Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors

ClinicalTrials.gov ID: NCT04840589

Public ClinicalTrials.gov record NCT04840589. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Phase I/Ib Trial Evaluating the Safety and Efficacy of BET Inhibitor, ZEN003694 With PD-1 Inhibitor, Nivolumab With or Without CTLA-4 Inhibitor, Ipilimumab in Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase I/Ib trial is to find out the best dose, possible benefits and/or side effects of BET bromodomain inhibitor ZEN-3694 (ZEN003694) when given in combination with nivolumab with or without ipilimumab in treating patients with solid tumors. ZEN003694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ZEN003694 in combination with nivolumab with or without ipilimumab may shrink or stabilize solid tumors.

Study identification

NCT ID: NCT04840589
Recruitment status: Suspended
Study type: Interventional
Phase: Phase 1
Lead sponsor: National Cancer Institute (NCI); NIH
Enrollment: 66 participants

Conditions and interventions

Conditions

Interventions

Drug · Procedure · Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 1, 2022
Primary completion: Aug 31, 2028
Completion: Aug 31, 2028
Last update posted: Aug 16, 2026

2022 – 2028

United States locations

U.S. sites: 9
U.S. states: 5
U.S. cities: 6

Facility	City	State	ZIP	Site status
National Cancer Institute Developmental Therapeutics Clinic	Bethesda	Maryland	20892	—
National Institutes of Health Clinical Center	Bethesda	Maryland	20892	—
Mount Sinai Hospital	New York	New York	10029	—
Montefiore Medical Center-Einstein Campus	The Bronx	New York	10461	—
Montefiore Medical Center-Weiler Hospital	The Bronx	New York	10461	—
Montefiore Medical Center - Moses Campus	The Bronx	New York	10467	—
Case Western Reserve University	Cleveland	Ohio	44106	—
Oregon Health and Science University	Portland	Oregon	97239	—
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04840589, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 16, 2026 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04840589 live on ClinicalTrials.gov.

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