Retifanlimab

Generic Name: Retifanlimab

Brand Names: Zynyz

Drug Type: Biotech

CAS Number: 2079108-44-2

Unique Ingredient Identifier: 2Y3T5IF01Z

Background: Retifanlimab is a humanized IgG4 kappa monoclonal antibody that binds to the programmed death receptor-1 (PD-1), blocking PD-1 interaction with its ligands, programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). By blocking the PD-1/PD-L1/2 pathway, retifanlimab potentiates T-cell activity and boosts the immune response against cancer cells. Other monoclonal antibodies that block PD-1 include pembrolizumab, nivolumab and cemiplimab.

On October 2021, Incyte Biosciences withdrew its application for a marketing authorization of retifanlimab for the treatment of squamous carcinoma of the anal canal. On March 2023, the FDA granted accelerated approval to retifanlimab for a different indication, the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The use of retifanlimab in combination with other oncology drugs for the treatment of metastatic gastroesophageal adenocarcinoma has also been evaluated.

Indication: Retifanlimab is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

Associated Conditions: Metastatic Locally Advanced Merkel Cell Carcinoma, Recurrent, locally advanced Merkel Cell Carcinoma

Clinical Trials

Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

Phase 3

Recruiting

Conditions: Metastatic Breast Cancer
Breast Neoplasm
End Stage Cancer
Breast Cancer
Breast Cancer Metastatic

Interventions: Drug: Treatment of Physician's Choice
Biological: SV-BR-1-GM
Drug: Cyclophosphamide
Drug: Interferon infiltration of the inoculation site
Drug: Retifanlimab

First Posted Date: 2023-10-10

Last Posted Date: 2025-04-24

Lead Sponsor: BriaCell Therapeutics Corporation

Target Recruit Count: 404

Registration Number: NCT06072612

Locations: 🇺🇸
Los Angeles cancer Network_Anaheim, Anaheim, California, United States
🇺🇸
Los Angeles Cancer Network_Corona, Corona, California, United States
🇺🇸
Los Angeles cancer Network_Fountain Vallley, Fountain Valley, California, United States

and more 54 locations

Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Unresectable Clinical Stage III Merkel Cell Carcinoma AJCC v8
Clinical Stage IV Merkel Cell Carcinoma AJCC v8
Merkel Cell Carcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Retifanlimab
Drug: Tuparstobart
Drug: Verzistobart

First Posted Date: 2023-09-28

Last Posted Date: 2025-01-28

Lead Sponsor: University of Washington

Target Recruit Count: 12

Registration Number: NCT06056895

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma

Phase 1

Recruiting

Conditions: Unmethylated Glioblastoma

Interventions: Biological: Personalized Neoantigen DNA vaccine
Biological: Retifanlimab
Device: TDS-IM v 2.0 electroporation device

First Posted Date: 2023-02-24

Last Posted Date: 2025-01-17

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 12

Registration Number: NCT05743595

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery

Phase 2

Recruiting

Conditions: Merkel Cell Carcinoma

Interventions: Drug: Retifanlimab
Drug: Cisplatin
Drug: Etoposide

First Posted Date: 2022-10-26

Last Posted Date: 2025-02-17

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 36

Registration Number: NCT05594290

Locations: 🇮🇹
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy

Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma

Phase 1

Recruiting

Conditions: Diffuse Large B-Cell Lymphoma
Grade 3b Follicular Lymphoma
High Grade B-Cell Lymphoma

Interventions: Procedure: Bone Marrow Biopsy
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Prednisone
Biological: Retifanlimab
Biological: Rituximab and Hyaluronidase Human
Biological: Tafasitamab
Drug: Vincristine
Procedure: Bone Marrow Aspiration
Procedure: Multigated Acquisition Scan
Other: Fludeoxyglucose F-18
Procedure: Positron Emission Tomography
Procedure: Computed Tomography
Procedure: Biospecimen Collection
Drug: Polatuzumab Vedotin

First Posted Date: 2022-07-13

Last Posted Date: 2024-11-20

Lead Sponsor: University of Washington

Target Recruit Count: 35

Registration Number: NCT05455697

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma

Phase 1

Active, not recruiting

Conditions: Pancreatic Ductal Adenocarcinoma

Interventions: Drug: Trametinib
Drug: Ruxolitinib
Drug: Retifanlimab

First Posted Date: 2022-07-01

Last Posted Date: 2025-03-03

Lead Sponsor: Peter Hosein, MD

Target Recruit Count: 35

Registration Number: NCT05440942

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma

Phase 2

Recruiting

Conditions: Astrocytoma
IDH Mutation
Oligodendroglioma
Glioma

Interventions: Drug: Retifanlimab
Drug: All-trans retinoic acid

First Posted Date: 2022-04-25

Last Posted Date: 2025-02-14

Lead Sponsor: Stephen Bagley, MD, MSCE

Target Recruit Count: 55

Registration Number: NCT05345002

Locations: 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 2

Active, not recruiting

Conditions: Head and Neck Cancer

Interventions: Drug: Retifanlimab
Drug: INCAGN02385
Drug: Placebo
Drug: INCAGN02390

First Posted Date: 2022-03-18

Last Posted Date: 2025-04-24

Lead Sponsor: Incyte Biosciences International Sàrl

Target Recruit Count: 176

Registration Number: NCT05287113

Locations: 🇬🇷
Saint Lukas Clinic, Thessaloniki, Greece
🇵🇱
Przychodnia Lekarska Komed Roman Karaszewski, Konin, Poland
🇵🇱
Nzoz Provita Prolife Centrum Medyczne, Tomaszow Mazowiecki, Poland

and more 86 locations

9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma

Phase 2

Active, not recruiting

Conditions: Pancreatic Adenocarcinoma

Interventions: Drug: 9-ING-41
Drug: Retifanlimab
Drug: Gemcitabine
Drug: Abraxane

First Posted Date: 2022-02-14

Last Posted Date: 2023-10-23

Lead Sponsor: Anwaar Saeed

Target Recruit Count: 32

Registration Number: NCT05239182

Locations: 🇺🇸
Kansas University Cancer Center, Fairway, Kansas, United States
🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)

Phase 2

Recruiting

Conditions: Gastric Adenocarcinoma
Esophageal Adenocarcinoma

Interventions: Drug: Capecitabine
Drug: Oxaliplatin
Drug: Retifanlimab

First Posted Date: 2022-01-04

Last Posted Date: 2024-08-02

Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Target Recruit Count: 25

Registration Number: NCT05177133

Locations: 🇳🇱
Amsterdam UMC, location VUmc, Amsterdam, Netherlands
🇳🇱
Academic Medical Center, Medical Oncology, Amsterdam, Netherlands
🇳🇱
Medisch Centrum Leeuwarden, Leeuwarden, Netherlands

and more 5 locations

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