How many Fianlimab clinical trials are there?

37 Fianlimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 18 are actively recruiting participants.

Are Fianlimab clinical trials recruiting in 2026?

Yes — 18 Fianlimab trials are actively recruiting in 2026, with 179 U.S. sites across 39 states. See the recruiting trials and the per-state site list further down this page.

What conditions is Fianlimab being studied for?

Fianlimab is being studied for Melanoma, Non-small Cell Lung Cancer, Fallopian Tube Cancer, Hepatocellular Carcinoma, Primary Peritoneal Cancer and 38 more. The trials are grouped by indication on this page.

What phase is Fianlimab in?

Fianlimab clinical trials span 3 Phase 3, 26 Phase 2, 3 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.

Who sponsors Fianlimab clinical trials?

The lead sponsor across the most Fianlimab trials is Regeneron Pharmaceuticals, with 18 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Fianlimab Clinical Trials (2026): 37 Studies for Melanoma & Non-small Cell Lung Cancer

Creator: Hipa.ai Research
Published: 2026-04-27T18:26:10.270Z

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: June 12, 2026.

37 Fianlimab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 29 indications (including Melanoma & Non-small Cell Lung Cancer) and 8,605 total planned enrollment. 3 Phase 3 Fianlimab trials and 26 Phase 2 are listed. 27 Fianlimab clinical trials are actively recruiting at 179 U.S. sites across 39 states. Most recent activity: NCT07365839 (Feb 2035).

Where to Participate: All Fianlimab Trial Sites in the U.S. (179 sites across 39 states)

Every actively recruiting Fianlimabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

State	Facility	City	Trial	Map
AL	The University of Alabama at Birmingham	Birmingham35233	NCT06787612	Map
AZ	Ironwood Cancer & Research Centers	Chandler85224	NCT06246916	Map
AZ	Banner MD Anderson Cancer Center	Gilbert85234	NCT06246916	Map
AR	University of Arkansas for Medical Sciences	Little Rock72205	NCT06246916	Map
CA	City of Hope Comprehensive Cancer Center	Duarte91010	NCT04590326	Map
CA	Providence Medical Foundation	Fullerton92835	NCT06246916	Map
CA	The City of Hope Orange County Lennar Foundation Cancer Center	Irvine92618	NCT04590326	Map
CA	Scripps Clinic Torrey Pines	La Jolla92037	NCT05137054	Map
CA	UC San Diego Health	La Jolla92037	NCT06787612	Map
CA	Cancer and Blood Specialty Clinic	Los Alamitos90720	NCT06246916	Map
CA	Cedars Sinai Medical Center	Los Angeles90048	NCT06787612	Map
CA	Cedars-Sinai Medical Center	Los Angeles90048	NCT06594991	Map
CA	University of California Los Angeles	Los Angeles90024	NCT06246916	Map
CA	Chao Family Comprehensive Cancer Center	Orange92868	NCT04590326	Map
CA	St. Joseph Hospital Orange	Orange92868	NCT06246916	Map
CA	University of California Irvine, UCI Medical Center	Orange92868	NCT06246916	Map
CA	Emad Ibrahim, MD, Inc.	Redlands92373	NCT06246916	Map
CA	Sutter Health	Sacramento95816	NCT06246916	Map
CA	University of California San Francisco (UCSF)	San Francisco94143	NCT06246916	Map
CA	Sansum Clinic	Santa Barbara93105	NCT06246916	Map
CA	St John's Cancer Institute	Santa Monica90404	NCT06246916	Map
CA	Stanford University (Data Collection Only)	Stanford94305	NCT06594991	Map
CO	Rocky Mountain Regional VA Medical Center	Aurora80045	NCT06246916	Map
CO	University of Colorado Cancer Center	Aurora80045	NCT06246916	Map
CO	The Melanoma And Skin Cancer Institute	Englewood80113	NCT06246916	Map
CT	Hartford Healthcare Alliance (Data Collection Only)	Hartford06102	NCT06594991	Map
CT	Yale Cancer Center	New Haven06510	NCT06246916	Map
FL	Clermont Oncology Center	Clermont34711	NCT06246916	Map
FL	University of Florida	Gainesville32611	NCT07058012	Map
FL	Cancer Specialist of North Florida	Jacksonville32256	NCT06246916	Map
FL	Mayo Clinic Florida	Jacksonville32224	NCT06246916	Map
FL	Mayo Clinic Jacksonville	Jacksonville32224	NCT06787612	Map
FL	University of Miami Sylvester Comprehensive Cancer Center	Miami33136	NCT06787612	Map
FL	Advent Health Cancer Institute	Orlando32804	NCT06787612	Map
FL	Orlando Health	Orlando32806	NCT06769698	Map
FL	Boca Raton Clinical Research (BRCR) Global	Tamarac33321	NCT06246916	Map
FL	H. Lee Moffitt Cancer Center	Tampa33612	NCT06246916	Map
FL	Tampa General Hospital Cancer Institute	Tampa33606	NCT06787612	Map
GA	University Cancer & Blood Center	Athens30607	NCT06246916	Map
GA	Emory University School of Medicine	Atlanta30308	NCT06769698	Map
GA	Winship Cancer Institute of Emory University	Atlanta30004	NCT05137054	Map
ID	Beacon Clinic	Coeur d'Alene83815	NCT06246916	Map
IL	Robert H. Lurie Comprehensive Cancer Center of Northwestern University	Chicago60611	NCT04590326	Map
IL	University of Chicago	Chicago60637	NCT06787612	Map
IL	University of Chicago Medical Center	Chicago60637	NCT04590326	Map
IL	Hope and Healing Cancer Services	Hinsdale60521	NCT06246916	Map
IL	Advocate Lutheran General Hospital	Park Ridge60068	NCT06246916	Map
IL	Illinois CancerCare	Peoria61615	NCT06246916	Map
IN	Fort Wayne Medical Oncology and Hematology	Fort Wayne46825	NCT06246916	Map
IN	Indiana University Health Simon Cancer Center	Indianapolis46202	NCT05137054	Map
KS	The University of Kansas Cancer Center	Westwood66205	NCT06246916	Map
KS	The University of Kansas Cancer Center	Westwood66205	NCT06787612	Map
KY	St. Elizabeth Healthcare	Edgewood41017	NCT06769698	Map
KY	Markey Cancer Center Clinical Research Organization	Lexington40536	NCT06246916	Map
KY	Norton Cancer Institute	Louisville40202	NCT06769698	Map
KY	Norton Cancer Institute, St. Matthews Clinic	Louisville40207	NCT06787612	Map
LA	Mary Bird Perkins Cancer Center	Baton Rouge70809	NCT06246916	Map
MD	Johns Hopkins SKCCC	Baltimore21231	NCT06205836	Map
MD	Maryland Oncology Hematology, P.A.	Columbia21044	NCT06246916	Map
MA	Dana Farber Cancer Institute Brookline Avenue	Boston02215	NCT04590326	Map
MA	Dana Farber/Harvard Cancer Center	Boston02215	NCT05137054	Map
MA	Massachusetts General Hospital	Boston02114	NCT04590326	Map
MA	Massachusetts General Hospital	Boston02114	NCT06787612	Map
MI	University of Michigan	Ann Arbor48109	NCT06246916	Map
MI	Henry Ford Cancer Institute/Henry Ford Health System	Detroit48202	NCT06246916	Map
MI	Karmanos Cancer Institute	Detroit48201	NCT04590326	Map
MI	Karmanos Cancer Institute	Detroit48201	NCT05137054	Map
MI	Karmanos Cancer Institute	Detroit48201	NCT06787612	Map
MN	Minnesota Oncology Hematology, P.A	Fridley55432	NCT06246916	Map
MN	Allina Health Cancer Institute	Minneapolis55407	NCT06246916	Map
MN	Mayo Clinic	Rochester55905	NCT05137054	Map
MN	Mayo Clinic in Rochester	Rochester55905	NCT06918132	Map
MO	Mercy South	St Louis63128	NCT06246916	Map
MO	VA St. Louis Healthcare System	St Louis63106	NCT06246916	Map
MO	Washington University	St Louis63110	NCT06246916	Map
MT	St. Vincent Healthcare	Billings59102	NCT06246916	Map
NE	Oncology Hematology West P.C. dba Nebraska Cancer Specialists	Omaha68130	NCT06246916	Map
NE	Oncology Hematology West P.C. dba Nebraska Cancer Specialists	Omaha68130	NCT06769698	Map
NV	Comprehensive Cancer Centers of Nevada	Las Vegas89148	NCT06246916	Map
NH	Dartmouth Hitchcock Medical Center	Lebanon03756	NCT06246916	Map
NJ	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge07920	NCT06594991	Map
NJ	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activites)	Basking Ridge07920	NCT06699602	Map
NJ	Hackensack Meridian Health (Data Collection Only)	Hackensack07601	NCT06594991	Map
NJ	John Theurer Cancer Center	Hackensack07601	NCT06246916	Map
NJ	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown07748	NCT06594991	Map
NJ	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown07748	NCT06699602	Map
NJ	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale07645	NCT06594991	Map
NJ	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale07645	NCT06699602	Map
NJ	Rutgers Cancer Institute of New Jersey	New Brunswick08901	NCT06246916	Map
NJ	The Valley Hospital Inc.	Paramus07652	NCT06246916	Map
NY	New York Oncology Hematology	Albany12206	NCT06246916	Map
NY	Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)	Commack11725	NCT06699602	Map
NY	Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)	Commack11725	NCT06594991	Map
NY	Memorial Sloan Kettering West Harrison (Limited Protocol Activities)	Harrison10604	NCT06699602	Map
NY	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison10604	NCT06594991	Map
NY	Columbia University Irving Medical Center/ New York Presbyterian Hospital	New York10032	NCT06571708	Map
NY	Memorial Sloan Kettering Cancer Center	New York10065	NCT04590326	Map
NY	Memorial Sloan Kettering Cancer Center (All Protocol Activites)	New York10065	NCT06699602	Map
NY	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York10065	NCT06594991	Map
NY	New York Presbyterian Hospital Columbia University Medical Center	New York10032	NCT05137054	Map
NY	Weill Cornell Medicine/New York Presbyterian Hospital	New York10021	NCT05137054	Map
NY	Montefiore Einstein Comprehensive Cancer Center (MECCC)	The Bronx10461	NCT06865339	Map
NY	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale11553	NCT06594991	Map
NY	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale11553	NCT06699602	Map
NC	Messino Cancer Center	Asheville28806	NCT06246916	Map
NC	University of North Carolina at Chapel Hill	Chapel Hill27599	NCT05137054	Map
NC	Levine Cancer Institute	Charlotte28204	NCT06246916	Map
NC	Novant Health Cancer Institute	Charlotte28204	NCT06246916	Map
NC	Novant Health Weisiger Cancer Institute - Charlotte	Charlotte28204	NCT06246916	Map
NC	Duke Health System	Durham27710	NCT06246916	Map
NC	Novant Health Zimmer Cancer Institute - Wilmington	Wilmington28401	NCT06246916	Map
NC	Wake Forest University Health Sciences	Winston-Salem27157	NCT05137054	Map
OH	Oncology Hematology Care Clinical Trials	Cincinnati45242	NCT06246916	Map
OH	Seidman Cancer Center	Cleveland44106	NCT06246916	Map
OH	Ohio State University	Columbus43210	NCT06769698	Map
OH	The Ohio State University James Cancer Hospital	Columbus43210	NCT05137054	Map
OH	The Ohio State University Wexner Medical Center	Columbus43210	NCT04590326	Map
OH	The Ohio State University Wexner Medical Center	Columbus43210	NCT06246916	Map
OH	The Ohio State University Comprehensive Cancer Center	Hilliard43026	NCT06787612	Map
OK	University of Oklahoma Health Sciences Center	Oklahoma City73104	NCT07223541	Map
OK	Oklahoma Cancer Specialists and Research Institute, LLC	Tulsa74146	NCT06246916	Map
OR	Oncology Associates of Oregon PC	Eugene97401	NCT06246916	Map
OR	Kaiser Foundation Hospitals	Portland97227	NCT06246916	Map
OR	Oregon Health and Science University	Portland97239	NCT06246916	Map
OR	Providence Cancer Institute	Portland97213	NCT06787612	Map
PA	St. Luke's University Health Network	Easton18045	NCT06246916	Map
PA	Fox Chase Cancer Center	Philadelphia19111	NCT06246916	Map
PA	Perelman School of Medicine at the University of Pennsylvania	Philadelphia19104	NCT04590326	Map
PA	University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center	Pittsburgh15232	NCT06246916	Map
PA	University of Pittsburgh Medical Center, Magee-Womens Hospital	Pittsburgh15213	NCT06787612	Map
PA	UPMC Hillman Cancer Center	Pittsburgh15232	NCT07223411	Map
PA	West Penn Hospital of Allegheny Health Network	Pittsburgh15224	NCT06787612	Map
RI	Lifespan Cancer Institute	Providence02903	NCT06246916	Map
SD	Avera Cancer Institute Sioux Falls	Sioux Falls57105	NCT06787612	Map
TN	Tennessee Oncology - Chattanooga	Chattanooga37404	NCT06246916	Map
TN	University of Tennessee Medical Center	Knoxville37920	NCT06246916	Map
TN	Sarah Cannon Research Institute (SCRI) Oncology Partners	Nashville37203	NCT06246916	Map
TN	Tennessee Oncology	Nashville37203	NCT06246916	Map
TN	Vanderbilt-Ingram Cancer Center	Nashville37232	NCT06769698	Map
TN	Vanderbilt-Ingram Cancer Center	Nashville37232	NCT07188896	Map
TX	Texas Oncology - Austin Central, Central Austin Cancer Center	Austin78731	NCT06246916	Map
TX	Texas Oncology - Austin Midtown, Midtown Medical Center I	Austin78705	NCT06246916	Map
TX	Texas Oncology - Bedford	Bedford76022	NCT06246916	Map
TX	Texas Oncology	Dallas75246	NCT06246916	Map
TX	Texas Oncology - Medical City	Dallas75230	NCT06246916	Map
TX	University of Texas Southwestern	Dallas75390	NCT05137054	Map
TX	UT Southwestern Medical Center	Dallas75390	NCT06787612	Map
TX	Center For Disease And Blood Disorder	Fort Worth76104	NCT06246916	Map
TX	Texas Oncology - Fort Worth	Fort Worth76104	NCT06246916	Map
TX	Texas Oncology - Grapevine	Grapevine76051	NCT06246916	Map
TX	Texas Oncology - Harlingen, Medical Arts Pavillion	Harlingen78550	NCT06246916	Map
TX	The University of Texas MD Anderson Cancer Center	Houston77030	NCT06246916	Map
TX	Texas Oncology - Longview	Longview75601	NCT06246916	Map
TX	Joe Arrington Cancer Research & Treatment Center	Lubbock79410	NCT06246916	Map
TX	Joe Arrington Cancer Research & Treatment Center	Lubbock79410	NCT06769698	Map
TX	Texas Oncology - McAllen	McAllen78503	NCT06246916	Map
TX	Texas Oncology-Palestine Cancer Center	Palestine75801	NCT06246916	Map
TX	Texas Oncology-Tyler, Northeast Texas Cancer Institute	Tyler75702	NCT06246916	Map
TX	Texas Oncology - Weslaco, Knapp Medical Plaza	Weslaco78596	NCT06246916	Map
UT	University of Utah Huntsman Cancer Institute	Salt Lake City84112	NCT06246916	Map
VA	University of Virginia	Charlottesville22908	NCT06246916	Map
VA	Inova Schar Cancer Institute	Fairfax22031	NCT06246916	Map
VA	Inova Schar Cancer Institute	Fairfax22031	NCT06769698	Map
VA	Virginia Cancer Specialists, PC	Fairfax22031	NCT06246916	Map
VA	Virginia Oncology Associates	Norfolk23502	NCT06246916	Map
VA	Virginia Commonwealth University Massey Cancer Center	Richmond23298	NCT06246916	Map
VA	Oncology & Hematology Associates of Southwest Virginia, Inc.	Roanoke24014	NCT06246916	Map
WA	Swedish Cancer Institute - Edmonds Campus	Edmonds98026	NCT06246916	Map
WA	Swedish Cancer Institute - Issaquah Campus	Issaquah98029	NCT06246916	Map
WA	Kadlec Clinic Hematology and Oncology	Kennewick99336	NCT06246916	Map
WA	Seattle Cancer Care Alliance at South Lake Union - G3630	Seattle98109	NCT04590326	Map
WA	Swedish Cancer Institute	Seattle98104	NCT06246916	Map
WA	Swedish Cancer Institute	Seattle98104	NCT06787612	Map
WA	VA Puget Sound Health Care System	Seattle98108	NCT05137054	Map
WV	West Virginia University	Morgantown26506	NCT06246916	Map
WI	University of Wisconsin	Madison53792	NCT06787612	Map
WI	University of Wisconsin Carbone Cancer Center	Madison53792	NCT04989946	Map
WI	University of Wisconsin Carbone Cancer Center	Madison53792	NCT06246916	Map
WI	Medical College of Wisconsin	Milwaukee53226	NCT06787612	Map

Fianlimab clinical trials at a glance: phase × recruitment status

Phase	recruiting	active not recruiting	enrolling by invitation	withdrawn	suspended	not yet recruiting	Total
P1	1	1				1	3
P1/P2	2						2
P2	12	3	1	1	1	8	26
P2/P3		2					2
P3	1	2					3
N/A	1						1

Recruiting Fianlimab clinical trials (27)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT ID	Title	Phase	Indication	Enrollment	Started
NCT07365839	CLeARCemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma	P1	Hepatocellular Carcinoma	20	Jul 2026
NCT05137054	A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments	P1	Multiple Myeloma	317	Aug 2022
NCT06246916	A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)	P3	Melanoma	560	Sep 2024
NCT07223411	Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma	—	Locally Advanced Melanoma	20	Nov 2025
NCT07223541	LAG-BOOSTCemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma	P2	Clear Cell Renal Cell Carcinoma	72	Jan 2026
NCT07346196	A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck	P2	Squamous Cell Carcinoma	90	Feb 2027
NCT06769698	A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma	P2	Head and Neck Squamous Cell Carcinoma (HNSCC)	120	Apr 2026
NCT07188896	RCCA Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)	P2	Advanced Renal Cell Carcinoma (aRCC)	120	Apr 2026
NCT07281768	Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer	P2	Colorectal Cancer	66	Jul 2026
NCT06205836	Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer	P2	Colorectal Cancer	44	Jun 2024
NCT07511036	PROSECCOPROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma	P2	Melanoma	20	Sep 2026
NCT07527325	TNTFianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma	P2	Melanoma (Skin)	35	Jul 2026
NCT07179315	A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment	P2	Head and Neck Cancer	68	Dec 2026
NCT07224022	NAChoCemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer	P2	Colon Cancer	24	Jul 2026
NCT06848088	A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment	P2	Melanoma	48	Apr 2025
NCT07234058	LAG-MAPSTrial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma	P2	Pleural Mesotheliomas	126	Feb 2026
NCT07058012	EMPIREA Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)	P2	Colo-rectal Cancer	79	Apr 2026
NCT06571708	NeoSTOP-ITGemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)	P2	Bladder Cancer	36	Aug 2025
NCT04989946	Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer	P1/P2	Prostate Cancer	60	Dec 2021
NCT06787612	Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer	P2	Ovarian Cancer	220	May 2025
NCT07414992	A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer	P2	Bladder Urothelial Carcinoma	44	May 2026
NCT06699602	A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma	P2	Renal Cell Carcinoma	10	Feb 2025
NCT06887088	ENCEFALOEncorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases	P2	Melanoma BRAF V600E/K Mutated	33	May 2025
NCT04590326	A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab	P1/P2	Ovarian Cancer	612	Dec 2020
NCT06594991	A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma	P2	Advanced Melanoma	88	Sep 2024
NCT06865339	TRIPLThoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer	P2	NSCLC	76	Aug 2025
NCT06918132	N-PLANCCemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer	P2	Lung Non-Small Cell Carcinoma	60	Apr 2025

Fianlimab clinical trials by indication

Melanoma (6)

NCT	Acronym	Phase	Status	Title
NCT06246916	—	P3	recruiting	A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
NCT05352672	—	P3	active not recruiting	Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
NCT06190951	—	P2	active not recruiting	A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
NCT07511036	PROSECCO	P2	not yet recruiting	PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma
NCT05608291	—	P3	active not recruiting	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
NCT06848088	—	P2	enrolling by invitation	A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment

Colorectal Cancer (2)

NCT	Acronym	Phase	Status	Title
NCT07281768	—	P2	not yet recruiting	Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer
NCT06205836	—	P2	recruiting	Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

Ovarian Cancer (2)

NCT	Acronym	Phase	Status	Title
NCT06787612	—	P2	recruiting	Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
NCT04590326	—	P1/P2	recruiting	A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab

Non-small Cell Lung Cancer (2)

NCT	Acronym	Phase	Status	Title
NCT05800015	—	P2/P3	active not recruiting	A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer
NCT03916627	—	P2	active not recruiting	Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients

Squamous Cell Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT07346196	—	P2	not yet recruiting	A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

Head and Neck Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT07179315	—	P2	not yet recruiting	A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment

Hepatocellular Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT07365839	CLeAR	P1	not yet recruiting	Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma

Melanoma (Skin) (1)

NCT	Acronym	Phase	Status	Title
NCT07527325	TNT	P2	not yet recruiting	Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma

Advanced Renal Cell Carcinoma (aRCC) (1)

NCT	Acronym	Phase	Status	Title
NCT07188896	RCC	P2	recruiting	A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)

Head and Neck Squamous Cell Carcinoma (HNSCC) (1)

NCT	Acronym	Phase	Status	Title
NCT06769698	—	P2	recruiting	A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Bladder Urothelial Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT07414992	—	P2	not yet recruiting	A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer

Pleural Mesotheliomas (1)

NCT	Acronym	Phase	Status	Title
NCT07234058	LAG-MAPS	P2	not yet recruiting	Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma

Colon Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT07224022	NACho	P2	not yet recruiting	Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer

Clear Cell Renal Cell Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT07223541	LAG-BOOST	P2	recruiting	Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma

Locally Advanced Melanoma (1)

NCT	Acronym	Phase	Status	Title
NCT07223411	—	N/A	recruiting	Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma

Bladder Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT06571708	NeoSTOP-IT	P2	recruiting	Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)

NSCLC (1)

NCT	Acronym	Phase	Status	Title
NCT06865339	TRIPL	P2	recruiting	Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer

Colo-rectal Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT07058012	EMPIRE	P2	recruiting	A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)

Melanoma BRAF V600E/K Mutated (1)

NCT	Acronym	Phase	Status	Title
NCT06887088	ENCEFALO	P2	recruiting	Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases

Lung Non-Small Cell Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT06918132	N-PLANC	P2	recruiting	Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer

Renal Cell Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT06699602	—	P2	recruiting	A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma

Cutaneous Squamous Cell Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT06384820	CSCC	P2	withdrawn	Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

Advanced Melanoma (1)

NCT	Acronym	Phase	Status	Title
NCT06594991	—	P2	recruiting	A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma

Resectable Non-small Cell Lung Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT06161441	—	P2	active not recruiting	A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

Locally Advanced Basal Cell Carcinoma (1)

NCT	Acronym	Phase	Status	Title
NCT05929664	—	P2	suspended	Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery

Advanced Non-Small Cell Lung Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT05785767	NSCLC	P2/P3	active not recruiting	A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Multiple Myeloma (1)

NCT	Acronym	Phase	Status	Title
NCT05137054	—	P1	recruiting	A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Prostate Cancer (1)

NCT	Acronym	Phase	Status	Title
NCT04989946	—	P1/P2	recruiting	Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer

Advanced Malignancies (1)

NCT	Acronym	Phase	Status	Title
NCT03233139	—	P1	active not recruiting	Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies

Fianlimab pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

Acronym	NCT	Phase	Status	Indication	Enrollment	PubMed
LAG-BOOST	NCT07223541	P2	recruiting	Clear Cell Renal Cell Carcinoma	72	—
RCC	NCT07188896	P2	recruiting	Advanced Renal Cell Carcinoma (aRCC)	120	—
PROSECCO	NCT07511036	P2	not yet recruiting	Melanoma	20	—
CSCC	NCT06384820	P2	withdrawn	Cutaneous Squamous Cell Carcinoma	0	—
TNT	NCT07527325	P2	not yet recruiting	Melanoma (Skin)	35	—
NACho	NCT07224022	P2	not yet recruiting	Colon Cancer	24	—
LAG-MAPS	NCT07234058	P2	not yet recruiting	Pleural Mesotheliomas	126	—
EMPIRE	NCT07058012	P2	recruiting	Colo-rectal Cancer	79	—
NeoSTOP-IT	NCT06571708	P2	recruiting	Bladder Cancer	36	—
ENCEFALO	NCT06887088	P2	recruiting	Melanoma BRAF V600E/K Mutated	33	—
TRIPL	NCT06865339	P2	recruiting	NSCLC	76	—
N-PLANC	NCT06918132	P2	recruiting	Lung Non-Small Cell Carcinoma	60	—

Terminated and withdrawn Fianlimab trials (2)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

NCT05929664suspendedCemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
NCT06384820withdrawnStudy of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

All Fianlimab trials (37)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT ID	Acronym	Title	Phase	Status	Enrollment	Sponsor	Started
NCT07365839	CLeAR	Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma	P1	not yet recruiting	20	Virginia Commonwealth University	Jul 2026
NCT05137054		A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments	P1	recruiting	317	Regeneron Pharmaceuticals	Aug 2022
NCT06246916		A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)	P3	recruiting	560	Regeneron Pharmaceuticals	Sep 2024
NCT05785767	NSCLC	A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)	P2/P3	active not recruiting	850	Regeneron Pharmaceuticals	Jun 2023
NCT05800015		A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer	P2/P3	active not recruiting	950	Regeneron Pharmaceuticals	Aug 2023
NCT07223411		Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma	—	recruiting	20	John Kirkwood	Nov 2025
NCT05352672		Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma	P3	active not recruiting	1,546	Regeneron Pharmaceuticals	Jul 2022
NCT07223541	LAG-BOOST	Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma	P2	recruiting	72	University of Oklahoma	Jan 2026
NCT07346196		A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck	P2	not yet recruiting	90	University of Chicago	Feb 2027
NCT05929664		Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery	P2	suspended	70	Thomas Jefferson University	Jul 2023
NCT06769698		A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma	P2	recruiting	120	Regeneron Pharmaceuticals	Apr 2026
NCT06190951		A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma	P2	active not recruiting	151	Regeneron Pharmaceuticals	Sep 2024
NCT07188896	RCC	A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)	P2	recruiting	120	Brian Rini	Apr 2026
NCT07281768		Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer	P2	not yet recruiting	66	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Jul 2026
NCT06205836		Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer	P2	recruiting	44	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Jun 2024
NCT07511036	PROSECCO	PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma	P2	not yet recruiting	20	M.D. Anderson Cancer Center	Sep 2026
NCT03916627		Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients	P2	active not recruiting	65	Regeneron Pharmaceuticals	Jul 2019
NCT06384820	CSCC	Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)	P2	withdrawn	0	Regeneron Pharmaceuticals	Nov 2024
NCT05608291		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	P3	active not recruiting	1,564	Regeneron Pharmaceuticals	Jan 2023
NCT07527325	TNT	Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma	P2	not yet recruiting	35	University of California, Irvine	Jul 2026
NCT07179315		A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment	P2	not yet recruiting	68	University of Chicago	Dec 2026
NCT07224022	NACho	Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer	P2	not yet recruiting	24	John Strickler, M.D.	Jul 2026
NCT06161441		A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery	P2	active not recruiting	195	Regeneron Pharmaceuticals	Jul 2024
NCT06848088		A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment	P2	enrolling by invitation	48	Regeneron Pharmaceuticals	Apr 2025
NCT07234058	LAG-MAPS	Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma	P2	not yet recruiting	126	Intergroupe Francophone de Cancerologie Thoracique	Feb 2026
NCT07058012	EMPIRE	A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)	P2	recruiting	79	NSABP Foundation Inc	Apr 2026
NCT06571708	NeoSTOP-IT	Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)	P2	recruiting	36	Columbia University	Aug 2025
NCT04989946		Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer	P1/P2	recruiting	60	University of Wisconsin, Madison	Dec 2021
NCT06787612		Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer	P2	recruiting	220	Regeneron Pharmaceuticals	May 2025
NCT07414992		A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer	P2	not yet recruiting	44	Memorial Sloan Kettering Cancer Center	May 2026
NCT06699602		A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma	P2	recruiting	10	Memorial Sloan Kettering Cancer Center	Feb 2025
NCT06887088	ENCEFALO	Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases	P2	recruiting	33	Grupo Español Multidisciplinar de Melanoma	May 2025
NCT04590326		A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab	P1/P2	recruiting	612	Regeneron Pharmaceuticals	Dec 2020
NCT06594991		A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma	P2	recruiting	88	Memorial Sloan Kettering Cancer Center	Sep 2024
NCT03233139		Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies	P1	active not recruiting	146	Regeneron Pharmaceuticals	Jun 2017
NCT06865339	TRIPL	Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer	P2	recruiting	76	Montefiore Medical Center	Aug 2025
NCT06918132	N-PLANC	Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer	P2	recruiting	60	Mayo Clinic	Apr 2025

Fianlimab clinical trials: frequently asked questions

How many Fianlimab clinical trials are there?: 37 Fianlimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 18 are actively recruiting participants.
Are Fianlimab clinical trials recruiting in 2026?: Yes — 18 Fianlimab trials are actively recruiting in 2026, with 179 U.S. sites across 39 states. See the recruiting trials and the per-state site list further down this page.
What conditions is Fianlimab being studied for?: Fianlimab is being studied for Melanoma, Non-small Cell Lung Cancer, Fallopian Tube Cancer, Hepatocellular Carcinoma, Primary Peritoneal Cancer and 38 more. The trials are grouped by indication on this page.
What phase is Fianlimab in?: Fianlimab clinical trials span 3 Phase 3, 26 Phase 2, 3 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Fianlimab clinical trials?: The lead sponsor across the most Fianlimab trials is Regeneron Pharmaceuticals, with 18 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Fianlimabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

Last refreshed June 12, 2026.

Related pages on Hipa.ai:

Fianlimab overview