Ovarian Cancer Clinical Trial
A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors.
This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks).
This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks) and will continue until either unacceptable toxicity or disease progression. Subjects may continue to receive treatment beyond documented RECIST 1.1 or disease progression. Subjects who are both CPI (checkpoint inhibitor) naÃ¯ve as well as subjects who have received or progressed following a CPI will be eligible and include the following tumor types: head and neck squamous cell carcinoma (HNSCC), cervical carcinoma, gastric or gastroesophageal carcinoma, endometrial carcinoma, tumor mutation burden high (TMB-H), select rare tumors and ovarian carcinoma.
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
Pre-specified wash-out of prior anti-PD1/PDL-1 therapy
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
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There are 14 Locations for this study
Phoenix Arizona, 85054, United States
Greenbrae California, 94904, United States
Los Angeles California, 90025, United States
Jacksonville Florida, 32224, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Oklahoma City Oklahoma, 73104, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
West Valley City Utah, 84119, United States
Fairfax Virginia, 22031, United States
London , , United Kingdom
London , , United Kingdom
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