marked.bio

anti-PD-1 antibody · antibody

cemiplimab

11 active trials across 9 of our biomarkers, targeting PD-1. Not approved for any biomarker on marked.bio yet.

Also known as REGN2810, Libtayo.

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
BRAF V600E 3 4 Phase 2
EGFR exon 19 deletion / L858R 2 2 Phase 1
MSI-H / dMMR 2 3 Phase 2
ALK fusion 1 1 Phase 1
BRCA1/2 mutation 1 1 Phase 1/2
FGFR3 alteration (mutation or fusion) 1 1 Phase 1
IDH1/2 mutation 1 1 Phase 1
KRAS G12C 1 1 Phase 1/2
RET fusion or mutation 1 1 Phase 1

Sponsors

Industry sponsors leading active biomarker-selected trials of cemiplimab.

  1. BioNTech 1
  2. Vyriad 1
  3. Biohaven Therapeutics 1

Trials

11 of 13 trials shown

  1. Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases

    Recruiting Phase 2 Grupo Español Multidisciplinar de Melanoma Started 2025Primary completion 2028-01 NCT06887088

    encorafenib FDA EUbinimetinib FDA EUcemiplimab

    A documented mutation in BRAF-V600 in the tumor tissue.

    BRAF V600EMelanoma BRAF V600E/K Mutated, Melanoma and Brain Metastases

  2. A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

    Recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2024Primary completion 2029-03 NCT06412198

    cetuximabcemiplimabadagrasib FDA EU

    …y confirmed diagnosis of advanced/metastatic microsatellite stable colorectal cancer with KRASG12C mutation with 1+ prior line(s) of therapy

    KRAS G12CMetastatic Colorectal Cancer, KRAS G12C Mutations

  3. The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2024Primary completion 2027-04 NCT05961709

    cemiplimab

    …on cancer that is deficient in mismatch repair (dMMR) or microsatellite Instability high (MSI-H) as determined by one of three methods:

    MSI-H / dMMRColon Cancer

  4. Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

    Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2024Primary completion 2030-05 NCT06205836

    cemiplimabFianlimab

    …ocalized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.

    MSI-H / dMMRColorectal Cancer

  5. Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI

    Recruiting Phase 1/2 Maastricht University Medical Center Started 2023Primary completion 2027-02 NCT04954599

    CP-506carboplatinipilimumabnivolumabpembrolizumabatezolizumabavelumabdurvalumabcemiplimab

    BRCA1/2 carriers), dedicated HRD genomic assays (including exome-sequencing) from liquid or tissue biopsie…

    BRCA1/2 mutationUnspecified Adult Solid Tumor, Protocol Specific

  6. Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients

    Active, not recruiting Phase 2 Vyriad Started 2020Primary completion 2026-10 NCT04291105

    VV1cemiplimab

    Note: Patients with BRAF V600-positive tumors with no clinically significant tumor-related symptoms nor evidence of rap…

    BRAF V600EMelanoma, Head and Neck Squamous Cell Carcinoma, Colo-rectal Cancer

  7. Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma

    Not yet recruiting Phase 1 National Cancer Institute (NCI) Started 2026Primary completion 2027-02 NCT07422363

    cemiplimab

    Note: Isocitrate dehydrogenase (IDH) status confirmed by immunohistochemistry (IHC) for IDH1 R132H + next-generation sequencing (NGS) for IDH1 and IDH2 hotspots

    IDH1/2 mutationRecurrent Glioblastoma, IDH-Wildtype, Recurrent Gliosarcoma, Recurrent WHO Grade 4 Glioma

  8. XL092 and Cemiplimab in BRAF WT Thyroid Cancer

    Recruiting Phase 1 UNC Lineberger Comprehensive Cancer Center Started 2025Primary completion 2028-03 NCT06902376

    cemiplimabzanzalintinib

    Must have BRAF V600E mutation-negative tumor, as determined by BRAF V600E immunohistochemistry on tumor tissue…

    BRAF V600EAnaplastic Thyroid Cancer, Thyroid Cancer, BRAF Mutation-Related Tumors

  9. A Phase 1 Study of BHV-1530 in Advanced Solid Tumors

    Recruiting Phase 1 Biohaven Therapeutics Started 2025Primary completion 2029-03 NCT06874335

    BHV-1530cemiplimab

    Other advanced or metastatic solid tumors with a documented activating FGFR3 alteration (mutation or fusion).

    FGFR3 alteration (mutation or fusion)Solid Tumor

  10. A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.

    Active, not recruiting Phase 1 M.D. Anderson Cancer Center Started 2023Primary completion 2028-01 NCT05704634

    cemiplimabKevzara (Sarilumab)

    NSCLC which harbours EGFR Exon 19 deletion.

    EGFR exon 19 deletion / L858RLung Cancer

  11. Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

    Recruiting Phase 1 BioNTech Started 2022Primary completion 2030-02 NCT05142189

    BNT116cemiplimabdocetaxelcarboplatinpaclitaxelgotistobartanti-B7-H3 antibody conjugated to topoisomerase I inhibitoranti-HER3 antibody conjugated to topoisomerase I inhibitorBispecific antibody for PD-L1 and VEGF-Aosimertinib FDA EUALK-inhibitor or RET-inhibitor

    Participants' NSCLC must have classical EGFR mutations, i.e., ex19Del or L858R.

    EGFR exon 19 deletion / L858RALK fusionRET fusion or mutationNon-Small Cell Lung Cancer