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Checkpoint Inhibitor

ZEN003694 + Nivolumab/Ipilimumab for Cancer

Phase 1
Recruiting
Led By Haider S Mahdi
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post-treatment
Awards & highlights

Study Summary

This trial is testing a new drug, ZEN003694, to see if it's effective and safe when given with nivolumab with or without ipilimumab to treat patients with solid tumors.

Who is the study for?
Adults with advanced solid tumors that have not responded to standard treatments may join this trial. They should have a good performance status, adequate organ function, and measurable disease that can be biopsied. Excluded are those with certain allergies, uncontrolled illnesses, severe heart conditions, active infections like HIV or hepatitis, recent immunosuppressive treatment, prior therapy targeting immune checkpoints or pregnant/breastfeeding women.Check my eligibility
What is being tested?
The trial is testing the combination of ZEN003694 (a drug blocking enzymes for cell growth) with Nivolumab and possibly Ipilimumab (both boost the immune system to fight cancer). It aims to determine the best dose and assess potential benefits or side effects in shrinking or stabilizing solid tumors.See study design
What are the potential side effects?
Possible side effects include allergic reactions similar to other monoclonal antibodies; issues related to immune system activation such as inflammation in organs; digestive problems; increased risk of infection due to immunotherapy drugs; and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have someone legally authorized to make decisions for me due to my impaired decision-making capacity.
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I am fully active and can carry on all pre-disease activities without restriction.
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My kidneys work well, with a creatinine clearance rate of 60 mL/min or higher.
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My cancer has spread, and standard treatments are not working or available.
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I am 18 years old or older.
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I have had 5 or fewer previous treatments for my condition.
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My cancer can be measured and biopsied according to specific criteria.
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I have another cancer type, but it won't affect this trial's treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2 recommended dose for the combined regimens
Safety and tolerability
Secondary outcome measures
Circulating tumor deoxyribonucleic acid
Clinical benefit
Incidence of adverse events
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Triplet treatment (nivolumab, ZEN003694, ipilimumab)Experimental Treatment9 Interventions
Patients receive nivolumab IV over 30 minutes on day 1, ipilimumab IV over 90 minutes on day 1, and ZEN003694 PO QD on days 1-21 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 5, patients are no longer treated with ipilimumab, but receive nivolumab IV over 30 minutes on day 1 and ZEN003694 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, a CT scan, a PET scan, and/or an x-ray as well as blood sample collection throughout the trial. Patients also undergo a biopsy during screening and on study.
Group II: Doublet treatment (ZEN003694, nivolumab)Experimental Treatment8 Interventions
Patients receive nivolumab IV over 30 minutes on day 1 and ZEN003694 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, a CT scan, a PET scan, and/or an x-ray as well as blood sample collection throughout the trial. Patients also undergo a biopsy during screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Positron Emission Tomography
2008
Completed Phase 2
~2260
Nivolumab
2014
Completed Phase 3
~4750
Biopsy
2014
Completed Phase 4
~840
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Ipilimumab
2014
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,281 Total Patients Enrolled
Haider S MahdiPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO
3 Previous Clinical Trials
193 Total Patients Enrolled

Media Library

Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04840589 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators currently accepting participants in this experiment?

"Affirmative. Clinicaltrials.gov's records show that this trial, posted on October 6th 2021, is still actively searching for participants. The study seeks to enrol 66 patients from 7 distinct medical sites."

Answered by AI

What maladies can be addressed through the utilization of BET Bromodomain Inhibitor ZEN-3694?

"ZEN-3694, a BET Bromodomain inhibitor, is an effective therapy for those previously treated with antiangiogenic agents and can be used to treat malignancies such as unresectable melanoma or squamous cell carcinoma."

Answered by AI

How many venues are responsible for overseeing the progress of this research project?

"As per the data on clinicaltrials.gov, this trial is recruiting patients at Montefiore Medical Center-Einstein Campus in Bronx, New york, National Cancer Institute Developmental Therapeutics Clinic in Bethesda, Maryland, and National Institutes of Health Clinical Center along with a further 7 sites."

Answered by AI

How many participants are engaging in this experiment?

"Affirmative. The details on clinicaltrials.gov verify that this experiment, which was initially published on October 6th 2021, is still enlisting volunteers. Approximately 66 patients are required from 7 distinct sites of study."

Answered by AI

Has the Food and Drug Administration given their seal of approval to BET Bromodomain Inhibitor ZEN-3694?

"The safety rating of BET Bromodomain Inhibitor ZEN-3694 was judged to be a 1 as this is early stage research, with sparse evidence regarding its efficacy and limited analysis on the drug's security."

Answered by AI

To what extent has ZEN-3694 been explored as a BET Bromodomain Inhibitor through prior clinical experiments?

"Currently, there are 764 studies related to the BET Bromodomain Inhibitor ZEN-3694 in progress. Of those active trials, 86 have moved into stage 3 of testing. The majority of these investigations are being conducted within Pittsburgh but they span 42751 locations around the world."

Answered by AI
~30 spots leftby Jan 2026