Skip to content
Bending the Curve Trial by Trial
?

KEYNOTE-028

Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal

Phase 1N = 25NCT02054806

Population
Patients with PD-L1-positive (1% or more) advanced anal carcinoma; of 43 evaluable for PD-L1, 32 (74%) were positive and 25 were enrolled between April and September 2014.
Design
Anal carcinoma cohort of the multicohort phase Ib KEYNOTE-028 trial in PD-L1-positive advanced solid tumours. Pembrolizumab 10 mg/kg intravenously every 2 weeks for up to 2 years or until confirmed progression or unacceptable toxicity. Primary endpoints: safety and overall response rate per investigator review (RECIST 1.1). Data cutoff 1 July 2015.
Primary endpoint
ORR
Arms
  • Pembrolizumab (experimental, n = 25): Pembrolizumab 10 mg/kg intravenously every 2 weeks for up to 2 years
People
Ott PA, senior author Bennouna J
Show the numbers
Results reported for KEYNOTE-028
EndpointAnalysisPembrolizumabControlEffect
ORRPatients with squamous cell carcinoma histology (n = 24)primaryOtt 201717% (5–37%)—Four confirmed partial responses among 24 patients; 10 (42%) had confirmed stable disease, a disease control rate of 58%. One further patient with non-squamous histology had confirmed stable disease.
Results reported for KEYNOTE-028
EndpointAnalysisPembrolizumabControlEffect
ORRPatients with squamous cell carcinoma histology (n = 24)primaryOtt 201717% (5–37%)—Four confirmed partial responses among 24 patients; 10 (42%) had confirmed stable disease, a disease control rate of 58%. One further patient with non-squamous histology had confirmed stable disease.
Primary publication: Ott PA, Piha-Paul SA, Munster P, Pishvaian MJ, van Brummelen EMJ, Cohen RB, et al. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017;28(5):1036-1041. PubMedDOI

Appears in

Sources

  1. Ott PA, Piha-Paul SA, Munster P, Pishvaian MJ, van Brummelen EMJ, Cohen RB, et al. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017;28(5):1036-1041.

    PubMedDOI