marked.bio

anti-PD-1 antibody · antibody

retifanlimab

7 active trials across 7 of our biomarkers, targeting PD-1. Not approved for any biomarker on marked.bio yet.

Also known as INCMGA00012, Zynyz.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
IDH1/2 mutation 3 3 Phase 1/2
BRAF V600E 1 1 Early Phase 1
BRCA1/2 mutation 1 1 Phase 2
KRAS G12D 1 1 Phase 1
MSI-H / dMMR 1 4 Phase 2
FGFR2 fusion or rearrangement 0 1 –
FGFR3 alteration (mutation or fusion) 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of retifanlimab.

  1. Incyte 1

Trials

7 of 11 trials shown

  1. Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC

    Not yet recruiting Phase 2 Massachusetts General Hospital Starts 2027Primary completion 2028-12 NCT07765836

    vilastobart (XTX101)retifanlimab

    Participant must have a germline or somatic pathogenic alteration in BRCA1, BRCA2, or PALB2 on tumor next generation sequencing (NGS) performed using a CLIA certif…

    BRCA1/2 mutationPancreatic Cancer Metastatic

  2. Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas

    Recruiting Phase 1/2 Mayo Clinic Started 2026Primary completion 2030-10 NCT07468136

    Eflornithineretifanlimab

    Grade 3 or 4 IDH1/2 mutant astrocytoma or

    IDH1/2 mutationAnaplastic Oligodendroglioma, Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4, Diffuse Astrocytoma

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

    Recruiting Phase 2 Stephen Bagley, MD, MSCE Started 2022Primary completion 2027-06 NCT05345002

    retifanlimabAll-trans retinoic acid

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

    IDH1/2 mutationGlioma, IDH Mutation, Astrocytoma, Oligodendroglioma

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

    Recruiting Phase 2 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Started 2021Primary completion 2025-05 NCT05177133

    capecitabineoxaliplatinretifanlimab

    dMMR identified by IHC of mismatch repair proteins MLH1, PMS2, MSH2 en MSH6

    MSI-H / dMMRStatus may be outdated, last updated 2024-08-02Gastric Adenocarcinoma, Esophageal Adenocarcinoma

  5. A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

    Recruiting Phase 1 Incyte Started 2024Primary completion 2027-01 NCT06179160

    INCB161734cetuximabretifanlimabGEMNabPmFOLFIRINOXFOLFOXFOLFIRIINCA33890

    Locally advanced or metastatic solid tumor with KRAS G12D mutation.

    KRAS G12DSolid Tumors

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

    Active, not recruiting Phase 1 Washington University School of Medicine Started 2023Primary completion 2026-04 NCT05743595

    Personalized Neoantigen DNA vaccineretifanlimab

    Patients with secondary glioblastoma, in particular those who are IDH1 or IDH2 mutant, will not be excluded.

    IDH1/2 mutationUnmethylated Glioblastoma

  7. A Trial to Evaluate CSF ctDNA and Safety of Plixorafenib Alone or With Retifanlimab in Patients With BRAF-altered Glioma

    Recruiting Early Phase 1 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2025Primary completion 2027-06 NCT06610682

    plixorafenibretifanlimab

    Histologic diagnosis of a primary CNS tumor with documented BRAF-V600E mutation by a CLIA approved DNA or RNA-based sequencing test (NGS or RNAseq).

    BRAF V600EBRAF V600E Mutation