trials Limited | Recruiting --> Active, not recruiting

P=N/A, N=1220, Recruiting, Hospital of Macerata | Trial completion date: Dec 2024 --> Sep 2027

P=N/A, N=242, Completed, Hospital Universitario Araba | Recruiting --> Completed

P1, N=16, Completed, City of Hope Medical Center | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jun 2024 | Trial primary completion date: Dec 2024 --> Jun 2024

P=N/A, N=287, Completed, Astellas Pharma Singapore Pte. Ltd. | Recruiting --> Completed

P1, N=69, Completed, German Cancer Research Center | Active, not recruiting --> Completed

Our results did not achieve the ORR threshold required to reject the null hypothesis in this cohort of unselected patients with relapsed/metastatic head and neck cancer. IL-6 and VEGF were associated with overall survival, whereas TGF-β and IL-4 correlated with irAEs.

P2, N=96, Recruiting, Abramson Cancer Center at Penn Medicine | Trial primary completion date: Nov 2024 --> Jul 2027

P2, N=67, Recruiting, Gruppo Oncologico del Nord-Ovest

Single-agent ICI therapy, such as cemiplimab (ORR 27.8%), has shown responses primarily in UV- and radiation-associated angiosarcomas, likely due to their higher tumor mutation burden (TMB), while dual ICI therapy (SWOG S1609, ORR 25%) suggests potential benefit but remains limited in cutaneous disease...The Alliance A091902 first-line trial (paclitaxel ± nivolumab) found no overall PFS benefit, though scalp/face angiosarcoma patients appeared to fare better, raising the question of whether ICI alone might be equally effective in this subset. The South Korean paclitaxel + avelumab trial (ORR 50%) showed promising response rates, but the lack of detailed subgroup analysis limits interpretation. Other chemotherapy-ICI combinations, such as doxorubicin plus pembrolizumab, have shown isolated responses but require further study in larger cohorts. Moving forward, better biomarkers are critical for identifying which patients benefit most from ICIs, and while TKI-ICI combinations appear to hold the most promise, chemotherapy-ICI strategies need further refinement to optimize sequencing and patient selection in angiosarcoma treatment.

P2, N=220, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Dec 2024 --> Jun 2025

P1/2, N=19, Terminated, M.D. Anderson Cancer Center | Trial completion date: Jun 2025 --> Feb 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Feb 2025; PI requested.

P2, N=33, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Mar 2025 --> Sep 2025

P2, N=14, Terminated, Dana-Farber Cancer Institute | N=24 --> 14 | Trial completion date: Sep 2031 --> Feb 2025 | Recruiting --> Terminated | Trial primary completion date: Sep 2025 --> Feb 2025; In agreement with the drug sponsor and the institution, the trial has been terminated due to slow accrual.

P2, N=4, Terminated, Case Comprehensive Cancer Center | Completed --> Terminated; PI preference

P1/2, N=0, Withdrawn, ImmunityBio, Inc. | Phase classification: P1b/2 --> P1/2

We conducted experiments on human non-small cell lung cancer and mouse colorectal carcinoma animal models to assess the efficacy of JQ1 and avelumab treatment on PD-L1 expression and immune cell infiltration by immuno-PET imaging. Although imaging CD8-positive T-cell infiltration did not predict tumoral response, imaging the unoccupied fraction of PD-L1 after treatment was predictive of tumor growth reduction and survival. Immuno-PET imaging with noncompetitive radioligands throughout the treatment course could improve the efficiency and support rationalization of the dosing regimen of immunotherapies.

P=N/A, N=360, Active, not recruiting, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed --> Active, not recruiting | Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Jun 2026

P1/2, N=19, Recruiting, Melanoma and Skin Cancer Trials Limited | N=38 --> 19 | Trial primary completion date: Jul 2025 --> Jul 2027

P3, N=121, Terminated, AIO-Studien-gGmbH | N=430 --> 121 | Recruiting --> Terminated; insufficient accrual rate

P4, N=135, Recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

P1, N=19, Active, not recruiting, University of Oklahoma | Trial completion date: Sep 2024 --> Sep 2025

M6223±BA had a manageable safety profile, with RDEs defined for both monotherapy and combination therapy. Further evaluation of M6223 is ongoing in combination with the PD-L1 inhibitor avelumab in patients with advanced urothelial carcinoma (JAVELIN Bladder Medley; NCT05327530).

P1, N=24, Terminated, Dana-Farber Cancer Institute | Phase classification: P1b --> P1 | Active, not recruiting --> Terminated; Stopped was stopped prematurely due to drug manufacturer withdrawing supply/funding. Patients already enrolled on study were allowed to continue treatment.

P2, N=80, Not yet recruiting, American University of Beirut Medical Center | Initiation date: Jan 2025 --> Apr 2025

Analyses of the association between NER level and treatment outcomes with avelumab plus axitinib versus sunitinib were inconclusive. NCT02684006.

P=N/A, N=599, Completed, Pfizer | Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Apr 2024 | Trial primary completion date: Mar 2025 --> Apr 2024

P1/2, N=18, Recruiting, Universitair Ziekenhuis Brussel | Phase classification: P1 --> P1/2 | Trial completion date: Dec 2020 --> Dec 2025 | Trial primary completion date: Dec 2020 --> Dec 2025 | Completed --> Recruiting

We emphasize the real-world applicability of maintenance avelumab for Japanese patients with la/mUC. Maintenance avelumab demonstrated favorable survival outcomes, consistent with clinical trial data. Identifying prognostic factors and optimizing treatment sequencing are essential strategies for improving outcomes in this patient population.

P2, N=18, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jan 2025 --> Jan 2027 | Trial primary completion date: Jan 2025 --> Jan 2027

P=N/A, N=300, Recruiting, Astellas Pharma Singapore Pte. Ltd. | Trial completion date: Oct 2024 --> Jan 2025 | Trial primary completion date: Oct 2024 --> Jan 2025

P2, N=60, Active, not recruiting, Alliance for Clinical Trials in Oncology | Trial completion date: Dec 2024 --> Dec 2028 | Trial primary completion date: Nov 2024 --> Nov 2026