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- | Libtayo (cemiplimab-rwlc) / Regeneron
Journal: Efficacy of Cemiplimab as Adjuvant or Neoadjuvant Therapy in the Treatment of Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - Apr 5, 2024
Cemiplimab has established its utility in the treatment of advanced cSCC, demonstrating clinical efficacy while generally having a tolerable adverse effect profile. Our preliminary results suggest that cemiplimab has potential as an adjuvant or neoadjuvant therapy in combination with surgery for treatment of cSCC.
- |||||| Libtayo (cemiplimab-rwlc) / Regeneron, vidutolimod (CMP-001) / Regeneron
Trial suspension: A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov) - Apr 4, 2024
P2, N=225, Suspended, Sponsor: Regeneron Pharmaceuticals
Our preliminary results suggest that cemiplimab has potential as an adjuvant or neoadjuvant therapy in combination with surgery for treatment of cSCC. Recruiting --> Suspended
- IMMUNE CHECKPOINT INHIBITORS-RELATED MYOSITIS: REAL-WORLD DATA FROM THE EUDRAVIGILANCE DATABASE (Poster View) - Mar 29, 2024 - Abstract #EULAR2024EULAR_1497;
Recruiting --> Suspended This study employed the EudraVigilance public version database to collect adverse events of six European Medicines Agency-approved ICIs
- | Libtayo (cemiplimab-rwlc) / Regeneron, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: A Vaccine (VSV-hIFN?-NIS) with or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma (clinicaltrials.gov) - Mar 28, 2024
P1, N=120, Recruiting, Sponsor: Mayo Clinic
This study employed the EudraVigilance public version database to collect adverse events of six European Medicines Agency-approved ICIs Trial completion date: Dec 2024 --> Apr 2032 | Trial primary completion date: Dec 2024 --> Dec 2028
- | Libtayo (cemiplimab-rwlc) / Regeneron
Journal: Multidisciplinary Management of Cutaneous Squamous Cell Carcinoma of the Scalp: An Algorithm for Reconstruction and Treatment. (Pubmed Central) - Mar 28, 2024
Effectively addressing scalp cSCC, especially in locally advanced or recurrent cases, demands a systematic approach integrating surgery, radiotherapy, and immunotherapy. Our multidisciplinary team's decision-making algorithm improved patient outcomes by offering a broader spectrum of therapeutic options that can synergistically achieve optimal results.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Journal: Extra-Anogenital Giant Cutaneous Squamous Cell Carcinomas. (Pubmed Central) - Mar 28, 2024
The authors emphasize the importance of early detection and prevention of modifiable risk factors, such as UV radiation, and a multidisciplinary approach to treatment. Other therapies, including immunotherapy, may become increasingly important.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial initiation date, Trial primary completion date, Tumor mutational burden: The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer (clinicaltrials.gov) - Mar 28, 2024
P2, N=50, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
Other therapies, including immunotherapy, may become increasingly important. Trial completion date: Apr 2027 --> Apr 2028 | Initiation date: Jan 2024 --> Jan 2025 | Trial primary completion date: Apr 2025 --> Apr 2026
- Libtayo (cemiplimab-rwlc) / Regeneron
A case of cemiplimab-induced hypercalcemia in metastatic squamous cell carcinoma () - Mar 23, 2024 - Abstract #NKFSCM2024NKF_SCM_504;
It is important to recognize ICI-associated hypercalcemia. Ongoing research is imperative to understand the underlying mechanisms and the optimal approaches to management.
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Successful Use of a PD1 Inhibitor in a High Immunologic Risk Kidney Transplant Recipient with Metastatic Cutaneous Squamous Cell Carcinoma () - Mar 23, 2024 - Abstract #NKFSCM2024NKF_SCM_502;
He remained on Cemiplimab for 6 months with stable creatinine... Future work is needed to develop IS management strategies that enable earlier ICI therapy exposure in KTR.
- | Trial completion date, Trial primary completion date: Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors (clinicaltrials.gov) - Mar 21, 2024
P3, N=578, Recruiting, Sponsor: Jason J. Luke, MD
Future work is needed to develop IS management strategies that enable earlier ICI therapy exposure in KTR. Trial completion date: Oct 2026 --> Oct 2028 | Trial primary completion date: Oct 2026 --> Oct 2028
- | Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date: Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer (clinicaltrials.gov) - Mar 19, 2024
P1, N=13, Active, not recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Trial completion date: Oct 2026 --> Oct 2028 | Trial primary completion date: Oct 2026 --> Oct 2028 Trial completion date: Dec 2025 --> Sep 2025 | Trial primary completion date: Dec 2024 --> Sep 2024
- ||| ubamatamab (REGN4018) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron, REGN5668 / Regeneron
Enrollment change, Trial primary completion date: R5668-ONC-1938: A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018 (clinicaltrials.gov) - Mar 18, 2024
P1/2, N=612, Recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Dec 2025 --> Sep 2025 | Trial primary completion date: Dec 2024 --> Sep 2024 N=326 --> 612 | Trial primary completion date: Jan 2027 --> Apr 2027
- | Libtayo (cemiplimab-rwlc) / Regeneron
Journal, Metastases: Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - Mar 18, 2024
P1/2
mTOR inhibitor and corticosteroids represent a favorable immunosuppressive regimen for KTRs with advanced CSCC receiving immunotherapy. This combination resulted in durable antitumor responses with no kidney rejection events (funded by Regeneron Pharmaceuticals [ClinicalTrials.gov identifier: NCT04339062]).
- ||||| BNT112 / BioNTech
Trial completion date, Trial termination, Monotherapy: PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - Mar 18, 2024
P1/2, N=75, Terminated, Sponsor: BioNTech SE
This combination resulted in durable antitumor responses with no kidney rejection events (funded by Regeneron Pharmaceuticals [ClinicalTrials.gov identifier: NCT04339062]). Trial completion date: Oct 2024 --> Jan 2024 | Active, not recruiting --> Terminated; Sponsor decision
- ||| Libtayo (cemiplimab-rwlc) / Regeneron, Ordspono (odronextamab) / Regeneron
Enrollment open: CLIO-1: A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies (clinicaltrials.gov) - Mar 17, 2024
P1, N=62, Recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Oct 2024 --> Jan 2024 | Active, not recruiting --> Terminated; Sponsor decision Active, not recruiting --> Recruiting
- | Libtayo (cemiplimab-rwlc) / Regeneron
Journal: Cemiplimab-Associated Eruption of Generalized Eruptive Keratoacanthoma of Grzybowski. (Pubmed Central) - Mar 17, 2024
Active, not recruiting --> Recruiting No abstract available
- MORPHOLOGIC SPECTRUM OF IMMUNOTHERAPY ASSOCIATED LIVER INJURY: A CLINICOPATHOLOGIC AND BIOCHEMICAL APPRAISAL (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5901;
Our study reports side effects of the already known, as well as novel & newer IT/ICIs such as anti-GUCY2C+CD3 bispecific antibodies & Cemiplimab. With newer immunotherapy agents being introduced into the ever-evolving landscape, pathologists must recognize the wide variety of hepatotoxicity, including rare forms such as the steatotic type.
- COLITIS DIAGNOSIS IN MELANOMA PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS (ICI) IN REAL-WORLD SETTINGS: TIMING OF ONSET AND PATTERNS OF CARE (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5088;
Of these 347 patients, 320 (92.2%) were initially treated with corticosteroids, 8 (2.3%) with biologics + corticosteroids, 12 (3.5%) with biologics, 5 (1.4%) with 5-aminosalicylates (5-ASAs) and 2 (0.6%) with 5-ASAs + corticosteroids. The median (IQR) duration between the initiation of ICI treatment to colitis onset was 4.3 (2.0-9.2) months and the median (IQR) duration of corticosteroid treatment was 2.7 (1.3-6.1) months.
- || IO-108 - Immune / Onc Therap
Phase classification, Trial completion date, Trial primary completion date, Monotherapy: IO-108-CL-001: First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Mar 14, 2024
P1, N=309, Active, not recruiting, Sponsor: Immune-Onc Therapeutics
The median (IQR) duration between the initiation of ICI treatment to colitis onset was 4.3 (2.0-9.2) months and the median (IQR) duration of corticosteroid treatment was 2.7 (1.3-6.1) months. Phase classification: P1b --> P1 | Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
- ||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment closed, HEOR, Real-world evidence: Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients (clinicaltrials.gov) - Mar 13, 2024
P=N/A, N=1000, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
Phase classification: P1b --> P1 | Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Mar 2024 Not yet recruiting --> Active, not recruiting
- || INI-4001 / Inimmune
New P1 trial: Trial of INI-4001 in Patients With Advanced Solid Tumours (clinicaltrials.gov) - Mar 11, 2024
P1, N=50, Not yet recruiting, Sponsor: Inimmune Corporation
- Libtayo (cemiplimab-rwlc) / Regeneron
Economic Evaluation for the United States (US) of the Overall Survival Analysis of Cemiplimab Plus Chemotherapy Treatment in Advanced Non-Small Cell Lung Cancer (NSCLC) With at Least 50% PD-L1 Positivity () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_569;
Not yet recruiting --> Active, not recruiting This economic evaluation suggested that, in comparison with cemiplimab alone, cemiplimab plus chemotherapy combination was a slightly more cost-effective treatment option (insignificant difference) for non-small cell lung cancer (NSCLC) patients with at least 50% (PD-L1) in the US.
- Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Cost-Effectiveness of Cemiplimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy As the First-Line Treatment for Advanced Non-Small Cell Lung Cancer: A Preliminary Study () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_377;
Our preliminary study showed that using a CCT regimen would result in lower costs with a loss of health outcome compared to using a PCT regimen as a first-line treatment for advanced NSCLC in the US. However, sensitivity analyses should be performed to confirm the robustness of the main findings.
- Libtayo (cemiplimab-rwlc) / Regeneron, Rituxan (rituximab) / Roche
A Successful Treatment Story of a Patient with Immune Checkpoint Inhibitor Associated Myositis and Myasthenia Gravis (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_2867;
Cemiplimab is an ICI used for the treatment of squamous cell skin cancer and has been associated with neuromuscular complications...She underwent plasma exchange followed by a second round of IVIG and was started on prednisone with minimal improvement...This case, with an overlap of ICI-associated myositis and myasthenia gravis, presents a diagnostic and treatment challenge, but ultimately resulted in a favorable treatment outcome. It underscores the importance of early application of the correct treatment and the role of rituximab in such cases.
- || Libtayo (cemiplimab-rwlc) / Regeneron
Clinical, PD(L)-1 Biomarker, IO biomarker: Safety and Immune Responses Following Anti-PD-1 Monoclonal Antibody Infusions in Healthy Persons With Human Immunodeficiency Virus on Antiretroviral Therapy. (Pubmed Central) - Mar 7, 2024
P1/2
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/?L who received 2 infusions of cemiplimab versus placebo...Clinical Trials Registration. NCT03787095.
- Libtayo (cemiplimab-rwlc) / Regeneron
miRNA lncRNA network associated with response to cemiplimab in cutaneous squamous cell carcinoma (Section 45) - Mar 5, 2024 - Abstract #AACR2024AACR_6460;
Preliminary analysis in pre-therapy plasma samples of cSCC validated the in silico data highlighting the inverse correlation between miR-148a/b and lnc (PVT1 and LINC00665). Further investigation will confirm the role of miR125a/b and miR148a/b as predictors of cemiplimab response.
- Tissue-specific thresholds and microenvironment correlates of tumor mutation burden associated with immunotherapy benefit and prognosis in microsatellite stable cancers (Ballroom 6 CF - Upper Level - Convention Center) - Mar 5, 2024 - Abstract #AACR2024AACR_3318;
Detectable survival benefits were noted over a broad range of TMB cutoffs across cancer types, and a dose-dependent relationship between TMB and outcomes was observed in a subset of cancers. These results may have implications for cancer-agnostic and universal TMB cutoffs to guide the use of anti-PD-1/L1 therapies, and underline the importance of tissue context in the clinical development of ICI biomarkers.
- Libtayo (cemiplimab-rwlc) / Regeneron
Veterans Health Administration: Decentralized clinical trials (Section 38) - Mar 5, 2024 - Abstract #AACR2024AACR_3113;
The DCT program builds upon the existing clinical infrastructure to conduct CTs on a national scale. The NOP DCT team is a component of the VA's Enhance Equity and Access to Clinical Trials (ENACT) initiative, which is part of Cancer Moonshot.
- Libtayo (cemiplimab-rwlc) / Regeneron
Response-Adapted Oncologic Surgery for Cutaneous Squamous Cell Carcinoma: Personalized Approach in the Immunotherapy Era (Grand Ballroom EF) - Mar 5, 2024 - Abstract #AHNSCOSM2024AHNS_COSM_10;
This study underscores the importance of personalized approaches, incorporating pretreated tumor size and stage considerations, in the paradigm shift towards optimizing outcomes for cutaneous squamous cell carcinoma patients. The findings advocate for including prospective response-adapted oncologic surgery as an outcome measure in phase 3 trials to assess the safety of RAOS in the context of immunotherapy aiming for organ preservation and minimizing surgical morbidity.
- |||| SAR441000 / Sanofi, BioNTech
Trial termination, Monotherapy: A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Mar 5, 2024
P1, N=77, Terminated, Sponsor: Sanofi
The findings advocate for including prospective response-adapted oncologic surgery as an outcome measure in phase 3 trials to assess the safety of RAOS in the context of immunotherapy aiming for organ preservation and minimizing surgical morbidity. Completed --> Terminated; Sponsor terminated the study for non-safety reasons
- | Trial completion, Trial completion date, Trial primary completion date, Adverse events, Checkpoint inhibition: EXIT: EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance Database (clinicaltrials.gov) - Mar 5, 2024
P=N/A, N=141630, Completed, Sponsor: Groupe Hospitalier Pitie-Salpetriere
Completed --> Terminated; Sponsor terminated the study for non-safety reasons Recruiting --> Completed | Trial completion date: Sep 2023 --> Feb 2024 | Trial primary completion date: Sep 2023 --> Dec 2023
- COMPARATIVE ANALYSIS OF BLEEDING AND THROMBOTIC RISKS AMONG IMMUNE CHECKPOINT INHIBITORS: INSIGHTS FROM THE FDA ADVERSE EVENT REPORTING SYSTEM (On-Demand/Online; Virtual) - Mar 2, 2024 - Abstract #THSNA2024THSNA_107;
Atezolizumab emerges with the highest PRR for anemia, also without statistical significance. Among pembrolizumab, nivolumab, and ipilimumab, nivolumab has the highest PRR of hemolysis.
- ||| SAR441000 / Sanofi, BioNTech
Trial completion, Monotherapy: A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Mar 1, 2024
P1, N=77, Completed, Sponsor: Sanofi
Among pembrolizumab, nivolumab, and ipilimumab, nivolumab has the highest PRR of hemolysis. Active, not recruiting --> Completed
- ||| REGN5093-M114 / Regeneron
Enrollment change, Trial completion date, Trial primary completion date: Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer (clinicaltrials.gov) - Feb 29, 2024
P1/2, N=237, Recruiting, Sponsor: Regeneron Pharmaceuticals
Active, not recruiting --> Completed N=83 --> 237 | Trial completion date: Dec 2026 --> Feb 2030 | Trial primary completion date: Dec 2026 --> Feb 2030
- |||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
Trial primary completion date: A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery (clinicaltrials.gov) - Feb 22, 2024
P3, N=1530, Recruiting, Sponsor: Regeneron Pharmaceuticals
N=83 --> 237 | Trial completion date: Dec 2026 --> Feb 2030 | Trial primary completion date: Dec 2026 --> Feb 2030 Trial primary completion date: Feb 2030 --> May 2028
- Libtayo (cemiplimab-rwlc) / Regeneron
Regional Experience of Cemiplimab, in Locally advanced and stage IV Head and Neck Cutaneous Squamous Cell Carcinomas () - Feb 22, 2024 - Abstract #ICHNO2024ICHNO_132;
Our review highlights the importance of careful case selection. An interesting question is whether patients who achieve complete response to treatment, require a full 2 years of Cemiplimab immunotherapy.
- ||| Libtayo (cemiplimab-rwlc) / Regeneron, Praluent (alirocumab) / Sanofi, Regeneron
Enrollment change: PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung (clinicaltrials.gov) - Feb 22, 2024
P2, N=60, Recruiting, Sponsor: Duke University
An interesting question is whether patients who achieve complete response to treatment, require a full 2 years of Cemiplimab immunotherapy. N=25 --> 60
- ||| pegenzileukin (SAR444245) / Sanofi
Enrollment change: A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201) (clinicaltrials.gov) - Feb 21, 2024
P1/2, N=46, Active, not recruiting, Sponsor: Sanofi
N=25 --> 60 N=80 --> 46
- |||||| Libtayo (cemiplimab-rwlc) / Regeneron
New trial, HEOR, Real-world evidence: Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients (clinicaltrials.gov) - Feb 21, 2024
P=N/A, N=1000, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- Libtayo (cemiplimab-rwlc) / Regeneron
Cemiplimab treatment in patients with locally advanced and metastatic secondary angiosarcomas (CEMangio): A phase II clinical trial in progress (Foyer Ground Floor) - Feb 20, 2024 - Abstract #SarcomaRC2024SARCOMA_RC_280;
- Libtayo (cemiplimab-rwlc) / Regeneron
First-line CEMiplimab in metastatic PENile squamous cell carcinoma: the CemPen study (Foyer Ground Floor) - Feb 20, 2024 - Abstract #SarcomaRC2024SARCOMA_RC_172;
- || Libtayo (cemiplimab-rwlc) / Regeneron, SAR439459 / Sanofi
Biomarker, P1 data, PK/PD data, Clinical Trial,Phase I, Journal, Combination therapy, Monotherapy, PD(L)-1 Biomarker, Metastases: Biomarker and pharmacodynamic activity of the transforming growth factor-beta (TGF?) inhibitor SAR439459 as monotherapy and in combination with cemiplimab in a phase I clinical study in patients with advanced solid tumors. (Pubmed Central) - Feb 20, 2024
P1
N=80 --> 46 SAR439459?
- | Ibrance (palbociclib) / Pfizer, Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, IO biomarker: Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma (clinicaltrials.gov) - Feb 20, 2024
P2, N=72, Recruiting, Sponsor: Alliance for Clinical Trials in Oncology
SAR439459? Suspended --> Recruiting
- || Libtayo (cemiplimab-rwlc) / Regeneron, vidutolimod (CMP-001) / Regeneron
Trial completion date, Trial primary completion date: A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov) - Feb 15, 2024
P2, N=225, Recruiting, Sponsor: Regeneron Pharmaceuticals
Suspended --> Recruiting Trial completion date: Mar 2027 --> Jul 2027 | Trial primary completion date: Mar 2027 --> Jul 2027
- | Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date: Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer (clinicaltrials.gov) - Feb 15, 2024
P2, N=36, Recruiting, Sponsor: Medical College of Wisconsin
Trial completion date: Mar 2027 --> Jul 2027 | Trial primary completion date: Mar 2027 --> Jul 2027 Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025
- ||| nezastomig (REGN5678) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron, REGN4336 / Regeneron
Enrollment change, Trial completion date, Trial primary completion date: A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer (clinicaltrials.gov) - Feb 15, 2024
P1/2, N=370, Recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025 N=199 --> 370 | Trial completion date: Aug 2026 --> Jan 2027 | Trial primary completion date: Aug 2026 --> Jan 2027
- ||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
Phase classification, Trial completion date: R3767-ONC-2011: Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma (clinicaltrials.gov) - Feb 15, 2024
P2/3, N=1925, Recruiting, Sponsor: Regeneron Pharmaceuticals
N=199 --> 370 | Trial completion date: Aug 2026 --> Jan 2027 | Trial primary completion date: Aug 2026 --> Jan 2027 Phase classification: P3 --> P2/3 | Trial completion date: Apr 2031 --> Aug 2032
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
New P3 trial: A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (clinicaltrials.gov) - Feb 15, 2024
P3, N=560, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- Libtayo (cemiplimab-rwlc) / Regeneron, tuvusertib (M1774) / EMD Serono
Phase Ib/IIa study of ATR inhibitor tuvusertib + anti-PD-1 cemiplimab in patients with advanced non-squamous (nsq) non-small cell lung cancer (NSCLC) that has progressed on prior anti-PD-(L)1 and platinum-based therapies (Congress Hall Foyer) - Feb 6, 2024 - Abstract #ELCC2024ELCC_440;
P1b/2a
Primary endpoints are investigator-assessed objective response (OR; RECIST v1.1), occurrence of adverse events (AE), and treatment-related AEs in phase Ib, and OR in phase a. Secondary endpoints in both phases include duration of response, progression-free survival, and overall survival. The study is open for enrollment in centres across the USA, Italy, Spain, France, Japan and Korea.
- Libtayo (cemiplimab-rwlc) / Regeneron, Yervoy (ipilimumab) / Ono Pharma, BMS
Patient-reported outcomes (PROs) of cemiplimab (CEMI) + platinum doublet chemotherapy (CHEMO) + ipilimumab (IPI) for first-line (1L) treatment of advanced non-small cell lung cancer (aNSCLC): EMPOWER-lung 3 part 1 (Congress Hall Foyer) - Feb 6, 2024 - Abstract #ELCC2024ELCC_400;
P3
Conclusions In patients with PD-L1 <50% aNSCLC, CEMI+IPI+CHEMO vs CHEMO resulted in significant overall improvement and delayed TTD in multiple cancer-related and lung cancer-specific PROs. Positive PROs further support the favourable benefit