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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04840589
Phase
PHASE1
Status
Suspended

Conditions

  • Metastatic Malignant Solid Neoplasm
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Platinum-Resistant Ovarian Carcinoma
  • Refractory Ovarian Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BET Bromodomain Inhibitor ZEN-3694 — DRUG
    Given PO
  • Biopsy Procedure — PROCEDURE
    Undergo a biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo a CT scan
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nivolumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo a PET scan
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray

Study Details

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.

Key Dates

Start date
Feb 2, 2022
Status verified
Feb 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Doublet treatment (ZEN003694, nivolumab)
    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.
  • Experimental: Triplet treatment (nivolumab, ZEN003694, ipilimumab)
    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 or 1-28 of each cycle. Cycles repeat 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 1-21 or 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.

Primary Outcome Measure

Safety and tolerability [ Time Frame: Up to 1 cycle of treatment for doublet group (4 weeks) and up to 2 cycles for triplet group (6 weeks) ]

Locations (9)

FacilityCityStateZIPSite coordinators
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Mount Sinai HospitalNew YorkNew York10029-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-
Montefiore Medical Center-Weiler HospitalThe BronxNew York10461-
Case Western Reserve UniversityClevelandOhio44106-
Oregon Health and Science UniversityPortlandOregon97239-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Bethesda, MD

By research site
National Cancer Institute Developmental Therapeutics Clinic· Bethesda, MDNational Institutes of Health Clinical Center· Bethesda, MDMount Sinai Hospital· New York, NYMontefiore Medical Center - Moses Campus· The Bronx, NYMontefiore Medical Center-Einstein Campus· The Bronx, NYMontefiore Medical Center-Weiler Hospital· The Bronx, NY

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