A Phase II Study of Anti-PD-1 (Pembrolizumab) in Combination With Carboplatin to Prevent Progression After Serologic Detection of Recurrent Ovarian Cancer
Overview
- Phase
- Phase 2
- Intervention
- Carboplatin
- Conditions
- Recurrent Fallopian Tube Carcinoma
- Sponsor
- University of Washington
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Rate of radiographic recurrence
- Status
- Active, Not Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
This phase II trial investigates how well pembrolizumab and carboplatin work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). 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. Chemotherapy drugs, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together with carboplatin may work better in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Detailed Description
OUTLINE: Patients receive carboplatin intravenously (IV) over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial. Patients also undergo blood sample collection on the trial. After the completion of study treatment, patients are followed up at 30 days, then every 3 months for year 1, and every 6 months for year 2.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy
- •Have a cancer antigen (CA)-125 that normalized after first-line therapy
- •CA-125 increased to more than twice the upper limit of normal or two times the nadir value after most recent second or later line of treatment
- •Have no measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- •Ascites and pleural effusions are not measurable disease, if asymptomatic
- •All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of the study
- •Have estimated life expectancy of at least 3 months
- •Be willing and able to provide written informed consent/assent for the trial
- •Be \>= 18 years of age on day of signing informed consent
- •Have a performance status of 0 or 1 on the on the Eastern Cooperative Oncology Group (ECOG) performance scale
Exclusion Criteria
- •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (if dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- •Short-term administration of systemic steroids (i.e., for allergic reactions or the management of immune-related adverse events \[irAEs\]) is allowed
- •Has symptomatic ascites or pleural effusions
- •History of borderline or low malignant potential ovarian cancer
- •Hypersensitivity to pembrolizumab or any of its excipients
- •Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
- •Has had prior chemotherapy, biologic therapy, targeted small molecule therapy, hormonal therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent
- •Note: Patients with =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study
- •Note: If a patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
Arms & Interventions
Treatment (carboplatin, pembrolizumab)
Patients receive carboplatin IV over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial. Patients also undergo blood sample collection on the trial.
Intervention: Carboplatin
Treatment (carboplatin, pembrolizumab)
Patients receive carboplatin IV over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial. Patients also undergo blood sample collection on the trial.
Intervention: Pembrolizumab
Treatment (carboplatin, pembrolizumab)
Patients receive carboplatin IV over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial. Patients also undergo blood sample collection on the trial.
Intervention: Computed Tomography
Treatment (carboplatin, pembrolizumab)
Patients receive carboplatin IV over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial. Patients also undergo blood sample collection on the trial.
Intervention: Magnetic Resonance Imaging
Treatment (carboplatin, pembrolizumab)
Patients receive carboplatin IV over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial. Patients also undergo blood sample collection on the trial.
Intervention: Biospecimen Collection
Outcomes
Primary Outcomes
Rate of radiographic recurrence
Time Frame: At 6 months
Progression-free survival
Time Frame: At 6 months
Secondary Outcomes
- Programmed cell death ligand 1 (PD-L1) expression(Up to 2 years)
- Changes in T cell activation(Baseline and 2 years)
- Overall survival(Up to 2 years)