Article Text

Download PDFPDF

Phase II, randomized, open-label study of durvalumab (MEDI4736) or tremelimumab monotherapy, or durvalumab + tremelimumab, in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): CONDOR
  1. Jill Gilbert1,
  2. Christophe Le Tourneau2,
  3. Hisham Mehanna3,
  4. Jerome Fayette4,
  5. Trishna Goswami5,
  6. Ugochi Emeribe5,
  7. Anthony Jarkowski III5,
  8. Giovanni Melillo5 and
  9. Lilian L Siu6
  1. Aff1 grid.152326.10000000122647217Vanderbilt University Nashville TN USA
  2. Aff2 grid.418596.70000000406396384Department of Medical OncologyInstitut Curie, Paris & Saint-Cloud France
  3. Aff3 grid.6572.60000000419367486Institute of Head and Neck Studies and EducationUniversity of Birmingham Birmingham UK
  4. Aff4 grid.25697.3f0000000121724233Centre Léon BérardUniversity of Lyon Lyon France
  5. Aff5 grid.418152.bAstraZeneca Gaithersburg MD USA
  6. Aff6 grid.231844.80000000404740428Princess Margaret Cancer Centre Toronto ON Canada

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Meeting abstracts


First-line palliative treatment for patients with R/M SCCHN includes platinum-based chemotherapy. There are no standard second-line options upon relapse and median survival is limited. In SCCHN, tumors create a highly immunosuppressive environment and evade immune detection by exploiting inhibitory immune checkpoints such as the programmed cell death ligand-1 (PD-L1)/programmed cell death-1 (PD-1) axis, making immunotherapy an attractive option to study in this disease. Durvalumab (MEDI4736) is a selective, high affinity human IgG1 mAb that blocks PD-L1 binding to PD-1 (IC50 0.1 nM) and CD80 (IC50 0.04 nM) that has shown promising antitumor activity in the SCCHN cohort of a Phase I/II study (NCT01693562). Tremelimumab is a selective human IgG2 mAb inhibitor of cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) that has been combined with durvalumab in a Phase Ib study in patients with NSCLC (NCT02000947), with encouraging clinical activity and a manageable safety profile. While anti-PD-1/PD-L1 monotherapy may be associated with greater clinical benefit in patients with PD-L1+ tumors, combination therapy has clinical activity in both PD-L1+ and PD-L1 patients in several solid tumors, enhancing the antitumor activity of anti-PD-1/PD-L1 agents in patients with PD-L1 tumors. The PD-L1 and CTLA-4 pathways are non-redundant and preclinical data indicate targeting both may induce synergistic antitumor effects. Here we describe the CONDOR study (NCT02319044), a Phase II study to determine the efficacy and safety of durvalumab monotherapy, tremelimumab monotherapy, and their combination in PD-L1 R/M SCCHN patients who have failed prior platinumtherapy.


This is a randomized, open-label, multicenter, global, Phase II study in immunotherapy-naïve patients with PD-L1 R/M SCCHN who have progressed during or after treatment with a platinum-containing regimen for R/M disease. Patients with tumoral PD-L1 expression below a pre-specified cut-off level of < 25% tumor cells with membrane staining, as determined by an immunohistochemistry assay, are deemed PD-L1. Patients (N=240) will be randomized 1:1:2 to receive durvalumab (10 mg/kg IV) monotherapy; tremelimumab (10 mg/kg IV) monotherapy; or durvalumab (20 mg/kg IV) plus tremelimumab (1 mg/kg IV) combination therapy for up to 12 months (Figure 1). Stratification factors include human papillomavirus (HPV) and smoking history. The primary endpoint is objective response rate (ORR; RECIST v1.1), based on independent central review. Secondary endpoints will further assess disease control rate, duration of response, progression-free survival, and overall survival; safety (CTCAE v4.03) and tolerability; and health-related quality of life. Exploratory outcomes include pharmacokinetics, immunogenicity, and potential biomarkers of response to treatment. Recruitment is ongoing.


Trial registration identifier NCT02319044.