P1, N=105, Recruiting, ImmunoGenesis | Phase classification: P1a/1b --> P1

P3; Trial completion date: Jun 2026 --> Jul 2027 | Trial primary completion date: Dec 2025 --> Aug 2024

P1, N=87, Active, not recruiting, Shattuck Labs, Inc. | Recruiting --> Active, not recruiting

P1, N=12, Not yet recruiting, Washington University School of Medicine

Our case represents a successful attempt at personalized treatment and provides preliminary evidence for the clinical use of downstaging therapy of androgen deprivation therapy, chemotherapy, and add-on zimberelimab for very-high-risk clinically localized PCa.

P2, N=25, Recruiting, Rutgers, The State University of New Jersey | Trial completion date: Dec 2022 --> Sep 2023 | Trial primary completion date: Dec 2022 --> Jun 2023

P1, N=87, Recruiting, Shattuck Labs, Inc. | Trial completion date: Dec 2022 --> Oct 2023 | Trial primary completion date: Nov 2022 --> Jul 2023

CME Provider and Supporter(s): This event is organized and accredited by Research to Practice and supported through educational grants provided by Astellas and Seagen Inc, AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, and Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC. Current clinical role of atezolizumab or pembrolizumab as first-line treatment for mUBC; importance of chemotherapy eligibility and PD-L1 status in patient selection for this strategy Appropriate incorporation of maintenance avelumab after front-line chemotherapy for mUBC Biologic rationale for the investigation of anti-PD-1/PD-L1 antibodies in combination with novel therapies (eg, enfortumab vedotin, erdafitinib) for previously untreated mUBC Recently presented efficacy and safety results from cohort K of the EV-103/KEYNOTE-869 study of first-line pembrolizumab in combination with enfortumab vedotin Potential clinical role of up-front pembrolizumab/enfortumab vedotin for patients with mUBC who are ineligible to receive cisplatin-based chemotherapy Preliminary data with erdafitinib in combination with cetrelimab for patients with previously untreated mUBC with FGFR3 or FGFR2 genetic alterations

P1, N=35, Recruiting, Peter Hosein, MD | Not yet recruiting --> Recruiting

P1/2, N=201, Terminated, Incyte Corporation | Completed --> Terminated

P1, N=35, Not yet recruiting, Peter Hosein, MD | Trial completion date: Apr 2026 --> Sep 2027 | Initiation date: Dec 2022 --> Mar 2023 | Trial primary completion date: Oct 2024 --> Mar 2025

TAR-200 was generally safe, well tolerated, and demonstrated preliminary efficacy in this elderly and frail cohort with limited treatment options. TAR-200 is currently under investigation in combination with the systemic inhibitor of programmed cell death protein-1 cetrelimab in the SunRISe clinical trials program (NCT04640623, NCT04658862, NCT04919512).

P1, N=46, Recruiting, Yale University | Trial completion date: Jul 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Feb 2025

P1, N=112, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Dec 2022 --> Jun 2023

NCT04262856

P1/2, N=36, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Dec 2022 --> Jun 2023

P2, N=335, Not yet recruiting, Gilead Sciences

P2, N=40, Active, not recruiting, Surface Oncology | Recruiting --> Active, not recruiting | Trial completion date: Nov 2023 --> Jul 2023 | Trial primary completion date: Nov 2023 --> May 2023

P2, N=20, Not yet recruiting, M.D. Anderson Cancer Center | Initiation date: Sep 2022 --> Dec 2022

P1/2, N=140, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Mar 2025 | Trial primary completion date: Nov 2023 --> Sep 2022

P2, N=55, Recruiting, Stephen Bagley, MD, MSCE | Not yet recruiting --> Recruiting

P1, N=146, Active, not recruiting, Boehringer Ingelheim | Trial primary completion date: Nov 2022 --> Aug 2023

P2, N=150, Active, not recruiting, Arcus Biosciences, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Nov 2022 --> Feb 2024

P1, N=230, Recruiting, Incyte Corporation | Trial completion date: Apr 2024 --> Dec 2023 | Trial primary completion date: Apr 2024 --> Dec 2023

LXN deficiency enhances PD-L2 expression rather than PD-L1 in macrophages, which lead to inhibition of T cells in tumor microenvironment. Collectively, we define a critical role of LXN/JAK1/STAT3 signal in macrophage and highlights the potential role of LXN in tumor immune-escape by regulating macrophage polarization, as well as the expression of immune checkpoint PD-L2.

P1, N=77, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Oct 2022 --> Jul 2023 | Trial primary completion date: Aug 2022 --> Jul 2023

The chemotherapy-free regimen of combined margetuximab/retifanlimab as first-line treatment in double biomarker-selected patients demonstrated a favorable toxicity profile compared with historical outcomes using chemotherapy plus trastuzumab. The ORR observed in this study compares favorably versus ORR observed with other chemotherapy-free approaches.

P1/2, N=36, Recruiting, BriaCell Therapeutics Corporation | N=60 --> 36

P2, N=62, Terminated, MacroGenics | Trial completion date: Apr 2024 --> Jul 2022 | Recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Jul 2022; Based on internal review of safety data

P3, N=720, Recruiting, Gilead Sciences | Not yet recruiting --> Recruiting

P2, N=162, Recruiting, Incyte Biosciences International Sàrl | Not yet recruiting --> Recruiting

P2, N=55, Not yet recruiting, Stephen Bagley, MD, MSCE | Initiation date: Jul 2022 --> Nov 2022

P2, N=25, Recruiting, Rutgers, The State University of New Jersey | Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Dec 2022

P1/2, N=150, Active, not recruiting, MacroGenics | Recruiting --> Active, not recruiting

P1b, N=18, Active, not recruiting, Arcus Biosciences, Inc. | N=80 --> 18

P1, N=210, Recruiting, Incyte Corporation | Trial completion date: Aug 2024 --> Jan 2025 | Trial primary completion date: Aug 2024 --> Jan 2025

P2, N=31, Recruiting, The First Affiliated Hospital with Nanjing Medical University

Approximately 220 patients enroll into 4 treatment Groups: A—CPI-naive MSI-H EC receiving retifanlimab monotherapy (up to 100 patients); B—CPI-naive dMMR or POLE-positive EC receiving retifanlimab monotherapy (up to 40 patients); D—EC with activating fibroblast growth factor receptor (FGFR1, 2 or 3) mutations or alterations outside of the kinase domain and regardless of prior CPI treatment receiving retifanlimab plus pemigatinib (up to 40 patients); F—CPI-experienced MSI-H EC receiving retifanlimab, INCAGN02385 (LAG-3 inhibitor), and INCAGN02390 (TIM-3 inhibitor) (up to 40 patients). Trial in progress: there are no available conclusions at the time of submission.

P2, N=300, Recruiting, Incyte Corporation | Trial completion date: Aug 2023 --> Jun 2025

This Phase Ia/Ib study (NCT03964233) is assessing BI 907828, an MDM2–p53 antagonist, combined with immune checkpoint inhibitors in TP53 wild-type cancers. In Phase Ia (dose escalation), patients with advanced/metastatic solid tumors received escalating doses of BI 907828 guided by a Bayesian Logistic Regression Model (starting dose 10 mg orally) plus ezabenlimab 240 mg (anti-PD-1 antibody) and BI 754111 600 mg (anti-LAG-3 antibody) every 21 days (q3w). The doublet combination of BI 907828 plus ezabenlimab showed a manageable safety profile and early signs of anti-tumor activity. Eleven patients remain on treatment; recruitment is ongoing.

P1b/2, N=342, Recruiting, Arcus Biosciences, Inc. | N=165 --> 342 | Trial completion date: Oct 2023 --> Dec 2025

Retifanlimab demonstrated clinically meaningful and durable antitumor activity, and an acceptable safety profile in patients with previously treated locally advanced or metastatic SCAC who have progressed on or are intolerant to platinum-based chemotherapy.