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Phase 2 N=14 Treatment

Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer

Malignant Ovarian Clear Cell Tumor · Recurrent Ovarian Carcinoma

Enrolled (actual)
14
Serious AEs
50.0%
Results posted
Dec 2022
Primary outcome: Primary: Complete or Partial Objective Tumor Response — 3 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Epacadostat (Drug); Pembrolizumab (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
National Cancer Institute (NCI)
Primary completion
Feb 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Complete or Partial Objective Tumor Response
3
SECONDARY
Number of Participants With Adverse Events of Grade 3 or Higher
9
SECONDARY
Progression-free Survival (PFS)
14
SECONDARY
Overall Survival (OS)
9

Summary

This phase II trial studies how well pembrolizumab and epacadostat work in treating patients with ovarian clear cell carcinoma that has come back (recurrent), remains despite treatment (persistent), or is growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and epacadostat may work better compared to usual treatment (surgery, radiation, or cytotoxic chemotherapy) in treating patients with ovarian clear cell carcinoma.

Eligibility Criteria

Inclusion Criteria

  • Primary tumors must be at least 50% clear cell histomorphology in order to be eligible or have a histologically documented recurrence with at least 50% clear cell histomorphology. Recurrence should be biopsy proven as per standard of care unless the tumor is located in an area deemed unsafe to biopsy. Histologic confirmation of the original primary tumor is required via the pathology report. The percentage of clear cell histomorphology must be documented in the pathology report or in an addendum to the original report. If slides of the primary tumor are not available for review due to disposal of slides by the histology laboratory (typically 10 years after diagnosis), a biopsy of the recurrent or persistent tumor is required to confirm at least 50% clear cell histomorphology, as long as tumor is located in an area deemed safe to biopsy. The percentage of clear cell involvement must be documented in the pathology report or in an addendum to the original report
  • All patents must have measurable disease, and at least one "target lesion" to be used to assess response as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray. Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Appropriate stage for study entry based on the following diagnostic workup:
  • History/physical examination within 28 days prior to registration
  • Imaging of target lesions within 28 days prior to registration
  • Further protocol-specific assessments
  • Recovery from adverse effects of recent surgery, radiotherapy or chemotherapy (residual grade 1 toxicity is considered recovered)
  • Any other prior therapy directed at the malignant tumor including chemotherapy, and biologic/targeted agents must be discontinued at least 4 weeks prior to registration. Any hormonal therapy directed at the malignant tumor must be discontinued at least 2 weeks prior to registration
  • Any prior radiation therapy must be completed at least 4 weeks prior to registration, and progression must be outside the radiation field
  • At least 4 weeks must have elapsed since any major surgery prior to registration
  • The trial is open only to women with recurrent or progressive clear cell carcinoma of the ovary
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 28 days prior to registration
  • Patients must have had one prior platinum-based chemotherapy for management of primary disease. Patients are allowed to receive, but are not required to receive, up to two additional cytotoxic regimens for management of recurrent or persistent disease
  • Absolute neutrophil count (ANC) >= 1, 500/ul (within 14 days prior to registration)
  • Platelets >= 100, 000/ul (within 14 days prior to registration)
  • Hemoglobin (Hgb) >= 8.0 g/dL within 14 days prior to registration (Note: the use of transfusion of other intervention to achieve a Hgb >= 8.0 g/dL is acceptable)
  • Creatinine = = 60 mL/min using Cockcroft-Gault formula (within 14 days prior to registration)
  • Bilirubin = 350, with no detectable viral load on quantitative polymerase chain reaction (PCR), and no opportunistic infection
  • Patients with treated hepatitis viral infections (hepatitis B and C) are eligible if they have completed definitive treatment at least 6 months prior, have no detectable viral load on quantitative PCR, and liver function tests (LFTs) meet eligibility requirements
  • Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
  • Therapy with monoamine oxidase inhibitors (MAOIs) and selective serotonin r
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03602586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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