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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002789-30 | EudraCT Number |
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The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma.
The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy (REGN3767) | Experimental | Group A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion. |
|
| Combination Therapy (REGN3767+cemiplimab) | Experimental | Group B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN3767 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of dose limiting toxicities (Dose Escalation Phase) | Baseline to 28 days | |
| Rate of adverse events (Dose Escalation Phase) | Baseline to 51 weeks | |
| Rate of serious adverse events (Dose Escalation Phase) | Baseline to 51 weeks | |
| Occurrence of death (Dose Escalation Phase) | Baseline to 51 weeks | |
| Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Escalation Phase) | Baseline to 51 weeks | |
| Area under the curve (AUC) computed from time zero to the time of the last concentration [AUCall] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks | |
| AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks | |
| AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks | |
| AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks | |
| AUC computed from time zero to the time of the last positive concentration [AUClast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase) | Baseline to week 51 | |
| Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase) | Baseline to week 51 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion / Exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Cancer Associates for Research and Excellence | Encinitas | California | 92024 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38900987 | Derived | Hamid O, Lewis KD, Weise A, McKean M, Papadopoulos KP, Crown J, Kim TM, Lee DH, Thomas SS, Mehnert J, Kaczmar J, Lakhani NJ, Kim KB, Middleton MR, Rabinowits G, Spira AI, Yushak M, Mehmi I, Fang F, Chen S, Mani J, Jankovic V, Wang F, Fiaschi N, Brennan L, Paccaly A, Masinde S, Salvati M, Fury MG, Kroog G, Lowy I, Gullo G. Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma. J Clin Oncol. 2024 Aug 20;42(24):2928-2938. doi: 10.1200/JCO.23.02172. Epub 2024 Jun 20. |
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| cemiplimab |
| Drug |
|
|
| Baseline to 51 weeks |
| AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to week 51 |
| Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase) | Baseline to 51 weeks |
| Mean residence time when the drug concentration profile is based on values up to and including the last positive concentration [MRTlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) | Baseline to 51 weeks |
| Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase) | Baseline to 51 weeks |
| Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase) | Baseline to 51 weeks |
| Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase) | Baseline to 51 weeks |
| Best overall response based on irRECIST criteria (Dose Escalation Phase) | Baseline to 51 weeks |
| Best overall response based on Lugano criteria (Dose Escalation Phase) | Baseline to 51 weeks |
| Duration of response based on RECIST criteria (Dose Escalation Phase) | Baseline to week 51 |
| Duration of response based on irRECIST criteria (Dose Escalation Phase) | Baseline to week 51 |
| Duration of response based on Lugano criteria (Dose Escalation Phase) | Baseline to week 51 |
| Disease control rate based on RECIST criteria (Dose Escalation Phase) | Baseline to 51 weeks |
| Disease control rate based on irRECIST criteria (Dose Escalation Phase) | Baseline to 51 weeks |
| Disease control rate based on Lugano criteria (Dose Escalation Phase) | Baseline to 51 weeks |
| Progression free survival based on RECIST (Dose Escalation Phase) | Baseline to 51 weeks |
| Progression free survival based on irRECIST (Dose Escalation Phase) | Baseline to 51 weeks |
| Progression free survival based on Lugano criteria (Dose Escalation Phase) | Baseline to 51 weeks |
| Incidence of adverse events (Dose Expansion Phase) | Baseline to 51 weeks |
| Incidence of serious adverse events (Dose Expansion Phase) | Baseline to 51 weeks |
| Incidence of death (Dose Expansion Phase) | From Baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months |
| Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Expansion Phase) | Baseline to 51 weeks |
| Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase) | Baseline to 51 weeks |
| California Cancer Associates For Research And Excellence |
| Fresno |
| California |
| 93720 |
| United States |
| University of California San Diego (UCSD) | La Jolla | California | 92093-0698 | United States |
| The Angeles Clinic | Los Angeles | California | 90025 | United States |
| University of California Davis Health Systems | Sacramento | California | 95817 | United States |
| California Pacific Medical Center (CPMC) | San Francisco | California | 94115 | United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Lombardi Comprehensive Cancer Center - MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| Orlando Health, Inc | Orlando | Florida | 32806 | United States |
| Winship Cancer Institute at Emory University | Atlanta | Georgia | 30322 | United States |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | United States |
| Dana Farber Cancer Institute | Jamaica Plain | Massachusetts | 02130 | United States |
| Henry Ford Health Hospital | Detroit | Michigan | 48202 | United States |
| Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | United States |
| Washington University in Saint Louis | St Louis | Missouri | 63110 | United States |
| John Theurer Cancer Center, Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| New Mexico Cancer Care Alliance-UNM Cancer Center | Albuquerque | New Mexico | 87131 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Northwell Health-Monter Cancer Center | Lake Success | New York | 11042 | United States |
| Laura & Isaac Perlmutter Cancer Center | New York | New York | 10016 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| University Hospitals Seidman Cancer Center and Case Western Reserve University | Cleveland | Ohio | 44087 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Hollings Cancer Center - Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| South Texas Oncology and Hematology | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Care Specialist, PC | Fairfax | Virginia | 22031 | United States |
| The University of Western Australia - The Queen Elizabeth II Medical Centre (QEIIMC) - Sir Charles Gairdner Hospital (SCGH) | Perth | Western Australia | 06009 | Australia |
| Royal Brisbane and Women's Hospital | Brisbane | 4029 | Australia |
| Peter Maccallum Cancer Centre (PMCC) | Melbourne | 3000 | Australia |
| St. Vincents University Hospital | Dublin | D04 T6F4 | Ireland |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Guy's Hospital | London | Europe | SE19RT | United Kingdom |
| University Of Oxford - Churchill Hospital | Headington | Oxford | OX37LJ | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000627974 | cemiplimab |
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