Libtayo (cemiplimab-rwlc)

P2, N=34, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting

P2, N=32, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Initiation date: Oct 2023 --> Feb 2024

P1, N=333, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2024 --> Apr 2024

P2, N=126, Not yet recruiting, Duke University

P3, N=790, Active, not recruiting, Regeneron Pharmaceuticals | Trial primary completion date: Jul 2023 --> Feb 2025

P2, N=140, Not yet recruiting, Regeneron Pharmaceuticals

P2, N=87, Recruiting, Vyriad, Inc. | Trial primary completion date: Mar 2024 --> Dec 2024

This study confirms the feasibility and the replicability of the cemiplimab nominal use in advanced CC, in a real-world practice in Italy.

Currently, seven ICIs, namely ipilimumab (anti-cytotoxic T lymphocyte-associated protein 4 [CTLA4]), pembrolizumab, nivolumab (anti-programmed cell death protein 1 [PD-1]), atezolizumab, avelumab, durvalumab, and cemiplimab (anti-PD-L1), have been approved for various cancer types. Consequently, ongoing studies are evaluating the next generation of ICIs, such as lymphocyte activation gene-3 (LAG3), T cell immunoglobulin and mucin-domain containing 3 (TIM3), and T cell immunoglobulin and ITIM domain (TIGIT). Our review provides a summary of clinical trials evaluating these novel immune checkpoints in cancer treatment.

No abstract available

P2, N=225, Suspended, Regeneron Pharmaceuticals | Recruiting --> Suspended

P1, N=120, Recruiting, Mayo Clinic | Trial completion date: Dec 2024 --> Apr 2032 | Trial primary completion date: Dec 2024 --> Dec 2028

This cohort study of patients who were treated with neoadjuvant cemiplimab or pembrolizumab for advanced cSCC from January 2018 to January 2023 was conducted at 2 academic institutions in Boston, Massachusetts. Outside of clinical trials, it is not infrequent for patients to opt out of surgery for regressing tumors. The inclusion of higher-risk patients and preference for nonsurgical treatment are 2 factors that might explain the numerically lower pathologic response rate in this institutional experience.

P2, N=50, Not yet recruiting, M.D. Anderson Cancer Center | Trial completion date: Apr 2027 --> Apr 2028 | Initiation date: Jan 2024 --> Jan 2025 | Trial primary completion date: Apr 2025 --> Apr 2026

P1, N=13, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 --> Sep 2025 | Trial primary completion date: Dec 2024 --> Sep 2024

P1/2, N=612, Recruiting, Regeneron Pharmaceuticals | N=326 --> 612 | Trial primary completion date: Jan 2027 --> Apr 2027

P1/2, N=75, Terminated, BioNTech SE | Trial completion date: Oct 2024 --> Jan 2024 | Active, not recruiting --> Terminated; Sponsor decision

P1, N=62, Recruiting, Regeneron Pharmaceuticals | Active, not recruiting --> Recruiting

P1, N=309, Active, not recruiting, Immune-Onc Therapeutics | Phase classification: P1b --> P1 | Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Mar 2024

P=N/A, N=1000, Active, not recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Active, not recruiting

P1, N=50, Not yet recruiting, Inimmune Corporation

This was a phase 1/2, randomized (4:1), double-blind, placebo-controlled study in adults with suppressed HIV on antiretroviral therapy with CD4+ counts ≥350 cells/μL who received 2 infusions of cemiplimab versus placebo...Clinical Trials Registration. NCT03787095.

P1, N=77, Terminated, Sanofi | Completed --> Terminated; Sponsor terminated the study for non-safety reasons

P=N/A, N=141630, Completed, Groupe Hospitalier Pitie-Salpetriere | Recruiting --> Completed | Trial completion date: Sep 2023 --> Feb 2024 | Trial primary completion date: Sep 2023 --> Dec 2023

P1, N=77, Completed, Sanofi | Active, not recruiting --> Completed

P1/2, N=237, Recruiting, Regeneron Pharmaceuticals | N=83 --> 237 | Trial completion date: Dec 2026 --> Feb 2030 | Trial primary completion date: Dec 2026 --> Feb 2030

P3, N=1530, Recruiting, Regeneron Pharmaceuticals | Trial primary completion date: Feb 2030 --> May 2028

P2, N=60, Recruiting, Duke University | N=25 --> 60

P1/2, N=46, Active, not recruiting, Sanofi | N=80 --> 46

P=N/A, N=1000, Not yet recruiting, Regeneron Pharmaceuticals

SAR439459 ± cemiplimab showed expected peripheral PD effects and TGFβ alteration. However, further studies are needed to identify biomarkers of response.

P2, N=72, Recruiting, Alliance for Clinical Trials in Oncology | Suspended --> Recruiting

P2, N=225, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Mar 2027 --> Jul 2027 | Trial primary completion date: Mar 2027 --> Jul 2027

P2, N=36, Recruiting, Medical College of Wisconsin | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025

P1/2, N=370, Recruiting, Regeneron Pharmaceuticals | N=199 --> 370 | Trial completion date: Aug 2026 --> Jan 2027 | Trial primary completion date: Aug 2026 --> Jan 2027

P2/3, N=1925, Recruiting, Regeneron Pharmaceuticals | Phase classification: P3 --> P2/3 | Trial completion date: Apr 2031 --> Aug 2032

P3, N=560, Not yet recruiting, Regeneron Pharmaceuticals

ICIs were significantly associated with neurologic risks, which cannot be generalized. A considerable increase in ICSR reporting frequency was observed with atezolizumab, cemiplimab, and nivolumab, while avelumab, pembrolizumab, durvalumab, and cemiplimab were linked with four potential signals. These findings suggest the consideration of a revision of the neurologic safety profile of ICIs. Furthermore, the necessity for additional ad-hoc research is emphasized.

P1/2, N=12, Active, not recruiting, Dana-Farber Cancer Institute | Phase classification: P1 --> P1/2

As a result of great achievements in clinical trials, 6 programmed death-1 inhibitors (sintilimab, camrelizumab, tislelizumab, pembrolizumab, cemiplimab, and nivolumab), 2 programmed death-ligand 1 inhibitors (sugemalimab and atezolizumab), and 1 cytotoxic T lymphocyte-associated antigen-4 inhibitor (ipilimumab) have been approved as first-line treatment for mNSCLC by the US Food and Drug Administration. Results from first-line trials have shown that almost all driver-negative mNSCLC are treated with ICIs and significantly prolong patient survival; however, the low response rate and adverse reactions to immunotherapy remain to be addressed. Here, we summarize the use of ICIs, including monotherapy and combination therapy, in the first-line treatment of mNSCLC in recent years and discuss the low response rate and adverse reactions of ICIs as well as the challenges and expectations for the first-line treatment of mNSCLC in the future.

P2, N=136, Not yet recruiting, European Organisation for Research and Treatment of Cancer - EORTC

P1/2, N=169, Recruiting, Sensei Biotherapeutics, Inc. | N=129 --> 169