Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors

Overview

About this study

The purpose of this study is to evaluate the effectiveness, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Histological or cytological diagnosis of a relevant tumor type as per the study protocol and not candidates for curative surgery or radiation therapy.
  • Available tumor tissue (archival or newly obtained core or excisional biopsy).
  • Adequate hematologic and end organ function as measured by laboratory screening panel in the 14 days prior to treatment.
  • Life expectancy greater than 12 weeks.
  • ECOG performance status of 0 to 1.
  • Adequate contraception for women of childbearing potential.
  • 6-month wash-out of prior anti-PD1/PDL-1 therapy.

Exclusion Criteria:

  • Concurrent active malignancy.
  • Major surgery within 4 weeks of treatment.
  • Subjects with active, known or suspected autoimmune diseases.
  • Prior treatment with CD137 agonists, anti-CTLA-4 and anti-TIGIT antibodies.
  • History of any Grade 3 or 4 immune-related AE toxicity from prior immunotherapy that resulted in treatment discontinuation.
  • History of immune-related adverse events that lead to discontinuation of anti-PD-1 or PDL-1 therapy.
  • Active infections of HIV, hepatitis B, hepatitis C.
  • Medical illness or abnormal laboratory finding that would, in the Study Investigator's judgement, increase the risk to the subject associated with participation in the study.
  • Pregnancy in female subjects.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Saravut Weroha, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Yujie Zhao, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
.
CLS-20512718

Mayo Clinic Footer