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Gene Symbol CDKN2A
Synonyms ARF | CAI2 | CDK4I | CDKN2 | CMM2 | INK4 | INK4A | MLM | MTS-1 | MTS1 | P14 | P14ARF | P16 | P16-INK4A | P16INK4 | P16INK4A | P19 | P19ARF | TP16
Gene Description CDKN2A, cyclin-dependent kinase inhibitor 2A, is a tumor suppressor (PMID: 30562755) that encodes p16 and p14ARF from alternate reading frames, which function to inhibit Cdk4 and Cdk6 and regulate Tp53 activity to promote cell-cycle arrest (PMID: 23875803, PMID: 17055429, PMID: 27428416). CDKN2A germline mutations are associated with familial atypical multiple mole melanoma and somatic mutations are highest in pancreatic (PMID: 32273725), HNSCC, NSCLC, and melanoma (PMID: 27283171), and deletion of CDKN2A may be prognostic in IDH-mutant glioma (PMID: 32385699).
NCBI Gene ID Chromosome Map Location Canonical Transcript Gene Role
1029 9 9p21.3 NM_000077 Tumor suppressor (PMID: 30606230)

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02546661 Phase I Danvatirsen + Durvalumab Durvalumab + Selumetinib AZD4547 Durvalumab + Olaparib Durvalumab AZD4547 + Durvalumab Durvalumab + Vistusertib Adavosertib + Durvalumab Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer (BISCAY) Active, not recruiting USA | GBR | FRA | ESP | CAN 0
NCT04966481 Phase III Cetuximab + Palbociclib Cetuximab Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor Recruiting USA 0
NCT04681469 Phase II Dostarlimab-gxly + Niraparib Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC (PRIME) Recruiting ITA 0
NCT04247282 Phase Ib/II Bintrafusp alfa Bintrafusp alfa + ETBX-011 + ETBX-051 + ETBX-061 ALT-803 + Bintrafusp alfa + ETBX-011 + ETBX-051 + ETBX-061 Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection Completed USA 0
NCT03389477 Phase II Cisplatin + Palbociclib Cetuximab + Palbociclib Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma Active, not recruiting USA 0
NCT04074785 Phase I Abemaciclib + Bevacizumab Abemaciclib w/Bevacizumab in Recurrent GBM Pts w/Loss of CDKN2A/B or Gain or Amplification of CDK4/6 Active, not recruiting USA 0
NCT04118036 Phase II Abemaciclib + Pembrolizumab Abemaciclib + Pembrolizumab In Glioblastoma Withdrawn USA 0
NCT03978689 Phase I CUE-101 + Pembrolizumab CUE-101 A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma Active, not recruiting USA 0
NCT05472220 Phase I Alpelisib + Carboplatin Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma Withdrawn 0
NCT01898494 Phase II Cisplatin Carboplatin Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer Active, not recruiting USA 0
NCT03811015 Phase II Cisplatin Nivolumab Cisplatin + Nivolumab Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer Recruiting USA 0
NCT05678348 Phase I Pyrimethamine Pyrimethamine as an Inhibitor of NRF2 in HPV-unrelated Locally Advanced Head and Neck Squamous Cell Carcinoma Recruiting USA 0
NCT03576417 Phase III Cisplatin Cisplatin + Nivolumab A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck (NIVOPOSTOP) Recruiting FRA 0
NCT02734537 Phase II Cisplatin Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery Recruiting USA 0
NCT03416153 Phase II Cetuximab Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer Active, not recruiting USA 0
NCT05053737 Phase Ib/II Atezolizumab Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV Unrelated HNSCC Recruiting USA 0
NCT04369937 Phase II Cisplatin + ISA101b + Pembrolizumab HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma Recruiting USA 0
NCT03601507 Phase II Alpelisib Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer Terminated USA 0
NCT05799144 Phase II pBI-11 vaccine + Pembrolizumab pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS>=1, hrHPV+ Oropharyngeal Cancer Recruiting USA 0
NCT03357757 Phase II Avelumab + Valproic acid Avelumab With Valproic Acid in Virus-associated Cancer (LATENT) Active, not recruiting CAN 0
NCT03088059 Phase II Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil Biomarker-based Study in R/M SCCHN (UPSTREAM) Active, not recruiting ITA | GBR | FRA | ESP | BEL 0
NCT05172245 Phase I Cisplatin + Ipatasertib Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer Recruiting USA | CAN 0
NCT03952585 Phase II Nivolumab Cisplatin De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer Suspended USA | CAN 0
NCT03715946 Phase II Nivolumab Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer Active, not recruiting USA 0
NCT05784012 Phase Ib/II Dostarlimab-gxly + Niraparib Cisplatin + Dostarlimab-gxly + Niraparib Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma (RADIAN) Recruiting ESP 0
NCT05845307 Phase I C188-9 Randomized Pre-surgical Window-of-Opportunity Trial of TTI-101 in Patients With Stage II-IV Resectable HPV-negative Squamous Cell Carcinoma of the Head and Neck Not yet recruiting USA 0
NCT03624231 Phase II Durvalumab Durvalumab + Tremelimumab Feasibility & Efficacy of Durvalumab+Tremelimumab+RT and Durvalumab+RT in Non-resect. Locally Advanced HPVnegativ HNSCC (DURTRE-RAD) Completed DEU 0
NCT04287868 Phase Ib/II Bintrafusp alfa + NHS-IL12 + PDS0101 Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies Active, not recruiting USA 0
NCT04643379 Phase II Carboplatin + Olaparib + Pembrolizumab Olaparib + Pembrolizumab Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma Active, not recruiting USA 0
NCT04708470 Phase Ib/II Bintrafusp alfa + Entinostat + NHS-IL12 Entinostat + NHS-IL12 A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Recruiting USA 0
NCT04459715 Phase III Cisplatin + Xevinapant Cisplatin A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 16
NCT04106362 Phase II Cisplatin Cetuximab + Cisplatin Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma Terminated USA 0
NCT04574583 Phase Ib/II Bintrafusp alfa + FPV-CV301 + MVA-BN-CV301 + SX-682 Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) Active, not recruiting USA 0
NCT04862650 Phase II Carboplatin + Cemiplimab + Paclitaxel Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Recruiting USA 0
NCT04852328 Phase II CUE-101 Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma Recruiting USA 0
NCT03618134 Phase Ib/II Durvalumab Durvalumab + Tremelimumab Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner Terminated USA 0
NCT03946358 Phase II Atezolizumab + UCPVax Combination of UCPVax Vaccine and Atezolizumab for the Treatment of Human Papillomavirus Positive Cancers (VolATIL) (VolATIL) Active, not recruiting FRA 0
NCT03242382 Phase II Palbociclib Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression. (PalboSarc) Recruiting ESP 0
NCT04555837 Phase Ib/II Alisertib + Pembrolizumab Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer Active, not recruiting USA 0
NCT04432597 Phase Ib/II PRGN-2009 Bintrafusp alfa + PRGN-2009 HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers Active, not recruiting USA 0
NCT04988074 Phase II Cemiplimab Carboplatin + Cemiplimab + Paclitaxel Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca (MINIMA) Recruiting USA 0
NCT03799445 Phase II Ipilimumab + Nivolumab Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma Recruiting USA 0
NCT03383094 Phase II Pembrolizumab Cisplatin + Radiotherapy Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer Recruiting USA 0
NCT03829722 Phase II Carboplatin + Nivolumab + Paclitaxel Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer Active, not recruiting USA 0
NCT03107182 Phase II Dexamethasone + Diphenhydramine + Famotidine + Fluorouracil + Hydroxyurea + Paclitaxel Carboplatin + Nab-paclitaxel + Nivolumab Cisplatin Carboplatin + Nivolumab + Paclitaxel Nivolumab Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer (OPTIMA-II) Active, not recruiting USA 0
NCT03838263 Phase II Nivolumab Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer (IMMUNEBOOST) Active, not recruiting FRA 0
NCT03834740 Phase I Everolimus + Ribociclib A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection Completed USA 0
NCT02540876 Phase I ABT-348 Ilorasertib in Treating Patients With CDKN2A-deficient Advanced or Metastatic Solid Cancers That Cannot Be Removed by Surgery Completed USA 0
NCT02693535 Phase II Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR) Recruiting USA 0
NCT02933736 Phase 0 Ribociclib Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients Active, not recruiting USA 0
NCT05094336 Phase Ib/II AMG193 AMG193 + Docetaxel AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (MTAP) Recruiting USA | GBR | FRA | DEU | CAN | BEL | AUT | AUS 5
NCT04391595 Phase I Abemaciclib + LY3214996 LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients Recruiting USA 0
NCT02334527 Phase II Palbociclib Phase II Trial of Palbociclib (PD-0332991) in Patients With Metastatic Urothelial Cancer (UC) After Failure of First-Line Chemotherapy Terminated USA 0
NCT04040205 Phase II Abemaciclib Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration Recruiting USA 0
NCT03435250 Phase I AG-270 + Docetaxel AG-270 + Gemcitabine + Nab-paclitaxel AG-270 Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss Terminated USA | FRA | ESP 0
NCT03110744 Phase II Palbociclib CDK4/6 Inhibition in Locally Advanced/Metastatic Chordoma (NCT-PMO-1601) Completed DEU 0
NCT01711658 Phase II Cisplatin + Lapatinib + Radiotherapy Cisplatin + Radiotherapy TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer. (TRYHARD) Completed USA | CAN 0
NCT02523014 Phase II Abemaciclib GSK2256098 Vismodegib Capivasertib Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas Recruiting USA 0
NCT02896335 Phase II Palbociclib Palbociclib In Progressive Brain Metastases Recruiting USA 0
NCT02478320 Phase II ABT-348 Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors Terminated USA 0
NCT02576444 Phase II Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib OLAParib COmbinations (OLAPCO) Terminated USA 0
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) Recruiting CAN 0
NCT02187783 Phase II Ribociclib LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) Completed USA 0
NCT01744652 Phase I Crizotinib + Dasatinib Dasatinib and Crizotinib in Advanced Cancer Completed USA 0
NCT03994796 Phase II Abemaciclib GDC-0084 Entrectinib Genetic Testing in Guiding Treatment for Patients With Brain Metastases Recruiting USA 0
NCT05861050 Phase Ib/II Glofitamab-gxbm + Lenalidomide + Obinutuzumab + Venetoclax Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma Recruiting USA 0
NCT04116541 Phase II Alectinib Cabozantinib Ribociclib + Siremadlin A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. (MegaMOST) Recruiting FRA 0
NCT02981940 Phase II Abemaciclib A Study of Abemaciclib in Recurrent Glioblastoma Active, not recruiting USA 0
NCT03356223 Phase II Abemaciclib Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6 (ABORL) Completed FRA 0
NCT05843253 Phase II Everolimus + Ribociclib Study of Ribociclib and Everolimus in HGG and DIPG Not yet recruiting USA | NLD | GBR | DEU | CAN | AUS 0
NCT05538572 Phase I PRT3645 A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors Active, not recruiting USA 1