This study is currently recruiting participants.
Number
000783-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children;Pregnant Women
Keywords
Immunotherapy; Rational Drug Combination; Immune Checkpoint; Epigenetic Drug Approach
Recruitment Keyword(s)
None
Condition(s)
Advanced Ovarian Cancer; Metastatic Cancer
Investigational Drug(s)
ZEN003694
Investigational Device(s)
Intervention(s)
Biological/Vaccine: Nivolumab Biological/Vaccine: Ipilimumab Drug: ZEN003694
Supporting Site
National Cancer Institute
Tumors that come back after treatment or spread throughout the body have a high risk of death. Epithelial ovarian cancer, in particular, is highly lethal: 63% of the women diagnosed with this disease in 2018 died. More effective treatments are needed.
Objective:
To test a study drug (ZEN003694) combined with two other drugs (nivolumab and ipilimumab) in people with advanced solid tumors or ovarian cancer.
Eligibility:
People aged 18 years and older who have a solid tumor or ovarian cancer. The cancer must have spread to other parts of the body and/or not responded to previous treatment.
Design:
Participants will be screened. They will have blood and urine tests. They will have a test of their heart function. Imaging scans will be taken. They will have a biopsy of their tumor.
Participants will take study drugs in 28-day cycles. They will take ZEN003694 as a capsule by mouth every day in the morning.
On the first day of each cycle, participants will get nivolumab; this drug is administered through a needle in a vein in the arm over 30 minutes. Some participants will also receive a third drug, ipilimumab, through a needle in a vein in the arm over 90 minutes. They will receive ipilimumab a maximum of 4 times.
Participants may continue with study treatment as long as the drugs are helping them.
Blood tests will be repeated throughout the study. Imaging scans will be repeated every 8 weeks.
Participants will have follow-up visits for up to a year after their last study treatment.
--Back to Top--
ELIGIBILITY CRITERIA: -Patients must have histologically confirmed metastatic or recurrent solid tumor malignancy for which standard curative or palliative measures do not exist or are no longer effective --Dose escalation: Metastatic or recurrent solid tumors with measurable or evaluable disease --Dose expansion exploratory cohorts (nivolumab + ipilimumab + ZEN003694): Recurrent BRCAwt epithelial ovarian carcinoma patients who have progressed or recurred within <6 months from prior platinum-based therapy --Dose escalation and expansion exploratory cohorts: Patients must have measurable and biopsiable disease (at least two lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 -No more than 5 lines of prior therapy for the dose escalation and expansion phases -In the expansion cohorts, up to 2 prior lines in the platinum-resistant setting is allowed -Patients with primary refractory ovarian cancer (who progressed while on primary 1L platinum therapy) will be excluded in the dose expansion cohorts but allowed in the dose escalation cohort -Patients who have had chemotherapy or radiotherapy more than 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and who have recovered from adverse events due to agents administered more than 4 weeks earlier are eligible. -Age >=18 with ECOG <= 1 -Women of child-bearing potential
-Patients must have histologically confirmed metastatic or recurrent solid tumor malignancy for which standard curative or palliative measures do not exist or are no longer effective
--Dose escalation: Metastatic or recurrent solid tumors with measurable or evaluable disease
--Dose expansion exploratory cohorts (nivolumab + ipilimumab + ZEN003694): Recurrent BRCAwt epithelial ovarian carcinoma patients who have progressed or recurred within <6 months from prior platinum-based therapy
--Dose escalation and expansion exploratory cohorts: Patients must have measurable and biopsiable disease (at least two lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
-No more than 5 lines of prior therapy for the dose escalation and expansion phases
-In the expansion cohorts, up to 2 prior lines in the platinum-resistant setting is allowed
-Patients with primary refractory ovarian cancer (who progressed while on primary 1L platinum therapy) will be excluded in the dose expansion cohorts but allowed in the dose escalation cohort
-Patients who have had chemotherapy or radiotherapy more than 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and who have recovered from adverse events due to agents administered more than 4 weeks earlier are eligible.
-Age >=18 with ECOG <= 1
-Women of child-bearing potential
Principal Investigator
Referral Contact
For more information: