MalignanciesPhase 1NCT03005782
Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers
A Phase 1 study testing REGN3767 and cemiplimab in people with Malignancies, run by Regeneron Pharmaceuticals at 43 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancies
- What is being tested?
- REGN3767 and cemiplimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 43 sitesin 5 countries
- Study dates
- 7 Nov 2016to 2 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dose escalation cohorts: Patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit AND who have not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require measurable disease
- Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function
Who cannot join
- Prior treatment with any LAG-3 targeting biologic or small molecule
- Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation
- Untreated or active central nervous system metastases - Ongoing or recent (within 5 years) evidence of significant autoimmune disease
- Corticosteroid therapy (>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug
- Myocardial infarction within 6 months
- Note: Other protocol defined Inclusion / Exclusion criteria apply
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
United States33 sites
New Mexico Cancer Care Alliance-UNM Cancer Center
Albuquerque, New Mexico, 87131
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
Roswell Park Cancer Institute
Buffalo, New York, 14263
Hollings Cancer Center - Medical University of South Carolina
Charleston, South Carolina, 29425
Levine Cancer Institute
Charlotte, North Carolina, 28204
University Hospitals Seidman Cancer Center and Case Western Reserve University
Cleveland, Ohio, 44087
Henry Ford Health Hospital
Detroit, Michigan, 48202
California Cancer Associates for Research and Excellence
Encinitas, California, 92024
Virginia Cancer Care Specialist, PC
Fairfax, Virginia, 22031
University of Kansas Clinical Research Center
Fairway, Kansas, 66205
California Cancer Associates For Research And Excellence
Fresno, California, 93720
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Dana Farber Cancer Institute
Jamaica Plain, Massachusetts, 02130
University of California San Diego (UCSD)
La Jolla, California, 92093-0698
Northwell Health-Monter Cancer Center
Lake Success, New York, 11042
The Angeles Clinic
Los Angeles, California, 90025
Miami Cancer Institute
Miami, Florida, 33176
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Laura & Isaac Perlmutter Cancer Center
New York, New York, 10016
Columbia University
New York, New York, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Orlando Health, Inc
Orlando, Florida, 32806
Rhode Island Hospital
Providence, Rhode Island, 02903
University of California Davis Health Systems
Sacramento, California, 95817
South Texas Oncology and Hematology
San Antonio, Texas, 78229
California Pacific Medical Center (CPMC)
San Francisco, California, 94115
Washington University in Saint Louis
St Louis, Missouri, 63110
Lombardi Comprehensive Cancer Center - MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Australia3 sites
Royal Brisbane and Women's Hospital
Brisbane, 4029
Peter Maccallum Cancer Centre (PMCC)
Melbourne, 3000
The University of Western Australia - The Queen Elizabeth II Medical Centre (QEIIMC) - Sir Charles Gairdner Hospital (SCGH)
Perth, Western Australia, 06009
United Kingdom2 sites
University Of Oxford - Churchill Hospital
Headington, Oxford, OX37LJ
Guy's Hospital
London, Europe, SE19RT
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (Anti-LAG-3 mAb) Administered Alone or in Combination With REGN2810 (Anti-PD-1 mAb) in Patients With Advanced Malignancies
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).
- Conditions
- Malignancies
- Being tested
- REGN3767, cemiplimab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN3767Drug
Also called fianlimab
cemiplimabDrug
Also called REGN2810
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: REGN3767 |
| 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 Receives: Drug: REGN3767; Drug: cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dose limiting toxicities (Dose Escalation Phase)
Measured: Baseline to 28 days
Rate of adverse events (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Rate of serious adverse events (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Occurrence of death (Dose Escalation Phase)
Measured: 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)
Measured: 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)
Measured: Baseline to 51 weeks
AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: 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)
Measured: Baseline to 51 weeks
AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to week 51
Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase)
Measured: 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)
Measured: Baseline to 51 weeks
Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Measured: Baseline to 51 weeks
Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase)
Measured: Baseline to 51 weeks
Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase)
Measured: Baseline to 51 weeks
Secondary outcomes (19)
Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase)
Measured: Baseline to week 51
Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase)
Measured: Baseline to week 51
Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Best overall response based on irRECIST criteria (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Best overall response based on Lugano criteria (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Duration of response based on RECIST criteria (Dose Escalation Phase)
Measured: Baseline to week 51
Duration of response based on irRECIST criteria (Dose Escalation Phase)
Measured: Baseline to week 51
Duration of response based on Lugano criteria (Dose Escalation Phase)
Measured: Baseline to week 51
Disease control rate based on RECIST criteria (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Disease control rate based on irRECIST criteria (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Disease control rate based on Lugano criteria (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Progression free survival based on RECIST (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Progression free survival based on irRECIST (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Progression free survival based on Lugano criteria (Dose Escalation Phase)
Measured: Baseline to 51 weeks
Incidence of adverse events (Dose Expansion Phase)
Measured: Baseline to 51 weeks
Incidence of serious adverse events (Dose Expansion Phase)
Measured: Baseline to 51 weeks
Incidence of death (Dose Expansion Phase)
Measured: 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)
Measured: Baseline to 51 weeks
Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase)
Measured: Baseline to 51 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start7 Nov 2016
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalignanciesStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005782
- Sponsor's protocol ID
- R3767-ONC-1613
- Other IDs
- 2016-002789-30, 2016
- Status last verified
- Apr 2024
- First submitted
- 18 Nov 2016
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lakhani NJ, Papadopoulos KP, Johnson ML, Park H, Wang D, Yap TA, Dowlati A, Maki RG, Ulahannan S, Lynce F, Kelly K, Williamson S, Malhotra J, Chen S, Gonzalez Ortiz A, Jankovic V, Paccaly A, Masinde S, Mani J, Lowy I, Gullo G, Sims T, Kroog G. First-in-Human Dose-Escalation Study of Fianlimab, an Antilymphocyte Activation Gene-3 Antibody, with Cemiplimab in Patients with Advanced Malignancies. Clin Cancer Res. 2024 Dec 16;30(24):5601-5611. doi: 10.1158/1078-0432.CCR-23-3883.
PubMed 39422598Hamid 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.
PubMed 38900987
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (Anti-LAG-3 mAb) Administered Alone or in Combination With REGN2810 (Anti-PD-1 mAb) in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT03005782
- Acronym / sponsor ID
- R3767-ONC-1613
- Conditions
- Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy (REGN3767) | Experimental | Drug: REGN3767Group 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 | Drug: REGN3767, Drug: cemiplimabGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dose escalation cohorts: Patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit AND who have not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require measurable disease
- Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function
Key exclusion criteria (6 listed)
- Prior treatment with any LAG-3 targeting biologic or small molecule
- Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation
- Untreated or active central nervous system metastases - Ongoing or recent (within 5 years) evidence of significant autoimmune disease
- Corticosteroid therapy (>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug
- Myocardial infarction within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN3767Also: fianlimab | Drug | Combination Therapy (REGN3767+cemiplimab), Monotherapy (REGN3767) |
| cemiplimabAlso: REGN2810 | Drug | Combination Therapy (REGN3767+cemiplimab) |
Primary outcome
Rate of dose limiting toxicities (Dose Escalation Phase)
Time frame: Baseline to 28 days
Rate of adverse events (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Rate of serious adverse events (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Occurrence of death (Dose Escalation Phase)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to 51 weeks
AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: 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)
Time frame: Baseline to 51 weeks
AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to week 51
Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase)
Time frame: 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)
Time frame: Baseline to 51 weeks
Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase)
Time frame: Baseline to 51 weeks
Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase)
Time frame: Baseline to 51 weeks
19 secondary outcomes
Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase)
Time frame: Baseline to week 51
Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase)
Time frame: Baseline to week 51
Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Best overall response based on irRECIST criteria (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Best overall response based on Lugano criteria (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Duration of response based on RECIST criteria (Dose Escalation Phase)
Time frame: Baseline to week 51
Duration of response based on irRECIST criteria (Dose Escalation Phase)
Time frame: Baseline to week 51
Duration of response based on Lugano criteria (Dose Escalation Phase)
Time frame: Baseline to week 51
Disease control rate based on RECIST criteria (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Disease control rate based on irRECIST criteria (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Disease control rate based on Lugano criteria (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Progression free survival based on RECIST (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Progression free survival based on irRECIST (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Progression free survival based on Lugano criteria (Dose Escalation Phase)
Time frame: Baseline to 51 weeks
Incidence of adverse events (Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Incidence of serious adverse events (Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Incidence of death (Dose Expansion Phase)
Time frame: 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)
Time frame: Baseline to 51 weeks
Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase)
Time frame: Baseline to 51 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Derived from this study: PubMed 39422598Lakhani NJ, Papadopoulos KP, Johnson ML, Park H, Wang D, Yap TA, Dowlati A, Maki RG, Ulahannan S, Lynce F, Kelly K, Williamson S, Malhotra J, Chen S, Gonzalez Ortiz A, Jankovic V, Paccaly A, Masinde S, Mani J, Lowy I, Gullo G, Sims T, Kroog G. First-in-Human Dose-Escalation Study of Fianlimab, an Antilymphocyte Activation Gene-3 Antibody, with Cemiplimab in Patients with Advanced Malignancies. Clin Cancer Res. 2024 Dec 16;30(24):5601-5611. doi: 10.1158/1078-0432.CCR-23-3883.
- Derived from this study: PubMed 38900987Hamid 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN3767 and cemiplimab in people with Malignancies, run by Regeneron Pharmaceuticals at 43 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, South Korea, Australia, United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dose limiting toxicities (Dose Escalation Phase) (time frame: Baseline to 28 days). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005782, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.