Your session is about to expire
← Back to Search
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)
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 belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My kidneys work well, with a creatinine clearance rate of 60 mL/min or higher.
Select...
My cancer has spread, and standard treatments are not working or available.
Select...
I am 18 years old or older.
Select...
I have had 5 or fewer previous treatments for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post-treatment
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 moreTrial 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
~4750
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.
Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.
Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,719 Previous Clinical Trials
40,963,467 Total Patients Enrolled
Haider S MahdiPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO
3 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Share this study with friends
Copy Link
Messenger