Michael J Birrer, PhD, MD

Research Program: Cancer Biology Faculty Rank: Vice Chancellor and Director, WPR Cancer Institute Campus: University of Arkansas for Medical Sciences College: College of Medicine Department: Internal Medicine

Cancer Research Interest

• Research Focus Area: Prevention, Treatment, Informatics, Detection, Carcinogenesis, Diagnosis/ Prognosis
• Type of Research: Clinical, Population Sciences
• Research Interest Statement: My lab is dedicated to the elucidation of the genomic basis for ovarian cancer. The lab has systematically analyzed the global gene.

Contact Information

• Email Address: MJBIRRER@UAMS.EDU
• Profiles Research Networking Software: View Profile

Open Clinical Trials

• “A Randomized, Open Label, Two-Arm, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination with Pembrolizumab Versus Pembrolizumab Monotherapy in Patients with Recurrent or Metastatic Cervical Cancer” (NCT06157151)
• “A Phase II, Single-Arm Study of Giredestrant in Patients with Grade 1 Endometrial Cancer” (NCT05634499)
• “An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) in Adult Participants with Advanced Solid Tumors” (NCT04794699)
• “An Open-Label, Phase 1b Study of SL-172154 (SIRPa-Fc-CD40L) Administered with Either Pegylated Liposomal Doxorubicin or Mirvetuximab Soravtansine in Subjects with Platinum-Resistant Ovarian Cancers ” (NCT05483933)
• “A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients with Advanced Solid Tumors” (NCT05252416)
• “A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients with Advanced or Metastatic Solid Tumors” (NCT04657068)

Active Grants

• Health Resources & Services Administration – 1 CE1HS52094-01-00
  “Community Project Funding/Congressionally Directed Spending - Construction”
  Principal Investigator
  09/30/23 – 09/29/26
• Health Resources & Services Administration – 1 CE1HS52481-01-00
  “Cancer Care Mobile Van and Mammography Equipment”
  Principal Investigator
  09/30/23 – 09/29/26
• Health Resources & Services Administration – 1 CE1HS52245-01-00
  “Regional Cancer Care Facilities and Equipment”
  Principal Investigator
  09/30/23 – 09/29/26
• Children's Tumor Foundation – CTF-2022-12-002
  “Adult NF Clinic Program Building Pilot Project”
  Co-Investigator
  07/01/22 – 06/30/24
• NIH/Nat. Cancer Institute – 3U10CA180868
  “NRG Oncology Network Group Operation Center”
  Principal Investigator
  03/01/21 – 02/28/25

Publications

• Ledermann JA, Shapira-Frommer R, Santin AD, [et al., including Birrer M]. Molecular determinants of clinical outcomes of pembrolizumab in recurrent ovarian cancer: Exploratory analysis of KEYNOTE-100. Gynecologic oncology. 2023 178:119-129. PMID: 37862791.
• Chowdhury S, Kennedy JJ, Ivey RG, [et al., including Birrer MJ]. Proteogenomic analysis of chemo-refractory high-grade serous ovarian cancer. Cell. 2023 186(16):3476-3498.e35. PMID: 37541199. PMCID: PMC10414761.
• Arend R, Dholakia J, Castro C, [et al., including Birrer M]. DKK1 is a predictive biomarker for response to DKN-01: Results of a phase 2 basket study in women with recurrent endometrial carcinoma. Gynecologic oncology. 2023 172:82-91. PMID: 37001446.
• LaFargue CJ, Amero P, Noh K, [et al., including Birrer MJ]. Overcoming adaptive resistance to anti-VEGF therapy by targeting CD5L. Nature communications. 2023 14(1):2407. PMID: 37100807. PMCID: PMC10133315.
• Tewari KS, Sill MW, Birrer MJ, [et al.]. Final survival analysis of topotecan and paclitaxel for first-line treatment of advanced cervical cancer: An NRG oncology randomized study. Gynecologic oncology. 2023 171:141-150. PMID: 36898292. PMCID: PMC10286827.
• Osann K, Wenzel L, McKinney C, [et al., including Birrer M]. Fear of recurrence, emotional well-being and quality of life among long-term advanced ovarian cancer survivors. Gynecologic oncology. 2023 171:151-158. PMID: 36905875. PMCID: PMC10681156.
• Penson RT, Ambrosio AJ, Whalen CA, [et al., including Birrer MJ]. Phase II Trials of Iniparib (BSI-201) in Combination with Gemcitabine and Carboplatin in Patients with Recurrent Ovarian Cancer. The oncologist. 2023. PMID: 36718018. PMCID: PMC10020803.
• Sato S, Gillette M, de Santiago PR, [et al., including Birrer MJ]. LINE-1 ORF1p as a candidate biomarker in high grade serous ovarian carcinoma. Scientific reports. 2023 13(1):1537. PMID: 36707610. PMCID: PMC9883229.
• Banerjee S, Drapkin R, Richardson DL, Birrer M. Targeting NaPi2b in ovarian cancer. Cancer treatment reviews. 2023 112:102489. PMID: 36446254.
• Farley JH, Brady WE, O'Malley D, [et al., including Birrer MJ]. A phase II evaluation of temsirolimus with carboplatin and paclitaxel followed by temsirolimus consolidation in clear cell ovarian cancer: An NRG oncology trial. Gynecologic oncology. 2022 167(3):423-428. PMID: 36244829. PMCID: PMC9789681.
• Campos S, Matulonis U, Berlin S, [et al., including Birrer MJ]. A randomized phase II trial of bevacizumab vs. bevacizumab and erlotinib as first-line consolidation after carboplatin, paclitaxel, and bevacizumab in newly diagnosed patients with mullerian tumors. International journal of clinical oncology. 2022 27(12):1881-1890. PMID: 36344654.
• Casablanca Y, Wang G, Lankes HA, [et al., including Birrer MJ]. Improving Risk Assessment for Metastatic Disease in Endometrioid Endometrial Cancer Patients Using Molecular and Clinical Features: An NRG Oncology/Gynecologic Oncology Group Study. Cancers. 2022 14(17). PMID: 36077609. PMCID: PMC9454742.
• Chowdhury S, Wang R, Yu Q, [et al., including Birrer MJ]. DAGBagM: learning directed acyclic graphs of mixed variables with an application to identify protein biomarkers for treatment response in ovarian cancer. BMC bioinformatics. 2022 23(1):321. PMID: 35931981. PMCID: PMC9354326.
• Birrer MJ, Fujiwara K, Oaknin A, [et al.]. The Changing Landscape of Systemic Treatment for Cervical Cancer: Rationale for Inhibition of the TGF-β and PD-L1 Pathways. Frontiers in oncology. 2022 12:814169. PMID: 35280818. PMCID: PMC8905681.
• Huang D, Chowdhury S, Wang H, [et al., including Birrer MJ]. Multiomic analysis identifies CPT1A as a potential therapeutic target in platinum-refractory, high-grade serous ovarian cancer. Cell reports. Medicine. 2021 2(12):100471. PMID: 35028612. PMCID: PMC8714940.
• Swisher EM, Aghajanian C, O'Malley DM, [et al., including Birrer MJ]. Impact of homologous recombination status and responses with veliparib combined with first-line chemotherapy in ovarian cancer in the Phase 3 VELIA/GOG-3005 study. Gynecologic oncology. 2021. PMID: 34906376.
• Bigelow EO, Harris J, Fakhry C, [et al., including Birrer MJ]. Risk stratification after recurrence of human papillomavirus (HPV)-related and non-HPV-related oropharyngeal cancer: Secondary analysis of NRG Oncology RTOG 0129 and 0522. Head & neck. 2021. PMID: 34729846. PMCID: PMC8783635.
• Huang D, Savage SR, Calinawan AP, [et al., including Birrer MJ]. A highly annotated database of genes associated with platinum resistance in cancer. Oncogene. 2021 40(46):6395-6405. PMID: 34645978. PMCID: PMC8602037.
• Monk BJ, Colombo N, Oza AM, [et al., including Birrer MJ]. Chemotherapy with or without avelumab followed by avelumab maintenance versus chemotherapy alone in patients with previously untreated epithelial ovarian cancer (JAVELIN Ovarian 100): an open-label, randomised, phase 3 trial. The Lancet. Oncology. 2021. PMID: 34363762.
• Krasner CN, Campos SM, Young CL, [et al., including Birrer MJ]. Sequential Phase II clinical trials evaluating CRLX101 as monotherapy and in combination with bevacizumab in recurrent ovarian cancer. Gynecologic oncology. 2021. PMID: 34243976.
• Grushko TA, Filiaci VL, Montag AG, [et al., including Birrer MJ]. Effects of Slide Storage on Detection of Molecular Markers by IHC and FISH in Endometrial Cancer Tissues From a Clinical Trial: An NRG Oncology/GOG Pilot Study. Applied immunohistochemistry & molecular morphology : AIMM. 2021. PMID: 34224438. PMCID: PMC8664981.
• Martinez A, Buckley M, Scalise CB, [et al., including Birrer MJ]. Understanding the effect of mechanical forces on ovarian cancer progression. Gynecologic oncology. 2021. PMID: 33888338. PMCID: PMC9115803.
• Zhu Y, Ferri-Borgogno S, Sheng J, [et al., including Birrer MJ]. SIO: A Spatioimageomics Pipeline to Identify Prognostic Biomarkers Associated with the Ovarian Tumor Microenvironment. Cancers. 2021 13(8). PMID: 33917869. PMCID: PMC8068305.
• Wenzel L, Osann K, McKinney C, [et al., including Birrer M]. Quality of Life and Adverse Events: Prognostic Relationships in Long-Term Ovarian Cancer Survival. Journal of the National Cancer Institute. 2021. PMID: 33729494. PMCID: PMC8486331.
• Buechel ME, Enserro D, Burger RA, [et al., including Birrer MJ]. Correlation of imaging and plasma based biomarkers to predict response to bevacizumab in epithelial ovarian cancer (EOC). Gynecologic oncology. 2021. PMID: 33712274. PMCID: PMC8327185.
• Moore KN, Oza AM, Colombo N, [et al., including Birrer MJ]. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Annals of oncology : official journal of the European Society for Medical Oncology. 2021. PMID: 33667670.
• Merritt MA, Strickler HD, Hutson AD, [et al., including Birrer MJ]. Sex Hormones, Insulin, and Insulin-like Growth Factors in Recurrence of High-Stage Endometrial Cancer. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. 2021. PMID: 33622671. PMCID: PMC8026669.
• Chi RA, van der Watt P, Wei W, [et al., including Birrer MJ]. Inhibition of Kpnβ1 mediated nuclear import enhances cisplatin chemosensitivity in cervical cancer. BMC cancer. 2021 21(1):106. PMID: 33530952. PMCID: PMC7852134.
• Martinez A, Buckley MS, Scalise CB, [et al., including Birrer MJ]. Utilization of a 3-D tissue engineered model to investigate the effects of perfusion on gynecologic cancer biology. Journal of tissue engineering. 2021 12:20417314211055015. PMID: 34820113. PMCID: PMC8606733.
• Roane BM, Meza-Perez S, Katre AA, [et al., including Birrer MJ]. Neutralization of TGFβ Improves Tumor Immunity and Reduces Tumor Progression in Ovarian Carcinoma. Molecular cancer therapeutics. 2020. PMID: 33323456. PMCID: PMC7933076.
• Betella I, Turbitt WJ, Szul T, [et al., including Birrer MJ]. Corrigendum to 'Wnt signaling modulator DKK1 as an immunotherapeutic target in ovarian cancer' [Gynecologic Oncology 157 (2020) 765-774]. Gynecologic oncology. 2020 159(1):295. PMID: 32839025.
• Moore KN, Birrer MJ, Marsters J, [et al.]. Phase 1b study of anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) in patients with platinum-sensitive recurrent ovarian cancer. Gynecologic oncology. 2020 158(3):631-639. PMID: 32534811.
• Tewari KS, Sill MW, Monk BJ, [et al., including Birrer MJ]. Circulating Tumor Cells In Advanced Cervical Cancer: NRG Oncology-Gynecologic Oncology Group Study 240 (NCT 00803062). Molecular cancer therapeutics. 2020. PMID: 32847980. PMCID: PMC7907274.
• Da Silva DM, Enserro DM, Mayadev JS, [et al., including Birrer MJ]. Immune Activation in Patients with Locally Advanced Cervical Cancer Treated with Ipilimumab Following Definitive Chemoradiation (GOG-9929). Clinical cancer research : an official journal of the American Association for Cancer Research. 2020. PMID: 32816895. PMCID: PMC7642021.
• Geistlinger L, Oh S, Ramos M, [et al., including Birrer MJ]. Multiomic Analysis of Subtype Evolution and Heterogeneity in High-Grade Serous Ovarian Carcinoma. Cancer research. 2020. PMID: 32747365. PMCID: PMC7572645.
• Santin AD, Filiaci V, Bellone S, [et al., including Birrer MJ]. Corrigendum to "Phase II evaluation of copanlisib, a selective inhibitor of Pi3kca, in patients with persistent or recurrent endometrial carcinoma harboring PIK3CA hotspot mutations: An NRG oncology study (NRG-GY008)" [Gynecol. Oncol. Rep. 31 (2020) 100532]. Gynecologic oncology reports. 2020 33:100590. PMID: 32885014. PMCID: PMC7452617.
• Myers AP, Konstantinopoulos PA, Barry WT, [et al., including Birrer M]. Phase II, 2-stage, 2-arm, PIK3CA mutation stratified trial of MK-2206 in recurrent endometrial cancer. International journal of cancer. 2020 147(2):413-422. PMID: 31714586. PMCID: PMC7214201.
• Betella I, Turbitt WJ, Szul T, [et al., including Birrer MJ]. Wnt signaling modulator DKK1 as an immunotherapeutic target in ovarian cancer. Gynecologic oncology. 2020 157(3):765-774. PMID: 32192732.
• Arend RC, Beer HM, Cohen YC, [et al., including Birrer MJ]. Ofranergene obadenovec (VB-111) in platinum-resistant ovarian cancer; favorable response rates in a phase I/II study are associated with an immunotherapeutic effect. Gynecologic oncology. 2020 157(3):578-584. PMID: 32265057.
• O'Malley DM, Matulonis UA, Birrer MJ, [et al.]. Phase Ib study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. Gynecologic oncology. 2020 157(2):379-385. PMID: 32081463.
• Qi R, Wang Y, Bruno PM, [et al., including Birrer MJ]. Author Correction: Nanoparticle conjugates of a highly potent toxin enhance safety and circumvent platinum resistance in ovarian cancer. Nature communications. 2020 11(1):1940. PMID: 32303677. PMCID: PMC7165165.
• Santin AD, Deng W, Frumovitz M, [et al., including Birrer M]. Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002). Gynecologic oncology. 2020 157(1):161-166. PMID: 31924334. PMCID: PMC7127981.
• Goldsberry WN, Meza-Perez S, Londoño AI, [et al., including Birrer MJ]. Inhibiting WNT Ligand Production for Improved Immune Recognition in the Ovarian Tumor Microenvironment. Cancers. 2020 12(3). PMID: 32213921. PMCID: PMC7140065.
• Alvarez Secord A, Bell Burdett K, Owzar K, [et al., including Birrer MJ]. Predictive Blood-Based Biomarkers in Patients with Epithelial Ovarian Cancer Treated with Carboplatin and Paclitaxel with or without Bevacizumab: Results from GOG-0218. Clinical cancer research : an official journal of the American Association for Cancer Research. 2020 26(6):1288-1296. PMID: 31919136. PMCID: PMC7073274.
• Oza AM, Matulonis UA, Alvarez Secord A, [et al., including Birrer MJ]. A Randomized Phase II Trial of Epigenetic Priming with Guadecitabine and Carboplatin in Platinum-resistant, Recurrent Ovarian Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research. 2020 26(5):1009-1016. PMID: 31831561. PMCID: PMC7056559.
• Santin AD, Filiaci V, Bellone S, [et al., including Birrer MJ]. Phase II evaluation of copanlisib, a selective inhibitor of Pi3kca, in patients with persistent or recurrent endometrial carcinoma harboring PIK3CA hotspot mutations: An NRG Oncology study (NRG-GY008). Gynecologic oncology reports. 2020 31:100532. PMID: 31934607. PMCID: PMC6951478.
• Arend RC, Davis AM, Chimiczewski P, [et al., including Birrer MJ]. EMR 20006-012: A phase II randomized double-blind placebo controlled trial comparing the combination of pimasertib (MEK inhibitor) with SAR245409 (PI3K inhibitor) to pimasertib alone in patients with previously treated unresectable borderline or low grade ovarian cancer. Gynecologic oncology. 2020 156(2):301-307. PMID: 31870556.
• Schwede M, Waldron L, Mok SC, [et al., including Birrer MJ]. The Impact of Stroma Admixture on Molecular Subtypes and Prognostic Gene Signatures in Serous Ovarian Cancer. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. 2020 29(2):509-519. PMID: 31871106. PMCID: PMC7448721.
• Krill L, Deng W, Eskander R, [et al., including Birrer M]. Overexpression of enhance of Zeste homolog 2 (EZH2) in endometrial carcinoma: An NRG Oncology/Gynecologic Oncology Group Study. Gynecologic oncology. 2020 156(2):423-429. PMID: 31843273. PMCID: PMC7103063.
• Makhlouf H, Watson MA, Lankes HA, [et al., including Birrer M]. Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials. American journal of clinical pathology. 2020 153(2):149-155. PMID: 31613330. PMCID: PMC7169836.
• Doo DW, Meza-Perez S, Londoño AI, [et al., including Birrer MJ]. Inhibition of the Wnt/β-catenin pathway enhances antitumor immunity in ovarian cancer. Therapeutic advances in medical oncology. 2020 12:1758835920913798. PMID: 32313567. PMCID: PMC7158255.
• Arend R, Martinez A, Szul T, Birrer MJ. Biomarkers in ovarian cancer: To be or not to be. Cancer. 2019 125 Suppl 24:4563-4572. PMID: 31967683.
• Westin SN, Sill MW, Coleman RL, [et al., including Birrer MJ]. Safety lead-in of the MEK inhibitor trametinib in combination with GSK2141795, an AKT inhibitor, in patients with recurrent endometrial cancer: An NRG Oncology/GOG study. Gynecologic oncology. 2019 155(3):420-428. PMID: 31623857. PMCID: PMC6922584.
• Yeung TL, Leung CS, Yip KP, [et al., including Birrer MJ]. Anticancer Immunotherapy by MFAP5 Blockade Inhibits Fibrosis and Enhances Chemosensitivity in Ovarian and Pancreatic Cancer. Clinical cancer research : an official journal of the American Association for Cancer Research. 2019 25(21):6417-6428. PMID: 31332047. PMCID: PMC6825539.
• Mirza MR, Bergmann TK, Mau-Sørensen M, [et al., including Birrer MJ]. A phase I study of the PARP inhibitor niraparib in combination with bevacizumab in platinum-sensitive epithelial ovarian cancer: NSGO AVANOVA1/ENGOT-OV24. Cancer chemotherapy and pharmacology. 2019 84(4):791-798. PMID: 31375879.
• Mirza MR, Åvall Lundqvist E, Birrer MJ, [et al.]. Niraparib plus bevacizumab versus niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial. The Lancet. Oncology. 2019 20(10):1409-1419. PMID: 31474354.
• Tewari KS, Burger RA, Enserro D, [et al., including Birrer MJ]. Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2019 37(26):2317-2328. PMID: 31216226. PMCID: PMC6879307.
• Thorsson V, Gibbs DL, Brown SD, [et al., including Birrer M J in Cancer Genome Atlas Research Network]. The Immune Landscape of Cancer. Immunity. 2019 51(2):411-412. PMID: 31433971.
• Lee EK, Tan-Wasielewski Z, Matulonis UA, [et al., including Birrer MJ]. Results of an abbreviated Phase Ib study of the HDAC6 inhibitor ricolinostat and paclitaxel in recurrent ovarian, fallopian tube, or primary peritoneal cancer. Gynecologic oncology reports. 2019 29:118-122. PMID: 31467965. PMCID: PMC6712364.
• Matulonis UA, Shapira-Frommer R, Santin AD, [et al., including Birrer M]. Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: results from the phase II KEYNOTE-100 study. Annals of oncology : official journal of the European Society for Medical Oncology. 2019 30(7):1080-1087. PMID: 31046082.
• Birrer MJ, Moore KN, Betella I, Bates RC. Antibody-Drug Conjugate-Based Therapeutics: State of the Science. Journal of the National Cancer Institute. 2019 111(6):538-549. PMID: 30859213.
• Ceppi L, Bardhan NM, Na Y, [et al., including Birrer MJ]. Real-Time Single-Walled Carbon Nanotube-Based Fluorescence Imaging Improves Survival after Debulking Surgery in an Ovarian Cancer Model. ACS nano. 2019 13(5):5356-5365. PMID: 31009198.
• Roane BM, Arend RC, Birrer MJ. Review: Targeting the Transforming Growth Factor-Beta Pathway in Ovarian Cancer. Cancers. 2019 11(5). PMID: 31091744. PMCID: PMC6562901.
• Randall LM, Birrer MJ, Herzog TJ. Ovarian Cancer Maintenance: Practice-Changing Data Calls for Changing Practice. The oncologist. 2019 24(5):576-579. PMID: 30894410. PMCID: PMC6516122.
• Brooks RA, Tritchler DS, Darcy KM, [et al., including Birrer MJ]. GOG 8020/210: Risk stratification of lymph node metastasis, disease progression and survival using single nucleotide polymorphisms in endometrial cancer: An NRG oncology/gynecologic oncology group study. Gynecologic oncology. 2019 153(2):335-342. PMID: 30827726. PMCID: PMC6486855.
• Krasner CN, Castro C, Penson RT, [et al., including Birrer MJ]. Final report on serial phase II trials of all-intraperitoneal chemotherapy with or without bevacizumab for women with newly diagnosed, optimally cytoreduced carcinoma of Müllerian origin. Gynecologic oncology. 2019 153(2):223-229. PMID: 30765148.