Ovarian Cancer Clinical Trial

A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors.

Summary

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).

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Full Description

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) naïve 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.

View Eligibility Criteria

Eligibility Criteria

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
Pre-specified 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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

125

Study ID:

NCT04761198

Recruitment Status:

Active, not recruiting

Sponsor:

Mereo BioPharma

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There are 14 Locations for this study

See Locations Near You

Mereo Investigator Site
Phoenix Arizona, 85054, United States
Mereo Investigator Site
Greenbrae California, 94904, United States
Mereo Investigator Site
Los Angeles California, 90025, United States
Mereo Investigator Site
Jacksonville Florida, 32224, United States
Mereo Investigator Site
Boston Massachusetts, 02215, United States
Mereo Investigator Site
Ann Arbor Michigan, 48109, United States
Mereo Investigator Site
Rochester Minnesota, 55905, United States
Mereo Investigator Site
New York New York, 10065, United States
Mereo Investigator Site
Durham North Carolina, 27710, United States
Mereo Investigator Site
Oklahoma City Oklahoma, 73104, United States
Mereo Investigator Site
Nashville Tennessee, 37203, United States
Mereo Investigator Site
Houston Texas, 77030, United States
Mereo Investigator Site
West Valley City Utah, 84119, United States
Mereo Investigator Site
Fairfax Virginia, 22031, United States
Royal Marsden
London , , United Kingdom
Sarah Cannon UK
London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

125

Study ID:

NCT04761198

Recruitment Status:

Active, not recruiting

Sponsor:


Mereo BioPharma

How clear is this clinincal trial information?

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