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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
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)
Creatinine clearance (CrCl) >= 60 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
Must not have
Bowel obstruction or any condition precluding oral intake
Prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post-treatment
Awards & highlights

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot eat or drink due to a blockage or condition.
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I have previously received treatments targeting the immune system.
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I am not taking any drugs that affect CYP3A4 or taking fluoxetine.
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I have an active heart condition.
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I do not have any unmanaged ongoing illnesses.
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I do not have active hepatitis or infections needing IV antibiotics.
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My cancer is a type of sarcoma or non-epithelial.
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I am allergic to certain medications similar to nivolumab, ipilimumab, or ZEN003694.
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I haven't taken high doses of steroids or immunosuppressants in the last 14 days.
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I have had issues like severe gut infections, blockages, or cancer spread in my abdomen.
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I have active brain metastases or cancer in the lining of my brain.

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
~1160
Nivolumab
2014
Completed Phase 3
~4740
Positron Emission Tomography
2008
Completed Phase 2
~2210
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Ipilimumab
2014
Completed Phase 3
~2610

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
BET bromodomain inhibitors like ZEN-3694 block proteins necessary for gene transcription involved in cell growth, thereby inhibiting tumor growth. Nivolumab and ipilimumab are monoclonal antibodies that enhance the immune system's ability to attack cancer cells by targeting and blocking the PD-1 and CTLA-4 receptors, respectively. These treatments are significant for cancer patients as they offer targeted and potentially more effective therapeutic options, leading to improved outcomes and personalized treatment plans.
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Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,335 Total Patients Enrolled
Haider S MahdiPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO
3 Previous Clinical Trials
160 Total Patients Enrolled

Media Library

Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04840589 — Phase 1
~24 spots leftby Jan 2026